Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

NCT05746884 | Recruiting

• 1 other identifier: 2022-A02660-43
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Duodenal Bleeding

Outcome Measures

Primary Outcomes (1)

• Bleeding rate requiring further intervention within 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)

  30 days

Study Arms (2)

Experimental Group with PuraStat®

EXPERIMENTAL

Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedure hemostasis at operator discretion and application of PuraStat®

Procedure: duodenal mucosectomy; Procedure: ampullectomy

Control Group

ACTIVE COMPARATOR

Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedural hemostasis at operator discretion

Procedure: duodenal mucosectomy; Procedure: ampullectomy

Interventions

duodenal mucosectomy PROCEDURE

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

Control Group; Experimental Group with PuraStat®

ampullectomy PROCEDURE

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

Control Group; Experimental Group with PuraStat®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Patient not benefiting from a social security scheme.

Sponsors & Collaborators

• Euraxi Pharma: collaborator
• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, France

RECRUITING

Central Study Contacts

Sarah LEBLANC, MD

CONTACT

622222064; sarahleblanc34@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind, controlled, comparative, randomized, multicentre, international post-marketing follow-up study of a CE marked medical device.

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 28, 2023
• Study Start: August 21, 2023
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)