Surgical Treatment of Pancreatic RCC Metastases

Study Overview
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Brief Summary
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Data from 26 patients undergoing resection of Pancreatic Metastases and extra-Pancreatic Metastases from RCC were retrospectively analysed. Clinical data were collected from a digital database and QoL was assessed through patient's interview and Karnofsky performance scale.

Detailed Description
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Retrospective data was analysed from 26 patients that were submitted to pancreatic resection between August 2002 and November 2015. Inclusion criteria were: single or multiple metastases in pancreas or extra pancreatic; primary RCC; never received chemotherapic treatment; patients that already received a previous pancreatic resection were also included. Cases were collected from two high-volume centres: Surgical Department Pietro Valdoni in Policlinico Umberto I and the Division of Transplantation and General Surgery at University of Pisa. Different kind of surgical approaches were taken into account in this study: duodenal-pancreatectomy, total-pancreatectomy and distal-pancreatectomy associated or not with other metastatic site resections. Surgery was performed either with classical open approach and modern robotic surgical approach, with the robot Da Vinci. Aim of surgical interventions were to remove all metastases in association to radical lymphadenectomy thus to achieve R0 result. All postoperative events occurring within 90 days of surgery were considered. Postoperative complications were graded according to Clavien-Dindo classification. Patients were followed-up 3 months after discharge and every 6 months thereafter. Patients had blood chemistries and CT scans at least every year. A database was used to record all patients' data. Results were analysed in terms of Operative Mortality and Morbidity, Actuarial Survival, Actuarial Disease-Free Survival and Quality of Life. Protocols were approved by the bioethical review committee and meet the guidelines of both University Sapienza of Rome and University of Pisa. QoL was measured by Karnofsky performance scale and through Activities of Daily Living scale (ADL), Instrumental Activities of Daily living scale (IADL), BMI evaluation, serum albumin and hemoglobin, also depression was evaluated as a parameter. QoL was defined by combination of these parameters as: excellent, good, fair, poor or very poor. A low Karnofsky scale index with inadequate social and environmental situations, a reduction in functional capacity with depression and severe weight-loss were identified as a decline in QoL. Data was analysed via Chi-square test, as well as Student's paired and unpaired t-tests. Actuarial relative survival and actuarial relative disease-free survival were described by Kaplan-Meier analysis. A log-rank test was used to compare continuous variables and was expressed by Kaplan-Meier curves. Homogeneity of the different groups to be compared was tested by chi-square test. Statistical significance was set at p ≤ 0,05.

Official Title
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Case Series: Combined, Surgical-only Treatment of Pancreatic and Extra-pancreatic Metastases From Renal Cell Carcinoma - a Quality of Life and Survival Analysis

Conditions
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Renal Cell Carcinoma, Metastases, Neoplasm

Intervention / Treatment
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* Procedure: duodenal-pancreatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: metastases from RCC surgically manageable lesions Exclusion Criteria: metastases from different malignancies other malignancies surgically unmanageable
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pancreatic Metastases<br>Patients with only pancreatic metastases from RCC | Procedure: duodenal-pancreatectomy<br>* surgical removal of metastatic repetitions in pancreas and/or other distal sites<br>* Other names: other metastases resection;|
| extra-pancreatic metastases<br>patients with extra pancreatic metastases from RCC | Procedure: duodenal-pancreatectomy<br>* surgical removal of metastatic repetitions in pancreas and/or other distal sites<br>* Other names: other metastases resection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Three years survival | follow up 36 months | 
| Survival 2 | five years survival | follow up 60 months | 
| Survival 3 | ten years Survival | follow up 120 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Karnofsky scale | common scale to evaluate patient's prognosis in clinical and surgical settings. Adimensional scale in a range of 0-100. Higher Karnofsky score is associated with better outcome, score is assessed in steps of 10 (0 - 10 - 20 - 30 - 40 - 50 - 60 - 70 - 80 - 90 - 100). | mean follow up 45 months range (6-163 months) | 
| Activity of daily living scale (ADL scale) | prognostic scale evaluated through validated questionnaires, adimensional scale in a range of 0-6 points. evaluates abilty of the patients to fullfill the common daily activities. Better outcome is associated with higher score. | mean follow up 45 months range (6-163 months) | 
| Instrumental Activity of daily living scale (IADL scale) | prognostic scale evaluated through validated questionnaires, adimensional scale in a range of 0-8 points. Evaluates ability of the patient to use the common day instruments. Better outcome is associated with higher score. | mean follow up 45 months range (6-163 months) | 
| Nutritional status | BMI monitoring in kg/m^2 | mean follow up 45 months range (6-163 months) | 
| Serum albumin | Serum albumin monitoring in g/dl | mean follow up 45 months range (6-163 months) | 
| Hemoglobin | Hemoglobin monitoring in g/dl | mean follow up 45 months range (6-163 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal cell carcinoma, pancreatic resection, robotic surgery, pancreatic metastases, quality of life