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

• ClinicalTrials.gov Identifier: NCT05746884
• Recruitment Status: Not yet recruiting
• First Posted: February 28, 2023
• Last Update Posted: February 28, 2023
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Information provided by (Responsible Party): GCS Ramsay Santé pour l'Enseignement et la Recherche

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Duodenal Bleeding	Procedure: duodenal mucosectomy; Procedure: ampullectomy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 234 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Single-blind, controlled, comparative, randomized, multicentre, international post-marketing follow-up study of a CE marked medical device.
• Masking: Single (Participant)
• Masking Description: single blind
• Primary Purpose: Treatment
• Official Title: Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
• Estimated Study Start Date: February 2023
• Estimated Primary Completion Date: September 2025
• Estimated Study Completion Date: September 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Bleeding rate requiring further intervention within 30 days [ Time Frame: 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)

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Sarah LEBLANC, MD; 622222064 ext +33; sarahleblanc34@hotmail.com

Sponsors and Collaborators

GCS Ramsay Santé pour l'Enseignement et la Recherche

More Information

• Responsible Party: GCS Ramsay Santé pour l'Enseignement et la Recherche
• ClinicalTrials.gov Identifier: NCT05746884
• Other Study ID Numbers: 2022-A02660-43
• First Posted: February 28, 2023
• Last Update Posted: February 28, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hemorrhage; Pathologic Processes