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Surgical Treatment of Pancreatic RCC Metastases

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03670992
Enrollment
26
Registered
2018-09-14
Start date
2016-01-10
Completion date
2017-01-10
Last updated
2018-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastases, Neoplasm, Renal Cell Carcinoma

Keywords

renal cell carcinoma, pancreatic resection, robotic surgery, pancreatic metastases, quality of life

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.

Interventions

PROCEDUREduodenal-pancreatectomy

surgical removal of metastatic repetitions in pancreas and/or other distal sites

Sponsors

Azienda Policlinico Umberto I
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* metastases from RCC * surgically manageable lesions

Exclusion criteria

* metastases from different malignancies * other malignancies * surgically unmanageable

Design outcomes

Primary

MeasureTime frameDescription
Survivalfollow up 36 monthsThree years survival
Survival 2follow up 60 monthsfive years survival
Survival 3follow up 120 monthsten years Survival

Secondary

MeasureTime frameDescription
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 statusmean follow up 45 months range (6-163 months)BMI monitoring in kg/m\^2
Hemoglobinmean follow up 45 months range (6-163 months)Hemoglobin monitoring in g/dl
Serum albuminmean follow up 45 months range (6-163 months)Serum albumin monitoring in g/dl
Karnofsky scalemean 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).
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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026