Surgical Treatment of Pancreatic RCC Metastases

September 13, 2018 updated by: Professor Stefania Brozzetti, Azienda Policlinico Umberto I

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00161
        • Department of Surgery "Pietro Valdoni"

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

26 patients, 12 male and 14 female age range 46 - 83, mean age 66 SD 9,1

Description

Inclusion Criteria:

  • metastases from RCC
  • surgically manageable lesions

Exclusion Criteria:

  • metastases from different malignancies
  • other malignancies
  • surgically unmanageable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pancreatic Metastases
Patients with only pancreatic metastases from RCC
Procedure: duodenal-pancreatectomy
surgical removal of metastatic repetitions in pancreas and/or other distal sites
Other Names:
  • total-pancreatectomy
  • distal-pancreatectomy
  • other metastases resection
extra-pancreatic metastases
patients with extra pancreatic metastases from RCC
Procedure: duodenal-pancreatectomy
surgical removal of metastatic repetitions in pancreas and/or other distal sites
Other Names:
  • total-pancreatectomy
  • distal-pancreatectomy
  • other metastases resection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Karnofsky scale
Time Frame: 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).
mean follow up 45 months range (6-163 months)
Activity of daily living scale (ADL scale)
Time Frame: 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.
mean follow up 45 months range (6-163 months)
Instrumental Activity of daily living scale (IADL scale)
Time Frame: 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.
mean follow up 45 months range (6-163 months)
Nutritional status
Time Frame: mean follow up 45 months range (6-163 months)
BMI monitoring in kg/m^2
mean follow up 45 months range (6-163 months)
Serum albumin
Time Frame: mean follow up 45 months range (6-163 months)
Serum albumin monitoring in g/dl
mean follow up 45 months range (6-163 months)
Hemoglobin
Time Frame: mean follow up 45 months range (6-163 months)
Hemoglobin monitoring in g/dl
mean follow up 45 months range (6-163 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Policlinico Umberto I

Investigators

  • Study Director: Stefania Brozzetti, professor, Policlinico Umberto I

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (ACTUAL)

January 10, 2016

Primary Completion (ACTUAL)

January 10, 2017

Study Completion (ACTUAL)

January 10, 2017

Study Registration Dates

First Submitted

September 7, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (ACTUAL)

September 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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