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

NCT06246448 | Recruiting

• 1 other identifier: CS001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Gall Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of retrieved lymph nodes

  Within 6 weeks after surgery

• Length of hospital stay

  Days

• Post-operative complications

  Within 90 days from surgery

• Quality of life of patients

  1 year

• Total cost

  1 year

Study Arms (2)

Robotic-assisted radical cholecystectomy

EXPERIMENTAL

Procedure: Robotic-assisted radical cholecystectomy

Open radical cholecystectomy

ACTIVE COMPARATOR

Procedure: Open radical cholecystectomy

Interventions

Robotic-assisted radical cholecystectomy PROCEDURE

Procedure will be performed robotic-assisted

Robotic-assisted radical cholecystectomy

Open radical cholecystectomy PROCEDURE

Procedure will be open

Open radical cholecystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska University Hospital: lead
• University Hospital, Linkoeping: collaborator
• Sahlgrenska University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Region Stockholm

Stockholm, Sweden

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Officials

• Christian Sturesson, PhD

  Region Stockholm, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Sturesson, PhD

CONTACT

0046812380000; christian.sturesson@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 7, 2024
• Study Start: January 23, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)