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Recruiting NCT07268365

Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?

No phase Interventional Cap-assisted Endoscopy Upper Gastro Intestinal Bleeding Endoscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: upper endoscopy, CAP.
Who it may be relevant to
Registry conditions: Cap-assisted Endoscopy, Upper Gastro Intestinal Bleeding, Endoscopy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • procedure time until endoscopic hemostasis is achieved [Time frame: 1 month]
Secondary outcome measures (7)
  • therapeutic success rate [Time frame: 1 month]
  • clinical success rate [Time frame: 1 month]
  • time until bleeding localization [Time frame: up to 1 month]
  • duration of hemostasis achievement [Time frame: up to 1 month]
  • endoscope stability [Time frame: up to 1 month]
  • lesion visualization [Time frame: up to 1 month]
  • hemostasis [Time frame: up to 1 month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Centre Hospitalier Universitaire d'Amiens — Amiens

Identifiers

NCT: NCT07268365 · PI2025_843_0158

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗