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Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

NCT05746884 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2026-02-27

No results posted yet for this study

Summary

The purpose of this study is to test whether prophylactic application of haemostatic gel will reduce the rate of clinically significant bleeding requiring intervention (such as blood transfusion, admission to hospital, other blood products) following endoscopic resection of advanced duodenal neoplasia compared to standard therapy.

Conditions

  • Duodenal Bleeding

Interventions

PROCEDURE

duodenal mucosectomy

Standard resection technique will be performed for duodenal mucosectomy, as well as the usual hemostasis at the discretion of the operator.

PROCEDURE

ampullectomy

Standard resection technique will be performed for ampullectomy, as well as the usual hemostasis at the discretion of the operator.

Sponsors & Collaborators

  • Euraxi Pharma

    collaborator INDUSTRY

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-21
Primary Completion
2028-09-30
Completion
2028-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05746884 on ClinicalTrials.gov