- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03670992
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
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Roma, Italy, 00161
- Department of Surgery "Pietro Valdoni"
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- metastases from RCC
- surgically manageable lesions
Exclusion Criteria:
- metastases from different malignancies
- other malignancies
- surgically unmanageable
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pancreatic Metastases
Patients with only pancreatic metastases from RCC
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surgical removal of metastatic repetitions in pancreas and/or other distal sites
Other Names:
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extra-pancreatic metastases
patients with extra pancreatic metastases from RCC
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surgical removal of metastatic repetitions in pancreas and/or other distal sites
Other Names:
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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
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five years survival
|
follow up 60 months
|
Survival 3
Time Frame: follow up 120 months
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ten years Survival
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follow up 120 months
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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).
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mean follow up 45 months range (6-163 months)
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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.
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mean follow up 45 months range (6-163 months)
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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.
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mean follow up 45 months range (6-163 months)
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Nutritional status
Time Frame: mean follow up 45 months range (6-163 months)
|
BMI monitoring in kg/m^2
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mean follow up 45 months range (6-163 months)
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Serum albumin
Time Frame: mean follow up 45 months range (6-163 months)
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Serum albumin monitoring in g/dl
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mean follow up 45 months range (6-163 months)
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Hemoglobin
Time Frame: mean follow up 45 months range (6-163 months)
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Hemoglobin monitoring in g/dl
|
mean follow up 45 months range (6-163 months)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Stefania Brozzetti, professor, Policlinico Umberto I
Publications and helpful links
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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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