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2019-03-01
2022-03-01
2022-07-31
100
NCT04245410
Universidad de Extremadura
Universidad de Extremadura
OBSERVATIONAL
Surgical Treatment of Pancreatic Metastases From Renal Cell Carcinoma
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-01-25 | N/A | 2020-11-02 |
2020-01-27 | N/A | 2020-11-03 |
2020-01-28 | N/A | 2020-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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. |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival (months) from surgical resection of pancreatic metastases | Up to 60 months |
| Disease free survival | Disease free survival (months) from surgical resection of pancreatic metastases | Up to 60 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Gerardo Blanco-Fernandez, MD Phone Number: 0034924218022 Email: gerardoblanco@unex.es |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
