Actively Recruiting
The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer Operation: Prospective Randomized Controlled Trial
Led by Saint Vincent's Hospital, Korea · Updated on 2024-05-22
88
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are comparing two types of liver surgery for patients with T2 or T3 gallbladder cancer. The study aims to evaluate and compare the rates of cancer recurrence and survival between patients undergoing wedge resection and those having 4b/5 bisegmentectomy. This trial involves patients identified through preoperative CT scans or those diagnosed after an initial simple gallbladder removal. Participants are randomly assigned to one of two surgery groups: wedge resection of the liver including the gallbladder fossa or 4b/5 bisegmentectomy of the liver. Apart from the extent of liver tissue removed, all other surgical procedures like lymph node dissection are performed the same for both groups. The study includes 88 patients, with 44 in each surgery group. During the study, researchers will monitor participants for cancer recurrence and overall survival rates, focusing on survival measured at one year. Patients will undergo standard follow-up care and assessments to track these outcomes. The study started in July 2014 and is planned to continue until December 2030.
CONDITIONS
Brief Title
The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with T2 or T3 gallbladder cancer on preoperative CT exam
- Patients pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy
You will not qualify if you...
- Presence of peritoneal seeding or distant metastasis
- Cancer cannot be completely removed by surgery
- Diagnosis of other malignancies such as adenosquamous carcinoma or sarcoma
- Pathologically diagnosed R1 or R2 resection
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Not specified
Participants undergo either wedge resection or bisegmentectomy of the liver as part of their surgical treatment for gallbladder cancer, followed by immediate post-operative care.
Duration - Up to 1 year
Participants are monitored after surgery to assess recurrence-free survival and overall survival rates.
Trial Site Locations
Total: 1 location
1
the Catholic University of Korea St. Vincent's Hospital
Suwon, South Korea, 16247
Actively Recruiting
Research Team
D
Dong Do You, MD, PhD
K
Kwang Yeol Paik, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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