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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02920554
Other study ID # XC14EIMI0009V
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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