Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-01-12 @ 6:37 AM
Study NCT ID:
NCT05886127
Status:
UNKNOWN
Last Update Posted:
2023-06-02
First Post:
2023-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Postsphincterotomy Bleeding With a Novel Self-assembling Peptide Hemostatic Gel.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of bleeding episodes after ERCP sfincterothomy or precut', 'timeFrame': 'One month'}], 'secondaryOutcomes': [{'measure': 'Number of nonbleeding complications after ERCP sfincterothomy or precut', 'timeFrame': 'One month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERCP', 'A novel haemostatic agent', 'Postsfincterothomy bleeding'], 'conditions': ['Biliary Obstruction', 'Complication of Treatment']}, 'referencesModule': {'references': [{'pmid': '2070995', 'type': 'BACKGROUND', 'citation': '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': '32679602', 'type': 'BACKGROUND', '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.'}, {'pmid': '32316041', 'type': 'BACKGROUND', '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.'}, {'pmid': '28545082', 'type': 'BACKGROUND', '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.'}, {'pmid': '19824118', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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 )', 'detailedDescription': '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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* . All patients indicated for ERCP with papilosphincterotomy or precut.\n* Participant is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Known allergy to a novel hemostatic agent\n* Gravidity\n* Inability to sign informed consent'}, 'identificationModule': {'nctId': 'NCT05886127', 'acronym': 'ERCPURA', 'briefTitle': 'Treatment of Postsphincterotomy Bleeding With a Novel Self-assembling Peptide Hemostatic Gel.', 'organization': {'class': 'OTHER', 'fullName': 'General University Hospital, Prague'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ERCP-PURA/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing ERCP with papilosphincterotomy or precut', 'description': 'All patients after ERCP papilosphincterotomy or precut will receive a novel hemostatic agent (Purastat®)', 'interventionNames': ['Device: A novel hemostatic agent (Purastat®)']}, {'label': 'Historical control', 'description': 'All patients who had ERCP with papilosphincterotomy or precut in the previous period, when a novel hemostatic gel (Purastat®) was not available.'}], 'interventions': [{'name': 'A novel hemostatic agent (Purastat®)', 'type': 'DEVICE', 'description': 'A novel hemostatic agent (Purasta®) will be applied on cutted ampulla of Vater', 'armGroupLabels': ['Patients undergoing ERCP with papilosphincterotomy or precut']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16000', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'petr hrabak', 'role': 'CONTACT', 'email': 'petr.hrabak@vfn.cz', 'phone': '224962580'}], 'facility': 'Petr Hrabak', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Petr Hrabak, MD', 'role': 'CONTACT', 'email': 'petr.hrabak@vfn.cz', 'phone': '224962580', 'phoneExt': '+420'}], 'overallOfficials': [{'name': 'Petr Hrabak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General University Hospital, Prague'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'We expect the availibility of CSR at the beginning of 2024 and will be available for 3 years', 'ipdSharing': 'YES', 'description': 'The results will be presented at Czech and Slovak gastroenterology meeting conference 2023 and in a peer-review journal.', 'accessCriteria': 'The results will be available on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General University Hospital, Prague', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Petr Hrabak', 'investigatorAffiliation': 'General University Hospital, Prague'}}}}