Does Timing of Completion Radical Cholecystectomy Determine the Survival in Incidental Carcinoma Gallbladder

NCT05114369 | Completed

• 1 other identifier: 00
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Various factors determine the long term survival in this non-uniform cohort of incidental gallbladder cancer. Timing of re-intervention is suggested to play an important role in the outcome. Few centers are proponents of early surgery in order to prevent dissemination, while others have suggested an intentional delay of 3 months to filter out cases with aggressive pathology. In the present study, investigators intend to evaluate the factors affecting survival in incidental Gallbladder Cancer (IGBC) with special reference to timing of re-intervention.

Conditions

Gall Bladder Carcinoma; Survival

Keywords

Incidental; Gallbladder cancer; Re-resection; Survival

Outcome Measures

Primary Outcomes (1)

• Survival based on timing of completion radical cholecystectomy

  Overall and disease free survival

  01.01.2009 to 31.12.2018

Secondary Outcomes (1)

• Determinants of factors associated with survival in incidental gallbladder carcinoma

  01.01.2009 to 31.12.2018

Study Arms (1)

Early (<4weeks), Intermediate (4-12 weeks) and Late (>12 weeks)

Interval between index cholecystectomy and radical re-resection with curative intent

Procedure: Curative surgery

Interventions

Curative surgery PROCEDURE

Early (<4weeks), Intermediate (4-12 weeks) and Late (>12 weeks)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All incidental carcinoma gallbladder patients who were admitted for possible curative resection during the study period (Jan 2009 to Dec 2018)

You may qualify if:

• All incidental carcinoma gallbladder patients who could undergo curative resection during the study period (Jan 2009 to Dec 2018)

You may not qualify if:

• Metastasis on preoperative investigation or on staging laparoscopy

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

MeSH Terms

Conditions

Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 10, 2021
• Study Start: January 1, 2009
• Primary Completion: December 31, 2018
• Study Completion: October 1, 2021
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share