Treatment of Postsphincterotomy Bleeding With a Novel Self-assembling Peptide Hemostatic Gel.

Recruiting

• Conditions: Biliary Obstruction; Complication of Treatment
• Interventions: Device: A novel hemostatic agent (Purastat®)

• Registration Number: NCT05886127
• Lead Sponsor: General University Hospital, Prague

Brief Summary

The aim of this observational study is to evaluate safety and efficacy of a novel self-assembling peptide hemostatic gel in reduction of bleeding after endoscopic sphincterotomy during ERCP (endoscopic retrograde cholangiopancreatography )

Detailed Description

ERCP with sfincterotomy or precut is connected with procedural or/and postprocedural bleeding. Estimated risk of bleeding is from 2% to 10%. Procedural bleeding is usually managed by diluted epinephrine injection, balloon tamponade, hemoclip or fully covered metalic self-expanding stent placement. There is no standard preventive treatment for patients with higher risk of delayed post-sphincterotomy bleeding. PuraStat®, 3D Matrix Europe SAS, Caluire-et-Cuire, France) is synthetic self-assembling peptide haemostatic gel indicated to stop bleeding from small blood vessel or oozing from capillaries. Purastat® is easily aplicated through a catheter during the ERCP procedure and it is not significantly prolonging the procedure. The transparent gel is not compromising the endoscopic view and enables to continue in procedure if necessary.

All patients after ERCP sfincterotomy or precut will recieve Purastat® during the procedure Adverse events (bleeding, cholangoitis, pancreatitis) will be monitored during following 4 weeks (ambulatory after hospital discharge) This cohort will be compared to historical control, when Purastat® was not available tu use.

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-05-23
• Last Update Submitted: 2023-05-23
• Study First Posted: 2023-06-02
• Last Update Posted: 2023-06-02
• Primary Completion: 2023-07-31
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• . All patients indicated for ERCP with papilosphincterotomy or precut.
• Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria

• Known allergy to a novel hemostatic agent
• Gravidity
• Inability to sign informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing ERCP with papilosphincterotomy or precut	A novel hemostatic agent (Purastat®)	All patients after ERCP papilosphincterotomy or precut will receive a novel hemostatic agent (Purastat®)

Primary Outcome Measures

Name	Time	Method
Number of bleeding episodes after ERCP sfincterothomy or precut	One month

Secondary Outcome Measures

Name	Time	Method
Number of nonbleeding complications after ERCP sfincterothomy or precut	One month

Trial Locations

Locations (1)

Petr Hrabak; 🇨🇿 Prague, Czechia