Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2026-02-22 @ 12:03 AM
Study NCT ID:
NCT04147403
Status:
UNKNOWN
Last Update Posted:
2019-11-01
First Post:
2019-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Extended Total Mesopancreas Excision(eTME) for Pancreatic Head Adenocarcinoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2019-10-30', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'The overall survival data were defined by (date of death)-(date of first diagnosis).The survival status of patients were retrieved from follow-up.'}], 'secondaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '5 years', 'description': 'The overall survival data were defined by (date of recurrence/progression)-(date of surgery).During follow-up period, abdominal enhanced CT, chest X-ray, tumor markers and routine blood tests were carried out to evaluate recurrence/progression.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pancreatic head adenocarcinoma; total mesopancreas excision;pancreaticoduodenectomy'], 'conditions': ['Pancreas Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The study of extended total mesopancreas excision(eTME) for pancreatic head adenocarcinoma is a retrospective multicenter cohort, collecting medical records and follow-up data of patients who underwent radical resection with pancreatic head adenocarcinoma.', 'detailedDescription': 'The objectives of the study are as follows:\n\n1. To evaluate the perioperative safety of extended total mesopancreas excision(eTME) for patients who diagnosed with resectable pancreatic head adenocarcinoma.\n2. To demonstrate the prognosis of extended total mesopancreas excision(eTME) for patients who diagnosed with resectable pancreatic head adenocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with resectable pancreatic head adenocarcinoma who underwent radical resection between January 1st 2008 and October 31st 2018 in collaborated tertiary hospital hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with pancreatic head adenocarcinoma who underwent curative-intent resection.\n2. Patients with accessible medical records\n\nExclusion Criteria:\n\n1. Patients with unknown chemotherapy sequence or status\n2. Patients with history of previous malignant tumors\n3. Patients with distant metastases'}, 'identificationModule': {'nctId': 'NCT04147403', 'briefTitle': 'A Study of Extended Total Mesopancreas Excision(eTME) for Pancreatic Head Adenocarcinoma.', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine', 'orgStudyIdInfo': {'id': 'ETMEFP_LYB_2019'}}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Boyong Shen, Ph.D.', 'role': 'CONTACT'}], 'facility': 'Ruijin Hospital,Affiliated to Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenhui Lou, Ph.D.', 'role': 'CONTACT'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gang Jin, Ph.D.', 'role': 'CONTACT'}], 'facility': 'Changhai Hospital Affiliated to Naval Medical University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '20092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingbin Liu, Ph.D.', 'role': 'CONTACT', 'email': 'laoniulyb@163.com', 'phone': '+8613918803900'}], 'facility': 'Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yingbin Liu, Ph.D.', 'role': 'CONTACT', 'email': 'laoniulyb@163.com', 'phone': '+8613918803900'}], 'overallOfficials': [{'name': 'Yingbin Liu, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Yingbin Liu, MD, PhD, FACS', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}