Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-01-28 @ 10:49 PM
Study NCT ID:
NCT03754595
Status:
UNKNOWN
Last Update Posted:
2018-11-27
First Post:
2018-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of 2D and 3D Laparoscopy in Laparoscopic Pancreaticoduodenectomy: a Prospective Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two parallel groups: 2DLaparoscopic pancreatoduodenectomy and 3DLaparoscopic pancreatoduodenectomy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-26', 'studyFirstSubmitDate': '2018-11-25', 'studyFirstSubmitQcDate': '2018-11-26', 'lastUpdatePostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Operative time', 'timeFrame': '12 hours', 'description': 'Durtion of operation'}, {'measure': 'Pancreatic fistula', 'timeFrame': 'Up to postoperative 30 days', 'description': "The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course."}], 'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '60 month', 'description': 'overall survival duration after surgical treatment'}], 'secondaryOutcomes': [{'measure': 'Overall complications', 'timeFrame': 'Up to postoperative 30 days', 'description': 'The proportion of all complications after operation accounted for the total number of patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['2D and 3D Laparoscopic pancreatoduodenectomy'], 'conditions': ['Pancreatoduodenectomy']}, 'descriptionModule': {'briefSummary': 'Pancreatic cancer is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Laparoscopic pancreatoduodenectomy is a standard radical procedure we are going to compare and discuss the advantages of 2D and 3D Laparoscopic pancreatoduodenectomy in our RCT study.', 'detailedDescription': 'This study is to compare the efficiency and safety between 2D laparoscopic pancreatoduodenectomy and 2D laparoscopic pancreaticoduodenectomy for pancreatic cancer. We design a prospective randomized study. Patients with malignant pancreatic tumor who underwent pancreatoduodenectomy are recruited to the study. After obtaining informed consent, eligible patients are randomly allocated to 2D laparoscopic or 3D laparoscopic group before the operation day . The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge: \\>18yr, \\<75yr Patients with pancreatic cancer or non-pancreatic cancers (biliary duct cancer or ampullary cancer) who underwent pancreatoduodenectomy Preoperative imaging assessment is resectable or borderline resectable -\n\nExclusion Criteria:\n\n\\- Benign tumors of the head of pancreas Enhanced CT diagnosis revealed that the excess of SMV was more than 180 degrees, or distant metastasis.\n\nconversion to laparotomy because of intraoperative difficulty'}, 'identificationModule': {'nctId': 'NCT03754595', 'briefTitle': 'Application of 2D and 3D Laparoscopy in Laparoscopic Pancreaticoduodenectomy: a Prospective Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Application of 2D and 3D Laparoscopy in Laparoscopic Pancreaticoduodenectomy: a Prospective Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'DaiMH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2D Laparoscopic pancreatoduodenectomy', 'description': 'Patients with pancreatic cancer treated by 2D Laparoscopic pancreatoduodenectomy', 'interventionNames': ['Procedure: 2D Laparoscopic pancreatoduodenectomy']}, {'type': 'EXPERIMENTAL', 'label': '3D Laparoscopic pancreatoduodenectomy', 'description': 'Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy', 'interventionNames': ['Procedure: 3D Laparoscopic pancreatoduodenectomy']}], 'interventions': [{'name': '3D Laparoscopic pancreatoduodenectomy', 'type': 'PROCEDURE', 'description': 'Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy', 'armGroupLabels': ['3D Laparoscopic pancreatoduodenectomy']}, {'name': '2D Laparoscopic pancreatoduodenectomy', 'type': 'PROCEDURE', 'description': '2D Laparoscopic pancreatoduodenectomy', 'armGroupLabels': ['2D Laparoscopic pancreatoduodenectomy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Cheng Ding, MD', 'role': 'CONTACT', 'email': 'dingcheng13@126.com', 'phone': '+861069152601'}], 'overallOfficials': [{'name': 'Menghua Dai, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking Union Medical Coll3ge hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}