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Search / Trial NCT06246448

Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer (ROBOCOP)

Launched by KAROLINSKA UNIVERSITY HOSPITAL · Jan 30, 2024

Trial Information

Current as of August 29, 2025

Recruiting

Keywords

ClinConnect Summary

The ROBOCOP trial is a study designed to compare two surgical methods for treating gallbladder cancer: robotic-assisted surgery and traditional open surgery. This trial is taking place at multiple hospitals around the world and aims to find out which method helps patients recover faster after surgery. The main goal is to see how quickly patients can return to their normal activities, while also looking at other important factors such as how long they stay in the hospital, any complications that might arise, and their overall quality of life after the procedure.

To participate in this trial, patients must be between 65 and 74 years old and have a specific type of gallbladder cancer that has been identified through imaging tests. They should also be healthy enough to undergo the surgery, as confirmed by their medical team. Patients who have had extensive previous surgeries in the upper abdomen or are pregnant are not eligible. If patients decide to join, they will be randomly assigned to one of the two surgery methods and can expect to be closely monitored throughout the process to ensure their safety and recovery.

Gender

ALL

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)

About Karolinska University Hospital

Karolinska University Hospital is a leading academic medical center in Sweden, renowned for its commitment to advanced healthcare research and innovative clinical practices. As a key sponsor of clinical trials, the hospital leverages its extensive expertise in medical research and collaboration with Karolinska Institutet, one of the world's foremost medical universities. The institution is dedicated to enhancing patient care through rigorous scientific investigation, focusing on a wide range of therapeutic areas. With a multidisciplinary approach and a strong emphasis on translational medicine, Karolinska University Hospital aims to bridge the gap between laboratory findings and clinical application, ultimately striving to improve health outcomes and advance medical knowledge.

Locations

Stockholm, , Sweden

Patients applied

0 patients applied

Trial Officials

Christian Sturesson, PhD

Principal Investigator

Region Stockholm, Stockholm, Sweden

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported