Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ? (CAP)

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.

Study Overview

• Status: Recruiting
• Conditions: Endoscopy; Cap-assisted Endoscopy; Upper Gastro Intestinal Bleeding
• Intervention / Treatment: Procedure: upper endoscopy; Procedure: CAP

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clara YZET, MD; Phone Number: 33+3 22 08 88 50; Email: yzet.clara@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80000
      • Recruiting
      • Centre Hospitalier Universitaire d'Amiens
      • Contact: Clara Yzet, MD; Phone Number: 03 22 08 88 50; Email: yzet.clara@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard upper endoscopy	Procedure: 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
Experimental: CAP; upper endoscopy with the placement of an endoscopic cap	Procedure: 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
procedure time until endoscopic hemostasis is achieved	procedure time until endoscopic hemostasis is achieved	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
therapeutic success rate	therapeutic success rate	1 month
clinical success rate	clinical success rate	1 month
time until bleeding localization	time until bleeding localization	up to 1 month
duration of hemostasis achievement	duration of hemostasis achievement	up to 1 month
endoscope stability	assessment of endoscopist satisfaction in terms of endoscope stability	up to 1 month
lesion visualization	lesion visualization	up to 1 month
hemostasis	hemostasis	up to 1 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: endoscopy; Cap-assisted endoscopy; upper gastro intestinal bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Pathological Conditions, Signs and Symptoms; Gastrointestinal Hemorrhage; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Gastroscopy
• Other Study ID Numbers: PI2025_843_0158

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