Clinical Trial Record

Return to Clinical Trials

Surgical Treatment of Pancreatic RCC Metastases


2016-01-10


2017-01-10


2017-01-10


26

Study Overview

Surgical Treatment of Pancreatic RCC Metastases

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.

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 ⋚ 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.

  • Renal Cell Carcinoma
  • Metastases, Neoplasm
  • PROCEDURE: duodenal-pancreatectomy
  • PAN001

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 Registration Dates Results Reporting Dates Study Record Updates

2018-09-07  

N/A  

2018-09-13  

2018-09-13  

N/A  

2018-09-14  

2018-09-14  

N/A  

2018-09  

Study Plan

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

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/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
: 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
Primary Outcome MeasuresMeasure DescriptionTime Frame
SurvivalThree years survivalfollow up 36 months
Survival 2five years survivalfollow up 60 months
Survival 3ten years Survivalfollow up 120 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Karnofsky scalecommon 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 statusBMI monitoring in kg/m^2mean follow up 45 months range (6-163 months)
Serum albuminSerum albumin monitoring in g/dlmean follow up 45 months range (6-163 months)
HemoglobinHemoglobin monitoring in g/dlmean follow up 45 months range (6-163 months)

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • metastases from RCC
  • surgically manageable lesions

  • Exclusion Criteria:

  • metastases from different malignancies
  • other malignancies
  • surgically unmanageable

Collaborators and Investigators

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


    • STUDY_DIRECTOR: Stefania Brozzetti, professor, Policlinico Umberto I

    Publications

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

    General Publications

    • Adler H, Redmond CE, Heneghan HM, Swan N, Maguire D, Traynor O, Hoti E, Geoghegan JG, Conlon KC. Pancreatectomy for metastatic disease: a systematic review. Eur J Surg Oncol. 2014 Apr;40(4):379-86. doi: 10.1016/j.ejso.2013.12.022. Epub 2014 Jan 15.
    • Tanis PJ, van der Gaag NA, Busch OR, van Gulik TM, Gouma DJ. Systematic review of pancreatic surgery for metastatic renal cell carcinoma. Br J Surg. 2009 Jun;96(6):579-92. doi: 10.1002/bjs.6606.
    • Grassi P, Doucet L, Giglione P, Grunwald V, Melichar B, Galli L, De Giorgi U, Sabbatini R, Ortega C, Santoni M, Bamias A, Verzoni E, Derosa L, Studentova H, Pacifici M, Coppa J, Mazzaferro V, de Braud F, Porta C, Escudier B, Procopio G. Clinical Impact of Pancreatic Metastases from Renal Cell Carcinoma: A Multicenter Retrospective Analysis. PLoS One. 2016 Apr 11;11(4):e0151662. doi: 10.1371/journal.pone.0151662. eCollection 2016.
    • Fikatas P, Klein F, Andreou A, Schmuck RB, Pratschke J, Bahra M. Long-term Survival After Surgical Treatment of Renal Cell Carcinoma Metastasis Within the Pancreas. Anticancer Res. 2016 Aug;36(8):4273-8.
    • Brozzetti S, Bini S, De Lio N, Lombardo C, Boggi U. Surgical-only treatment of pancreatic and extra-pancreatic metastases from renal cell carcinoma - quality of life and survival analysis. BMC Surg. 2020 May 13;20(1):101. doi: 10.1186/s12893-020-00757-0.