Surgical Treatment of Pancreatic Metastases From Renal Cell Carcinoma (PANMEKID)

November 2, 2020 updated by: Gerardo Blanco-Fernández, Universidad de Extremadura

Pancreatic metastases are a rare entity. In cases of metastatic renal carcinoma (RCC) it can present as isolated pancreatic metastasis, considering the possibility of surgical resection.

Goals:

  • Define survival after resection of pancreatic cancer metastases renal in a wide range of our country.
  • Identify predictive survival factors

Methods:

Retrospective multicenter study in which cases of pancreatic resection due to renal cancer metastases.

Study Overview

Status

Unknown

Conditions

Detailed Description

Introduction:

Pancreatic metastases are a rare entity and often synonymous with broader dissemination. However, in cases of metastatic renal carcinoma (RCC) it can present as isolated pancreatic metastasis, considering the possibility of surgical resection. Most of the literature refers to isolated cases or short series, with the Johns Hopkins Hospital series being the largest in a single published center (1,2). In all of them, survival after resection is prolonged.

Recently, due to the results obtained with the tyrosine kinase inhibitor drugs, the value of resection of metastases of RCC origin has been questioned in an Italian multicenter study (3), although other studies consider that resection can improve the prognosis if It is associated with these drugs (4).

Justification:

The existing literature is limited to short series or mostly isolated cases. There are no clear prognostic factors that are limited in most cases to being merely descriptive studies.

Goals:

  • Define survival after resection of pancreatic cancer metastases renal in a wide range of our country.
  • Identify predictive survival factors that allow establishing Subgroups of patients with the greatest benefit after surgery or, conversely, those who potentially do not benefit from drug treatment.

Method:

Retrospective multicenter study in which cases of pancreatic resection due to renal cancer metastases are collected until December 2019, identified by each of the centers included in the study. A data collection sheet has been designed for each case that will be sent to the participating centers. To know which centers could have performed some pancreatic resection due to renal cancer metastases, an email has been sent to all members of the Spanish association of surgeons and Spanish members of International Hepato-pancreatic and biliary surgery association and this information has been included on their websites. The study variables include those related to demographic data of the patient, with the primary tumor, with the presentation of pancreatic metastasis, pancreas surgery and short-term and long-term postoperative follow-up.

Statistic analysis The data will be analyzed using the IBM SPSS Statistics for Mac version 22.0 program (IBM Corp., Orchard Road Armonk, New York, US). Student's t, Mann Whitney U, Chi-square, or Fisher's test will be used according to the parameters studied. Categorical data will be presented as frequency and percentage. Continuous data will be presented as mean and standard deviation or median and interquartile range depending on the distribution of the data. Subgroups created to compare characteristics and results will be measured using Mann Whitney U, Chi-square or Kruskal Wallis test. A p <0.05 will be considered statistically significant.

Limitations of the study:

The main limitation is the retrospective and multicenter nature that can lead to selection or information bias.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Badajoz, Spain, 06080
        • Recruiting
        • Gerardo Blanco-Fernández
        • Contact:
          • Gerardo Blanco-Fernández, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients operated from renal cell carcinoma in the past that have developed pancreatic metastases. They are included in the study after pancreatic resection.

Description

Inclusion Criteria:

  • Patients with resecable pancreatic metastases from RCC

Exclusion Criteria:

  • Unresecable pancreatic metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients surgically treated of pancreatic metastases from RCC
Patients surgically treated of pancreatic metastases from renal cell carcinoma. Pancreaticoduodenectomy, distal pancreatectomy or total pancreatectomy are included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to 60 months
Overall survival (months) from surgical resection of pancreatic metastases
Up to 60 months
Disease free survival
Time Frame: Up to 60 months
Disease free survival (months) from surgical resection of pancreatic metastases
Up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Extremadura

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

July 31, 2022

Study Registration Dates

First Submitted

January 25, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (ACTUAL)

January 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UE-CHUB 001-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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