Digestive and Liver Disease
Volume 38, Issue 12 , Pages 867-878, December 2006

Capsule endoscopy: Where are we after 6 years of clinical use?

  • M. Pennazio

      Affiliations

    • Corresponding Author InformationTel.: +39 011 6333622; fax: +39 011 6333623.

Gastroenterology Unit 2, Department of Gastroenterology and Clinical Nutrition, S. Giovanni A.S. Hospital, Via Cavour 31, 10123 Turin, Italy

Received 4 September 2006; accepted 5 September 2006.

Article Outline

Abstract 

Capsule endoscopy has revolutionised the management of digestive tract diseases by providing a new non-invasive way to view the entire small bowel mucosa directly. Obscure gastrointestinal bleeding is the primary and best validated indication to capsule endoscopy, which when used as first-line exploration is the most efficient strategy as regards diagnosis. In these patients, the technique is also helpful for effective decision-making concerning subsequent treatments. There is significant uncertainty regarding the role of capsule endoscopy in patients with Crohn's disease. Although it is clearly more sensitive than conventional imaging modalities, the implications of the lesions identified with this technique are not fully understood. Further prospective studies are required to identify the clinical settings where capsule endoscopy is most effective in these patients. Capsule endoscopy may potentially lead to diagnosis of small bowel tumours earlier in their course; it should be used as first-line surveillance procedure in patients with Peutz–Jeghers syndrome, and it may be of clinical value in selected patients with familial adenomatous polyposis. Although preliminary results are promising, additional research is necessary to determine its role in the diagnosis and management of coeliac disease, as well as for the diagnosis of oesophageal and large bowel disorders. Well-designed studies are also needed to better define the impact of capsule endoscopy on health care use and clinical outcome of patients with intestinal diseases.

Keywords: Capsule endoscopy, Coeliac disease, Crohn's disease, Obscure bleeding, Polyposis syndromes

 

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1. Background 

Throughout the history of medicine the small bowel has been a difficult organ to study. For many centuries, diagnosis of diseases involving the small bowel was based on the medical history of subjective and objective symptoms. The information was then compared with that provided, as time passed, first by autopsy, then by radiology and surgical findings, and finally by in vivo biopsies, which could often only be performed with relatively complex and contrived techniques.

Small bowel visualisation by radiographic techniques, including small bowel follow-through and small bowel enteroclysis, is limited as they are ineffective in detecting superficial mucosal lesions. Conventional barium studies have nowadays been replaced by cross-sectional techniques, such as computed tomography (CT) and magnetic resonance imaging (MRI) with enteroclysis, which improve not only visualisation of the intestinal lumen, but also detection of intestinal wall and extraluminal diseases. These investigations, however, can be uncomfortable for the patient, are difficult to interpret, involve more radiation exposure.

Small bowel endoscopy has the advantage of direct visualisation of the intestinal mucosa and, above all, of carrying out targeted biopsies. Push enteroscopy (PE) is an effective diagnostic and therapeutic procedure, however, it only allows exploration of the proximal small bowel [1]. Intraoperative enteroscopy is the most complete but also the most invasive means of examining the small bowel [2].

In 2000, the development of capsule endoscopy (CE) opened a new chapter in small bowel examination [3]. It has extended diagnostic capabilities, and made available an efficacious technology enabling rapid and very often accurate diagnosis. Despite its valuable diagnostic potential, CE can only detect and record small bowel pathology; currently, the device is unable to take biopsies or perform any therapeutic procedures. It is however of great utility in planning the most appropriate therapeutic strategy. More recently, a new technique called double-balloon enteroscopy (DBE) has been introduced into clinical practice [4]. DBE has the potential to examine the entire length of the small bowel with biopsy and therapeutic capability. It is a time consuming method that requires specialist training, but if a lesion can first be visualised by CE, then DBE can be used as a confirmatory or therapeutic modality.

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2. Description of the procedure 

CE is a simple, non-invasive procedure that is well accepted by the patient and can be performed on an outpatient basis. The PillCam™ SB videocapsule (Given Imaging Ltd., Yoqneam, Israel) is a wireless capsule (11mm×26mm), which contains a miniaturised camera, a light source and a wireless circuit for the acquisition and transmission of signals [5]. In short, after an overnight fast, the patient swallows a capsule, usually with a few sips of water; as the device is passively propelled through the gastrointestinal (GI) tract by peristalsis, images are transmitted to a data recorder worn on a belt outside the body. After 8h, the data recorder is connected to a computer workstation, the data are downloaded, processed and, finally, high quality endoscopic images can be viewed on a monitor. The capsule is passed in the patient's stool, usually within 24–48h, and not reused. Reading time is on average 40–60min. As a rule, one should interpret the images in the ‘light’ of the clinical history [6]. Since its development, additional support systems have been added to the software to assist the reader—a localisation capability and a suspected blood indicator. The former is however too imprecise, and the accuracy of the latter also needs improvement. A multiviewing feature, quick view, and automatic mode view modalities have also been added to shorten review time. Although they may be helpful for this purpose, they do not substitute for complete and careful reading of the images. A handheld device (RAPID Access) that enables real-time viewing and remote data recorder initialisation will shortly be released. Research is underway to develop capsules with propulsive and therapeutic capabilities.

In October 2005, Olympus Corporation (Tokyo, Japan) released a new small bowel capsule (EndoCapsule) in Europe. The system comprises a capsule with automatic brightness control, a recorder unit, antenna lead set and a real-time viewer with colour LCD monitor. A recent small prospective study compared the two devices in a group of 20 patients with obscure gastrointestinal bleeding (OGIB) [7]. The quality of the acquired images, completeness of small bowel evaluation, and diagnostic yield were reported to be similar despite the different technological features of the two capsules.

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3. Practical issues 

CE provides end-to-end visualisation of the small bowel. However, the presence of dark or opaque intestinal contents or of a motility disorder may preclude successful investigation by causing incomplete visualisation of the intestinal mucosa. Several studies have examined the possibilities of improving bowel cleanliness, shortening transit times by means of medications (polyethylene glycol, prokinetics, simethicone) and postural tricks. These studies are however heterogeneous in both design and results and, for these reasons, the best type and dosage of medications remains to be established with appropriately-designed studies [8].

Oesophageal diverticula, gastric bypasses and motility disorders of the stomach and oesophagus that might prevent the capsule reaching the duodenum can easily be circumvented by endoscopic placement of the capsule: several delivery devices are now available for this purpose [9].

As it is time consuming to review capsule video studies, one potential cost-effective strategy is the use of nurse endoscopists to report images. Some studies have shown that highly motivated nurses trained to read CE can detect clinically significant lesions at the same rate as physicians [10], [11]. However, the drawing of conclusions and formulation of patient management proposals still require a good knowledge of digestive pathology together with experience in interpreting endoscopic images, and must be left to specialised physicians, who have full responsibility for correct diagnostic interpretation [12], [13].

Inter-observer variability in the interpretation of capsule examinations has been reported to be good among experienced endoscopists [14], but there is still considerable variability in the terminology and classification of abnormal images. A CE minimal standard terminology (CE-MST) has recently been developed to overcome this problem [15].

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4. Established indications 

Indications for a CE investigation of the small bowel are as many as are the intestinal diseases. The fields in which the scientific evidence is most solid are in evaluating patients with obscure bleeding, inflammatory bowel diseases, suspected small bowel tumours, hereditary polyposis syndromes and complicated coeliac disease [16], [17] (Table 1).

Table 1. Most common indications to CE
OGIB
Suspected CD
Suspected small bowel tumours and surveillance in patients with polyposis syndromes
Suspected or refractory malabsorbitive syndromes (e.g., coeliac disease)

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5. Contraindications 

As is the case with any diagnostic procedure, there are patients who are appropriate for study with this device and others who are not. Suspected or known GI obstruction is listed as a contraindication, due to the risk of capsule retention [9], [16], [17], [18] (Table 2). It is also unwise to use CE in demented patients, or in those with known motility disorders or intestinal pseudo-obstruction. Swallowing disorders may result in ineffective swallowing with misplacement of the capsule in or around the pyriform sinuses or in the trachea. They should be carefully investigated before capsule ingestion; in this situation endoscopic placement of the capsule is mandatory [9]. Another concern is that CE signals could cause electromagnetic interference and alter cardiac pacemaker (CP) or implanted cardiac defibrillator (ICD) function. Evidence is accumulating about the safety of CE in patients with CPs and ICDs implanted in the chest [19], [20] However, until more data is available, it is recommended that these procedures be done in hospital under continuous monitoring, with support from the patient's cardiologist. No data is available on patients undergoing oesophageal CE or on patients with CPs or ICDs implanted in the abdomen. These patients should undergo CE in a monitored environment. The safety of CE in pregnancy has not been established.

Table 2. Contraindications to CE
Patients with known or suspected GI obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing
Patients with CPs or other implanted electro-medical devices
Patients with swallowing disorders
Pregnancy

Patients should not undergo MRI after having completed a CE until they have passed the capsule. Informed consent before any capsule study should include mention of possible capsule retention requiring surgery, potential complications related to swallowing of the capsule, potential risks for electromagnetic interference and the possibility of an incomplete study that might necessitate its repetition [17].

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6. Complications 

CE has proved to be an extraordinarily safe device to use. Over 340,000 capsules have been deployed worldwide with no reported deaths and with few side effects. The main complication is that the capsule may become impacted in intestinal strictures. Capsule retention is defined as capsule present and confirmed by a plain abdominal radiograph at 2 weeks post ingestion [21]. This means that the capsule will be retained indefinitely in the small bowel unless some intervention is undertaken. Capsule retention remains a major concern for physicians performing CE, since this adverse event may theoretically lead to surgery or additional endoscopy in a patient who might otherwise have been treated medically, or who might have remained asymptomatic from their stricture. As a rule, CE should only be performed in patients who are medically fit for surgery [22].

Capsule retention is distinct from slow and incomplete transit without any anatomic abnormality, which may occur in up to 20% of examinations. Preliminary studies using strict exclusion criteria report a retention rate of 0.75% [23]. In a recent multicentre study of 733 capsule examinations performed for different clinical reasons, capsule retention occurred in 1.9% [24]. It is now clear that the rate of indefinite retention depends on the indication to the examination [21] (Table 3). The risk of retention is high in patients with prolonged NSAID use (Fig. 1), abdominal radiation injury, extensive Crohn's enteritis [25], and prior major abdominal surgery or small bowel resection [26]. Retention should be suspected when the colon is not visualised during the 8h acquisition time, and the patient does not see the capsule in the toilet; a plain abdominal radiograph at 2 weeks post ingestion may confirm the suspicion.

Table 3. Frequency of capsule retention
Healthy volunteers (%)0
OGIB (%)1.5
Suspected CD (%)1.4
Known CD (%)4–13
Suspected small bowel obstruction (%)21

Before indicating a capsule examination, the patient's medical history should be carefully assessed and, if small bowel strictures are suspected, imaging studies should be performed to obtain information about luminal patency. Barium studies have limited sensitivity for predicting capsule passage. CT or MRI enteroclysis are promising, but published studies are still limited [21]. The patency capsule (an inert capsule identical in size to the actual endoscopic capsule, which dissolves in 2–3 days if not excreted, designed precisely to test the permeability of the small bowel prior to the real examination) has been used as a screening test to assess the passage of an endoscopic capsule in patients at risk for small bowel strictures [27], [28]. There has been concern, however, about the efficacy and safety of this device [29]. A modified ‘Agile’ patency capsule has recently been developed, with two end plugs that ensure better penetration of intestinal juice and prevent delayed initiation of the dissolution process. Further testing is however required before clinical use. DBE might be an alternative to CE in high-risk patients with suspected stenosis. This method has also proved to be useful for endoscopic retrieval of entrapped capsules [30].

There is almost never an immediate need to remove a capsule, since it may safely remain within the patient for months. In some patients with inflammatory strictures, a course of treatment with corticosteroids or with infliximab has, on occasion, been shown to be useful in an attempt to induce capsule passage. It is crucial for physicians to remember that whenever there is capsule retention, there is an important underlying pathological cause [21]. The ultimate management plan must thus include surgical removal.

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7. Investigation of specific diseases: OGIB 

The commonest indication to CE is for evaluation of OGIB, which accounts for approximately 5% of all GI bleeds. OGIB is defined as bleeding of unknown origin that persists or recurs (i.e., recurrent or persistent iron deficiency anaemia, faecal occult blood test positivity or visible bleeding) after a negative initial or primary endoscopy (upper and/or lower GI endoscopy) [31]. Patients with OGIB pose difficult diagnostic and management problems: they require numerous blood transfusions and repeated hospital admissions; they undergo multiple diagnostic procedures, consume increased health care resources, and have their health related quality of life significantly affected. In these patients, the source of bleeding is frequently located in the small bowel, and may be due to a number of conditions, including vascular lesions (Fig. 2) [32], tumours (Fig. 3) [33], and inflammatory lesions (Fig. 4), [34].

7.1. Evidence for use of CE in OGIB 

CE can significantly improve diagnosis for patients who have OGIB. In preliminary studies, a potential bleeding source was identified in 38–93% of patients undergoing CE [35]. A multicentre study [36] classified lesions detected at CE according to their bleeding potential. Highly relevant (P2) lesions included angioectasias, large ulcerations, tumours or varices. Those of uncertain relevance (P1) included red spots, and small isolated erosions. Low relevance (P0) lesions included visible submucosal veins, non-bleeding diverticula and nodules without mucosal break. The most recent studies have considered only lesions with high bleeding potential as diagnostic, showing that a definite bleeding source is identified in approximately half of patients undergoing CE [37]. The clinical accuracy of the diagnosis made with CE in patients who have OGIB has been reported to be good: positive predictive value (PPV) is around 95%, and negative predictive value (NPV) ranges between 83% and 100% [38], [39], [40].

CE, compared prospectively with other imaging methods, has also shown a numerically higher diagnostic yield in OGIB [36], [41], [42], [43]. A more precise estimation of its potential benefit in this condition has been provided by two recent meta-analyses. One analysed 17 studies (484 examinations) and reported that the incremental yield of CE over PE and small bowel barium radiography for clinically significant findings was ≥30%, primarily because visualisation of additional vascular and inflammatory lesions is possible by CE [44]. Similarly, another meta-analysis of nine studies (289 examinations) found the absolute pooled difference in rate of positive findings between CE and alternative modalities to be 37% [45]. On the basis of these results, it has been suggested that the normal diagnostic protocol for cases of OGIB be modified to start from less invasive methods. Careful repeat studies of the upper and lower GI tract should be performed before evaluation of the small bowel, because of the significant miss rate of initial endoscopy; however, CE should be used immediately after these studies have given negative results, provided that there is no suspected obstruction [38], [46], [47]. CE has also been proposed as a diagnostic modality in patients with iron-deficiency anaemia [48].

Patient selection and timing of the procedure are crucial factors in optimising the yield of CE. In a prospective study [38], CE findings were positive in 47 of 100 consecutive OGIB patients. When stratified by type of bleeding, however, a positive site of bleeding or active bleeding was seen in 24 of 26 (92%) patients with ongoing obscure-overt bleeding, 4 of 31 (13%) patients with obscure-overt bleeding during the past year, and 19 of 43 (44%) patients with obscure-occult bleeding. Other studies published subsequently have addressed the issue of the yield of CE and type of bleeding and have confirmed the prior finding [37]. As a rule, patients with ongoing obscure-overt bleeding and with obscure-occult bleeding are the best candidates for CE; the closer the bleeding episode to CE, furthermore, the higher its diagnostic yield [37], [38], [49]. High transfusion requirements and low haemoglobin values have also been reported as useful clinical parameters to predict diagnostic yield [50], [51].

Some patients may also require repeated CE examinations to maximise the yield of capsule diagnosis. If the initial study is non-diagnostic, repeat CE for persistent OGIB may increase diagnostic yield [52], [53]. When bleeding persists and is clinically severe, however, it might be better to perform a conventional endoscopic procedure with therapeutic possibilities, rather than repeating CE. This point needs to be clarified by further prospective comparative studies.

Recent reports have stressed the utility of DBE for patients with OGIB [54], [55]. In this clinical setting, the diagnostic value of CE and DBE has been shown to be similar [37]. However, the most efficient way to use DBE and CE in the diagnostic algorithm of OGIB remains to be determined: should CE always be used as initial diagnostic imaging test (provided that potential strictures have been excluded) before DBE? or should DBE be the first approach because of its therapeutic capabilities? DBE is a time consuming method, and therefore it seems obvious that indications must be carefully selected, the choice of endoscope insertion route being the most important issue. At present it is suggested that an initial diagnostic imaging employing CE might be followed by DBE for treatment or histopathological diagnosis. Prior CE can also help to decide which approach should be attempted first with DBE [56], [57], [58], [59]. Future prospective large studies are however needed to assess the cost-effectiveness and budget impact of different strategies. An algorithm for the diagnosis and management of OGIB, which may be fine tuned through further research, is shown in Fig. 5.

  • View full-size image.
  • Fig. 5. 

    Proposed algorithm for the diagnosis and management of OGIB. Adapted from [60]. PE: push enteroscopy; IOE: intraoperative enteroscopy; DBE: double-balloon enteroscopy; CE: capsule endoscopy.

  • *Upper and lower GI endoscopy should be repeated (‘second-look’ endoscopy) before investigation of the small bowel and will frequently identify lesions overlooked at the initial endoscopy.

  • §Patients with significantly active bleeding and unsuitable for endoscopy.

  • ^ Especially if it was not repeated before CE.

7.2. Impact on patient management and outcomes 

If CE is to play a significant role in diagnosing bleeding sources, its use must contribute to changes in patient management that lead to enduring positive patient outcomes. Negative as well as positive findings on CE could minimise further examinations, resulting in improved patient's quality of life, reduced economic costs and prompt treatment aimed at bleeding resolution. The evaluation of clinical outcome must also include the evaluation of side effects and complications, which could have a negative impact on the patient's health and quality of life.

A recent consensus statement estimated that CE ‘influenced clinical decisions’ in 22–88% of patients undergoing this procedure [60], but it is difficult to determine whether the change in management improved health outcomes. Most studies with long-term follow-up data [38], [40], [47], [51], [61], [62] appear to indicate a positive influence of CE diagnosis on the clinical outcome of patients who have OGIB, although the proportion of patients with lasting positive outcomes after CE is significantly smaller than the proportion of patients for whom a diagnosis is initially made. The two largest full articles show that patient management dictated by CE results may lead to resolution of bleeding in approximately 2/3 of patients [38], [51]. Others have described a significant reduction of further endoscopic procedures or hospitalisation after CE [40], [62]. In most studies, however, clinical outcome after CE was to a great extent the result of a series of treatments having differing efficacy that were not always undertaken on the basis of CE results, because a standardised intervention protocol had not been established a priori. Therefore, additional prospective studies are needed to better define the impact on patients outcomes in OGIB [60].

Current evidence appears to indicate that, at least for some OGIB patients, for example those with Crohn's disease (CD) (Fig. 4), and those with tumours (Fig. 3), an early diagnosis such as that obtained through CE may favourably influence the clinical outcome thanks to the prompt application of treatment of proven efficacy. In addition, recent reports [47], [63] suggest that also negative cases at CE may have a favourable outcome, because the rebleeding rate in these patients appears to be low. It has thus been suggested that further invasive investigations can be deferred in patients with negative CE until clinical rebleeding occurs. The situation is more complex for the remaining patients, who are the majority: those with angioectasias (Fig. 2). It is known that the bleeding pattern in these patients may evolve with time, and that bleeding stops spontaneously in about 50% of cases. Although rapid diagnosis is feasible with CE, there is no convincing demonstration of the efficacy of endoscopic or medical treatment in these patients. This is confirmed by the finding that, in almost all published outcome studies, rebleeding was more frequent in patients who had angioectasias, many being diffuse lesions. At least with regard to endoscopic treatment, however, methods such as DBE potentially offer greater guarantees of therapeutic radicality than those used to date in patients with angioectasias. It is to be hoped that future outcome studies will concentrate on these subjects to determine whether, in the framework of a detailed therapeutic protocol, interventions performed during DBE have an impact on patient outcome.

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8. Inflammatory bowel diseases 

Inflammatory bowel diseases collectively cause significant lifestyle sacrifices and suffering, and millions of Euros are spent in related health care costs every year, partially due to a lack of effective diagnostic procedures and therapies. Diagnosis of CD is achieved through a composite of clinical, endoscopic, radiographic, serological and histopathological findings. Despite the availability of a wide array of diagnostic tools, early mucosal changes often cannot be detected by traditional methods (particularly if these changes are located in the small bowel). Since early intervention has a greater likelihood of inducing remission, there is clearly a pressing need for a gold standard test to correctly diagnose small bowel CD in its early stages [64].

8.1. Evidence for use of CE in CD 

The obvious advantage of CE is the ability to non-invasively visualise ulcers (Fig. 4), subtle erosions and inflammation in the part of the gut that was previously inaccessible to direct visualisation, including in patients in whom disease at the ileocecal valve prevents intubation of the ileum. Several studies have shown CE to be useful and safe in patients with a clinical and/or biological suspicion of CD and negative radiological and endoscopic evaluations [65], [66], [67]. The pooled yield of CE in this clinical setting has been reported to be 69.59% [64]. CE has also been found superior to small bowel barium radiography, colonoscopy with ileoscopy, CT or MR enteroclysis, and PE for diagnosing nonstricturing small bowel CD [41], [42], [66], [68], [69], [70], [71], [72]. However, a recent meta-analysis showed that the superiority of CE over alternate methodologies was primarily due to a significant incremental yield with CE in patients with established CD being evaluated to document flares. CE was not significantly better that other diagnostic modalities to make the diagnosis of CD [73].

A significant shortcoming of CE is the lack of validated capsule criteria to reliably diagnose CD [74]. Lesions discovered at CE are consistent with, but not diagnostic of CD, the specificity of lesions found at CE in this clinical setting being unknown. Indeed, finding multiple small bowel erosions should raise the question of CD, with a broad differential varying from incidental findings [75], to non-steroidal anti inflammatory drug (NSAID) damage, or infection. As a consequence, the criteria used to date for diagnosing CD at CE, such as detection of at least three small bowel ulcerations [76], or ten or more aphthae [71] must be validated by prospective controlled studies. The natural history of patients with isolated small bowel erosions also needs to be clarified.

8.2. Impact on patient management 

An important issue is whether the abnormalities observed may influence subsequent patient management. When CE is performed to diagnose CD, it must be taken into account that misinterpretation of findings or false-positive testing may have severe clinical consequences, such as the unnecessary use of toxic and expensive medications, and the stigma of being diagnosed with a serious chronic disease [77]. The ability to confirm a diagnosis histologically is an incontrovertible advantage of traditional endoscopy [78], even if histology is not always definitive. A complete knowledge of the patient's clinical history is always needed to establish a correct diagnosis.

CE can be of value in patients with established CD, without strictures, when management will be affected by further defining recurrent disease. For example, if the extent of the disease can be determined more precisely, the patient may be given an explanation, if standard therapy does not help, and switched to immunosuppressive therapy earlier than would be possible without the capsule examination. Similarly, patients with clinically suspected relapsing CD may not have active disease at CE, and thus unnecessary and potentially harmful empiric therapy is unwarranted without capsule imaging [68], [77]. Although not capable of providing the mucosal detail of CE, CT/MR enteroclysis or bowel ultrasound [79] may be used in conjunction with CE to provide a complete assessment of both mucosal and extra luminal disease.

CE has been used to assess early postoperative recurrence and so to guide therapy [80]. Its sensitivity to detect recurrence in the neoterminal ileum is reported to be inferior to that of ileocolonoscopy, but it detected more proximal lesions than ileocolonoscopy. At present, it is suggested that CE cannot systematically replace ileocolonoscopy in the regular management of patients after surgery. CE may be of value for patients who have indeterminate colitis who are failing medical therapy, or who may require colectomy. Correct diagnosis can guide the choice of medical therapy and in some cases may indicate the best surgical approach [76]. CE may also be useful in assessing the value of early aggressive treatment in healing small bowel mucosal lesions. In must be stressed, however, that there is no prospective data on these two latter indications.

Overall, future studies designed to specifically evaluate outcomes in subgroups of patients with CD should facilitate extrapolation to clinical practice.

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9. Inherited polyposis syndromes 

Several studies have underlined the benefits of performing CE in patients with polyposis syndromes [81], [82], [83], [84]. CE was found to be superior to small bowel follow-through in Peutz–Jeghers syndrome (PJS), but was not reliable for accurate sizing of polyps [81]. At present it is suggested that CE should be performed at diagnosis in all patients with PJS, as the primary surveillance modality every 2 years from the age of 10, and as part of the investigation of patients with symptoms. Additional information to evaluate the size and location of polyps, which is useful for planning the appropriate therapeutic strategy, can be provided by CT/MRI [82]. The coupling of CE with DBE and polypectomy may offer an ideal follow-up and treatment method for these patients, possibly avoiding surgery [85].

The role of CE is less clear in familial adenomatous polyposis (FAP). There is no indication to systematically perform CE when the diagnosis of FAP is made. CE may miss duodenal/periampullary polyps and is not useful for assessing the papilla. CE may be considered as a part of surveillance for patients with severe duodenal polyposis (Spigelman stage III°–IV°) [83], [84]. Future studies should evaluate whether CE will impact on health-care use and clinical outcomes of patients with polyposis syndromes.

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10. Small bowel tumours 

A small bowel tumour is diagnosed in approximately 2.5–9% of patients submitted to CE, indicating that the frequency of these neoplasms is considerably higher than was previously thought [86], [87]. The commonest indication to CE in patients with small bowel tumours is OGIB [88], and at least 50% of tumours identified at CE are malignant (Fig. 3). They are often unsuspected and were not found by other methods. The different types of tumours as well as benign and malignant lesions are, however, hard to distinguish and the rate of false negatives at CE is unknown. Recent studies suggest that CE is a useful tool in the investigation of specific tumours such as lymphomas [89], or neuroendocrine tumours [90].

Overall, the benefits of pursuing a capsule study in this clinical setting need to be characterised further in terms of the impact on outcome and prognosis [87].

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11. Coeliac disease 

Endoscopic changes typical of coeliac disease, especially the scalloping and mosaic patterns can easily be detected by CE (Fig. 6), [91]. The high specificity of these visual endoscopic markers was confirmed by a preliminary small prospective study. The sensitivity and specificity of CE in recognizing villous atrophy were 70% and 100%, respectively [92]. More recently, CE was compared with duodenal histology (gold-standard) in 43 patients with suspected coeliac disease: the sensitivity of CE in diagnosing coeliac disease was 87.5% and specificity was 90.9% [93]. At present, CE may offer an alternative to duodenal biopsy in patients who have a positive coeliac antibody panel, and who are unable or unwilling to undergo conventional upper GI endoscopy [94]. Further prospective studies are however needed to determine the sensitivity and specificity of assessment of the degree of villous atrophy. CE also provides information on how much bowel is involved in coeliac disease, but the significance of this knowledge in unclear [95]. Diagnosis of coeliac disease may be made in some patients who have undergone CE for a variety of symptoms, and in whom it had not been considered before the procedure. It is, therefore, essential that physicians, who perform CE, and those who review the images, are aware of the variety of mucosal appearances in patients who have coeliac disease [94], [95].

CE in conjunction with DBE, can be of value for evaluating and characterizing small bowel mucosal abnormalities in patients with alarm symptoms (weight loss, anaemia, abdominal pain) despite a closely followed gluten-free diet. CE might also be useful in long-term surveillance of patients who have coeliac disease, to detect malignancies [94], [95], [96].

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12. Other possible applications 

A variety of small bowel disorders have been shown to provide possible applications of CE. This device has been used to evaluate intestinal damage due to NSAIDs, which is probably commoner than previously suspected [75], [97], [98]. In NSAID-induced enteropathy, CE shows patchy redness, erosions, ulcers, and strictures, which often cause web- or membrane-like narrowing of the bowel lumen (Fig. 1). However, all findings are non-specific, and can be seen with both cyclooxygenase-1 (COX-1) and COX-2 agents. The effects of NSAIDs in the small bowel must be included in differential diagnosis in patients with obscure bleeding. Due to the increased risk of capsule retention typical of this condition, an intestinal stenosis must be ruled out before CE may be performed [9], [21], [22].

CE has been shown to be an effective method for diagnosing paediatric patients with suspected CD, polyposis, and obscure bleeding [99]. The size of the capsule precludes its use in infants and very young children. Front-loading of the gastroscope with a capsule is a suitable alternative approach, permitting deposition of the capsule directly into the duodenum in children unwilling or incapable of swallowing it [100].

CE has proved to be useful in patients who have had small bowel transplantation to monitor the small bowel for graft rejection [101]. Similarly, it appeared to be more sensitive and less invasive than upper GI endoscopy in the management of acute GI graft-versus-host disease after bone-marrow transplantation [102]. CE can also provide an accurate assessment of small bowel involvement in patients with Whipple's disease (Fig. 7), with intestinal lymphangiectasia [91], [103], with systemic diseases such as acquired immunodeficiency syndrome [104] or with metabolic disorders [91]. In patients with portal hypertension, CE may show small bowel mucosal abnormalities such as red spots, varices or angiodysplasia-like lesions [105]. The clinical significance of these findings, however, needs to be confirmed prospectively.

CE appears not to play an important role in patients with recurrent abdominal pain of unknown origin [106]: its yield in this clinical setting is rather low, ranging from 6% to 17%. Additional symptoms, such as iron-deficiency anaemia, inflammatory signs, or weight loss [107] may justify the use of CE after normal work-up, especially in the search for CD or small bowel tumour.

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13. Possible indications in other gut segments 

13.1. Oesophagus 

A new videocapsule, (PillCam™ ESO, Given Imaging), has been developed for the detection of mucosal disease in patients with heartburn. It is a double-ended device of exactly the same size as the small bowel unit, which provides seven images per second from each end. At the time of the test, the patient should be fasting for 2h. Transit of the PillCam ESO is slowed by the patient swallowing the device in the supine position, with gradual elevation to the upright position over a 5min period. This device has provided images of the oesophageal mucosa that are comparable to those obtained by conventional endoscopy. The average reading time varies between 5min and 15min [108]. Pilot studies assessing the accuracy of the PillCam ESO for detecting Barrett's oesophagus in patients with chronic gastro-oesophageal reflux [109], and for visualizing oesophageal varices in patients who have known portal hypertension have shown promising results [110], [111]. In a recent prospective study, however, the PillCam ESO was 67% sensitive and 84% specific in identifying Barrett's oesophagus; positive and NPVs were 56% and 89%, respectively [112]. Inadequate visualisation of the gastro-oesophageal junction was deemed to be the cause of this suboptimal accuracy, which might be improved by advances in ingestion protocol and capsule calibration.

Overall, this new technique requires further and more extensive evaluation as well as assessment of its cost-effectiveness.

13.2. Large bowel 

The PillCam Colon capsule endoscopy (PCCE, Given Imaging) is the latest development in the field of wireless endoscopy. The potential benefits of a diagnostic device that is non-invasive, practically without complications and well-accepted by the patient appear intuitively obvious: it could be applied for the purpose of colorectal cancer screening, it could be an adjunct to incomplete colonoscopy or an alternative to patients who refuse standard colonoscopy. In a small prospective pilot study, PCCE was compared to colonoscopy for colorectal cancer screening: sensitivity of PCCE to detect patients with polyps was 81% and specificity 60% [113].

These preliminary results of PCCE deserve further investigation. The major challenges to this new method include effective colon cleaning, complete visualisation of the colon and cost.

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14. Conclusions 

As the future of micro-devices in medicine unfolds, CE has established itself as a valuable diagnostic tool for doctors and their patients. Obscure bleeding is the primary and best-validated indication to CE, which when used as a first-line exploration is the most efficient strategy as regards diagnosis. In these patients, the technique is also helpful in achieving effective decision-making concerning subsequent treatments.

There is significant uncertainty regarding the role of CE in patients with CD. Although it is clearly more sensitive than conventional imaging modalities, the implications of lesions identified with this technique are not fully understood. Further prospective studies are required in order to identify the clinical settings where CE will be most effective in these patients.

CE may potentially lead to diagnosis of small bowel tumours earlier in their course; it should be used as first-line surveillance procedure in patients with PJS, and it may be of clinical value in selected patients with FAP.

Although preliminary results are promising, additional research is necessary to determine its role in the diagnosis and management of coeliac disease, as well as for the diagnosis of oesophageal and large bowel disorders. Several other indications to CE are currently under evaluation, the potential benefits of which should be tested by the standards of evidence-based medicine.

Well-designed studies are also needed to better define the impact of CE on health-care use and clinical outcome of patients with intestinal diseases [114].

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Conflict of interest statement 

None declared.

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PII: S1590-8658(06)00501-9

doi:10.1016/j.dld.2006.09.007

Digestive and Liver Disease
Volume 38, Issue 12 , Pages 867-878, December 2006

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