Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
26 participants
OBSERVATIONAL
2016-01-10
2017-01-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Pancreatic Metastases
Patients with only pancreatic metastases from RCC
duodenal-pancreatectomy
surgical removal of metastatic repetitions in pancreas and/or other distal sites
extra-pancreatic metastases
patients with extra pancreatic metastases from RCC
duodenal-pancreatectomy
surgical removal of metastatic repetitions in pancreas and/or other distal sites
Interventions
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duodenal-pancreatectomy
surgical removal of metastatic repetitions in pancreas and/or other distal sites
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* surgically manageable lesions
Exclusion Criteria
* other malignancies
* surgically unmanageable
ALL
No
Sponsors
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Azienda Policlinico Umberto I
OTHER
Responsible Party
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Professor Stefania Brozzetti
Professor
Principal Investigators
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Stefania Brozzetti, professor
Role: STUDY_DIRECTOR
Policlinico Umberto I
Locations
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Department of Surgery "Pietro Valdoni"
Roma, , Italy
Countries
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References
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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.
Other Identifiers
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PAN001
Identifier Type: -
Identifier Source: org_study_id
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