The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer
Primary Purpose
Gallbladder Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
wedge resection
bisegmentectomy
Sponsored by
About this trial
This is an interventional treatment trial for Gallbladder Cancer focused on measuring gallbladder cancer, bisegmentectomy
Eligibility Criteria
Inclusion Criteria:
- Patients with T2 or T3 gallbladder cancer on preoperative CT exam
- Patients who are pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy
Exclusion Criteria:
- Peritoneal seeding or distant metastasis
- Impossible to resect the cancer radically
- Pathologically diagnosed to other malignancy such as adenosquamous carcinoma, sarcoma, etc.
- R1 or R2 resection were pathologically diagnosed.
Sites / Locations
- the Catholic University of Korea St. Vincent's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
wedge resection
bisegmentectomy
Arm Description
The extent of hepatic resection is wedge resection of gallbladder fossa
The extent of hepatic resection is 4b/5 bisegmentectomy
Outcomes
Primary Outcome Measures
Survival rates
Secondary Outcome Measures
Full Information
NCT ID
NCT02920554
First Posted
September 28, 2016
Last Updated
September 28, 2016
Sponsor
Saint Vincent's Hospital, Korea
1. Study Identification
Unique Protocol Identification Number
NCT02920554
Brief Title
The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer
Official Title
The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer Operation: Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Vincent's Hospital, Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The extent of hepatic resection for gallbladder cancer can be done from a wedge resection to 4b/5 bisegmentectomy. This study aims to compare the recurrence rates and survival rates between wedge resection group and bisegmentectomy group. Patients with T2 or T3 gallbladder cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy were enrolled. All patients are randomly assigned to wedge resection or bisegmentectomy group. Number of patients in each group is 44. Primary endpoint is recurrence-free-survival rates and overall survival rates.
Detailed Description
The extent of hepatic resection for gallbladder cancer has a wide range. A partial hepatectomy involving the gallbladder fossa is a critical part of the resection but can range from a wedge resection to an anatomic resection of segments 4b and 5 to an extended right hepatectomy. This study enrolls Patients with T2 or T3 gallbladder cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy. Eighty eight patients are randomized to wedge resection group or bisegmentectomy group. Except the extent of hepatic resection, all the procedures including hepatoduodenal,common hepatic, posterior pancreatic lymph node dissection are same.
Primary endpoint is recurrence-free-survival rates and overall survival rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Cancer
Keywords
gallbladder cancer, bisegmentectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
wedge resection
Arm Type
Active Comparator
Arm Description
The extent of hepatic resection is wedge resection of gallbladder fossa
Arm Title
bisegmentectomy
Arm Type
Active Comparator
Arm Description
The extent of hepatic resection is 4b/5 bisegmentectomy
Intervention Type
Procedure
Intervention Name(s)
wedge resection
Intervention Description
The extent of hepatic resection is wedge resection of liver including gallbladder fossa
Intervention Type
Procedure
Intervention Name(s)
bisegmentectomy
Intervention Description
The extent of hepatic resection is 4b/5 bisegmentectomy of liver
Primary Outcome Measure Information:
Title
Survival rates
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with T2 or T3 gallbladder cancer on preoperative CT exam
Patients who are pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy
Exclusion Criteria:
Peritoneal seeding or distant metastasis
Impossible to resect the cancer radically
Pathologically diagnosed to other malignancy such as adenosquamous carcinoma, sarcoma, etc.
R1 or R2 resection were pathologically diagnosed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Do You, MD, PhD
Phone
82-31-249-8303
Email
tzanggu@catholic.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Kwang Yeol Paik, MD, PhD
Email
kpaik@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Do You, MD, PhD
Organizational Affiliation
the Catholic Universityof Korea St. Vincent's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
the Catholic University of Korea St. Vincent's Hospital
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer
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