Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

Not Applicable

Recruiting

• Conditions: Duodenal Bleeding
• Interventions: Procedure: duodenal mucosectomy; Procedure: ampullectomy

• Registration Number: NCT05746884
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief 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.

Detailed Description

This is a post-marketing follow-up study of a CE marked medical device, controlled, comparative, randomized, multicentre, international single-blind.

The main objective is to evaluate the efficacy and safety of PuraStat in duodenal endoscopic mucosal resection or ampullectomy.

This study will be carried out in France in 3 investigative centers. The duration of patient participation in the study is approximately 37 days depending on the time between the selection and the endoscopic intervention.

Study Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-02-28
• Study Start: 2023-08-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

Ampullary lesions

• Single ampullary lesion ≥ 10mm
• Resection via hot ampullectomy, injection/Endoscopic mucosal resection of adjacent lateral spreading component Duodenal Lesions
• ≤ 2 lesions
• Lesion ≥15mm
• Resection via hot Endoscopic mucosal resection
• Morphology: 0-Is, 0-IIa/b/c or combination, submucosal lesions

Exclusion Criteria

• Inability to provide informed consent (including people with cognitive impairment);
• Pregnant or breastfeeding women;
• Allergy to PuraStat®;
• "Cold" mucosal endoscopic resection;
• Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
• Participating patient, or in a period of exclusion from another clinical trial;
• Patient not benefiting from a social security scheme.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	duodenal mucosectomy	Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedural hemostasis at operator discretion
Experimental Group with PuraStat®	duodenal mucosectomy	Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedure hemostasis at operator discretion and application of PuraStat®
Control Group	ampullectomy	Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedural hemostasis at operator discretion
Experimental Group with PuraStat®	ampullectomy	Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedure hemostasis at operator discretion and application of PuraStat®

Primary Outcome Measures

Name	Time	Method
Bleeding rate requiring further intervention within 30 days	30 days	Rate of clinically significant delayed postoperative bleeding requiring further intervention within 30 days (such as blood transfusion, packed cell transfusion or administration of other blood products, hospitalization or repeat endoscopy)

Trial Locations

Locations (1)

Hôpital Privé Jean Mermoz; 🇫🇷 Lyon, France