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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Biliary Obstruction, Complication of Treatment

Intervention / Treatment
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* Device: A novel hemostatic agent (Purastat®)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing ERCP with papilosphincterotomy or precut<br>All patients after ERCP papilosphincterotomy or precut will receive a novel hemostatic agent (Purastat®) | Device: A novel hemostatic agent (Purastat®)<br>* A novel hemostatic agent (Purasta®) will be applied on cutted ampulla of Vater<br>|
| Historical control<br>All patients who had ERCP with papilosphincterotomy or precut in the previous period, when a novel hemostatic gel (Purastat®) was not available. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bleeding episodes after ERCP sfincterothomy or precut |  | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of nonbleeding complications after ERCP sfincterothomy or precut |  | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, A novel haemostatic agent, Postsfincterothomy bleeding