Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?

NCT ID: NCT07268365

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-16
• Study Completion Date: 2026-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

standard upper endoscopy

standard upper endoscopy

Group Type: ACTIVE_COMPARATOR

upper endoscopy

Intervention Type: 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

upper endoscopy with the placement of an endoscopic cap

Group Type: EXPERIMENTAL

upper endoscopy

Intervention Type: 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

Intervention Type: 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

Interventions

upper endoscopy

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

Intervention Type: PROCEDURE

CAP

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, France

Site Status: RECRUITING

Countries

France

Central Contacts

Clara YZET, MD

Role: CONTACT

yzet.clara@chu-amiens.fr

33+3 22 08 88 50

Facility Contacts

Clara Yzet, MD

Role: primary

yzet.clara@chu-amiens.fr

03 22 08 88 50

Other Identifiers

PI2025_843_0158

Identifier Type: -

Identifier Source: org_study_id