Effectiveness Study of the BioVac Direct Suction Device in Upper Gastrointestinal Bleeding

Does the BioVac Direct Suction Device Increase Identification of the Bleeding Source in Upper Gastrointestinal Bleeding: a Randomized Clinical Trial

Upper endoscopy is performed for upper gastrointestinal bleeding (bleeding in the esophagus, stomach, or part of the duodenum) to identify and potentially treat the cause of bleeding. However, blood clots often make visualization difficult during endoscopy. The current practice is to try to wash off and suction up these blood clots with the endoscope. However, this is often not successful due to blood clots blocking the suction channel.

A new device has been approved by Health Canada that attaches to the endoscope and helps prevent blockage. It is believed that this device will help doctors suck out blood clots and potentially improve visualization, identification of the cause of bleeding, and possibly health outcomes, although this has never been proven. The purpose of the this clinical trial is to test whether the device works and whether it can help patients with this type of bleeding.

Study Overview

• Status: Terminated
• Conditions: Gastrointestinal Hemorrhage
• Intervention / Treatment: Device: BioVac Direct Suction Device; Device: Standard Endoscopy Suction

Detailed Description

STUDY DESIGN:

This is a randomized double blind clinical trial of the BioVac suction device versus standard endoscopy suction for UGIB. The study will be performed at London Health Sciences Center Victoria Campus and University Campus with an anticipated recruitment period of 2.5 years.

STUDY POPULATION:

All patients over the age of 18 admitted to hospital with a diagnosis of UGIB will be considered for recruitment. Patients already admitted to hospital with another diagnosis who develop UGIB will also be included.

INTERVENTION:

Patients will undergo EGD for UGIB as per standard clinical practice. If the bleeding source is not found within the first 5 minutes (timer starts once EGD passes upper esophageal sphincter) due to blood clots, the patient may benefit from additional suctioning. The patient will be randomized in blocks of 2-6 stratified by site to either the BioVac device or endoscopy suction. Those randomized to the BioVac device will use it to irrigate and suction as much blood as possible until the bleeding source is found or until the endoscopist feels that additional time would not help. Those randomized to endoscopy suction will do the same without the BioVac device. Due to the suctioning power of the study device, a placebo is not possible. Our original intention was to record the endoscopy video to blindly assess the outcome. Unfortunately, this ended up not being possible for technical reasons.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Patients presenting with fresh blood hematemesis, coffee ground emesis, or melena
2. Patients with hematochezia and hypotension (systolic blood pressure < 90 mm Hg) or tachycardia (heart rate > 110 beats per minute)

Exclusion Criteria

1. Identification of a bleeding source within the first 5 minutes of the upper endoscopy or no blood seen in the upper GI tract as these patients do not require additional suctioning.
2. Age < 18.
3. No endoscopy was performed.
4. Endoscopy previously performed for current episode of UGIB.
5. Patients unable to consent and who do not have a substitute decision maker.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioVac Direct Suction Device; Experimental arm	Device: BioVac Direct Suction Device; The BioVac Direct Suction Device (US Endoscopy) is an endoscopic device that enhances the suction power of the gastroscope.
Active Comparator: Standard Endoscopy Suction; Control arm	Device: Standard Endoscopy Suction; Standard Endoscopy Suction refers to the suction provided on the gastroscope (Olympus EVIS EXERA III).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of cause of bleeding on upper endoscopy	The cause of bleeding will be classified by location (esophagus, stomach, duodenum) and etiology (inflammation, ulcer, mass, varices, angioectasia, Dieulafoy, other).	Once at the time of endoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Application of any endoscopic therapy	Treated as a dichotomous outcome (yes, no). Endoscopic therapy include injection, electrocautery, hemostatic clip, variceal banding, or Hemospray	Once at the time of endoscopy
Rebleeding	Rebleeding is defined to have occurred for any of the following: vomiting of fresh blood, shock (systolic blood pressure < 90 mm Hg or heart rate > 110 beats per minute) with melena after stabilization, or a drop in hemoglobin of > 20 g/L within 24 hours after a transfusion to a level > 70 g/L	Measured once 7 days after endoscopy
Transfusion requirement	Total number of units of blood transfused 7 days after endoscopy	Measured once 7 days after endoscopy
Length of hospital stay		Measured once 30 days after endoscopy
Need for interventional radiology or surgery		Measured once 30 days after endoscopy
30 day mortality		Measured once 30 days after endoscopy
Need for repeat EGD within 72 hours		Measured once 7 days after endoscopy
Procedure duration		Once at the time of endoscopy video review

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure related adverse events	Adverse events related to the EGD will be noted, including intraprocedural hypotension, oxygen desaturation, aspiration, and perforation.	Measured once 48 hours after endoscopy

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Michael SL Sey, MD, London Health Sciences Centre-Victoria Campus, Western University

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: May 29, 2014
• First Posted (Estimate): May 30, 2014

Study Record Updates

• Last Update Posted (Estimate): November 15, 2016
• Last Update Submitted That Met QC Criteria: November 14, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Endoscopy; Endoscopic Hemostasis; Upper gastrointestinal tract
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: 105394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided