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

Saint Vincent's Hospital, Korea

Status: Enrolling

Conditions: Gallbladder Cancer

Treatments: Procedure: wedge resection; Procedure: bisegmentectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02920554

XC14EIMI0009V

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

wedge resection

Active Comparator group

Description:

The extent of hepatic resection is wedge resection of gallbladder fossa

Treatment:

Procedure: wedge resection

bisegmentectomy

Active Comparator group

Description:

The extent of hepatic resection is 4b/5 bisegmentectomy

Treatment:

Procedure: bisegmentectomy