Clinical trial NCT05886127: Treatment of Postsphincterotomy Bleeding With a Novel Self-assembling Peptide Hemostatic Gel.
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biliary Obstruction
Complication of Treatment
Keywords: ERCP
A novel haemostatic agent
Postsfincterothomy bleeding
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients indicated for ERCP with sphincterotomy or precut at our endoscopy centre. Patients are mostly reffered from adjacent territory belonging to our hospital (non-selected cohort)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of bleeding episodes after ERCP sfincterothomy or precut
timeFrame: One month
Secondary outcomes:
measure: Number of nonbleeding complications after ERCP sfincterothomy or precut
timeFrame: One month
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Petr Hrabak
Study officials:
affiliation: General University Hospital, Prague
name: Petr Hrabak
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lin WC, Lin HH, Hung CY, Shih SC, Chu CH. Clinical endoscopic management and outcome of post-endoscopic sphincterotomy bleeding. PLoS One. 2017 May 17;12(5):e0177449. doi: 10.1371/journal.pone.0177449. eCollection 2017.
citation: Tsou YK, Lin CH, Liu NJ, Tang JH, Sung KF, Cheng CL, Lee CS. Treating delayed endoscopic sphincterotomy-induced bleeding: epinephrine injection with or without thermotherapy. World J Gastroenterol. 2009 Oct 14;15(38):4823-8. doi: 10.3748/wjg.15.4823.