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

Last updated: May 20, 2024
Sponsor: Saint Vincent's Hospital, Korea
Overall Status: Active - Recruiting

Phase

N/A

Condition

Biliary Tract Cancer

Gall Bladder Disorders

Treatment

wedge resection

bisegmentectomy

Clinical Study ID

NCT02920554
XC14EIMI0009V
  • Ages 19-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with T2 or T3 gallbladder cancer on preoperative CT exam

  • Patients who are pathologically diagnosed as T2 or T3 gallbladder cancer afterinitial simple cholecystectomy

Exclusion

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

Total Participants: 88
Treatment Group(s): 2
Primary Treatment: wedge resection
Phase:
Study Start date:
July 01, 2014
Estimated Completion Date:
December 31, 2030

Study 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.

Connect with a study center

  • the Catholic University of Korea St. Vincent's Hospital

    Suwon, 16247
    Korea, Republic of

    Active - Recruiting

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