The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer Operation: Prospective Randomized Controlled Trial

Conditions
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Gallbladder Cancer

Intervention / Treatment
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* Procedure: wedge resection
* Procedure: bisegmentectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: wedge resection<br>The extent of hepatic resection is wedge resection of gallbladder fossa | Procedure: wedge resection<br>* The extent of hepatic resection is wedge resection of liver including gallbladder fossa<br>|
| Active Comparator: bisegmentectomy<br>The extent of hepatic resection is 4b/5 bisegmentectomy | Procedure: bisegmentectomy<br>* The extent of hepatic resection is 4b/5 bisegmentectomy of liver<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rates |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gallbladder cancer, bisegmentectomy