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

NCT05886127 | Unknown

• 1 other identifier: ERCP-PURA/1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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 )

Conditions

Biliary Obstruction; Complication of Treatment

Keywords

ERCP; A novel haemostatic agent; Postsfincterothomy bleeding

Outcome Measures

Primary Outcomes (1)

• Number of bleeding episodes after ERCP sfincterothomy or precut

  One month

Secondary Outcomes (1)

• Number of nonbleeding complications after ERCP sfincterothomy or precut

  One month

Study Arms (2)

Patients undergoing ERCP with papilosphincterotomy or precut

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

Device: A novel hemostatic agent (Purastat®)

Historical control

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

Interventions

A novel hemostatic agent (Purastat®) DEVICE

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

Patients undergoing ERCP with papilosphincterotomy or precut

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• General University Hospital, Prague: lead

Study Sites (1)

Petr Hrabak

Prague, 16000, Czechia

RECRUITING

Related 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.

  PMID: 2070995 BACKGROUND

• 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.

  PMID: 32679602 BACKGROUND

• 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.

  PMID: 32316041 BACKGROUND

• 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.

  PMID: 28545082 BACKGROUND

• 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.

  PMID: 19824118 BACKGROUND

Study Officials

• Petr Hrabak

  General University Hospital, Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petr Hrabak, MD

CONTACT

224962580; petr.hrabak@vfn.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: August 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: October 30, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: We expect the availibility of CSR at the beginning of 2024 and will be available for 3 years
• Access Criteria: The results will be available on request.

Locations

CZ (1)