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A231 A RANDOMIZED CLINICAL TRIAL TO DETERMINE THE EFFICACY OF THE BIOVAC DIRECT SUCTION DEVICE DURING UPPER GASTROINTESTINAL BLEEDING: A FEASIBILITY ANALYSIS


ABSTRACT: Abstract Background Inadequate visualization during upper gastrointestinal bleeding (UGIB) is a common problem. The BioVac direct suction device is designed to enhance endoscopic suction to improve visualization. We initiated a randomized clinical trial to determine the efficacy of this device (NCT02150941). Aims In this report, we present the results of a feasibility analysis. Methods Between July 2014 and June 2016, patients admitted to two academic hospitals undergoing endoscopy for UGIB with suspicion of active bleeding (ie. fresh blood hematemesis, hemodynamic instability, acute drop in hemoglobin) were invited to participate. EGD was performed and patients where the source of bleeding was not found due to poor visualization after 5 minutes were randomized to BioVac or standard endoscopy suction. Due to the difference in suctioning power, a placebo was not possible. Instead, the procedure was recorded and assessed by a blinded outcome assessor. The procedure was otherwise performed at the discretion of the endoscopist without input from the study staff. The primary outcome was whether the bleeding source was found. Secondary outcomes included the mucosa visualization score, endoscopic therapy, need for repeat endoscopy within 7 days, rebleeding, and 30-day mortality. Results Over 24 months, a total of 70 subjects were recruited. 60 subjects were excluded due to the source of bleeding being found within the first 5 minutes or there being no blood in the upper GI tract. Of the 10 subjects randomized, 7 were assigned to standard endoscopy suction and 3 to BioVac. The mean (SD) age was 68.3 (13.4) and 30% were females. 60% presented with fresh blood hematemesis, 30% had a history of cirrhosis, 50% bled as an inpatient, and 60% had an ASA score of ?4. The source of bleeding was found in 66% in the BioVac group and 71% among the controls. The mean (SD) mucosal visualization score was 15.3 (2.6) for BioVac and 7.7 (3.3) for controls although there was no difference in the application of endoscopy therapy (33% in both groups). 33% in the BioVac group and 83% in the control group required a repeat endoscopy within 7 days. No patients rebleed or died in the BioVac group compared to 3 who rebleed and 4 who died in the control. Conclusions Study feasibility is hampered by low recruitment and high exclusion rates. A multi-centre approach to increase recruitment and the development of a better clinical prediction tool for active bleeding are required. Funding Agencies Vantage Endoscopy

SUBMITTER: Gregor H 

PROVIDER: S-EPMC6507613 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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