Safety and efficacy of the M2A patency capsule for diagnosis of critical intestinal patency: results of a prospective clinical trial

BACKGROUND AND AIM: The presence of a critical intestinal stricture is a contraindication for conventional capsule endoscopy for the risk of impaction. Prior assessment of intestinal patency can substantially minimize this risk. The aim of the present study was to assess the safety and efficacy of the M2A patency capsule (PC) for verification of intestinal strictures. METHODS: The M2A PC consists of a biodegradable body surrounding a small radiofrequency identification (RFID) tag. This capsule was administered to patients with known or suspected intestinal strictures. Patency was verified if the capsule was excreted intact. The capsule disintegrated into small fragments and only the RFID tag was excreted if retained at the stricture beyond a stipulated time. The patency scanner was used to detect the RFID tag externally. The M2A video capsule (VC) was administered to patients who excreted the intact capsule. RESULTS: Twenty-six patients with known or suspected intestinal strictures were administered the M2A PC. This included 16 (61%) patients with tuberculosis, eight (31%) with Crohn's disease, and one each of postoperative and malignant strictures. Eight capsules were excreted intact within 72 h and two at 109 and 110 h. Fifteen capsules disintegrated in the G(I) tract and one capsule was removed during surgery. No PC-related complications were noted. Six of the eight patients who tested positive for patency were tested with the regular M2A VC with normal excretion. CONCLUSION: The M2A PC is a reliable indicator of functional patency in suspected or even known cases of intestinal stricture. It could be used prior to conventional capsule endoscopy to predict and minimize the risk of impaction.     

Use of the Given Patency System for the screening of patients at high risk for capsule retention

BACKGROUND: Capsule enteroscopy is a non-invasive diagnostic tool for the study of the small bowel. Due to the risk of capsule retention, capsule enteroscopy is contraindicated in patients with suspected small bowel strictures. The Given Patency Capsule is a disintegration time-controlled capsule developed to identify patients with strictures that may cause capsule enteroscopy retention. The presence of the patency capsule within the patient's body can be detected by a radio-frequency scanner. AIM OF THE STUDY: To evaluate safety and usefulness of the patency capsule in preventing capsule retention in patients at high risk. PATIENTS AND METHODS: Thirty-two patients were studied. Indications for patency capsule were: (A) Crohn's disease (18), (B) previous intestinal surgery (7), (C) previous obstruction (1), A+B (3), A+C (1), B+C (2). Patients were evaluated with the scanner at 72 h from ingestion. RESULTS: At 72 h, 24 patients had already excreted the intact capsule in the stool. Of these, two experienced abdominal pain during capsule passage. In the other eight patients, the scanner detected the presence of the patency capsule. Four of them excreted the capsule intact in the stool after 72-96 h, the remaining four never found the capsule in the stool. The 26 patients who excreted the patency capsule intact without experiencing abdominal pain were deemed eligible for the capsule enteroscopy procedure, which was performed uneventfully in the 25 who agreed to undergo the examination. CONCLUSIONS: The patency capsule is useful to identify, among patients at high risk, those who can be submitted to capsule enteroscopy without risks of capsule retention.     

Agile patency system eliminates risk of capsule retention in patients with known intestinal strictures who undergo capsule endoscopy

BACKGROUND: Capsule endoscopy (CE) of the small bowel has become a standard diagnostic tool, but there have been concerns regarding the risk of capsule retention in certain high-risk groups. The Agile patency system, an ingestible and dissolvable capsule with an external scanner, was developed to allow physicians to perform CE with greater confidence that the capsule will be safely excreted in patients at risk for capsule retention. OBJECTIVE: Our purpose was to assess the ability of the device to help physicians identify which patients with known strictures may safely undergo CE. DESIGN: Patients with known strictures ingested the new patency capsule and underwent periodic scanning until it was excreted. The intestinal tract was considered to be sufficiently patent if the capsule was excreted intact or if the capsule was not detected by the scanner at 30 hours after ingestion. If patency was established, then standard CE was performed. SETTING: International multicenter study. PATIENTS: A total of 106 patients with known strictures. INTERVENTION: Agile patency system. MAIN OUTCOME MEASUREMENTS: Performance and safety of Agile patency system. RESULTS: A total of 106 patients ingested the patency capsule. Fifty-nine (56%) excreted it intact and subsequently underwent CE. There were no cases of capsule retention. Significant findings on CE were found in 24 (41%). There were 3 severe adverse events. CONCLUSIONS: These results suggest that the Agile patency system is a useful tool for physicians to use before CE in patients with strictures to avoid retention. This group of patients may have a high yield of clinically significant findings at CE. This capsule may determine whether patients who have a contraindication to CE may safely undergo CE and obtain useful diagnostic information.     

The risk of retention of the capsule endoscope in patients with known or suspected Crohn's disease

OBJECTIVES: Capsule endoscopy (CE) allows visualization of the mucosa of the entire small bowel and is therefore a potentially important tool in the evaluation of patients with known or suspected Crohn's disease (CD). However, small bowel strictures, which are not uncommon in Crohn's, are considered to be a contraindication to CE for fear of capsule retention. Our goal was to determine the risk of capsule retention in patients with suspected or known CD. METHODS: We retrospectively reviewed the records of 983 CE cases performed at three private gastroenterology practices between December 2000 and December 2003, and selected those with suspected or proven Crohn's. RESULTS: A total of 102 cases were identified in which CE was used in patients with suspected (N = 64) or known (N = 38) CD. Only one of 64 patients (1.6%) with suspected CD had a retained capsule. However, in five of 38 (13%) patients with known Crohn's, the capsule was retained proximal to a stricture. Of the five cases of retained capsules, three strictures were previously unknown. In four cases, the obstructing lesions were resected without complications, leading to complete resolution of the patient's underlying symptoms. One patient chose not to undergo surgery and has remained without an episode of small bowel obstruction for over 38 months. CONCLUSIONS: Capsule retention occurred in 13% (95% CI 5.6%-28%) of patients with known CD, but only in 1.6% (95% CI 0.2%-10%) with suspected Crohn's. A retained capsule may indicate unsuspected strictures in Crohn's that may require an unexpected, but therapeutic, surgical intervention. Patients and physicians should be aware of these potential risks when using CE in CD.     

Contraindications for video capsule endoscopy

Video capsule endoscopy(VCE) has been applied in the last 15 years in an increasing field of applications. Although many contraindications have been put into perspective, some precautions still have to be considered. Known stenosis of the gastrointestinal tract is a clear contraindication for VCE unless surgery is already scheduled or at least has been considered as an optional treatment modality. In patients with a higher incidence of stenosis, as in an established diagnosis of Crohn's disease, clinical signs of obstruction, prior radiation or surgical small bowel resection, a preceding test with the self-dissolving patency capsule can override this contraindication. Endoscopic placement of the capsule should be considered in patients with swallowing disorders to avoid aspiration. Esophageal or gastric motility disorders may require endoscopic capsule transport or application of prokinetics if the real-time viewer proofs delayed transit. In pregnant women, VCE should be restricted to urgent cases where diagnosis cannot be postponed after delivery, as data on safety are missing. There is theoretical and clinical evidence that patients with implanted cardiac devices such as a pacemaker, cardioverters or left heart assist devices, can safely undergo VCE in spite of still existing contraindication by manufacturers. Children from the age of 2 years have safely undergone VCE. Although video capsules are not proven safe with magnetic resonance imaging(MRI), first single cases of patients incidentally undergoing MRI with an incorporated capsule have been reported, showing susceptibility artifacts but no signs of clinical harm.     

Video capsule endoscopy in inflammatory bowel disease

Video capsule endoscopy(VCE) has evolved to become an important tool for the non-invasive examination of the small bowel, which hitherto had been relatively inaccessible to direct visualisation. VCE has beenshown to play a role in monitoring the activity of small bowel Crohn's disease and can be used to assess the response to anti-inflammatory treatment in Crohn's disease. For those patients with Crohn's disease who have undergone an intestinal resection, VCE has been assessed as a tool to detect post-operative recurrence. VCE may also aid in the reclassification of patients with a diagnosis of Inflammatory Bowel Disease Unclassified to Crohn's disease. The evolution of colon capsule endoscopy(CCE) has expanded the application of this technology further. The use of CCE to assess the activity of ulcerative colitis has been described. This advance in capsule technology has also fuelled interest in its potential role as a minimally invasive tool to assess the whole of GI tract opening the possibility of its use for the panenteric assessment of Crohn's disease. VCE is a safe procedure. However, the risk of a retained capsule is higher in patients with suspected or confirmed Crohn's disease compared with patients having VCE examination for other indications. A retained video capsule is rare after successful passage of a patency capsule which may be utilised to pre-screen patients undergoing VCE. This paper describes the use of VCE in the assessment of inflammatory bowel disease.     

Capsule endoscopy retention: is it a complication?

BACKGROUND: Capsule endoscopy has been found superior to barium x-rays and push enteroscopy in the investigation of obscure gastrointestinal bleeding and in the evaluation of suspected Crohn's disease. Currently, small bowel obstruction and strictures are considered by many physicians to be a contraindication to capsule endoscopy for fear of capsule retention or impaction. The goal of this study was to reassess this conventional wisdom that capsule endoscopy is contraindicated in small bowel obstruction and to determine the safety and efficacy of capsule endoscopy in the evaluation of patients with suspected stricture or small bowel obstruction. STUDY: A retrospective chart review was performed using a database of 568 capsule endoscopy cases performed between August 2001 and November 2003. Cases of suspected small bowel obstruction were selected and reviewed. RESULTS: Nineteen cases were identified in which capsule endoscopy was used in the setting of suspected small bowel obstruction. The diagnosis of suspected small bowel obstruction was based on symptoms alone in 8 cases and on symptoms plus abnormal radiographs in the remaining 11 cases. Capsule endoscopy made a definitive diagnosis in 5 of the 19 cases (26%): 2 Crohn's strictures, 1 radiation induced stricture, 1 nonsteroidal anti-inflammatory drug induced stricture, and 1 MALT lymphoma. The capsule was retained proximal to a stricture in 4 cases, in which the obstructing lesions were electively resected without complications. There was no case in which administration of the capsule led to an acute small bowel obstruction. CONCLUSIONS: Capsule endoscopy can be safely used to help identify the etiology and site of a small bowel obstruction. Retention of the capsule may indicate the presence of a lesion requiring surgery, but small bowel obstruction or strictures are not in themselves contraindications to the procedure. It is understood, however, that retention may lead to surgery in a patient who otherwise may have been treated medically without surgery for the same illness (eg, Crohn's disease and nonsteroidal anti-inflammatory drug enteropathy).     

Clinical utility, safety and tolerability of capsule endoscopy in urban Southeast Asian population

AIM: Capsule endoscopy has demonstrated its clinical utility in the evaluation of small bowel pathology in several Western studies. In this prospective study, we aimed to determine the clinical utility, safety and tolerability of capsule endoscopy in the evaluation of suspected small bowel disease in an urban Southeast Asian population.METHODS: We used the given (M2A) capsule endoscopy system in 16 consecutive patients with suspected small bowel pathology. In 9 patients the indication was obscure gastrointestinal bleeding, while in 6 patients it was to determine the extent of small bowel involvement in Crohn‘s disease. One patient underwent capsule endoscopy for evaluation of chronic abdominal pain. Patient‘‘s tolerabilityto the procedure was evaluated by standardized questionnaires and all patients were reviewed at one week to ensure that the capsule had been excreted without any adverse events.RESULTS: Abnormal findings were present in 8 patients (50 %). The cause of obscure gastrointestinal bleeding was determined in 5 out of 9 patients. Findings included 2 cases of angiodysplasia, 2 cases of jejunal ulcers and 1 case of both angiodysplasia and jejunal ulcer. One patient had smallbowel erosions and foci of erythema of doubtful significance. Ileal lesions were diagnosed in 2 out of 6 patients with Crohn‘‘s disease. Capsule endoscopy was well tolerated by allpatients. One patient with Crohn‘‘s disease had a complication of capsule retention due to terminal ileum stricture. Thecapsule eventually passed out spontaneously after 1 month. CONCLUSION: Our study, which represented the first Asian series, further confirms the diagnostic utility, safety and tolerability of wireless capsule endoscopy.     

Clinical usefulness of transabdominal ultrasonography prior to patency capsule for suspected small-bowel strictures

Objective: Patency capsule (PC) examination has made it possible to perform capsule endoscopy (CE) in patients with a suspected small-bowel stricture. However, PC has some drawbacks, so we assessed the usefulness of transabdominal ultrasonography (TUS) prior to PC in patients with suspected small-bowel strictures to avoid unnecessary PC examination. Patients and methods: Fifty-two patients who underwent TUS prior to PC were enrolled in this study. TUS findings were classified as follows: intestinal narrowing and distension at the oral side (Type A); extensive bowel wall thickening (Type B); focal bowel wall thickening (Type C) or no abnormality detected (Type D). We evaluated the TUS and PC findings for the detection of small-bowel strictures. Results: Double-balloon endoscopy (DBE) revealed small-bowel strictures in 13 of 50 patients (26%). TUS yielded Type B or C findings in 12 of 13 patients (92%), while PC revealed strictures in all 13 patients. In Crohn’s disease (CD) patients with Type B TUS findings, 8 of 9 (89%) had small-bowel strictures on DBE. However, only two of six non-CD patients (33%) with Type B TUS findings had small-bowel strictures. The incidence of Type B strictures was significantly higher in CD patients. Conclusions: CD patients with Type B TUS findings should not undergo PC or CE because of the high rate of small-bowel strictures. Non-CD patients diagnosed with Type B TUS strictures, as well as patients diagnosed with Type C or D strictures should undergo CE after confirming small-bowel patency using PC.     

Patency and agile capsules

Small bowel strictures can be missed by current diagnostic methods. The Patency capsule is a new non-endoscopic dissolvable capsule which has as an objective of checking the patency of digestive tract, in a non-invasive manner. The available clinical trials have demonstrated that the Patency capsule is a good tool for assessment of the functional patency of the small bowel, and it allows identification of those patients who can safely undergo a capsule endoscopy, despite clinical and radiographic evidence of small-bowel obstruction. Some cases of intestinal occlusion have been reported with the Patency capsule, four of them needed surgery. So, a new capsule with two timer plugs （Agile capsule） has been recently developed in order to minimize the risk of occlusion. This new device stars its dissolution process earlier （30 h after ingestion） and its two timer plugs have been designed to begin the disintegration even when the device is blocked in a tight stricture.     

Expanding role of capsule endoscopy in inflammatory bowel disease

Capsule endoscopy has been shown to detect small bowel inflammatory changes better than any other imaging modality. Selection criteria have been optimized to increase the yield of capsule endoscopy in patients suspected to have Crohn＇s disease. Capsule endoscopy allows for earlier diagnosis of Crohn＇s disease of the small bowel and improved diagnosis of colitis in patients where it is unclear if they suffer from Crohn＇s or ulcerative colitis. A test capsule is available to assess for small bowel strictures and thus avoid capsule retention. A common language has been developed and a new scoring index will be added to capsule software. It is envisioned that the manner in which we treat Crohn＇s disease in the future will change, based on earlier diagnosis and treatment aimed at mucosal healing rather than symptom improvement.     

Video capsule endoscopy: procedure, indications and diagnostic yield

Video capsule endoscopy (VCE) is a new noninvasive imaging technique for the complete small bowel. It provides good to excellent visualisation of the mucosa of the small bowel and has a high diagnostic yield in selected patients with gastrointestinal blood loss of suspected small bowel origin and in patients with Crohn's disease. In comparison with small bowel X-ray and push enteroscopy, diagnostic yield appears to be superior. Although VCE is becoming increasingly popular, good studies on its clinical implications and application are only just emerging. In this paper we review the possibilities and limitations of clinical application of VCE.     

Video capsule endoscopy of the small bowel.

PURPOSE OF REVIEW: It is now more than 6 years since capsule endoscopy was first introduced to the gastroenterological community. This disposable 26 x 11 mm video capsule, containing its own optical dome, light source, batteries, transmitter and antenna, is swallowed with water after a 12 h fast. The capsule is propelled via peristalsis through the gastrointestinal tract, capturing about 60 000 digital images, and is excreted naturally. Capsule endoscopy has become a first-line tool for detecting abnormalities in the small bowel, because all other imaging technologies are rather ineffective. This review covers recent developments in capsule endoscopy technology and provides an update of its main indications. RECENT FINDINGS: There are some clear indications for capsule endoscopy: obscure gastrointestinal bleeding, suspected small bowel tumour (in which it is becoming a primary investigational tool), suspected Crohn's disease, surveillance of inherited polyposis syndromes, drug-induced small bowel injury, and any abnormal small bowel imaging. Controversy persists regarding what is a normal small bowel appearance, which is exacerbated by the inability to take biopsies and thus differentiate between entities; with technological advances, however, it is hoped that this will be addressed. SUMMARY: Capsule endoscopy has been incorporated into the gastroenterologists' daily life, changing the approach to many small bowel pathologies.     

Diagnosis of small bowel Crohn's disease: a prospective comparison of capsule endoscopy with magnetic resonance imaging and fluoroscopic enteroclysis

BACKGROUND AND AIMS: The diagnostic yield of capsule endoscopy (CE) compared with magnetic resonance imaging (MRI) in small bowel Crohn's disease is not well established. We prospectively investigated CE, MRI, and double contrast fluoroscopy in patients with suspected small bowel Crohn's disease. METHODS: Fifty two consecutive patients (39 females, 13 males) were investigated by MRI, fluoroscopy and--if bowel obstruction could be excluded--by CE. In 25, Crohn's disease was newly suspected while the diagnosis of Crohn's disease (non-small bowel) had been previously established in 27. RESULTS: Small bowel Crohn's disease was diagnosed in 41 of 52 patients (79%). CE was not accomplished in 14 patients due to bowel strictures. Of the remaining 27 patients, CE, MRI, and fluoroscopy detected small bowel Crohn's disease in 25 (93%), 21 (78%), and 7 (of 21; 33%) cases, respectively. CE was the only diagnostic tool in four patients. CE was slightly more sensitive than MRI (12 v 10 of 13 in suspected Crohn's disease and 13 v 11 of 14 in established Crohn's disease). MRI detected inflammatory conglomerates and enteric fistulae in three and two cases, respectively. CONCLUSION: CE and MRI are complementary methods for diagnosing small bowel Crohn's disease. CE is capable of detecting limited mucosal lesions that may be missed by MRI, but awareness of bowel obstruction is mandatory. In contrast, MRI is helpful in identifying transmural Crohn's disease and extraluminal lesions, and may exclude strictures.     

Wireless capsule video endoscopy：Three years of experience

AIM:To review and summerize the current literatue regarding M2A wireless capsule endoscopy.METHODS:Peer reviewed publications regarding the use of capsule endoscopy as well as our personal experience were reviewed.RESULTS:Review of the literature dearly showed that capsule endoscopy was superior th enteroscopy,small bowel follow through and computerized tomography in aptients with obscure qastrointestinal bleeding,iron deficiency anemia,or suspected Crohn‘s disease.It was very sensitive for the diagnosis of small bowel tumors and for survailance of small bowel pathology in patients with Gardner syndrome or familial adenomatous polyposeis syndrome.Its role in celiac disease and in patients with kmown Crohn‘s disease was currently being investigated.CONGLUSION:Capsule video endoscopy is a superior and more sensitive diagnostic tool than barium follow through,enteroscopy and entero-CT in establishing the diagnosis of many small bowel pathologyes.     

Longest duration of retention of video capsule: A case report and literature review

Video capsule endoscopy (VCE) is a safe innovative tool for investigating obscure gastrointestinal bleeding, Crohn’s disease and other small bowel pathologies. The capsule is usually excreted with faeces within 24-48 h. Retention of capsule rarely occurs, and it usually depends on the indication of VCE. The longest reported case of capsule retention in the literature is 2.5 years. Surgical approach is considered effective to retrieve the retained capsule. We present a case of asymptomatic retention of capsule for four and half years in a 49-year-old man who underwent VCE to explore the cause of obscure gastrointestinal bleeding. It was successfully retrieved endoscopically. We will also briefly review the literature regarding the causes, different presentations and management of capsule retention.     

Diagnosing small bowel Crohn's disease with wireless capsule endoscopy

BACKGROUND: The small bowel is the most commonly affected site of Crohn's disease (CD) although it may involve any part of the gastrointestinal tract. The current methodologies for examining the small bowel are x ray and endoscopy. AIMS: To evaluate, for the first time, the effectiveness of wireless capsule endoscopy in patients with suspected CD of the small bowel undetected by conventional modalities, and to determine the diagnostic yield of the M2A Given Capsule. PATIENTS: Seventeen patients (eight males, mean age 40 (15) years) with suspected CD fulfilled study entry criteria: nine had iron deficiency anaemia (mean haemoglobin 10.5 (SD 1.8) g%), eight had abdominal pain, seven had diarrhoea, and three had weight loss. Small bowel x ray and upper and lower gastrointestinal endoscopic findings were normal. Mean duration of symptoms before diagnosis was 6.3 (SD 2.2) years. METHODS: Each subject swallowed an M2A Given Capsule containing a miniature video camera, batteries, a transmitter, and an antenna. Recording time was approximately eight hours. The capsule was excreted naturally in the patient's bowel movement, and the data it contained were retrieved and interpreted the next day. RESULTS: Of the 17 study participants, 12 (70.6%, six males, mean age 34.5 (12) years) were diagnosed as having CD of the small bowel according to the findings of the M2A Given Capsule. CONCLUSIONS: Wireless capsule endoscopy diagnosed CD of the small bowel (diagnostic yield of 71%). It was demonstrated as being an effective modality for diagnosing patients with suspected CD undetected by conventional diagnostic methodologies.     

Video capsule endoscopy in a group of networked users: effective and cost saving

BACKGROUND: At present extensive application of video capsule endoscopy (VCE) as the most innovative diagnostic tool for small bowel diseases is limited by its high costs. The present study describes the first experience in the mobile use of VCE in a cooperation of associated gastroenterology departments in different hospitals. METHODS: The VCE device was bought by a centrally located hospital. In the case of a need for VCE elsewhere the mobile equipment was brought to the respective hospital. The examination was done on site by local physicians, who additionally were responsible for the procedure itself. The evaluation of the VCE pictures was carried out exclusively by the Ophysicians of the central hospital. RESULTS: Within 15 months VCE was performed in 40 patients (19 male, 21 female; age 61 +/- 14 years). Ten examinations were performed in the central hospital, 30 in the associated gastroenterology departments of other hospitals. Indications for VCE were obscure GI bleeding (65 %), chronic diarrhea and Crohn's disease (17.5 %) or suspected small bowel neoplasms (17.5 %). Clinically relevant pathological abnormalities were detected in 62.5 % of the patients, mainly ulcerations and erosions. Complications were non-spontaneous capsule passage in one patient. Compared to a single hospital, the multicenter use of VCE increased the frequency of investigations four times and reduced expenses to almost 30 %. CONCLUSIONS: The mobile use of VCE makes this innovative technique available for every patient while remaining in his local gastroenterology department. Additionally, this concept accelerates amortization and improves the quality of evaluation by focusing experience.     

Indications and Limitations Associated with the Patency Capsule Prior to Capsule Endoscopy

The retention of the capsule used during small bowel capsule endoscopy (SBCE) is a serious complication that can occur in patients with known or suspected small bowel stenosis, and a prior evaluation of the patency of the gastrointestinal (GI) tract is therefore essential. Patency capsule (PC) is a non-diagnostic capsule the same size as the diagnostic SBCE. To date, there are no clear guidelines regarding the contraindications for undergoing a PC evaluation prior to SBCE. Each small bowel disorder has specific occasions to inhibit the progress of PC and SBCE, even though they do not have any stenotic symptoms or abnormalities on imaging. In this review, we summarize the indications and limitations of PC prior to SBCE, especially the contraindications, and discuss clinical scenarios in which even PC should be avoided, and therefore such areas of stenosis should be evaluated by alternative modalities. We thus propose this new algorithm to evaluate the patency of the GI tract for patients with suspected and known small bowel stenosis in order that they may undergo SBCE safely.     

Capsule endoscopy and Crohn's disease

Capsule endoscopy has been shown to detect small bowel inflammatory changes better than any other imaging modality. Selection criteria have been optimized to increase the yield of capsule endoscopy in patients suspected of having Crohn's disease. Capsule endoscopy allows for earlier diagnosis of Crohn's disease of the small bowel and improved diagnosis of colitis in patients where it is unclear if they suffer from Crohn's or ulcerative colitis. A test capsule is available to assess for small bowel strictures and thus avoid capsule retention. It is envisioned that the manner in which we treat Crohn's disease in the future will change, based on earlier diagnosis and treatment aimed at mucosal healing rather than symptom improvement.