NCT06061744

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

8 months

First QC Date

September 5, 2023

Last Update Submit

September 25, 2023

Conditions

Gallbladder Cancer

Outcome Measures

Primary Outcomes (7)

  • Conversion

    Conversion to open surgery

    intraoperative

  • Blood Loss

    Intraoperative estimated blood loss

    intraoperative

  • operative time

    Operative time of the procedure

    Intraoperative

  • Post operatives complications

    Complications according to Clavien Dindo

    Up to 90 days from surgery

  • Pathological outcomes

    Specimen margins involvement according to the AJCC 8th edition

    Up to 1 month from surgery

  • Survival

    Overall survival after surgery in months

    From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  • recurrence

    Disease free survival in months

    From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Study Arms (3)

Open approach

Gallbladder cancer with hepatectomy and lymphadenectomy which underwent surgery by classical open approach

Robotic approach

Gallbladder cancer with hepatectomy and lymphadenectomy which underwent surgery by any type of robotic surgical device approach

Other: Minimally invasive surgery

Laparoscopic approach

Gallbladder cancer with hepatectomy and lymphadenectomy which underwent surgery by laparoscopic approach

Other: Minimally invasive surgery

Interventions

Minimally invasive surgeryOTHER

laparoscopic or robotic surgical approach for the treatment of gallbladder cancer

Laparoscopic approachRobotic approach

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsalder 18 years old
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who have undergone Robotic, Laparoscopic and Open liver resection with lymphadenectomy for \>T1b gallbladder cancers

You may qualify if:

  • \>T1b gallbladder cancers
  • Age at least 18 years;
  • Types of surgery include Robotic, Laparoscopic and Open approach
  • A statement by each centre will be required confirming the number of procedures - minimum 1 year of follow up

You may not qualify if:

  • \- not completed data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Gallbladder Neoplasms

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FACS

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 29, 2023

Study Start

April 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 30, 2024

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

ES(1)