- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05114369
Does Timing of Completion Radical Cholecystectomy Determine the Survival in Incidental Carcinoma Gallbladder (IGBC)
5. november 2021 opdateret af: Sanjay Gandhi Postgraduate Institute of Medical Sciences
Does Timing of Completion Radical Cholecystectomy Determine the Survival Outcome in Incidental Carcinoma Gallbladder - a Single Center Retrospective Analysis
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
48
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
All incidental carcinoma gallbladder patients who were admitted for possible curative resection during the study period (Jan 2009 to Dec 2018)
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Early (<4weeks), Intermediate (4-12 weeks) and Late (>12 weeks)
Interval between index cholecystectomy and radical re-resection with curative intent
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Survival based on timing of completion radical cholecystectomy
Tidsramme: 01.01.2009 to 31.12.2018
|
Overall and disease free survival
|
01.01.2009 to 31.12.2018
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Determinants of factors associated with survival in incidental gallbladder carcinoma
Tidsramme: 01.01.2009 to 31.12.2018
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2009
Primær færdiggørelse (Faktiske)
31. december 2018
Studieafslutning (Faktiske)
1. oktober 2021
Datoer for studieregistrering
Først indsendt
11. oktober 2021
Først indsendt, der opfyldte QC-kriterier
5. november 2021
Først opslået (Faktiske)
10. november 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. november 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. november 2021
Sidst verificeret
1. november 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 00
Plan for individuelle deltagerdata (IPD)
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INGEN
IPD-planbeskrivelse
The final data sheet can be shared and not the individual data as the data was retrieved from online database
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