Robotic surgery for gallbladder cancer treatment
Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer - An International, Multi-centre, Single Blinded, Randomized Controlled Superiority Trial
This study is testing whether robotic surgery for gallbladder cancer helps patients recover faster and have fewer complications compared to traditional open surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06246448 on ClinicalTrials.gov |
What this trial studies
The Robocop trial is an international, multi-centre, single-blinded, randomized controlled trial comparing robotic-assisted radical cholecystectomy to open resection for patients with suspected or confirmed gallbladder cancer. Patients will be randomly assigned in a 1:1 ratio to either surgical approach within an enhanced recovery setting. The primary goal is to evaluate the time to functional recovery, while secondary outcomes include hospital stay duration, resection margins, lymph node retrieval, postoperative complications, quality of life, and associated costs.
Who should consider this trial
Good fit: Ideal candidates are patients with radiologically suspected or confirmed incidental gallbladder cancer who are fit for radical cholecystectomy.
Not a fit: Patients with previous extensive upper abdominal surgery, pregnancy, or intraoperative findings requiring different surgical approaches will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery times and improved outcomes for patients undergoing surgery for gallbladder cancer.
How similar studies have performed: Previous studies have shown promising results with robotic-assisted surgeries, suggesting potential benefits, although this specific approach is being tested for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with radiologically suspected or confirmed (≥T1b) incidental gallbladder cancer after cholecystectomy with an indication of radical cholecystectomy, without the need for resection of extrahepatic bile ducts, as decided at a multidisciplinary team conference. * Patient sufficiently fit to undergo radical cholecystectomy according to surgeon and anaesthesiologist. Exclusion Criteria: * Previous extensive surgery in the upper abdomen (for example open liver surgery) * Pregnancy * Intraoperative findings of dissemination (patient is then excluded after randomization) * Intraoperative findings of the need to perform resection of extrahepatic bile ducts (patient is then excluded after randomization). * Intraoperative findings leading to a simple cholecystectomy only (patient is then excluded after randomization)
Where this trial is running
Stockholm
- Region Stockholm — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Christian Sturesson, PhD — Region Stockholm, Stockholm, Sweden
- Study coordinator: Christian Sturesson, PhD
- Email: christian.sturesson@regionstockholm.se
- Phone: 0046812380000
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.