Surgical Treatment of Pancreatic RCC Metastases

• ClinicalTrials.gov Identifier: NCT03670992
• Recruitment Status: Completed
• First Posted: September 14, 2018
• Last Update Posted: September 14, 2018
• Sponsor: Azienda Policlinico Umberto I
• Information provided by (Responsible Party): Professor Stefania Brozzetti, Azienda Policlinico Umberto I

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Renal Cell Carcinoma; Metastases, Neoplasm	Procedure: duodenal-pancreatectomy

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 Design

• Study Type: Observational
• Actual Enrollment: 26 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: January 10, 2016
• Actual Primary Completion Date: January 10, 2017
• Actual Study Completion Date: January 10, 2017

Groups and Cohorts

Group/Cohort	Intervention/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; Other Names: total-pancreatectomy; distal-pancreatectomy; other metastases resection
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; Other Names: total-pancreatectomy; distal-pancreatectomy; other metastases resection

Outcome Measures

Primary Outcome Measures :

1. Survival [ Time Frame: follow up 36 months ]
   Three years survival
2. Survival 2 [ Time Frame: follow up 60 months ]
   five years survival
3. Survival 3 [ Time Frame: follow up 120 months ]
   ten years Survival

Secondary Outcome Measures :

1. 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).
2. 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.
3. 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.
4. Nutritional status [ Time Frame: mean follow up 45 months range (6-163 months) ]
   BMI monitoring in kg/m^2
5. Serum albumin [ Time Frame: mean follow up 45 months range (6-163 months) ]
   Serum albumin monitoring in g/dl
6. Hemoglobin [ Time Frame: mean follow up 45 months range (6-163 months) ]
   Hemoglobin monitoring in g/dl

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

26 patients, 12 male and 14 female age range 46 - 83, mean age 66 SD 9,1

Criteria

Inclusion Criteria:

• metastases from RCC
• surgically manageable lesions

Exclusion Criteria:

• metastases from different malignancies
• other malignancies
• surgically unmanageable

Contacts and Locations

Locations

Italy

Department of Surgery "Pietro Valdoni"

Roma, Italy, 00161

Sponsors and Collaborators

Azienda Policlinico Umberto I

Investigators

• Study Director: Stefania Brozzetti, professor; Policlinico Umberto I

More Information

Publications of Results:

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.

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.

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 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Professor Stefania Brozzetti, Professor, Azienda Policlinico Umberto I
• ClinicalTrials.gov Identifier: NCT03670992
• Other Study ID Numbers: PAN001
• First Posted: September 14, 2018
• Last Update Posted: September 14, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Professor Stefania Brozzetti, Azienda Policlinico Umberto I:

renal cell carcinoma; pancreatic resection; robotic surgery; pancreatic metastases; quality of life

Additional relevant MeSH terms:

Carcinoma; Neoplasm Metastasis; Neoplasms, Second Primary; Carcinoma, Renal Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases