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

NCT ID: NCT02920554

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2030-12-31

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.

Conditions

Gallbladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

wedge resection

The extent of hepatic resection is wedge resection of gallbladder fossa

Group Type: ACTIVE_COMPARATOR

wedge resection

Intervention Type: PROCEDURE

The extent of hepatic resection is wedge resection of liver including gallbladder fossa

bisegmentectomy

The extent of hepatic resection is 4b/5 bisegmentectomy

Group Type: ACTIVE_COMPARATOR

bisegmentectomy

Intervention Type: PROCEDURE

The extent of hepatic resection is 4b/5 bisegmentectomy of liver

Interventions

wedge resection

The extent of hepatic resection is wedge resection of liver including gallbladder fossa

Intervention Type: PROCEDURE

bisegmentectomy

The extent of hepatic resection is 4b/5 bisegmentectomy of liver

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Vincent's Hospital, Korea

OTHER

Sponsor Role: lead

Responsible Party

YOU DONG DO

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong Do You, MD, PhD

Role: STUDY_DIRECTOR

the Catholic Universityof Korea St. Vincent's Hospital

Locations

the Catholic University of Korea St. Vincent's Hospital

Suwon, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Dong Do You, MD, PhD

Role: CONTACT

tzanggu@catholic.ac.kr

82-31-249-8303

Kwang Yeol Paik, MD, PhD

Role: CONTACT

kpaik@catholic.ac.kr

Other Identifiers

XC14EIMI0009V

Identifier Type: -

Identifier Source: org_study_id