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

Sponsor

Saint Vincent's Hospital, Korea (Other)

Overall Status

Recruiting

CT.gov ID

NCT02920554

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gallbladder Cancer	Procedure: wedge resection Procedure: bisegmentectomy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Survival rates [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the Catholic University of Korea St. Vincent's Hospital	Suwon		Korea, Republic of	16247

Sponsors and Collaborators

Saint Vincent's Hospital, Korea

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

YOU DONG DO, Associated Professor, Saint Vincent's Hospital, Korea

ClinicalTrials.gov Identifier:

NCT02920554

Other Study ID Numbers:

XC14EIMI0009V

First Posted:

Sep 30, 2016

Last Update Posted:

Sep 30, 2016

Last Verified:

Sep 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by YOU DONG DO, Associated Professor, Saint Vincent's Hospital, Korea

gallbladder cancer

bisegmentectomy

Additional relevant MeSH terms:

Gallbladder Neoplasms

Study Results

No Results Posted as of Sep 30, 2016