Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?

NCT07268365 | Recruiting

• 1 other identifier: PI2025_843_0158
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

High digestive bleeding (HDH) is a medical emergency associated with high morbidity and mortality rates and significant healthcare costs. Upper endoscopy can locate the bleeding and treat it. However, the source of bleeding can be difficult to identify, even for the most experienced endoscopists, due to the location of the bleeding (posterior wall of the bulb, gastric or duodenal folds, papillary region, esophagogastric junction), instability of the tube due to gastric and pyloric contractions and respiratory movements, leading to longer procedure times, hemostasis failure, or even the absence of bleeding visualization. The use of a cap attached to the endoscope facilitates exploration of blind areas of the colonic mucosa located behind folds, thus reducing the rate of missed polyps and cecal intubation time. To date, there is no study evaluating the systematic use of a cap in patients with suspected high digestive bleeding. A series of four cases demonstrated its benefit, allowing for better exposure of the bleeding lesion, better unfolding of intestinal folds, and thus a more effective and quicker hemostatic treatment.

Conditions

Cap-assisted Endoscopy; Upper Gastro Intestinal Bleeding; Endoscopy

Keywords

Cap-assisted endoscopy; upper gastro intestinal bleeding; endoscopy

Outcome Measures

Primary Outcomes (1)

• procedure time until endoscopic hemostasis is achieved

  procedure time until endoscopic hemostasis is achieved

  1 month

Secondary Outcomes (7)

• therapeutic success rate

  1 month

• clinical success rate

  1 month

• time until bleeding localization

  up to 1 month

• duration of hemostasis achievement

  up to 1 month

• endoscope stability

  up to 1 month

Study Arms (2)

standard upper endoscopy

ACTIVE COMPARATOR

standard upper endoscopy

Procedure: upper endoscopy

CAP

EXPERIMENTAL

upper endoscopy with the placement of an endoscopic cap

Procedure: upper endoscopy; Procedure: CAP

Interventions

upper endoscopy PROCEDURE

All patients with the inclusion criteria will be randomized (randomization 1:1) to undergo either an upper endoscopy with an endoscopic cap or without a cap

CAP; standard upper endoscopy

CAP PROCEDURE

All patients with the inclusion criteria will be randomized (randomization 1:1) to undergo either an upper endoscopy with an endoscopic cap or without a cap

CAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient \> 18 years old
• Upper GI bleeding suspected in presence of melena or hematemesis
• Glasgow Blatchford score \> 8
• Upper gastroscopy at Amiens University Hospital
• Follow-up at Amiens university hospital
• Presence of gastric or duodenal ulcer requiring endoscopic hemostasis (FORREST Ia, Ib, IIa, IIb)
• No opposition to the study
• No guardianship or curators

You may not qualify if:

• Patient with clinical suspicion of portal hypertension
• Known liver failure
• Patient with digestive hemorrhage related to a lesion located beyond the 2nd duodenum
• Patient with digestive hemorrhage related to a varicose lesion (esophageal or gastric varices)
• Patient with bleeding associated with esophagitis
• Patient with bleeding associated with angiodysplasias

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, 80000, France

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Clara YZET, MD

CONTACT

33+3 22 08 88 50; yzet.clara@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 5, 2025
• Study Start: October 16, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)