Clinical trial NCT02150941: Effectiveness Study of the BioVac Direct Suction Device in Upper Gastrointestinal Bleeding
Official title: Does the BioVac Direct Suction Device Increase Identification of the Bleeding Source in Upper Gastrointestinal Bleeding: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastrointestinal Hemorrhage
Keywords: Upper gastrointestinal tract
Endoscopy
Endoscopic Hemostasis
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identification of cause of bleeding on upper endoscopy
timeFrame: Once at the time of endoscopy
Secondary outcomes:
measure: Application of any endoscopic therapy
timeFrame: Once at the time of endoscopy
measure: Rebleeding
timeFrame: Measured once 7 days after endoscopy
measure: Transfusion requirement
timeFrame: Measured once 7 days after endoscopy
measure: Length of hospital stay
timeFrame: Measured once 30 days after endoscopy
measure: Need for interventional radiology or surgery
timeFrame: Measured once 30 days after endoscopy
measure: 30 day mortality
timeFrame: Measured once 30 days after endoscopy
measure: Need for repeat EGD within 72 hours
timeFrame: Measured once 7 days after endoscopy
measure: Procedure duration
timeFrame: Once at the time of endoscopy video review
Other outcomes:
measure: Procedure related adverse events
timeFrame: Measured once 48 hours after endoscopy
Locations:
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
Study officials:
affiliation: London Health Sciences Centre-Victoria Campus, Western University
name: Michael SL Sey, MD
role: PRINCIPAL_INVESTIGATOR
References: