Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-05 @ 6:25 PM
Study NCT ID:
NCT06190535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Administration of Etamsylate Reduce Postpancreatectomy Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004979', 'term': 'Ethamsylate'}], 'ancestors': [{'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2024-01-03', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of postoperative early (24-48 hours) digestive hemorrhage', 'timeFrame': '24-48 hours, postoperative day Day 1, Day 2', 'description': 'Blood in NT, hematemesis in the postoperative course'}], 'secondaryOutcomes': [{'measure': 'Operative mortality', 'timeFrame': '30 day', 'description': 'In hospital or 30 day mortality'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpancreatectomy Hemorrhage']}, 'descriptionModule': {'briefSummary': 'In several studies comparing the tow types of pancreato-digestive anastomosis: pancreatogastrostomy (PG) and pancreatojejunostomy (PJ), authors concluded that PG exposed to more postpancreatectomy hemorrhage (PPH) especially early, digestive and moderate hemorrhage classified as type A according to the classification of the ISGPS.\n\nIn this way we try to test the ability of the enteral administration through the nasogastric tube of Etamsylate for 48 hours after Whipple to reduce the rate of digestive PPH and mortality.', 'detailedDescription': 'Whipple procedure is usually performed for periampullary malignancies. If the mortality of this intervention has been markedly decreased, it persists a morbid one. Morbidity is mainly due to postoperative leak of the pancreato-digestive anastomosis or postoperative pancreatic fistula (POPF), but also to postpancreatectomy hemorrhage (PPH). In several studies comparing the tow types of pancreato-digestive anastomosis: pancreatogastrostomy (PG) and pancreatojejunostomy (PJ), authors concluded that PG exposed to more postpancreatectomy hemorrhage (PPH) especially early, digestive and moderate hemorrhage classified as type A according to the classification of the ISGPS. In this case of hemorrhage, blood generally comes from pancreatic stump which is anastomosed or telescoped in the stomac. Incomplete hemostasis , soft pancreatic tissue and vascular fragility can help PPH to occur.\n\nEtamsylate is an antihemorrhagic agent which works by increasing the resistance in the endothelium of capillaries and stimulating platelet adhesion. It also inhibits synthesis and action of prostaglandins causing platelet disaggregation, vasodilation and increased capillary permeability.\n\nIn this way, the investigators try to test the ability of the enteral administration through the nasogastric tube of Etamsylate for 48 hours after Whipple to reduce the rate of digestive PPH and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing Whipple procedure regardless the type of pathology and in which a PG is performed.\n\nExclusion Criteria:\n\n* Patients undergoing Whipple procedure regardless the type of pathology and in which a PJ is performed.'}, 'identificationModule': {'nctId': 'NCT06190535', 'acronym': 'PGPPH1', 'briefTitle': 'Can Administration of Etamsylate Reduce Postpancreatectomy Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'University of Sfax'}, 'officialTitle': 'Doses Systematic Per Oral Administration of Etamsylate Can Reduce Postpancreatectomy Hemorrhage From Pancreatic Stump in Pancreatogastrostomy', 'orgStudyIdInfo': {'id': 'PGPPH1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etamsylate +', 'description': 'Arm in which etamsylate (Dicynone injectable 250mg/2ml) is administrated through the nasogastric tube (NT) 2 ampules twice (X2)/day for 48 hours.', 'interventionNames': ['Drug: Etamsylate']}, {'type': 'NO_INTERVENTION', 'label': 'the standard postoperative treatment', 'description': 'Arm in which patients have the standard postoperative treatment'}], 'interventions': [{'name': 'Etamsylate', 'type': 'DRUG', 'description': 'Enteral administration of Etamsylate as solution galenic form', 'armGroupLabels': ['Etamsylate +']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3029', 'city': 'Sfax', 'country': 'Tunisia', 'contacts': [{'name': 'Ali Kchaou, MD', 'role': 'CONTACT', 'email': 'kchaouali179@gmail.com', 'phone': '0021622815765'}, {'name': 'Ahmed Tlili, MD', 'role': 'CONTACT', 'email': 'ahmed_wuchu@yahoo.fr', 'phone': '0021624101075'}], 'facility': 'Ali Kchaou', 'geoPoint': {'lat': 34.74056, 'lon': 10.76028}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sfax', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ali Kchaou MD FACS', 'investigatorFullName': 'Ali Kchaou', 'investigatorAffiliation': 'University of Sfax'}}}}