Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT05755594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-06
First Post:
2023-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Study on the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D003137', 'term': 'Common Bile Duct Diseases'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The way of surgery.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2031-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2023-02-23', 'studyFirstSubmitQcDate': '2023-02-23', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of long-term Survival', 'timeFrame': '3 years', 'description': 'survival will be documented 3 years after surgery'}], 'secondaryOutcomes': [{'measure': 'Unplanned re-admission rate after discharge within 30 days', 'timeFrame': '3 months', 'description': 'Serious discomfort requiring re-admission within 30 days after discharge will be recorded, and the safety of the surgical method will be evaluated by this indicator'}, {'measure': 'Incidence of postoperative complications', 'timeFrame': '2 months', 'description': 'During hospitalization, common complications of pancreaticoduodenectomy, such as postoperative pancreatic fistula, bile leak, gastrojejunostomy leak, and delayed gastric emptying, will be recorded according to the international diagnostic criteria to evaluate the short-term safety of this surgical approach'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Robot-assisted pancreaticoduodenectomy', 'Safety and Efficacy', 'randomized controlled trial'], 'conditions': ['Pancreatic Cancer', 'Common Bile Duct Diseases', 'Periampullary Carcinoma']}, 'descriptionModule': {'briefSummary': 'Further studies are needed to investigate the prognosis and perioperative safety of patients undergoing robotic-assisted pancreaticoduodenectomy. In this study, clinical data and prognostic data of patients undergoing this procedure were prospectively collected and analyzed to explore its safety and efficacy.', 'detailedDescription': 'Perioperative clinical data and prognostic data of patients undergoing robotic-assisted pancreaticoduodenectomy were collected and analyzed to explore the safety and efficacy of this surgical approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years old\n* Preoperative imaging suggested the presence of space occupying in the head of the pancreas, ampullary abdomen, and distal common bile duct tumor lesions to be treated with Pancreaticoduodenectomy\n* No distant transfer\n* No significant vascular invasion was received\n\nExclusion Criteria:\n\n* With tumors of other organs\n* Patients unable to tolerate anesthesia and operation due to serious abnormalities in functions of heart, lung and other important organs\n* Patients found intraoperative peripheral organ metastasis combined with excision of other organs or found intraoperative radical excision could not be performed and underwent palliative drainage surgery or end the surgery\n* Preoperative adjuvant therapy was given'}, 'identificationModule': {'nctId': 'NCT05755594', 'briefTitle': 'A Prospective Study on the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of University of South China'}, 'officialTitle': 'A Prospective Study on the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy', 'orgStudyIdInfo': {'id': 'USC-4310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Robot-assisted Pancreaticoduodenectomy', 'description': 'By performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci robotic surgical system and assisted by another surgeon for the entire procedure', 'interventionNames': ['Procedure: Robot-assisted Pancreaticoduodenectomy']}], 'interventions': [{'name': 'Robot-assisted Pancreaticoduodenectomy', 'type': 'PROCEDURE', 'description': 'By performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci robotic surgical system and assisted by another surgeon for the entire procedure', 'armGroupLabels': ['Robot-assisted Pancreaticoduodenectomy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Guodong Chen, PhD', 'role': 'CONTACT', 'email': 'Chenguodong@usc.edu.cn', 'phone': '(+86)15211450345'}, {'name': 'Danjun Chen, PhD', 'role': 'CONTACT', 'email': 'nhfykyb@163.com', 'phone': '(+86)13789353900'}], 'overallOfficials': [{'name': 'Guodong Chen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of University of South China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of University of South China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}