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A randomized controlled trial comparing efficacy of early video capsule endoscopy with standard of care in the approach to nonhematemesis GI bleeding (with videos).

ABSTRACT: BACKGROUND AND AIMS:Patients presenting with nonhematemesis GI bleeding (NHGIB) represent a diagnostic challenge for physicians. We performed a randomized controlled trial to assess the benefits of deployment of a video capsule soon after admission in the management of patients presenting with melena, hematochezia, or severe anemia compared with standard of care management. METHODS:Patients admitted with NHGIB were randomized and placed into 1 of 2 study groups. In the experimental group, patients ingested a video capsule soon after admission to the hospital. These patients had further endoscopic workup based on the findings from the capsule. Patients in the control group underwent endoscopic evaluation (ie, upper endoscopy, capsule endoscopy, and/or colonoscopy) to identify the source of bleeding as directed by the attending gastroenterologist's interpretation of their clinical presentation. The primary endpoint for this study was the rate of localization of bleeding during hospitalization. RESULTS:Eighty-seven patients were included in this study: 45 randomized to the standard of care arm and 42 to the early capsule arm. A bleeding source was localized in 64.3% of the patients in the early capsule arm and in 31.1% of the patients in the standard of care arm (P < .01). The likelihood of endoscopic localization of bleeding over time was greater for patients receiving early capsule endoscopy compared with those in the standard of care arm (adjusted hazard ratio, 2.77; 95% confidence interval, 1.36-5.64). CONCLUSIONS:For patients admitted to the hospital for NHGIB, early capsule endoscopy is a safe and effective alternative for the detection of the source of bleeding. (Clinical trial registration number: NCT02442830.).

SUBMITTER: Marya NB

PROVIDER: S-EPMC6501558 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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A randomized controlled trial comparing efficacy of early video capsule endoscopy with standard of care in the approach to nonhematemesis GI bleeding (with videos).

Marya Neil B NB Jawaid Salmaan S Foley Anne A Han Samuel S Patel Krunal K Maranda Louise L Kaufman Daniel D Bhattacharya Kanishka K Marshall Christopher C Tennyson Joseph J Cave David R DR

Gastrointestinal endoscopy 20180620 1

<h4>Background and aims</h4>Patients presenting with nonhematemesis GI bleeding (NHGIB) represent a diagnostic challenge for physicians. We performed a randomized controlled trial to assess the benefits of deployment of a video capsule soon after admission in the management of patients presenting with melena, hematochezia, or severe anemia compared with standard of care management.<h4>Methods</h4>Patients admitted with NHGIB were randomized and placed into 1 of 2 study groups. In the experimenta ...[more]

PMID: 29935143

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Project description:BackgroundVideo capsule endoscopy (VCE) is a commonly used test for the evaluation of obscure gastrointestinal bleeding. However, long-term outcomes of patients undergoing VCE are unclear.AimsTo evaluate the long-term outcomes in patients undergoing VCE for suspected obscure bleeding including iron deficiency anemia (IDA), and determine the need for additional intervention for persistence or recurrence of symptoms in patients with a diagnostic as well as non-diagnostic VCE.DesignRetrospective cohort study within a large county hospital system.MethodsWe collected information on indications and findings of VCE and outcomes including further testing, bleeding, and hemoglobin (Hgb) at last follow-up through structured review of the electronic health records. VCE findings were classified as active bleeding or high potential for bleeding (P2), intermediate potential (P1) or without any disruption of the mucosa, and no potential for bleeding (P0). We compared demographic and clinical characteristics between patients with and without normal Hgb at the time of last follow up.ResultsWe examined 116 patients who underwent VCEs performed for obscure gastrointestinal (GI) bleeding during 2010 to 2012 with mean duration of follow up after VCE completion of 571 days (standard deviation [SD]?=?248). Abnormal VCE findings (37.9% for P1 lesions, 44.8% for P2 lesions) were seen in 106 (87.9%) patients. Additional diagnostic testing was performed in 55/116 (47.4%) (67.7% GI procedures). Hgb was restored to normal range in 59/116 (50.9%) by end of follow up which were attributed to iron supplementation and/or discontinuation of non-steroidal anti-inflammatory drugs (NSAIDs) in a majority. Twenty six of 116 patients experienced rebleeding (22.4%).ConclusionsThe diagnostic yield of VCE is high among patients with obscure GI bleeding. More than 50% of patients achieve normal Hgb in the long term with conservative measures such as iron supplementation and the discontinuation of NSAIDs.

Project description:ImportanceEvaluation of acute gastrointestinal (GI) bleeding using invasive endoscopic procedures comprising the standard of care (SOC)-upper endoscopy and colonoscopy-can expose the endoscopy staff to SARS-CoV-2. Video capsule endoscopy (VCE) does not generate aerosols and only requires 1 person to manage the procedure.ObjectiveTo examine the safety of VCE for the initial evaluation of GI bleeding at the peak of the COVID-19 pandemic to identify signs of active bleeding while minimizing patient and personnel exposure, saving personal protective equipment, and avoiding invasive or unnecessary procedures.Design, setting, and participantsA multicenter (UMass Memorial Medical Center and Louisiana State University Health Sciences Center) retrospective cohort study including 146 patients with COVID-19 who received VCE as the first-line diagnostic modality was conducted from March 15 to June 15, 2020, compared with SOC in January 2020 for evaluation of GI bleeding. The association between treatment and outcomes was estimated using multivariable regression adjusting for potential confounders. Propensity score matching was used to verify the results.Main outcomes and measuresThe primary end point was detection of active bleeding or stigmata of recent bleeding. Secondary end points included the number of patients requiring any invasive procedures, number of additional procedures, rates of rebleeding and rehospitalization, transfusion requirements, and mortality.ResultsAmong 146 patients, 92 (63.0%) were men; mean (SD) age was 64.93 (14.13) years in the COVID-19 group and 61.33 (13.39) years in the SOC group. Active bleeding or stigmata of recent bleeding was observed in 44 (59.5%) patients in the COVID-19 group compared with 18 (25.0%) in the SOC group (adjusted odds ratio, 5.23; 95% CI, 2.23 to 12.27). Only 36 patients (48.7%) in the COVID-19 group required any invasive procedure during the hospitalization compared with 70 (97.2%) in the SOC group (adjusted odds ratio, 0.01; 95% CI, 0.001 to 0.08). The mean (SD) number of invasive procedures was 0.59 (0.77) per patient in the COVID-19 group compared with 1.18 (0.48) per patient in the SOC group (adjusted difference, -0.54; 95% CI, -0.77 to -0.31). Both approaches appeared to be safe and there was no significant difference in transfusion requirements, rebleeding, rehospitalization, or in-hospital mortality. No mortality was attributed to GI bleeding in either group.Conclusions and relevanceIn this cohort study, first-line diagnostic evaluation of acute GI bleeding using VCE appeared to be a safe and useful alternative to the traditional approach of upper endoscopy and colonoscopy. Use of VCE was associated with increased detection of active bleeding and a reduced number of invasive procedures and unnecessary exposure of personnel to SARS-CoV-2 and use of personal protective equipment.

Dataset Information

A randomized controlled trial comparing efficacy of early video capsule endoscopy with standard of care in the approach to nonhematemesis GI bleeding (with videos).

Publications

A randomized controlled trial comparing efficacy of early video capsule endoscopy with standard of care in the approach to nonhematemesis GI bleeding (with videos).

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