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

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ClinicalTrials.gov Identifier: NCT02920554
Recruitment Status : Recruiting
First Posted : September 30, 2016
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
YOU DONG DO, Saint Vincent's Hospital, Korea

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2014
Estimated Primary Completion Date : June 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Survival rates [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920554


Contacts
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Contact: Dong Do You, MD, PhD 82-31-249-8303 tzanggu@catholic.ac.kr
Contact: Kwang Yeol Paik, MD, PhD kpaik@catholic.ac.kr

Locations
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Korea, Republic of
the Catholic University of Korea St. Vincent's Hospital Recruiting
Suwon, Korea, Republic of, 16247
Sponsors and Collaborators
Saint Vincent's Hospital, Korea
Investigators
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Study Director: Dong Do You, MD, PhD the Catholic Universityof Korea St. Vincent's Hospital

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Responsible Party: YOU DONG DO, Associated Professor, Saint Vincent's Hospital, Korea
ClinicalTrials.gov Identifier: NCT02920554     History of Changes
Other Study ID Numbers: XC14EIMI0009V
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by YOU DONG DO, Saint Vincent's Hospital, Korea:
gallbladder cancer
bisegmentectomy

Additional relevant MeSH terms:
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Gallbladder Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases