The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 28, 2016
CompletedFirst Posted
Study publicly available on registry
September 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
May 22, 2024
May 1, 2024
16.4 years
September 28, 2016
May 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival rates
3year 5 year
1 year
Study Arms (2)
wedge resection
ACTIVE COMPARATORThe extent of hepatic resection is wedge resection of gallbladder fossa
bisegmentectomy
ACTIVE COMPARATORThe extent of hepatic resection is 4b/5 bisegmentectomy
Interventions
The extent of hepatic resection is wedge resection of liver including gallbladder fossa
The extent of hepatic resection is 4b/5 bisegmentectomy of liver
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the Catholic University of Korea St. Vincent's Hospital
Suwon, 16247, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dong Do You, MD, PhD
the Catholic Universityof Korea St. Vincent's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
September 28, 2016
First Posted
September 30, 2016
Study Start
July 1, 2014
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
May 22, 2024
Record last verified: 2024-05