Surgical Treatment of Pancreatic RCC Metastases
- Conditions
- Metastases, NeoplasmRenal Cell Carcinoma
- Interventions
- Procedure: duodenal-pancreatectomy
- Registration Number
- NCT03670992
- Lead Sponsor
- Azienda Policlinico Umberto I
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- metastases from RCC
- surgically manageable lesions
- metastases from different malignancies
- other malignancies
- surgically unmanageable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description extra-pancreatic metastases duodenal-pancreatectomy patients with extra pancreatic metastases from RCC Pancreatic Metastases duodenal-pancreatectomy Patients with only pancreatic metastases from RCC
- Primary Outcome Measures
Name Time Method Survival follow up 36 months Three years survival
Survival 3 follow up 120 months ten years Survival
Survival 2 follow up 60 months five years survival
- Secondary Outcome Measures
Name Time Method Activity of daily living scale (ADL scale) mean follow up 45 months range (6-163 months) 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.
Instrumental Activity of daily living scale (IADL scale) mean follow up 45 months range (6-163 months) 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.
Nutritional status mean follow up 45 months range (6-163 months) BMI monitoring in kg/m\^2
Serum albumin mean follow up 45 months range (6-163 months) Serum albumin monitoring in g/dl
Hemoglobin mean follow up 45 months range (6-163 months) Hemoglobin monitoring in g/dl
Karnofsky scale mean follow up 45 months range (6-163 months) 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).
Trial Locations
- Locations (1)
Department of Surgery "Pietro Valdoni"
🇮🇹Roma, Italy