Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-23 @ 3:37 AM
Study NCT ID:
NCT03081351
Status:
UNKNOWN
Last Update Posted:
2017-03-16
First Post:
2017-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended Retroperitoneal Lymphadenectomy and Nerve Plexus Clearance Versus Standard Lymphadenectomy in Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-10', 'studyFirstSubmitDate': '2017-03-05', 'studyFirstSubmitQcDate': '2017-03-10', 'lastUpdatePostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 100 months', 'description': 'The overall survival of the patients from the time of surgery until the date of pass-away.'}], 'secondaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': 'From date of randomization until the date of first documented progression( local recurrence or metastasis), assessed up to 100 months.', 'description': 'The time of the surgery until the date of the local recurrence or metastasis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extended retroperitoneal lymphadenectomy, Nerve plexus clearance, Survival benefit'], 'conditions': ['Pancreaticoduodenectomy']}, 'referencesModule': {'references': [{'pmid': '24368638', 'type': 'BACKGROUND', 'citation': 'Jang JY, Kang MJ, Heo JS, Choi SH, Choi DW, Park SJ, Han SS, Yoon DS, Yu HC, Kang KJ, Kim SG, Kim SW. A prospective randomized controlled study comparing outcomes of standard resection and extended resection, including dissection of the nerve plexus and various lymph nodes, in patients with pancreatic head cancer. Ann Surg. 2014 Apr;259(4):656-64. doi: 10.1097/SLA.0000000000000384.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial is about the survival benefit of extended lymphadenectomy and nerve clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic adenocarcinoma，which is a multicenter，prospective，ramdomized clinical trials.', 'detailedDescription': 'The purpose of this clinical trial is for assessing the survival benefit of extended lymphadenectomy and nerve clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic adenocarcinoma. And we will focus on the R0 resection using LEEPP(Leeds Pathology Protocol) methods to check whether the tumor is eradicated or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-70 years; Karnofsky performance\\>70; preoperative diagnosis as resectable pancreatic head cancer; patients' relative have signed consent form.\n\nExclusion Criteria:\n\n* also have severe cardiopulmonary disease, autoimmune disease, chronic renal failure disease; recurrent pancreatic tumor or unresectable tumor; benign pancreatic tumor; also have other malignant tumors."}, 'identificationModule': {'nctId': 'NCT03081351', 'briefTitle': 'Extended Retroperitoneal Lymphadenectomy and Nerve Plexus Clearance Versus Standard Lymphadenectomy in Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Extended Retroperitoneal Lymphadenectomy and Nerve Plexus Clearance Versus Standard Lymphadenectomy in Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head in a Chinese Population:A Multicenter, Open-label, Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': '20170305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'extended lymphadenectomy and nerve clearance', 'description': 'The investigators will implement the pancreaticoduodenectomy using the principle of "Total Peripancreas Excision" to resect the lymph node and nerve plexus. The lymph node include standard 5,6,8a,12b1,12b2,12c,12a-b,14a-b,17a-b and extended 8p,9,12a,12p,14a-d,16a2,16b1 of the abdominal lymph node.', 'interventionNames': ['Procedure: extended lymphadenectomy and nerve clearance']}, {'type': 'EXPERIMENTAL', 'label': 'standard lymphadenectomy', 'description': 'The investigators will implement the pancreaticoduodenectomy using the standard lymphadenectomy. The lymph node include 5,6,8a,12b1,12b2,12c,12a-b,14a-b,17a-b of the abdominal lymph node.', 'interventionNames': ['Procedure: standard lymphadenectomy']}], 'interventions': [{'name': 'extended lymphadenectomy and nerve clearance', 'type': 'PROCEDURE', 'description': 'The investigators will implement the pancreaticoduodenectomy using the principle of "Total Peripancreas Excision" to resect the lymph node and nerve plexus. The lymph node include standard 5,6,8a,12b1,12b2,12c,12a-b,14a-b,17a-b and extended 8p,9,12a,12p,14a-d,16a2,16b1 of the abdominal lymph node.', 'armGroupLabels': ['extended lymphadenectomy and nerve clearance']}, {'name': 'standard lymphadenectomy', 'type': 'PROCEDURE', 'description': 'The investigators will implement the pancreaticoduodenectomy using the standard lymphadenectomy. The lymph node include 5,6,8a,12b1,12b2,12c,12a-b,14a-b,17a-b of the abdominal lymph node.', 'armGroupLabels': ['standard lymphadenectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenhui Lou, MD', 'role': 'CONTACT', 'email': 'wenhuilou@aliyun.com', 'phone': '021-64041990', 'phoneExt': '3450'}, {'name': 'Wenchuan Wu, MD', 'role': 'CONTACT', 'email': 'wu.wenchuan@zs-hospital.sh.cn', 'phone': '021-64041990', 'phoneExt': '2909'}, {'name': 'Wenhui Lou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wenchuan Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yuan Fang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wenhui Lou, MD', 'role': 'CONTACT', 'email': 'lou.wenhui@zs-hospital.sh.cn', 'phone': '+8664041990', 'phoneExt': '2909'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Huashan Hospital', 'class': 'OTHER'}, {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'Changhai Hospital', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, {'name': "Jiangsu Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}