Clinical Trials Logo
  1. Home
  2. Gall Bladder Cancer
  3. NCT06246448

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

Gall Bladder Cancer Clinical Trial

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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06246448
Study type Interventional
Source Karolinska University Hospital
Contact Christian Sturesson, PhD
Phone 0046812380000
Email christian.sturesson@regionstockholm.se
Status Recruiting
Phase N/A
Start date January 23, 2024
Completion date March 2027
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04164069 - Dasatinib for the Prevention of Oxaliplatin-Induced Neuropathy in Patients With Metastatic Gastrointestinal Cancer Receiving FOLFOX Chemotherapy With or Without Bevacizumab Phase 1
Recruiting NCT06101277 - Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG) N/A
Completed NCT01135849 - B-Receptor Signaling in Cardiomyopathy N/A
Recruiting NCT04856761 - A Study of Capecitabine Versus S-1 as Adjuvant Therapy in Patients With Biliary Tract Carcinoma After Surgical Resection
Withdrawn NCT01875549 - Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent N/A
Recruiting NCT04426669 - A Study of Metastatic Gastrointestinal Cancers Treated With Tumor Infiltrating Lymphocytes in Which the Gene Encoding the Intracellular Immune Checkpoint CISH Is Inhibited Using CRISPR Genetic Engineering Phase 1/Phase 2
Recruiting NCT06214572 - Radiation Therapy in Unresectable Gall Bladder Cancer Phase 2/Phase 3
Completed NCT01016639 - Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer Phase 1/Phase 2
Recruiting NCT03668418 - Xenotransplantation of Primary Cancer Samples in Zebrafish Embryos
Recruiting NCT05506943 - A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002) Phase 2/Phase 3
Recruiting NCT05000294 - Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types Phase 1/Phase 2
Recruiting NCT05102110 - Feasibility Study to Investigate Rectal Mucus in Aero-Digestive Tract Cancer.
Recruiting NCT05712356 - A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors Phase 2
Terminated NCT00767234 - Permission to Collect Blood Over Time for Research N/A
Completed NCT03985072 - Study With Andes-1537 in Patients With Specific Types of Advanced Solid Tumor Phase 1