Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient > 18 years old

Upper GI bleeding suspected in presence of melena or hematemesis

Glasgow Blatchford score > 8

Upper gastroscopy at Amiens University Hospital

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • upper endoscopy

    Procedure/Surgery

    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/Surgery

    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

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: standard upper endoscopyActive comparator 1 intervention
Group B: CAPExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

procedure time until endoscopic hemostasis is achieved

procedure time until endoscopic hemostasis is achieved

Time frame
1 month

Secondary outcomes

1

therapeutic success rate

therapeutic success rate

Time frame
1 month
2

clinical success rate

clinical success rate

Time frame
1 month
3

time until bleeding localization

time until bleeding localization

Time frame
up to 1 month
4

duration of hemostasis achievement

duration of hemostasis achievement

Time frame
up to 1 month

Other outcomes

Sponsors and contacts

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