Clinical trial NCT04245410: Surgical Treatment of Pancreatic Metastases From Renal Cell Carcinoma
Official title: Surgical Treatment of Pancreatic Metastases From Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Procedure
Disease Free Survival
Overall Survival
Keywords: Renal cell carcinoma
Pancreatic metastases
Resection
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with resecable pancreatic metastases from RCC

Exclusion Criteria:

* Unresecable pancreatic metastases

Primary outcomes:
measure: Overall survival
timeFrame: Up to 60 months
measure: Disease free survival
timeFrame: Up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Gerardo Blanco-Fernández
Study officials:
References:
citation: Tosoian JJ, Cameron JL, Allaf ME, Hruban RH, Nahime CB, Pawlik TM, Pierorazio PM, Reddy S, Wolfgang CL. Resection of isolated renal cell carcinoma metastases of the pancreas: outcomes from the Johns Hopkins Hospital. J Gastrointest Surg. 2014 Mar;18(3):542-8. doi: 10.1007/s11605-013-2278-2. Epub 2013 Oct 26.
citation: Lee SR, Gemenetzis G, Cooper M, Javed AA, Cameron JL, Wolfgang CL, Eckhauser FE, He J, Weiss MJ. Long-Term Outcomes of 98 Surgically Resected Metastatic Tumors in the Pancreas. Ann Surg Oncol. 2017 Mar;24(3):801-807. doi: 10.1245/s10434-016-5619-z. Epub 2016 Oct 21.
citation: Santoni M, Conti A, Partelli S, Porta C, Sternberg CN, Procopio G, Bracarda S, Basso U, De Giorgi U, Derosa L, Rizzo M, Ortega C, Massari F, Iacovelli R, Milella M, Di Lorenzo G, Buti S, Cerbone L, Burattini L, Montironi R, Santini D, Falconi M, Cascinu S. Surgical resection does not improve survival in patients with renal metastases to the pancreas in the era of tyrosine kinase inhibitors. Ann Surg Oncol. 2015;22(6):2094-100. doi: 10.1245/s10434-014-4256-7. Epub 2014 Dec 4.
citation: Chang YH, Liaw CC, Chuang CK. The role of surgery in renal cell carcinoma with pancreatic metastasis. Biomed J. 2015 Mar-Apr;38(2):173-6. doi: 10.4103/2319-4170.137771.