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NCT Number: NCT02920554

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

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.

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Catholic University of Korea St. Vincent's Hospital

Suwon, 16247, South Korea

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wedge resection

Procedure

The extent of hepatic resection is wedge resection of liver including gallbladder fossa

bisegmentectomy

Procedure

The extent of hepatic resection is 4b/5 bisegmentectomy of liver

Primary outcomes

  1. Survival rates

    Time frame: 1 year

    3year 5 year

Study contacts

Contact information is provided by the study sponsor or research team.

Dong Do You, MD, PhD

CONTACT

[email protected]

82-31-249-8303

Kwang Yeol Paik, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Saint Vincent's Hospital, Korea

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2030
Study completion
2030
First posted
Sep 30, 2016
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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