Surgical Treatment of Pancreatic RCC Metastases

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670992
• Other study ID #: PAN001
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastases, Neoplasm
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Renal Cell Carcinoma

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)