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

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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

48

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Early (<4weeks), Intermediate (4-12 weeks) and Late (>12 weeks)
Interval between index cholecystectomy and radical re-resection with curative intent

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2009

Primær fullføring (Faktiske)

31. desember 2018

Studiet fullført (Faktiske)

1. oktober 2021

Datoer for studieregistrering

Først innsendt

11. oktober 2021

Først innsendt som oppfylte QC-kriteriene

5. november 2021

Først lagt ut (Faktiske)

10. november 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2021

Sist bekreftet

1. november 2021

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

The final data sheet can be shared and not the individual data as the data was retrieved from online database

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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