An interventional study of wedge resection and bisegmentectomy in Gallbladder Cancer, sponsored by Saint Vincent's Hospital, Korea. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by Saint Vincent's Hospital, Korea · Not applicable, Interventional, and Treatment
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.
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.
255 studies on the registry are indexed under Gallbladder Neoplasms; 61 are open to participants now.
This study's planned enrollment of 88 is above the median of 56 across 190 interventional studies indexed under Gallbladder Neoplasms.
Browse Gallbladder Neoplasms studies →Saint Vincent's Hospital, Korea is the lead sponsor of 20 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
The extent of hepatic resection is wedge resection of gallbladder fossa
Procedure: wedge resection
The extent of hepatic resection is 4b/5 bisegmentectomy
Procedure: bisegmentectomy
The extent of hepatic resection is wedge resection of liver including gallbladder fossa
The extent of hepatic resection is 4b/5 bisegmentectomy of liver
Survival rates
3year 5 year
Time frame: 1 year
Plan to share: Undecided
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Saint Vincent's Hospital, Korea