Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Duodenal Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

single blind

Study Groups

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Experimental Group with PuraStat®

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

Group Type EXPERIMENTAL

duodenal mucosectomy

Intervention Type PROCEDURE

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

ampullectomy

Intervention Type PROCEDURE

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

Control Group

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

Group Type ACTIVE_COMPARATOR

duodenal mucosectomy

Intervention Type PROCEDURE

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

ampullectomy

Intervention Type PROCEDURE

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

Interventions

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duodenal mucosectomy

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

Intervention Type PROCEDURE

ampullectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No