Clincosm LogoSign in Get a demo

Renal Cell Carcinoma Metastases to Pancreas

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT05882747
Collaborator
(none)
25
Enrollment
144
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Patients' outcome was studied after surgery for renal cell carcinoma. The primary outcome was overall survival and desease free survival. Secondary outcame was complications to surgery.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Study design. The study is a single-center study and includes all patients from the age of 18 who underwent a pancreatic resection due to metastasis from RCC from 1. January 2011 to 31. December 2021. Patients, who underwent additional pancreatic resection after surgery for metastatic RCC, were excluded. The follow-up period ended 31. December 2022.

    Data collection. Data are collected from a prospectively maintained database of pancreatic operations, from the electronic hospital record systems Orbit and EPIC, the Danish National Pathology Data Registry, and from the National Register of Death. All Danish Nationals have a unique Central Person Registration number that enables searching of health data.

    Outcome. Extracted data included patient demographics, date, and site of nephrectomy, Leibovich score, type of pancreatic resection, 30-days postoperative complications according to the Clavien-Dindo classification system, procedure specific complications (pancreatic fistula or biliary leak) according to the International Study Group on Pancreatic Surgery (ISGPS), pathology of resected pancreatic specimen. Postoperative data included time and site of disease recurrence after pancreatic resection, disease free survival (DS) and overall survival (OS). The postoperative follow-up included standard imaging surveillance with computed tomography scan (CT) of the chest and abdomen at specific intervals depending on the Leibovich score.

    Statistics. Clinicopathologic characteristics were summarized using descriptive statistics. Data are presented as median and range if not otherwise stated. Categorial data are presented as numbers or percentage and were analysed with Fisher's exact test. The Kaplan-Meier method was used to estimate survival. Post-pancreatectomy survival was defined as date of pancreatic resection to death. Post-pancreatectomy disease free survival was defined as the median time from the date of pancreatic resection to the date of detection of recurrence of disease, expressed in months. Statistical analysis was performed using GraphPad Version 9.5.1 La Holla, CA. The study was reported according to the STROCSS guidelines.

    Ethics The study is a register study and was conducted in accordance with the principles stated in the Declaration of Helsinki. No approval was required according to the Danish National Health Board. The use of register data followed the General Data Protection Regulation of the European Union and was approved by the Danish Data Protection Agency (RH -2015-07, nr. 03616) and patients' consent.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    25 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Results of Surgery for Renal Cell Carcinoma Metastases in the Pancreas
    Actual Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Dec 31, 2021
    Actual Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. overall survival [1. January 2011 to 31. December 2022]

      observational

    2. disease free survival [1. January 2011 to 31. December 2022]

      observational

    Secondary Outcome Measures

    1. complications [1. january 2011 to 31. December 2022]

      observational

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: Participants, who underwent pancreatic resection for metastatic renal cell carcinoma -

    Exclusion Criteria: Participants, who underwent additional pancreatic resection after surgery for metastatic renal cell carcinoma.

    -

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    • Principal Investigator: carsten p hansen, MD, DMSc, Rigshospitalet, Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    carsten palnaes hansen, consultant, DMSC, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT05882747
    Other Study ID Numbers:
    • RH-2023-3
    First Posted:
    May 31, 2023
    Last Update Posted:
    May 31, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by carsten palnaes hansen, consultant, DMSC, Rigshospitalet, Denmark
    Pancreatic resection, pancreatic metastase
    Additional relevant MeSH terms:
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of May 31, 2023