Treatment of Postsphincterotomy Bleeding With a Novel Self-assembling Peptide Hemostatic Gel. (ERCPURA)
May 23, 2023 updated by: Petr Hrabak, General University Hospital, Prague
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
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 )
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Petr Hrabak, MD
- Phone Number: +420 224962580
- Email: petr.hrabak@vfn.cz
Study Locations
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-
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Prague, Czechia, 16000
- Recruiting
- Petr Hrabak
-
Contact:
- petr hrabak
- Phone Number: 224962580
- Email: petr.hrabak@vfn.cz
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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)
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients undergoing ERCP with papilosphincterotomy or precut
All patients after ERCP papilosphincterotomy or precut will receive a novel hemostatic agent (Purastat®)
|
A novel hemostatic agent (Purasta®) will be applied on cutted ampulla of Vater
|
|
Historical control
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?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of bleeding episodes after ERCP sfincterothomy or precut
Time Frame: One month
|
One month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of nonbleeding complications after ERCP sfincterothomy or precut
Time Frame: One month
|
One month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Petr Hrabak, General University Hospital in Prague
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Estimated)
July 31, 2023
Study Completion (Estimated)
October 30, 2023
Study Registration Dates
First Submitted
May 23, 2023
First Submitted That Met QC Criteria
May 23, 2023
First Posted (Estimated)
June 2, 2023
Study Record Updates
Last Update Posted (Estimated)
June 2, 2023
Last Update Submitted That Met QC Criteria
May 23, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERCP-PURA/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The results will be presented at Czech and Slovak gastroenterology meeting conference 2023 and in a peer-review journal.
IPD Sharing Time Frame
We expect the availibility of CSR at the beginning of 2024 and will be available for 3 years
IPD Sharing Access Criteria
The results will be available on request.
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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