Using a haemostatic gel to prevent bleeding after duodenal surgery
Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
This study is testing a special gel to see if it can help prevent bleeding after surgery for advanced duodenal growths compared to regular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05746884 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a haemostatic gel, PuraStat, in reducing significant bleeding after endoscopic resection of advanced duodenal neoplasia compared to standard treatment. It is a multicentre, international, single-blind, randomized controlled trial conducted in France. Participants will undergo procedures such as duodenal mucosectomy or ampullectomy, with the study lasting approximately 37 days from selection to intervention. The primary focus is on the safety and efficacy of the gel in preventing the need for blood transfusions or hospital admissions due to bleeding.
Who should consider this trial
Good fit: Ideal candidates include patients with specific ampullary or duodenal lesions who are undergoing endoscopic resection.
Not a fit: Patients who are pregnant, breastfeeding, or have allergies to PuraStat will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of post-operative bleeding and improve patient outcomes after duodenal surgeries.
How similar studies have performed: While this approach is based on a CE marked medical device, the specific application in this context is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lyon
- Hôpital Privé Jean Mermoz — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Sarah LEBLANC, MD
- Email: sarahleblanc34@hotmail.com
- Phone: 622222064
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.