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

NCT ID: NCT05114369

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-01

Study Completion Date

2021-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gall Bladder Carcinoma Survival

Keywords

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Incidental Gallbladder cancer Re-resection Survival

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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

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

Curative surgery

Intervention Type PROCEDURE

Interventions

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Curative surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanjay Gandhi Postgraduate Institute of Medical Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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00

Identifier Type: -

Identifier Source: org_study_id