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Robot-assisted vs Laparoscopic vs Open Radical Cholecystectomy for Gallbladder Cancer

NCT06061744 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2023-09-29

No results posted yet for this study

Summary

The gallbladder is the most common primary cancer site among the biliary tracts and its incidence is increasing. Its prognosis is still poor with a 5-year survival of almost 20%.

Cholecystectomy is curative in patients with Tis and T1a. For patients with resectable T1b and above disease, radical cholecystectomy is advocated consisting of en bloc resection of the gallbladder, wedge resection of the liver or segment 4b, extrahepatic bile duct, and the regional lymph nodes.

The aim of this study is to compare patients who have undergone Robotic, Laparoscopic and Open liver resection with lymphadenectomy for \>T1b gallbladder cancers in a case-matched analysis using propensity scores. The primary endpoints are intra- and postoperative outcomes, and the secondary endpoints long-term oncologic outcomes and feasibility and adequacy of minimally invasive versus traditional open approach.

Conditions

  • Gallbladder Cancer

Interventions

OTHER

Minimally invasive surgery

laparoscopic or robotic surgical approach for the treatment of gallbladder cancer

Sponsors & Collaborators

  • Hospital del Mar

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2023-12-01
Completion
2024-01-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06061744 on ClinicalTrials.gov