Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-03-14 @ 4:03 AM
Study NCT ID:
NCT02920567
Status:
UNKNOWN
Last Update Posted:
2016-09-30
First Post:
2016-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-07-12', 'releaseDate': '2019-04-22'}], 'estimatedResultsFirstSubmitDate': '2019-04-22'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D015282', 'term': 'Octreotide'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 282}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-28', 'studyFirstSubmitDate': '2016-09-28', 'studyFirstSubmitQcDate': '2016-09-28', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of pancreatic secretion', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Rate of pancreatic fistula', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Periampullary Tumors']}, 'referencesModule': {'references': [{'pmid': '6128648', 'type': 'BACKGROUND', 'citation': 'Bauer W, Briner U, Doepfner W, Haller R, Huguenin R, Marbach P, Petcher TJ, Pless. SMS 201-995: a very potent and selective octapeptide analogue of somatostatin with prolonged action. Life Sci. 1982 Sep 13;31(11):1133-40. doi: 10.1016/0024-3205(82)90087-x.'}, {'pmid': '1733360', 'type': 'BACKGROUND', 'citation': 'Buchler M, Friess H, Klempa I, Hermanek P, Sulkowski U, Becker H, Schafmayer A, Baca I, Lorenz D, Meister R, et al. Role of octreotide in the prevention of postoperative complications following pancreatic resection. Am J Surg. 1992 Jan;163(1):125-30; discussion 130-1. doi: 10.1016/0002-9610(92)90264-r.'}, {'pmid': '2543144', 'type': 'BACKGROUND', 'citation': 'Di Carlo V, Chiesa R, Pontiroli AE, Carlucci M, Staudacher C, Zerbi A, Cristallo M, Braga M, Pozza G. Pancreatoduodenectomy with occlusion of the residual stump by Neoprene injection. World J Surg. 1989 Jan-Feb;13(1):105-10; discussion 110-1. doi: 10.1007/BF01671167.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide was injected subcutaneously every 8 hours for 7 days. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure and amounted.\n\nPrimary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.', 'detailedDescription': 'This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide of 100ug(1mL) was injected subcutaneously just before operation and every 8 hours for 7 days postoperatively. The placebo group was managed with normal saline (1mL) for same period. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure (Barovac) and amounted.\n\nPostoperative care of patients was same between groups such as pain control and supportive care. The amount of drained pancreatic juice via external stent was recorded everyday.\n\nPrimary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will undergo pancreatoduodenectomy for periampullary tumors\n\nExclusion Criteria:\n\n* Patients with preoperative pancreatitis\n* Patients who did not undergo pancreatoduodenectomy\n* Patients who underwent bypass surgery or total pancreatectomy\n* Patients who injection of octreotide less than 5 days'}, 'identificationModule': {'nctId': 'NCT02920567', 'briefTitle': 'Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion', 'organization': {'class': 'OTHER', 'fullName': "Saint Vincent's Hospital, Korea"}, 'officialTitle': 'Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion and Pancreatic Fistula After Pancreatoduodenectomy', 'orgStudyIdInfo': {'id': 'XC12MIMI0138V'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'octreotide', 'description': 'After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days', 'interventionNames': ['Drug: Octreotide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Octreotide', 'type': 'DRUG', 'otherNames': ['Treatment'], 'description': 'After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days', 'armGroupLabels': ['octreotide']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['control'], 'description': 'After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16247', 'city': 'Suwon', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': "the Catholic University of Korea St. Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'centralContacts': [{'name': 'Dong Do You, MD, PhD', 'role': 'CONTACT', 'email': 'tzanggu@catholic.ac.kr', 'phone': '82312498303'}, {'name': 'Kwang Yeol Paik, MD, Phd', 'role': 'CONTACT', 'email': 'kpaik@catholic.ac.kr'}], 'overallOfficials': [{'name': 'Dong Do You, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Catholic University of Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Saint Vincent's Hospital, Korea", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'YOU DONG DO', 'investigatorAffiliation': "Saint Vincent's Hospital, Korea"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-04-22', 'type': 'RELEASE'}, {'date': '2019-07-12', 'type': 'RESET'}], 'unpostedResponsibleParty': "YOU DONG DO, Associated Professor, Saint Vincent's Hospital, Korea"}}}}