Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07268365

Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-12-05

72

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Upper gastrointestinal bleeding is a serious medical emergency with high risks and costs. This trial evaluates whether using a cap attached to the endoscope during upper endoscopy can improve the detection and treatment of bleeding sources that are difficult to see due to their location and movements during the procedure. Previous small cases showed that the cap may help expose bleeding areas better and allow quicker treatment. Participants are randomly assigned to receive either a standard upper endoscopy or an upper endoscopy with a cap attached. The cap aids in exploring hidden areas behind folds in the digestive tract. The study will compare these two approaches to see if the cap reduces procedure time and improves treatment success. During the study, participants will undergo endoscopy to identify and treat bleeding ulcers. Researchers will measure how long it takes to stop the bleeding, how well the bleeding site is seen, and the stability of the endoscope. Follow-up assessments will occur up to one month after the procedure to evaluate clinical and therapeutic success and monitor participant outcomes.

CONDITIONS

Brief Title

Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is older than 18 years
  • Suspected upper gastrointestinal bleeding with melena or hematemesis
  • Glasgow Blatchford score greater than 8
  • Planned upper gastroscopy at Amiens University Hospital
  • Willing to have follow-up at Amiens University Hospital
  • Presence of gastric or duodenal ulcer requiring endoscopic hemostasis (FORREST Ia, Ib, IIa, IIb)
  • No opposition to participation in the study
  • Not under guardianship or curatorship
Not Eligible

You will not qualify if you...

  • Clinical suspicion of portal hypertension
  • Known liver failure
  • Bleeding lesion located beyond the second part of the duodenum
  • Digestive bleeding related to varicose lesions (esophageal or gastric varices)
  • Bleeding associated with esophagitis
  • Bleeding associated with angiodysplasias

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants undergo upper endoscopy with or without an endoscopic cap to manage acute upper gastrointestinal bleeding.

1 procedure visit (in-person)

Follow-up

Duration - Up to 1 month

Participants are monitored for up to 1 month to assess outcomes such as hemostasis and clinical success after the procedure.

Follow-up visits as scheduled for up to 1 month

Trial Site Locations

Total: 1 location

1

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, France, 80000

Actively Recruiting

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Research Team

C

Clara YZET, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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