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PubMed2005

Clinical evaluation of the use of the M2A patency capsule system before a capsule endoscopy procedure, in patients with known or suspected intestinal stenosis.

BACKGROUND AND STUDY AIM: The main complication of video capsule endoscopy (VCE) is the blocking of the capsule by a gastrointestinal stenosis. The "patency capsule" is a self-dissolving capsule that is the same size as the video capsule. It contains a radiofrequency identification (RFID) tag that allows it to be detected by a scanning device placed on the abdominal wall. When its passage is blocked by a stenosis, the patency capsule dissolves in 40-80 hours after ingestion. The aim of this study was to evaluate the usefulness of this system in patients with suspected intestinal stenosis but also requiring VCE. PATIENTS AND METHODS: 22 patients (16 men; 46 +/- 18 years; 15 with diagnosed or suspected Crohn's disease, two with suspected intestinal tumor, and two on nonsteroidal anti-inflammatory drugs) were first investigated with an abdominal CT plus enteroclysis (entero-CT, n = 15) or a small-bowel follow-through (SBFT, n = 7). The patency capsule was then administered at around 09.00 to fasting patients. The presence of the patency capsule in the digestive tract was assessed 30 hours later using the hand-held scanner. When the patency capsule was detected, a plain abdominal film was obtained, and this was repeated every 24 hours until capsule expulsion. RESULTS: At 30 hours after ingestion, the patency capsule was detected in 17 patients (72.3 %): in the area of the small intestine (n = 6) and in the colon (n = 11). In all the patients in whom the capsule was blocked in the small intestine, the stenosis had been suspected on CT or SBFT. In three patients, the delay in progression of the patency capsule led to cancellation of the VCE procedure. In three patients, the patency capsule induced a symptomatic intestinal occlusion, which resolved spontaneously in one and required emergency surgery in two. Although these two patients would have been obliged to undergo operation for their primary disease in any case, the procedure had to be brought forward. In one patient, the capsule passed through the stenosis without symptoms. All patients in whom the progression of the patency capsule was delayed had an established or suspected diagnosis of Crohn's disease. CONCLUSIONS: The current technical development of the patency capsule limits its use in clinical practice, as it did not detect stenoses undiagnosed by CT or SBFT. The start of dissolution at 40 hours after ingestion is too slow to prevent episodes of intestinal occlusion. Patients with Crohn's disease are most likely to be at risk of blockage of progression of the capsule and should benefit from a CT investigation before VCE. However, a careful interview eliciting the patient's medical history and symptoms remains the most useful indicator with regard to suspicion of an intestinal stenosis.

Adolescent↗
PubMed2005

The utility of capsule endoscopy and its role for diagnosing pathology in the gastrointestinal tract.

BACKGROUND: Capsule endoscopy (CE) is a new device that enables visualization of areas of the small bowel that were previously inaccessible through other noninvasive procedures. The purpose of this study is to evaluate this new diagnostic tool and its efficacy in finding occult GI tract pathology. METHODS: A single-institution retrospective review was completed on patients undergoing CE from January 2002 to September 2004. Data evaluated included indications for CE, results of previous studies, CE findings, and complications of the CE study. RESULTS: A total of 702 CE studies in 652 patients were performed during the study period. Suspicious GI bleeding presenting as anemia, guaiac positive stools, or history of gross bleeding were the most common reasons to perform CE (75.8%). Other indications included abdominal pain (11.5%), diarrhea (3.1%), or others (9.5%). In studies performed for GI bleeding (N = 532), a source was found in 49.3% of CE studies. Arteriovenous malformation (AVM) was the most common reported finding (43.9%), followed by ulcer (24.1%), colon or gastric pathology (14.1%), mass/tumor (9.1%), and stricture (6.9%). Patients with abdominal pain (n = 81) had findings 46.9% of the time including edema/ulcer (47.4%), stricture (10.5%), mass/tumor (26.3%), gastric pathology (10.5%), AVM (2.6%), or sprue (2.6%). Patients with diarrhea (n = 22) had findings 45.5% of the time including edema/ulcer (75%), mass/tumor (12.5%), or sprue (12.5%). A total of 66 patients underwent operative exploration after a CE study at this institution either because of the observed findings or for other reasons. There were 12 (1.7%) CE studies in which the capsule was retained and required surgical removal. Pathology at the retention site included benign strictures or adhesions (n = 9, 75%), Crohn's stricture (n = 1, 8.3%) carcinoid tumor (n = 1, 8.3%), and villous adenoma (n = 1, 8.3%). CONCLUSIONS: CE is an accurate study to locate abnormalities in the GI tract that may have either been missed by previous diagnostic studies or cannot be observed through other non-invasive means. When used for diagnostic challenges such as GI bleeding with no apparent source, CE can be helpful in guiding surgical decisions in patients and thus should be integrated as part of the diagnostic workup.

Endoscopy, Gastrointestinal↗
PubMed2006

Sensitivity-specificity trade-off for capsule endoscopy in IBD: is it worth it?

There are a growing number of reports comparing wireless capsule endoscopy (CE) to other diagnostic tests for use in patients with Crohn's disease. A meta-analysis of these studies in this issue of the Journal showed that the "diagnostic yield" of detecting lesions suggestive of active Crohn's disease is much higher with CE compared to other tests. Routine use of CE in Crohn's disease will increase true-positive testing, but also will increase the number of false-positive tests. Since the penalty of false-positive testing is very high (unnecessary use of toxic and expensive medications, and the stigma of being diagnosed with a serious chronic disease), CE should be used only in limited clinical situations. In particular, CE may be helpful in Crohn's disease patients without a stricture whose physician needs an added measure of certainty that active disease is present.

Capsules↗
PubMed2005

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.

Acute Disease↗
PubMedDate not supplied

Capsule endoscopy in obscure gastrointestinal bleeding--an Indian experience.

BACKGROUND: Obscure gastrointestinal bleeding (OGIB) is a common indication for capsule endoscopy (CE). Reports on diagnostic yield of CE in this situation show a wide variation. We evaluated the diagnostic yield and clinical impact of CE in patients with OGIB. METHODS: We reviewed the medical records of patients with OGIB who underwent CE at our institution between June 2002 and October 2005. RESULTS: 154 patients (mean age 47 [SD 17] years; 117 men), including 74 with overt OGIB and 80 with occult OGIB, underwent CE. CE yielded positive findings in 57 of 74 patients (77%) with overt OGIB and 22 of 80 (27%) of those with occult OGIB (p < 0.0001); the overall positive diagnostic yield was 52%. NSAID-induced lesions (15%), angiodysplasias (14%) and aphthous ulcers (12%) were the most frequent findings. CE helped in planning further management in 79% of patients with overt OGIB and 26% of those with occult OGIB. CONCLUSION: CE is a useful diagnostic technique in patients with OGIB, especially those with overt OGIB.

Adult↗
PubMed2006

Advances in pediatric gastroenterology: introducing video camera capsule endoscopy.

The video camera capsule endoscope is a gastrointestinal endoscope approved by the U.S. Food and Drug Administration in 2001 for use in diagnosing gastrointestinal disorders in adults. In 2003, the agency approved the device for use in children ages 10 and older, and the endoscope is currently in use at Arkansas Children's Hospital. A capsule camera, lens, battery, transmitter and antenna together record images of the small intestine as the endoscope makes its way through the bowel. The instrument is used with minimal risk to the patient while offering a high degree of accuracy in diagnosing small intestine disorders.

Capsules↗
PubMed2005

Capsule endoscopy: improving transit time and image view.

AIM: To evaluate the effect of various methods of small bowel preparation on the transit time and the quality of visualization of the entire small bowel mucosa. METHODS: Ninety-five patients underwent capsule endoscopy (CE) by easily swallowing the capsule. They were divided into three study groups according to the preparation used: group A (n = 26) by polyethylene glycol (PEG) liter or with sodium phosphate (SP) 12 h prior to the CE study; group B (n = 29) by erythromycin 1 h prior to the CE study; and group C (n = 40) without any preparation. Visualization ranged from good to satisfactory to poor. RESULTS: The gastric emptying time in the group prepared with erythromycin was shorter but without statistical significance and the small bowel transit time was unaffected. In elderly subjects prepared by PEG or SP, the gastric emptying time was significantly longer (163.7 min, P = 0.05). The transit times of the three sub-groups were not affected by gender or pathology. The grade of cleaning of the entire study group was 3.27+/-1.1. The erythromycin group presented significantly the worst quality of images (P = 0.05) compared to the other sub-groups. Age, gender, and pathology had no effect on the quality of the cleaning of the small bowel in the sub-groups. One (1.05%) case had no natural excretion. CONCLUSION: Erythromycin markedly reduces gastric emptying time, but has a negative effect on the quality of the image in the small bowel. The preparation of elderly subjects with PEG or SP has a negative effect on the small bowel transit time.

Adolescent↗
PubMed2005

Given capsule endoscopy in celiac disease: evaluation of diagnostic accuracy and interobserver agreement.

BACKGROUND AND AIMS: Capsule endoscopy (CE) has been increasingly used for diagnosing diseases of the small bowel. It is an attractive technique for assessing celiac disease (CD) because it is noninvasive and provides a close and magnified view of the mucosa of the entire small bowel. In this study, we evaluated the accuracy of CE and interobserver agreement in recognizing villous atrophy (VA) using histopathology as the reference. We also explored the extent of small bowel involvement with CD and the relationship between the length of the affected bowel and the clinical presentation. METHODS: Ten CD patients with histologically proven VA and the same number of controls were subjected to CE. Four, blinded to histology findings, investigators (two with and two without prestudy CE experience) were asked to diagnose VA on CE images. RESULTS: Based on assessment of all four investigators, the overall sensitivity, specificity, PPV, and NPV of CE in diagnosing VA were 70%, 100%, 100%, and 77%, respectively. The sensitivity and the specificity of the test was 100% when the reports of experienced capsule endoscopists only were analyzed. The interobserver agreement was perfect (kappa= 1.0) between investigators with prestudy CE experience and poor (kappa= 0.2) between the investigators who had limited prestudy exposure to CE. Celiac patients with extensive small bowel involvement had typical symptoms of malabsorption (diarrhea, weight loss) as opposed to mild and nonspecific symptoms in patients whose disease was limited to the proximal small bowel. CE was tolerated well by all study participants with 95% reporting absence of any discomfort. CONCLUSIONS: Although based on a small sample size, the study suggests that CE may be useful in assessing patients with CD. Familiarity with CE technology appears to be a critical factor affecting the accuracy of the test. Larger studies are warranted to more precisely define the advantages and limitations of CE in CD.

Atrophy↗
PubMed2006

Diagnosis and outcome of small bowel tumors found by capsule endoscopy: a three-center Australian experience.

OBJECTIVE: The objective of the study was to examine diagnosis and outcome in a series of patients with small bowel tumors detected by capsule endoscopy (CE) in three Australian centers. METHODS: Review of prospectively collected data from 416 CEs identified 27 tumors in 26 patients. Clinical parameters, tumor histology, and follow-up are reported. RESULTS: Twenty-seven tumors were identified in 26 patients (mean age 61 +/- 13.7 yr). Indications for CE were obscure gastrointestinal (GI) bleeding (21), suspected tumor (3), abdominal pain (1), diarrhea (1). Prior radiology found a possible lesion in 8 of 23 (35%). Nine tumors were proven benign: hamartoma (4), cystic lymphangioma (1), primary amyloid (1), lipoma (1). Two lesions were non-neoplastic: heterotopic gastric mucosa and inflammatory fibroid polyp. Seventeen tumors were malignant: five adenocarcinomas, six carcinoids, two melanoma metastases, two gastrointestinal stromal tumors (GIST), one colon carcinoma metastasis, one non-Hodgkin's lymphoma. Tumors were surgically resected in 23 patients. Resection was considered curative in 12 (52%). Mean duration of follow-up was 26 +/- 13.7 months. Of the five patients with primary adenocarcinoma only one remains disease free. Three of the six with carcinoid tumors have had no recurrence up to 51 months postresection. Both patients with GIST are disease free. Anemia resolved after surgery in the patients with melanoma. CONCLUSIONS: Small bowel tumors are a significant finding at CE and are often missed by other methods of investigation. In many patients, detection of a tumor alters management and improves outcome. Even in malignant lesions, treatment is potentially curative in the absence of metastatic disease.

Adult↗
PubMed2006

Application of capsule endoscopy in small intestine diseases: analysis of 28 cases in Kaohsiung Medical University Hospital.

Capsule endoscopy (CE) is used to diagnose small intestine disease. Many studies have shown a better lesion detection rate in obscure gastrointestinal (GI) bleeding than with other surveyed techniques. Our study investigates the diagnostic value of CE in patients with suspicious small intestine diseases. Between October 2004 and January 2006, patients who had suspected small intestine disease underwent CE in Kaohsiung Medical University Hospital. Presenting symptoms included obscure GI bleeding, abdominal pain, diarrhea, microcytic anemia, and other indications. CE results were analyzed as a proportion of total lesion detection rate and also with regard to obscure GI bleeding and abdominal pain for analysis. A total of 28 patients, including 12 males and 16 females, were enrolled for CE examination. Overall, small intestine lesions were detected in 20 cases (71.4%), with negative findings in eight cases. For obscure GI bleeding, the total lesion detection rate was 85.7% (12 of 14 patients) but the diagnostic rate was only 35.7% (five of 14 cases). In patients with abdominal pain, four of seven (57.1%) had small intestine lesions. In conclusion, CE survey has a good lesion detection rate for small intestine disease, especially for patients with obscure GI bleeding, and is helpful in the diagnosis of unexplained abdominal pain.

Abdominal Pain↗
PubMed2002

Role of capsule endoscopy in the management of patients with obscure gastrointestinal bleeding.

The recent emergence of capsule endoscopy has entailed a relevant diagnostic imaging advance for gastrointestinal conditions, especially those involving the small bowel. Gastrointestinal haemorrhage of obscure origin is probably the most widely accepted indication for this new technique, and promising results have been reported from series extant to date. In view of data available on this new modality, and looking forward to having wide, well designed studies fr corroboration, this paper suggests a tentative algorithm for the management of this patient group.

Algorithms↗
PubMed2005

Feasibility and diagnostic utility of video capsule endoscopy for the detection of small bowel polyps in patients with hereditary polyposis syndromes.

OBJECTIVES: At present, surveillance of premalignant small bowel polyps in hereditary polyposis syndromes has a number of limitations. Capsule endoscopy (CE) is a promising new method to endoscopically assess the entire length of the small bowel. METHODS: We prospectively examined 40 patients with hereditary polyposis syndromes (29 familial adenomatous polyposis (FAP), 11 Peutz-Jeghers syndrome (PJS)). Results were compared with push-enteroscopy (PE) results in FAP and with esophagogastroduodenoscopy, PE, (MR)-enteroclysis, and surgical specimen in PJS patients. RESULTS: A total of 76% of the patients with FAP with duodenal adenomas (n = 21) had additional adenomas in the proximal jejunum that could be detected by CE and PE. Moreover, 24% of these FAP patients had further polyps in the distal jejunum or ileum that could only be detected by CE. In contrast, in FAP patients without duodenal polyps (n = 8), jejunal or ileal polyps occurred rarely (12%). CE detected polyps in 10 of 11 patients with PJS, a rate superior to all other reference procedures employed. Importantly, the findings of CE had immediate impact on further clinical management in all PJS patients. CONCLUSIONS: Our results suggest that CE may be of clinical value in selected patients with FAP, whereas in PJS, CE could be used as first line surveillance procedure.

Adenomatous Polyposis Coli↗
PubMedDate not supplied

Capsule endoscopy examination of patients with obscure gastrointestinal bleeding: evaluation of clinical impact.

BACKGROUND: Wireless video capsule endoscopy (WVCE) has been reported to contribute to the diagnostic management of patients with obscure gastrointestinal bleeding (OGB). Nevertheless, clinical impact data is lacking. The aim of our study was to determine the clinical outcome of patients undergoing WVCE for OGB. PATIENTS AND METHODS: 38 patients who were referred for OGB and who underwent WVCE examination were included in this study. A questionnaire was sent to the referring doctors after the capsule investigation. The following items were investigated: the final diagnosis of OGB, treatment applied and clinical outcome. RESULTS: Data was recorded for 26 patients out of 38 (17F, 9M). The mean age was 63 years (range, 21-84). A positive finding was noted in 11 patients. Findings included small bowel lesions in 7 cases and gastroduodenal lesions in 4 cases. As a result of the capsule investigation, specific therapy was administered in 9 patients. Six of the 9 patients treated had no further anemia. Final diagnosis of OGB was in agreement with positive findings of WVCE in all these 11 patients. Among the 15 patients with a negative WVCE, 9 had a digestive lesion (3 small bowel lesions) as a final diagnosis. CONCLUSION: Patients with a positive result at WVCE had further intervention in 82% and were successfully treated in 67% of cases. We had no false positive results in this study, which suggest a high positive predictive value of WVCE. Moreover, negative WVCE had also an indirect clinical impact.

Adult↗
PubMed2004

Wireless capsule endoscopy for obscure gastrointestinal bleeding: a single-centre, one-year experience.

BACKGROUND: Wireless capsule endoscopy (CE) is increasingly being used in the investigation of obscure gastrointestinal (GI) bleeding, but some studies have found that many of the bleeding lesions recognized by this technique are within the reach of conventional endoscopy. METHODS: The results of CE performed in the authors' centre in a 12 month period for obscure GI bleeding were retrospectively reviewed. RESULTS: Of the 46 patients with obscure GI bleeding, CE found a definite or probable cause in 19 (41%) and a possible cause in another 10 (22%), with an overall diagnostic yield of 63%. One of these lesions was found to be within reach of conventional gastroscopy, two were within reach of push enteroscopy, four were within reach of colonoscopy and one was within reach of retrograde enteroscopy through a stoma. The percentage of patients with a bleeding source within reach of routine endoscopy but missed during pre-CE endoscopy was significantly higher for those patients having endoscopy only in the community (30% [eight of 27]) versus in the authors' centre (0% [zero of 19]). CONCLUSIONS: CE was valuable for diagnosing bleeding lesions not only within the small bowel, but also in the stomach and colon. However, "second-look" endoscopy may be considered before ordering CE for obscure GI bleeding when local expertise is available.

Adult↗
PubMed2006

Positive coeliac serology in irritable bowel syndrome patients with normal duodenal biopsies: Video capsule endoscopy findings and HLA-DQ typing may affect clinical management.

OBJECTIVES: To investigate a group of IBS patients (Rome criteria) with positive coeliac serology (EMA, TTG, IgG or IgA AGA) and normal small bowel biopsies. Video capsule endoscopy (VCE) findings of the small bowell were compared with DQ-typing. METHODS: Twenty-two patients with chronic abdominal pain (with or without diarrhea) and at least one positive result of any of the coeliac serological markers (AGA, TTG, EMA) and normal duodenal biopsy were enrolled and underwent VCE. Twelve healthy volunteers with VCE served as control group. Coeliac related HLA DQ2 or DQ8 markers were determined. RESULTS: 12/ 22 (55%) patients had small bowel abnormalities with VCE. No mucosal abnormalities were recognized in the control group (p = 0.002). Inflammatory changes were classified as moderate or pronounced. Eight patients (36%) had moderate changes and four patients (18%) demonstrated pronounced changes. Only 6 of the 21 IBS patients were positive for DQ2 and/or DQ8. CONCLUSIONS: The patients in this study fulfilled the diagnostic Rome criteria for Irritable Bowel Syndrome. We suggest that patients with positive coeliac serology and normal duodenal biopsies should undergo HLA typing. In patients positive for DQ2 and/or DQ8, a VCE should be performed. Patients with mucosal abnormalities compatible with CD should be considered as a group distinct from IBS patients and could be tested with gluten challenge or treated with a gluten free diet.

Adolescent↗
PubMed2007

A new approach to blue rubber bleb nevus syndrome: the role of capsule endoscopy and intra-operative enteroscopy.

Blue rubber bleb nevus syndrome (BRBNS) is a rare vascular malformation disorder with cutaneous and visceral lesions frequently associated with serious, even fatal bleeding and anemia. The syndrome is considered to be autosomaly predominantly inherited. Intra-operative enteroscopy (IOE) is the best method of identification of all lesions (particularly the small ones, less than 3 mm) and treatment by endoscopic electro-coagulation or surgical excision. Capsule wireless endoscopy is optimal for screening before the IOE and for monitoring the effect of therapy (in patients with BRBNS). We report two cases of BRBNS. Anemia, gastrointestinal bleeding, gastrointestinal malformations and multifocal venous malformations of the skin were present in both of our cases. Gastrointestinal lesions were identified by gastroscopy, colonoscopy and capsule endoscopy. The multiple venous malformations were treated partly by endoscopic electro-coagulation (lesions up to 4 mm in diameter) and by wedge resection. Both of our patients were 12-year-old girls at the time of operation. In the first patient 31 venous malformations of the small bowel were coagulated, two were resected by the surgeon. In the second patient 20 lesions were coagulated endoscopically and another 31 nevi were resected during an 8 h procedure. The first girl is doing fine 4 years after the procedure, the second was allowed home 2 weeks after the procedure in excellent condition. IOE is a unique method of small bowel investigation and concurrently provides a solution for pathological findings. Capsule endoscopy is a feasible non-invasive screening procedure. We believe that a radical eliminatory approach by means of combined surgery and IOE is indicated for the BRBNS to prevent ongoing gastrointestinal bleeding.

Arteriovenous Malformations↗
PubMed2005

Complications, limitations, and failures of capsule endoscopy: a review of 733 cases.

BACKGROUND: Although a variety of technical and clinical problems of capsule endoscopy have been reported, their incidence and clinical importance are unknown. The objective was to evaluate the incidence and the type of such events. METHODS: This was a retrospective analysis of 733 consecutive examinations at 4 large referral centers. The main outcome measurements were that the problems were classified as "technical," i.e., related to the functioning of the equipment, and "clinical," i.e., related to patient characteristics. For each type of event, the causes and the impact on the ability to reach a diagnosis were examined. RESULTS: A total of 183 problems were recorded in 174 patients (23.7%): one problem occurred in 165 patients, two in 9 patients. In 8.46% of patients, technical limitations or failures, or clinical complications prevented or hampered diagnosis. Technical problems (e.g., gaps in the recordings, short duration of capsule batteries, failure of downloading) occurred in the early phase of capsule use in 8.6% of examinations and prevented or hampered diagnosis in 2.9%. Clinical problems (difficulty/inability to swallow the capsule, incomplete small-bowel examination) occurred in 16.4% of examinations and hampered or prevented diagnosis in 6.4%. Capsule retention that required surgical or endoscopic retrieval occurred in 1.9% of cases. CONCLUSIONS: Technical problems were rare and hampered or prevented the diagnosis in a very small number of cases. The majority of clinical failures were related to an incomplete small-bowel examination.

Adolescent↗
PubMed2005

Does the "Suspected Blood Indicator" improve the detection of bleeding lesions by capsule endoscopy?

BACKGROUND: The "Suspected Blood Indicator" (SBI), a feature included in the software for interpretation of capsule endoscopy (CE), is designed to facilitate detection of bleeding lesions in the small bowel. This study evaluated the sensitivity and the specificity of the SBI in patients who underwent CE for obscure GI bleeding (OGIB). METHODS: CE recordings from patients with OGIB recruited in 7 centers were read by experts blinded to the red SBI tags. They classified lesions of interest as bleeding or as having a potential for bleeding that was high (P2), low (P1), or absent (P0). The SBI tags then were marked by a another investigator. Concordance was acknowledged when frames selected by the expert reader, and those tagged by the SBI had the same time code. RESULTS: A total of 156 recordings were evaluated. In 83, there was either no lesion (n = 71) or a P0 lesion (n = 12); these CE recordings were regarded as normal. Among the 73 abnormal recordings, 114 P2 and 92 P1 lesions were identified. A total of 154 red tags were analyzed. Sensitivity, specificity, and positive and negative predictive values of SBI were 37%, 59%, 50%, and 46%, respectively, for detection of the presence of a P2 or P1 lesion in front of a red tag. CONCLUSIONS: SBI-based detection of intestinal lesions with the potential for bleeding is of limited clinical value in practice and does not reduce the time required for interpretation of CE.

Endoscopes, Gastrointestinal↗