Comparing two surgical methods for treating gallbladder cancer
The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer Operation: Prospective Randomized Controlled Trial
This study is testing which surgical method, wedge resection or bisegmentectomy, works better for people with T2 or T3 gallbladder cancer to see if it helps them live longer without the cancer coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Saint Vincent's Hospital, Korea Academic / other |
| Locations | 1 site (Suwon) |
| Trial ID | NCT02920554 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of wedge resection versus bisegmentectomy in patients with T2 or T3 gallbladder cancer. Patients are randomly assigned to one of the two surgical approaches, with a total of 88 participants. The primary focus is on evaluating recurrence-free survival rates and overall survival rates following the surgeries. Both procedures involve similar lymph node dissection techniques, ensuring that the only variable is the extent of liver resection performed.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with T2 or T3 gallbladder cancer who are eligible for surgical intervention.
Not a fit: Patients with peritoneal seeding, distant metastasis, or other malignancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the most effective surgical approach for improving survival rates in gallbladder cancer patients.
How similar studies have performed: Other studies have explored surgical approaches for gallbladder cancer, but this specific comparison of wedge resection and bisegmentectomy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Suwon
- the Catholic University of Korea St. Vincent's Hospital — Suwon, South Korea (Recruiting)
Study contacts
- Study coordinator: Dong Do You, MD, PhD
- Email: tzanggu@catholic.ac.kr
- Phone: 82-31-249-8303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.