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

Last updated: May 23, 2023
Sponsor: General University Hospital, Prague
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Disorders

Hemorrhage

Treatment

A novel hemostatic agent (Purastat®)

Clinical Study ID

NCT05886127
ERCP-PURA/1
  • Ages > 18
  • All Genders

Study 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 )

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: A novel hemostatic agent (Purastat®)
Phase:
Study Start date:
August 01, 2022
Estimated Completion Date:
October 30, 2023

Study 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.

Connect with a study center

  • Petr Hrabak

    Prague, 16000
    Czechia

    Active - Recruiting

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