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

NCT06061744 · Hospital del Mar · Updated 29 Sept 2023

What is being tested
Minimally invasive surgery
For
Gallbladder Cancer
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 600 people. The full rules are on the registry page.
Where
Spain
When
Starts or started 1 April 2023, ends 30 Jan 2024. Registered 29 Sept 2023.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT06061744

Sites

  • Hospital del MarBarcelona, Spain