NCT05886127

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

Treatment of Immediate and Prevention of Delayed Bleeding After Endoscopic Retrograde Cholangiopancreatography Sphincterothomy or Precut With a Novel Self-assembling Peptide Hemostatic Gel. A Single Centre Prospective Observational Nonrandomized Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: General University Hospital, Prague · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Obstruction
• Complication of Treatment

Interventions

Type	Name	Description
DEVICE	A novel hemostatic agent (Purastat®)	A novel hemostatic agent (Purasta®) will be applied on cutted ampulla of Vater

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-07-31
• Completion: 2023-10-30
• First posted: 2023-06-02
• Last updated: 2023-06-02

Locations

1 site across 1 country: Czechia