Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-03-09 @ 11:10 AM
Study NCT ID:
NCT03722732
Status:
UNKNOWN
Last Update Posted:
2021-08-02
First Post:
2018-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016577', 'term': 'Pancreaticoduodenectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-30', 'studyFirstSubmitDate': '2018-10-02', 'studyFirstSubmitQcDate': '2018-10-25', 'lastUpdatePostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative blood loss in ml, quantitative', 'timeFrame': '24 hours', 'description': 'blood loss will be assessed with the help of a formula which uses preoperative and post operative hematocrit, blood volume and PCV'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periampullary Carcinoma']}, 'descriptionModule': {'briefSummary': 'the study is designed to compare the blood loss between laparoscopic vs open pancreaticoduodenectomy in a randomized clinical trial', 'detailedDescription': 'the study will assess the difference in the amount of blood loss in Lap vs Open WPD. the amount of blood loss will be calculated on the basis of a formula which takes pre operative and post operative hematocrit, PCV and blood volume into consideration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of both the sex aged between \\>18 years.\n2. Patients with a diagnosis of resectable periampullary carcinoma on imaging.\n3. Patients with ASA grade 1 or 2\n\nExclusion Criteria:\n\n* 1\\) Patients found to have unresectable disease on radiological investigation. 2) Patients with ASA grade 3 or above'}, 'identificationModule': {'nctId': 'NCT03722732', 'briefTitle': 'Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Govind Ballabh Pant Hospital'}, 'officialTitle': 'Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma - A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'F.1/IEC/MAMC/63/03/18/NO325'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Open pancreaticoduedenectomy', 'description': 'will include all the patients who will undergo open pancreaticoduodenectomy', 'interventionNames': ['Procedure: pancreaticoduodenectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic pancreaticoduodenectomy', 'description': 'will include all the patients undergoing laparoscopic pancreaticoduodenectomy', 'interventionNames': ['Procedure: pancreaticoduodenectomy']}], 'interventions': [{'name': 'pancreaticoduodenectomy', 'type': 'PROCEDURE', 'description': 'pancreaticoduodenectomy either laparoscopically or open will be done', 'armGroupLabels': ['Laparoscopic pancreaticoduodenectomy', 'Open pancreaticoduedenectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110002', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'hirdaya h nag, ms', 'role': 'CONTACT', 'email': 'hirdayanag@gmail.com', 'phone': '91 11 23234242', 'phoneExt': '5220'}, {'name': 'hirdaya h nag, ms', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'G B Pant Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'centralContacts': [{'name': 'H H Nag, MS', 'role': 'CONTACT', 'email': 'hirdayanag@gmail.com', 'phone': '9718599260'}, {'name': 'Aditya sharma, MCH resident', 'role': 'CONTACT', 'email': 'adi.mamc@gmail.com', 'phone': '9718599258'}], 'overallOfficials': [{'name': 'H H Nag, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GBPant Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Govind Ballabh Pant Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hirdaya H Nag, MS', 'investigatorAffiliation': 'Govind Ballabh Pant Hospital'}}}}