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NCT Number: NCT07268365

Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?

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.

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Key information

Conditions

Cap-assisted Endoscopy Digestive System Diseases Endoscopy Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Upper Gastro Intestinal Bleeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, 80000, France

Location status: Recruiting

Location contact

Clara Yzet, MD

CONTACT

[email protected]

03 22 08 88 50

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. procedure time until endoscopic hemostasis is achieved

    Time frame: 1 month

    procedure time until endoscopic hemostasis is achieved

Secondary outcomes

  1. therapeutic success rate

    Time frame: 1 month

    therapeutic success rate

  2. clinical success rate

    Time frame: 1 month

    clinical success rate

  3. time until bleeding localization

    Time frame: up to 1 month

    time until bleeding localization

  4. duration of hemostasis achievement

    Time frame: up to 1 month

    duration of hemostasis achievement

  5. endoscope stability

    Time frame: up to 1 month

    assessment of endoscopist satisfaction in terms of endoscope stability

  6. lesion visualization

    Time frame: up to 1 month

    lesion visualization

  7. hemostasis

    Time frame: up to 1 month

    hemostasis

Study contacts

Contact information is provided by the study sponsor or research team.

Clara YZET, MD

CONTACT

[email protected]

33+3 22 08 88 50

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: CAP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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