Gallbladder Cancer
Conditions
Keywords
gallbladder cancer, bisegmentectomy
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.
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.
Interventions
PROCEDUREwedge resection
The extent of hepatic resection is wedge resection of liver including gallbladder fossa
PROCEDUREbisegmentectomy
The extent of hepatic resection is 4b/5 bisegmentectomy of liver
Sponsors
Saint Vincent's Hospital, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rates | 1 year | 3year 5 year |
Countries
South Korea
Contacts
Primary ContactDong Do You, MD, PhD
Backup ContactKwang Yeol Paik, MD, PhD
Outcome results
None listed