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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gallbladder Cancer
• Intervention / Treatment: Procedure: wedge resection; Procedure: bisegmentectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dong Do You, MD, PhD; Phone Number: 82-31-249-8303; Email: tzanggu@catholic.ac.kr
• Study Contact Backup: Name: Kwang Yeol Paik, MD, PhD; Email: kpaik@catholic.ac.kr

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of, 16247
    • Recruiting
    • The Catholic University Of Korea St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: wedge resection; The extent of hepatic resection is wedge resection of gallbladder fossa	Procedure: wedge resection; The extent of hepatic resection is wedge resection of liver including gallbladder fossa
Active Comparator: bisegmentectomy; The extent of hepatic resection is 4b/5 bisegmentectomy	Procedure: bisegmentectomy; The extent of hepatic resection is 4b/5 bisegmentectomy of liver

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rates	3year 5 year	1 year

Collaborators and Investigators

• Sponsor: Saint Vincent's Hospital, Korea
• Investigators: Study Director: Dong Do You, MD, PhD, the Catholic Universityof Korea St. Vincent's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: September 28, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimated): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: gallbladder cancer; bisegmentectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gallbladder Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms; Gallbladder Neoplasms
• Other Study ID Numbers: XC14EIMI0009V

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED