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

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Duodenal Bleeding

Treatments: Procedure: ampullectomy; Procedure: duodenal mucosectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05746884

2022-A02660-43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 234 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

234 participants in 2 patient groups

Experimental Group with PuraStat®

Experimental group

Description:

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

Treatment:

Procedure: duodenal mucosectomy

Procedure: ampullectomy

Control Group

Active Comparator group

Description:

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

Treatment:

Procedure: duodenal mucosectomy

Procedure: ampullectomy