Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06246448

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

Led by Karolinska University Hospital · Updated on 2025-09-05

94

Participants Needed

1

Research Sites

161 weeks

Total Duration

On this page

Sponsors

K

Karolinska University Hospital

Lead Sponsor

U

University Hospital, Linkoeping

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Region Stockholm

Stockholm, Sweden

Actively Recruiting

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Research Team

C

Christian Sturesson, PhD

CONTACT

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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