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

Biliary Obstruction Clinical Trial

— ERCPURA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05886127
• Other study ID #: ERCP-PURA/1
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: May 2023
• Source: General University Hospital, Prague
• Contact: Petr Hrabak, MD
• Phone: 224962580
• Email: petr.hrabak[@]vfn.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 )

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 30, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Obstruction
• Complication of Treatment
• Hemorrhage

Intervention

Device:
• A novel hemostatic agent (Purastat®)
A novel hemostatic agent (Purasta®) will be applied on cutted ampulla of Vater

Locations

Country	Name	City	State
Czechia	Petr Hrabak	Prague

Sponsors (1)

Lead Sponsor	Collaborator
General University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (5)

Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2. — View Citation

de Nucci G, Reati R, Arena I, Bezzio C, Devani M, Corte CD, Morganti D, Mandelli ED, Omazzi B, Redaelli D, Saibeni S, Dinelli M, Manes G. Efficacy of a novel self-assembling peptide hemostatic gel as rescue therapy for refractory acute gastrointestinal bleeding. Endoscopy. 2020 Sep;52(9):773-779. doi: 10.1055/a-1145-3412. Epub 2020 Apr 21. — View 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. — View Citation

Subramaniam S, Kandiah K, Chedgy F, Fogg C, Thayalasekaran S, Alkandari A, Baker-Moffatt M, Dash J, Lyons-Amos M, Longcroft-Wheaton G, Brown J, Bhandari P. A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial. Endoscopy. 2021 Jan;53(1):27-35. doi: 10.1055/a-1198-0558. Epub 2020 Jul 17. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of bleeding episodes after ERCP sfincterothomy or precut		One month
Secondary	Number of nonbleeding complications after ERCP sfincterothomy or precut		One month