Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding (PURASTAT)

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.

Study Overview

• Status: Recruiting
• Conditions: Duodenal Bleeding
• Intervention / Treatment: Procedure: duodenal mucosectomy; Procedure: ampullectomy

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 Type: Interventional
• Enrollment (Estimated): 234
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah LEBLANC, MD; Phone Number: +33 622222064; Email: sarahleblanc34@hotmail.com

Study Locations

• France
  • Lyon, France
    • Recruiting
    • Hopital Prive Jean Mermoz
    • Contact: Sarah LEBLANC, MD; Email: s.leblanc@gelmad.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group with PuraStat®; Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedure hemostasis at operator discretion and application of PuraStat®	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.
Active Comparator: Control Group; Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedural hemostasis at operator discretion	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 2022-A02660-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No