The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: wedge resection, bisegmentectomy.
- Who it may be relevant to
- Registry conditions: Gallbladder Cancer. Basic parameters: 19 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer Operation: Prospective Randomized Controlled Trial
Overview
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.
Interventions
- Procedure wedge resection
The extent of hepatic resection is wedge resection of liver including gallbladder fossa - Procedure bisegmentectomy
The extent of hepatic resection is 4b/5 bisegmentectomy of liver
Primary outcome measures
- Survival rates [Time frame: 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- the Catholic University of Korea St. Vincent's Hospital — Suwon
Identifiers
NCT: NCT02920554 · XC14EIMI0009V