Gall Bladder CancerROBOCOPNCT06246448
Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer (ROBOCOP)
A study testing Robotic-assisted radical cholecystectomy and Open radical cholecystectomy in people with Gall Bladder Cancer, run by Karolinska University Hospital at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gall Bladder Cancer
- What is being tested?
- Robotic-assisted radical cholecystectomy and Open radical cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSweden
- Study dates
- 23 Jan 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Region Stockholm
Stockholm
Christian Sturesson, PhD, christian.sturesson@regionstockholm.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Gall Bladder Cancer
- Being tested
- Robotic-assisted radical cholecystectomy, Open radical cholecystectomy
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted radical cholecystectomyProcedure or surgery
Procedure will be performed robotic-assisted
Open radical cholecystectomyProcedure or surgery
Procedure will be open
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted radical cholecystectomy | Experimental | Not described Receives: Procedure: Robotic-assisted radical cholecystectomy |
| Open radical cholecystectomy | Active comparator | Not described Receives: Procedure: Open radical cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Days from operation
Secondary outcomes (6)
Number of retrieved lymph nodes
As reported by pathologists
Measured: Within 6 weeks after surgery
Length of hospital stay
Time from operation until hospital discharge (days)
Measured: Days
Post-operative complications
Classified according to Clavien-Dindo
Measured: Within 90 days from surgery
Quality of life of patients
Using quality of life formulaire EORTC QLQ-C30
Measured: 1 year
Total cost
Direct and indirect cost measured in euros
Measured: 1 year
Abdominal wall complaints
Using the ventral hernia pain questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start23 Jan 2024
- Primary completionOct 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gall Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Linkoeping, Sahlgrenska University Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Christian Sturesson, Karolinska University Hospital
- Investigators
- Christian Sturesson, PhD, Principal investigator, Region Stockholm, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246448
- Sponsor's protocol ID
- CS001
- Acronym
- ROBOCOP
- Status last verified
- Aug 2025
- First submitted
- 22 Jan 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40621784
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer - An International, Multi-centre, Single Blinded, Randomized Controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT06246448
- Acronym / sponsor ID
- ROBOCOP / CS001
- Conditions
- Gall Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Linkoeping, Sahlgrenska University Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted radical cholecystectomy | Experimental | Procedure: Robotic-assisted radical cholecystectomy |
| Open radical cholecystectomy | Active comparator | Procedure: Open radical cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted radical cholecystectomyProcedure will be performed robotic-assisted | Procedure or surgery | Robotic-assisted radical cholecystectomy |
| Open radical cholecystectomyProcedure will be open | Procedure or surgery | Open radical cholecystectomy |
Primary outcome
Time to functional recovery
Time frame: Days from operation
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Derived from this study: PubMed 40621784Wallgren 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.
- Individual participant dataSharing planned: No
Related trials for Gall Bladder Cancer
RecruitingObservational study
Incidental Gallbladder Carcinoma :Incidence and Clinical Significance in Specimens From Routine Cholecystectomies in Sohag Locality
Gall Bladder Carcinoma
Active, not recruitingPhase 2
Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)
Advanced Biliary Tract Carcinoma, Advanced Gallbladder Carcinoma
Active, not recruitingPhase 2/3
Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of Gallbladder Cancer
Stage II Gallbladder Cancer AJCC v8, Stage IIA Gallbladder Cancer AJCC v8
Active, not recruitingPhase 3
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
Biliary Tract Cancer
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
Biliary Tract Cancer, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Sturesson, PhD principal investigator
Region Stockholm, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted radical cholecystectomy and Open radical cholecystectomy in people with Gall Bladder Cancer, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Sturesson, PhD (0046812380000, christian.sturesson@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to functional recovery (time frame: Days from operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06246448, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.