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Recruiting NCT06246448

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

No phase Interventional Gall Bladder Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robotic-assisted radical cholecystectomy, Open radical cholecystectomy.
Who it may be relevant to
Registry conditions: Gall Bladder Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer - An International, Multi-centre, Single Blinded, Randomized Controlled Superiority Trial

Overview

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.

Detailed description

Robotic-assisted surgery is hypothesised to reduce time to functional recovery by 2 days compared with open surgery. With a power of 80% and alpha of 0.05, the sample size needed in each arm to test superiority is 35 patients. With an expected 25% drop-out rate, 47 patients will be randomized in each group, with a total of 94 patients to be randomized in the trial.

Interventions

  • Procedure Robotic-assisted radical cholecystectomy
    Procedure will be performed robotic-assisted
  • Procedure Open radical cholecystectomy
    Procedure will be open

Primary outcome measures

  • Time to functional recovery [Time frame: Days from operation]
Secondary outcome measures (6)
  • Number of retrieved lymph nodes [Time frame: Within 6 weeks after surgery]
  • Length of hospital stay [Time frame: Days]
  • Post-operative complications [Time frame: Within 90 days from surgery]
  • Quality of life of patients [Time frame: 1 year]
  • Total cost [Time frame: 1 year]
  • Abdominal wall complaints [Time frame: 1 year]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Region Stockholm — Stockholm

Publications

  • Wallgren H, Gilg S, Ansorge C, Sparrelid E, Sturesson C. Initial experience with robotic-assisted resection for suspected or confirmed gallbladder cancer - comparison with open technique in a single centre retrospective observational cohort study. Scand J Gastroenterol. 2025 Jul 7:1-6. doi: 10.1080/00365521.2025.2525902. Online ahead of print. PMID 40621784

Identifiers

NCT: NCT06246448 · CS001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗