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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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Project description:BackgroundUpper gastrointestinal (GI) bleeding is one of the most common, high risk emergency disorders in the western world. Almost nothing has been reported on longer term prognosis following upper GI bleeding. The aim of this study was to establish mortality up to three years following hospital admission with upper GI bleeding and its relationship with aetiology, co-morbidities and socio-demographic factors.MethodsSystematic record linkage of hospital inpatient and mortality data for 14 212 people in Wales, UK, hospitalised with upper GI bleeding between 1999 and 2004 with three year follow-up to 2007. The main outcome measures were mortality rates, standardised mortality ratios (SMRs) and relative survival.ResultsMortality at three years was 36.7% overall, based on 5215 fatalities. It was highest for upper GI malignancy (95% died within three years) and varices (52%). Compared with the general population, mortality was increased 27-fold during the first month after admission. It fell to 4.3 by month four, but remained significantly elevated during every month throughout the three years following admission. The most important independent prognostic predictors of mortality at three years were older age (mortality increased 53 fold for people aged 85 years and over compared with those under 40 years); oesophageal and gastric/duodenal malignancy (48 and 32 respectively) and gastric varices aetiologies (2.8) when compared with other bleeds; non-upper GI malignancy, liver disease and renal failure co-morbidities (15, 7.9 and 3.9); social deprivation (29% increase for quintile V vs I); incident bleeds as an inpatient (31% vs admitted with bleeding) and male patients (25% vs female).ConclusionOur study shows a high late as well as early mortality for upper GI bleeding, with very poor longer term prognosis following bleeding due to malignancies and varices. Aetiologies with the worst prognosis were often associated with high levels of social deprivation.

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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

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