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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gall Bladder Cancer
• Intervention / Treatment: Procedure: Robotic-assisted radical cholecystectomy; Procedure: Open radical cholecystectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Sturesson, PhD; Phone Number: 0046812380000; Email: christian.sturesson@regionstockholm.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Region Stockholm
    • Contact: Christian Sturesson, PhD; Email: christian.sturesson@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic-assisted radical cholecystectomy	Procedure: Robotic-assisted radical cholecystectomy; Procedure will be performed robotic-assisted
Active Comparator: Open radical cholecystectomy	Procedure: Open radical cholecystectomy; Procedure will be open

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to functional recovery	As defined as: 1. has adequate pain control with oral analgesics only (NRS<5) 2. is independently mobile at the preoperative level 3. is able to maintain sufficient oral caloric intake (minimum of 50% required calories) 4. has no need for intravenous fluid administration 5. has no clinical signs of infection or infection treated with peroral antibiotics only	Days from operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of retrieved lymph nodes	As reported by pathologists	Within 6 weeks after surgery
Length of hospital stay	Time from operation until hospital discharge (days)	Days
Post-operative complications	Classified according to Clavien-Dindo	Within 90 days from surgery
Quality of life of patients	Using quality of life formulaire EORTC QLQ-C30	1 year
Total cost	Direct and indirect cost measured in euros	1 year
Abdominal wall complaints	Using the ventral hernia pain questionnaire	1 year

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Rigshospitalet, Denmark; University Hospital, Linkoeping; Sahlgrenska University Hospital
• Investigators: Principal Investigator: Christian Sturesson, PhD, Region Stockholm, Stockholm, Sweden

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Biliary Tract Neoplasms; Gallbladder Neoplasms
• Other Study ID Numbers: CS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No