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

General University Hospital, Prague

Status: Enrolling

Conditions: Complication of Treatment; Biliary Obstruction

Treatments: Device: A novel hemostatic agent (Purastat®)

Study type: Observational

Funder types: Other

Identifiers

NCT05886127

ERCP-PURA/1

Details and patient eligibility

About

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 )

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Patients undergoing ERCP with papilosphincterotomy or precut

Description:

All patients after ERCP papilosphincterotomy or precut will receive a novel hemostatic agent (Purastat®)

Treatment:

Device: A novel hemostatic agent (Purastat®)

Historical control

Description:

All patients who had ERCP with papilosphincterotomy or precut in the previous period, when a novel hemostatic gel (Purastat®) was not available.