Early Videocapsule Endoscopy for Upper Gastrointestinal Bleeding

A Randomized Controlled Trial Evaluating the Efficacy of Early Videocapsule Endoscopy Following Negative Gastroscopy in Patients Presenting With Suspected Upper Gastrointestinal Bleeding

The objective of this study is to determine whether early video capsule endoscopy (VCE) immediately after a negative gastroscopy in the setting of suspected upper gastrointestinal bleeding (UGIB) improves patient outcomes as compared to the standard approach which typically involves performing colonoscopy prior to small bowel investigations. We aim to examine the differences in diagnostic yield, total number of procedures, length of hospitalization, mortality rates, and healthcare cost between the two groups.

Study Overview

• Status: Recruiting
• Conditions: Small Bowel Bleeding
• Intervention / Treatment: Procedure: Videocapsule endoscopy

Detailed Description

UGIB is common medical emergency with an annual hospitalization rate of 67 cases per 100,000 and costing in excess of 1 billion dollars in the US.1 In Alberta, Canada, annual incidence of UGIB due to peptic ulcers alone is between 35.4 to 41.2 cases per 100,000 with an overall in-hospital mortality rate of 8.5%.2 The presentation of acute UGIB are variable, but most have visible signs of bleeding such as hematemesis, coffee-ground-emesis or melena.3 Clinically, these findings are used to guide management plans. For instance, a patient with suspected UGIB based on clinical presentation will typically undergo gastroscopy as the initial diagnostic test.4,5 However, it is becoming increasingly clear that clinical signs of bleeding do not always correlate with location of bleeds. Despite melena being the most common presenting symptom for UGIB, more than 10% of melena arise from the small bowel or right colon.3,4 Similarly, 15% of hematochezia, which are thought to be signs of colonic bleeding, in fact have bleeding sources in the upper GI tract.6 In essence, bleeding can be anywhere along the gastrointestinal tract regardless of patient's presentation. This poses a significant challenge for clinicians in determining which investigations to pursue in patients with suspected UGIB after a negative gastroscopy. Currently, there are no clear guidelines on this subject matter.4,5 In clinical practice, such patients often undergo colonoscopy to rule out colonic sources of bleed, before small bowel investigations with cross-sectional imaging and VCE. This is a time-consuming approach that requires multiple invasive procedures, leading to patient discomfort, prolonged hospitalization, and increased cost. The utility of colonoscopy in suspected UGIB have also been questioned by previous study that reported a diagnostic yield of less than 5%.7 Furthermore, proceeding with colonoscopy first will cause delays in small bowel investigation which may lower the detection rate of small bowel lesions.8 With these in mind, we propose the study of an alternative diagnostic approach which prioritizes small bowel investigation over colonic investigation. We propose early VCE following negative gastroscopy instead of colonoscopy. VCE is a pill shaped camera that is well tolerated, non-invasive, and offers superior mucosal imaging of the small bowel compared to cross-sectional imaging in the setting of GI bleeding.9 This approach would likely have higher diagnostic yield than the traditional approach of conducting colonoscopy first.

At the present, patients with suspected UGIB and negative gastroscopy pose significant diagnostic challenges for clinicians. This study aims to help determine the importance of prioritizing small bowel investigation in this clinical setting. If this study can demonstrate the safety and efficacy of the early small bowel investigation, the results will fundamentally change the approach and management of patients with acute GI bleeding, potentially leading to better patient outcomes, reduced hospitalization, and healthcare savings.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergio Zepeda-Gomez, MD; Phone Number: 780-248-1578; Email: zepedago@ualberta.ca
• Study Contact Backup: Name: David Yang, MD; Phone Number: 647-502-7658; Email: dyyang@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Recruiting
      • University of Alberta Hospital
      • Contact: Sergio Zepeda-Gomez; Phone Number: 7802481578; Email: zepedago@ualberta.ca
      • Contact: David Yang; Phone Number: 6475027658; Email: dyyang@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years

• New onset of acute gastrointestinal bleeding defined as:

  1. The presence of melena/maroon stool on physical exam OR history of melena/maroon stool within 48 hours of emergency room presentation PLUS
  2. Hemoglobin drop of ≥ 20 g/L from patient's baseline
• Have capacity to consent
• Hemodynamically stable (i.e. blood pressure >100/60 or pulse <110 at the time of consent)
• Initial gastroscopy negative for active bleeding or potential bleeding source

Exclusion Criteria:

• Inability to provide consent due to lack of capacity, language barrier or other reasons
• Pregnant women
• Prior history of small bowel surgery
• Prior history of Crohn's disease
• Prior history of small bowel or colonic strictures
• Prior history of abdominal radiation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early small bowel investigation; Patients in the early small bowel investigation group will undergo VCE immediately after their initial negative gastroscopy	Procedure: Videocapsule endoscopy; Endoscopic drop of videocapsule in duodenum after initial negative gastroscopy
Active Comparator: Colonoscopy; Participants with negative gastroscopy will undergo bowel preparation and colonoscopy the next day	Procedure: Videocapsule endoscopy; Endoscopic drop of videocapsule in duodenum after initial negative gastroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield	Diagnostic yield of videocapsule endoscopy after initial negative gastroscopy	30 days
Diagnostic yield of colonoscopy after initial negative gastroscopy		30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Time from presentation to localization of bleeding source	30 days
Recurrence of bleeding	30 days
Length of stay in hospital	30 days
Adverse events in both groups	30 days

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: Pro00111216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No