Prospective, multicenter randomized controlled trial of the self-assembling hemostatic gel PuraStat to prevent delayed bleeding after endoscopicresections

Not Applicable

• Conditions: K63.5; K31.7; Polyp of colon; Polyp of stomach and duodenum

• Registration Number: DRKS00028119
• Lead Sponsor: Asklepios Kliniken Hamburg GmbH Vertreten durch ASKLEPIOS proresearch Lohmühlenstraße 5 Haus J-D20099

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-30
• Study Completion: 2024-05-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

Age = 18 years
- Large (= 10mm in the duodenum or = 20mm in the colorectum) non-peduncled polyps deemed endoscopically resectable. Patients with more than one lesion can be included as long as the cumulative diameter of all resected lesions is no more than 100mm in the colorectum or 50mm in the duodenum. All lesions in the intervention group larger than 5mm must also be treated with PuraStat.
- Planned hot snare resection of the polyps (en bloc or piecemeal)
- Able and willing to give informed consent

Exclusion Criteria

- Planed Cold snare resection of the polyp
- Significantly impaired coagulation (Quick < 50 %, PTT > 50 sec., Platelet count < 50 /nl)
- Dual antiplatelet therapy
- Single antiplatelet therapy combined with plasmatic anticoagulant agents (Heparin, Direct oral Anticoagulants, Vitamin K Antagonists, etc.)
- Pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically relevant delayed bleeding (CRDB) within 30 days after endoscopic resection.<br>

Secondary Outcome Measures

Name	Time	Method
Individual components of the primary endpoint:<br>o CRDB-related transfusion of blood products<br>o CRDB-related unplanned endoscopy<br>o CRDB-related prolongation of hospital stay<br>o CRDB-related re-admission to hospital care.<br>· Other complications within 30 days after endoscopic resection (abdominal pain, fever,<br>perforation)<br>· Degree of wound healing of the mucosal defect and scarring of the initial resection site at followup<br>endoscopy*<br>· Recurrence of resected lesions at follow-up endoscopy*<br>* (scheduled 8 – 10 weeks after resection in keeping with current guideline recommendations)