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

Gallbladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02920554
• Other study ID #: XC14EIMI0009V
• Status: Recruiting
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 2030

Study information

• Verified date: May 2024
• Source: Saint Vincent's Hospital, Korea
• Contact: Dong Do You, MD, PhD
• Phone: 82-31-249-8303
• Email: tzanggu[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gallbladder Cancer
• Gallbladder Neoplasms

Intervention

Procedure:
• wedge resection
The extent of hepatic resection is wedge resection of liver including gallbladder fossa
• bisegmentectomy
The extent of hepatic resection is 4b/5 bisegmentectomy of liver

Locations

Country	Name	City	State
Korea, Republic of	the Catholic University of Korea St. Vincent's Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Saint Vincent's Hospital, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rates	3year 5 year	1 year