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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03670992
Other study ID # PAN001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 10, 2016
Est. completion date January 10, 2017

Study information

Verified date September 2018
Source Azienda Policlinico Umberto I
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date January 10, 2017
Est. primary completion date January 10, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- metastases from RCC

- surgically manageable lesions

Exclusion Criteria:

- metastases from different malignancies

- other malignancies

- surgically unmanageable

Study Design


Intervention

Procedure:
duodenal-pancreatectomy
surgical removal of metastatic repetitions in pancreas and/or other distal sites

Locations

Country Name City State
Italy Department of Surgery "Pietro Valdoni" Roma

Sponsors (1)

Lead Sponsor Collaborator
Azienda Policlinico Umberto I

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. Review — View Citation

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. — View Citation

Grassi P, Doucet L, Giglione P, Grünwald 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 — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Survival Three years survival follow up 36 months
Primary Survival 2 five years survival follow up 60 months
Primary Survival 3 ten years Survival follow up 120 months
Secondary Karnofsky scale 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)
Secondary 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)
Secondary 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)
Secondary Nutritional status BMI monitoring in kg/m^2 mean follow up 45 months range (6-163 months)
Secondary Serum albumin Serum albumin monitoring in g/dl mean follow up 45 months range (6-163 months)
Secondary Hemoglobin Hemoglobin monitoring in g/dl mean follow up 45 months range (6-163 months)
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