Surgical Treatment of Pancreatic Metastases From Renal Cell Carcinoma — PANMEKID  

Overall Survival Clinical Trial

Official title: Surgical Treatment of Pancreatic Metastases From Renal Cell Carcinoma

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Disease Free Survival
• Neoplasm Metastasis
• Overall Survival
• Surgical Procedure

• NCT number: NCT04245410
• Study type: Observational
• Source: Universidad de Extremadura
• Contact: Gerardo Blanco-Fernandez, MD
• Phone: 0034924218022
• Email: gerardoblanco@unex.es
• Status: Recruiting
• Start date: March 1, 2019
• Completion date: July 31, 2022