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

Survival Clinical Trial

— IGBC  

Official title:

Does Timing of Completion Radical Cholecystectomy Determine the Survival Outcome in Incidental Carcinoma Gallbladder - a Single Center Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05114369
• Other study ID #: 00
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2021
• Source: Sanjay Gandhi Postgraduate Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Surgical Gastroenterology department at our institute is a tertiary referral center for hepatobiliary malignancies; covering a large part of North and North-east India. The details and progress reports of patients of Gallbladder Cancer (GBC) being referred to and treated at the institute is maintained in a prospective manner on hospital data base. This includes demographic data, presenting complains, details of relevant investigations done outside and in the hospital, previous surgery, pre-hospital course, operative findings, post operative course and final histopathology. Being a retrospective analysis of data not affecting clinical outcomes, ethical approval was not taken. During the study period (Jan 2009 to Dec 2018), 1049 participants with diagnosis of GBC (including 91 IGBC participants) were admitted; 239/958 participants with diagnosis of GBC and 48/91 with diagnosis of GBC could undergo resection with curative intent. Information regarding adjuvant therapy, recurrence, and survival were retrieved through data maintained on follow up out-patient cards till December 2019. Few participants who stopped visiting the hospital were contacted telephonically or through letters. All available histopathology blocks and slides following the index cholecystectomy were re-reviewed by the pathologists in the institute. Tumor type, differentiation and primary T stage were documented for majority of cases. Interval between index cholecystectomy and date of re-operation was calculated for all the participants and divided into 3 groups: Early (<4weeks), Intermediate (4-12 weeks) and Late (>12 weeks). Primary objective was to assess the effect of tumor characteristics and the time gap (between index surgery and re-resection) on overall survival following curative (R0/R1) resection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 1, 2021
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

All incidental carcinoma gallbladder patients who could undergo curative resection during the study period (Jan 2009 to Dec 2018) Exclusion Criteria: Metastasis on preoperative investigation or on staging laparoscopy

Related Conditions & MeSH terms

• Carcinoma
• Gall Bladder Carcinoma
• Survival
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Curative surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanjay Gandhi Postgraduate Institute of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival based on timing of completion radical cholecystectomy	Overall and disease free survival	01.01.2009 to 31.12.2018
Secondary	Determinants of factors associated with survival in incidental gallbladder carcinoma	Factors related to primary surgery (residual disease, primary T stage), type of resection (Wedge resection, Segment 4B-5 excision or Common bile duct excision), tumor characteristics (differentiation and lymohovascular invasion) and final stage (AJCC 8th edition)	01.01.2009 to 31.12.2018