NCT06246448 Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer (ROBOCOP)
| NCT ID | NCT06246448 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska University Hospital |
| Condition | Gall Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2024-01-23 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 94 participants in total. It began in 2024-01-23 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Robocop trial is an international multi-centre, single blinded, randomized controlled superiority trial conducted in centres experienced in robotic-assisted liver surgery. Eligible patients for radical cholecystectomy will be randomized in a 1:1 ratio to undergo robotic-assisted or open resection within an enhanced recovery setting. The primary endpoint is time to functional recovery. Secondary endpoints include length of hospital stay, resection margin, number of retrieved lymph nodes, postoperative complications, quality of life, abdominal wall complaints and direct and indirect costs.
Eligibility 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)
Contact & Investigator
Christian Sturesson, PhD
PRINCIPAL INVESTIGATOR
Region Stockholm, Stockholm, Sweden
Frequently Asked Questions
Who can join the NCT06246448 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gall Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06246448 currently recruiting?
Yes, NCT06246448 is actively recruiting participants. Contact the research team at christian.sturesson@regionstockholm.se for enrollment information.
Where is the NCT06246448 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT06246448 clinical trial?
NCT06246448 is sponsored by Karolinska University Hospital. The principal investigator is Christian Sturesson, PhD at Region Stockholm, Stockholm, Sweden. The trial plans to enroll 94 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.