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

Gall Bladder Cancer Clinical Trial

— ROBOCOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246448
• Other study ID #: CS001
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2024
• Est. completion date: March 2027

Study information

• Verified date: January 2024
• Source: Karolinska University Hospital
• Contact: Christian Sturesson, PhD
• Phone: 0046812380000
• Email: christian.sturesson[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: March 2027
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Gall Bladder Cancer
• Gallbladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
Sweden	Region Stockholm	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska University Hospital	Rigshospitalet, Denmark, Sahlgrenska University Hospital, Sweden, University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

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