Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05882747
Other study ID # RH-2023-3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date December 31, 2022

Study information

Verified date May 2023
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients' outcome was studied after surgery for renal cell carcinoma. The primary outcome was overall survival and desease free survival. Secondary outcame was complications to surgery.


Description:

Study design. The study is a single-center study and includes all patients from the age of 18 who underwent a pancreatic resection due to metastasis from RCC from 1. January 2011 to 31. December 2021. Patients, who underwent additional pancreatic resection after surgery for metastatic RCC, were excluded. The follow-up period ended 31. December 2022. Data collection. Data are collected from a prospectively maintained database of pancreatic operations, from the electronic hospital record systems Orbit and EPIC, the Danish National Pathology Data Registry, and from the National Register of Death. All Danish Nationals have a unique Central Person Registration number that enables searching of health data. Outcome. Extracted data included patient demographics, date, and site of nephrectomy, Leibovich score, type of pancreatic resection, 30-days postoperative complications according to the Clavien-Dindo classification system, procedure specific complications (pancreatic fistula or biliary leak) according to the International Study Group on Pancreatic Surgery (ISGPS), pathology of resected pancreatic specimen. Postoperative data included time and site of disease recurrence after pancreatic resection, disease free survival (DS) and overall survival (OS). The postoperative follow-up included standard imaging surveillance with computed tomography scan (CT) of the chest and abdomen at specific intervals depending on the Leibovich score. Statistics. Clinicopathologic characteristics were summarized using descriptive statistics. Data are presented as median and range if not otherwise stated. Categorial data are presented as numbers or percentage and were analysed with Fisher's exact test. The Kaplan-Meier method was used to estimate survival. Post-pancreatectomy survival was defined as date of pancreatic resection to death. Post-pancreatectomy disease free survival was defined as the median time from the date of pancreatic resection to the date of detection of recurrence of disease, expressed in months. Statistical analysis was performed using GraphPad Version 9.5.1 La Holla, CA. The study was reported according to the STROCSS guidelines. Ethics The study is a register study and was conducted in accordance with the principles stated in the Declaration of Helsinki. No approval was required according to the Danish National Health Board. The use of register data followed the General Data Protection Regulation of the European Union and was approved by the Danish Data Protection Agency (RH -2015-07, nr. 03616) and patients' consent.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Participants, who underwent pancreatic resection for metastatic renal cell carcinoma - Exclusion Criteria: Participants, who underwent additional pancreatic resection after surgery for metastatic renal cell carcinoma. -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

References & Publications (38)

Anderson B, Williams GA, Sanford DE, Liu J, Dageforde LA, Hammill CW, Fields RC, Hawkins WG, Strasberg SM, Doyle MB, Chapman WC, Khan AS. A 22-year experience with pancreatic resection for metastatic renal cell carcinoma. HPB (Oxford). 2020 Feb;22(2):312-317. doi: 10.1016/j.hpb.2019.05.019. Epub 2019 Jul 23. — View Citation

Azawi NH, Tesfalem H, Mosholt KS, Hoyerup P, Jensen ES, Malchau E, Fode M. Recurrence rates and survival in a Danish cohort with renal cell carcinoma. Dan Med J. 2016 Apr;63(4):A5208. — View Citation

Ballarin R, Spaggiari M, Cautero N, De Ruvo N, Montalti R, Longo C, Pecchi A, Giacobazzi P, De Marco G, D'Amico G, Gerunda GE, Di Benedetto F. Pancreatic metastases from renal cell carcinoma: the state of the art. World J Gastroenterol. 2011 Nov 21;17(43):4747-56. doi: 10.3748/wjg.v17.i43.4747. — View Citation

Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CR, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28. — View Citation

Benhaim R, Oussoultzoglou E, Saeedi Y, Mouracade P, Bachellier P, Lang H. Pancreatic metastasis from clear cell renal cell carcinoma: outcome of an aggressive approach. Urology. 2015 Jan;85(1):135-40. doi: 10.1016/j.urology.2014.09.034. — View Citation

Bianchi M, Sun M, Jeldres C, Shariat SF, Trinh QD, Briganti A, Tian Z, Schmitges J, Graefen M, Perrotte P, Menon M, Montorsi F, Karakiewicz PI. Distribution of metastatic sites in renal cell carcinoma: a population-based analysis. Ann Oncol. 2012 Apr;23(4):973-80. doi: 10.1093/annonc/mdr362. Epub 2011 Sep 2. — View Citation

Blanco-Fernandez G, Fondevila-Campo C, Sanjuanbenito A, Fabregat-Prous J, Secanella-Medayo L, Rotellar-Sastre F, Pardo-Sanchez F, Prieto-Calvo M, Marin-Ortega H, Sanchez-Cabus S, Diez-Valladares L, Alonso-Casado O, Gonzalez-Serrano C, Rodriguez-Sanjuan JC, Garcia-Plaza G, Jaen-Torrejimeno I, Suarez-Munoz MA, Becerra-Massare A, Rio PS, Pando E, Lopez-Andujar R, Munoz-Forner E, Rodriguez-Lopez M, Pereira F, Serrablo-Requejo A, Turrion VS, Garrido MJ, Burdio F, Martin-Perez E, Estevan-Estevan R, Lopez-Guerra D, Castell-Gomez J, Salinas-Gomez J, Lopez-Baena JA, Lopez-Ben S, Solar-Garcia L, Perez-Alonso AJ, Martinez-Insfran LA, Blas JL, Cornejo M, Gutierrez-Calvo A, Pozo CD, Ochando-Cerdan F, Munoz-Bellvis L, Rebollar-Saenz J, Sanchez B, Jover JM, Gomez-Bravo MA, Ramia JM, Rojas-Holguin A. Pancreatic metastases from renal cell carcinoma. Postoperative outcome after surgical treatment in a Spanish multicenter study (PANMEKID). Eur J Surg Oncol. 2022 Jan;48(1):133-141. doi: 10.1016/j.ejso.2021.08.011. Epub 2021 Aug 11. — View Citation

Chiti G, Grazzini G, Cozzi D, Danti G, Matteuzzi B, Granata V, Pradella S, Recchia L, Brunese L, Miele V. Imaging of Pancreatic Neuroendocrine Neoplasms. Int J Environ Res Public Health. 2021 Aug 24;18(17):8895. doi: 10.3390/ijerph18178895. — View Citation

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. — View Citation

Fottner A, Szalantzy M, Wirthmann L, Stahler M, Baur-Melnyk A, Jansson V, Durr HR. Bone metastases from renal cell carcinoma: patient survival after surgical treatment. BMC Musculoskelet Disord. 2010 Jul 3;11:145. doi: 10.1186/1471-2474-11-145. — View Citation

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. — View Citation

Heidsma CM, Engelsman AF, van Dieren S, Stommel MWJ, de Hingh I, Vriens M, Hol L, Festen S, Mekenkamp L, Hoogwater FJH, Daams F, Klumpen HJ, Besselink MG, van Eijck CH, Nieveen van Dijkum EJ. Watchful waiting for small non-functional pancreatic neuroendocrine tumours: nationwide prospective cohort study (PANDORA). Br J Surg. 2021 Aug 19;108(8):888-891. doi: 10.1093/bjs/znab088. — View Citation

Jaen-Torrejimeno I, Rojas-Holguin A, Lopez-Guerra D, Ramia JM, Blanco-Fernandez G. Pancreatic resection for metastatic renal cell carcinoma. A systematic review. HPB (Oxford). 2020 Apr;22(4):479-486. doi: 10.1016/j.hpb.2019.10.017. Epub 2019 Oct 28. — View Citation

Kalra S, Atkinson BJ, Matrana MR, Matin SF, Wood CG, Karam JA, Tamboli P, Sircar K, Rao P, Corn PG, Tannir NM, Jonasch E. Prognosis of patients with metastatic renal cell carcinoma and pancreatic metastases. BJU Int. 2016 May;117(5):761-5. doi: 10.1111/bju.13185. Epub 2015 Jul 6. — View Citation

Koch M, Garden OJ, Padbury R, Rahbari NN, Adam R, Capussotti L, Fan ST, Yokoyama Y, Crawford M, Makuuchi M, Christophi C, Banting S, Brooke-Smith M, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Nimura Y, Figueras J, DeMatteo RP, Buchler MW, Weitz J. Bile leakage after hepatobiliary and pancreatic surgery: a definition and grading of severity by the International Study Group of Liver Surgery. Surgery. 2011 May;149(5):680-8. doi: 10.1016/j.surg.2010.12.002. Epub 2011 Feb 12. — View Citation

Krautz C, Nimptsch U, Weber GF, Mansky T, Grutzmann R. Effect of Hospital Volume on In-hospital Morbidity and Mortality Following Pancreatic Surgery in Germany. Ann Surg. 2018 Mar;267(3):411-417. doi: 10.1097/SLA.0000000000002248. — View Citation

Leibovich BC, Blute ML, Cheville JC, Lohse CM, Frank I, Kwon ED, Weaver AL, Parker AS, Zincke H. Prediction of progression after radical nephrectomy for patients with clear cell renal cell carcinoma: a stratification tool for prospective clinical trials. Cancer. 2003 Apr 1;97(7):1663-71. doi: 10.1002/cncr.11234. — View Citation

Ljungberg B, Albiges L, Abu-Ghanem Y, Bedke J, Capitanio U, Dabestani S, Fernandez-Pello S, Giles RH, Hofmann F, Hora M, Klatte T, Kuusk T, Lam TB, Marconi L, Powles T, Tahbaz R, Volpe A, Bex A. European Association of Urology Guidelines on Renal Cell Carcinoma: The 2022 Update. Eur Urol. 2022 Oct;82(4):399-410. doi: 10.1016/j.eururo.2022.03.006. Epub 2022 Mar 26. — View Citation

Lyon TD, Roussel E, Sharma V, Carames G, Lohse CM, Costello BA, Boorjian SA, Thompson RH, Joniau S, Albersen M, Leibovich BC. International Multi-institutional Characterization of the Perioperative Morbidity of Metastasectomy for Renal Cell Carcinoma. Eur Urol Oncol. 2023 Feb;6(1):76-83. doi: 10.1016/j.euo.2022.11.003. Epub 2022 Dec 9. — View Citation

Malleo G, Salvia R, Maggino L, Marchegiani G, D'Angelica M, DeMatteo R, Kingham P, Pulvirenti A, Sereni E, Jarnagin WR, Bassi C, Allen PJ, Butturini G. Long-term Outcomes After Surgical Resection of Pancreatic Metastases from Renal Clear-Cell Carcinoma. Ann Surg Oncol. 2021 Jun;28(6):3100-3108. doi: 10.1245/s10434-021-09649-w. Epub 2021 Feb 11. — View Citation

Milanetto AC, Morelli L, Di Franco G, David A, Campra D, De Paolis P, Pasquali C. A Plea for Surgery in Pancreatic Metastases from Renal Cell Carcinoma: Indications and Outcome from a Multicenter Surgical Experience. J Clin Med. 2020 Oct 13;9(10):3278. doi: 10.3390/jcm9103278. — View Citation

Morera-Ocon FJ, Sabater-Orti L, Munoz-Forner E, Perez-Griera J, Ortega-Serrano J. Considerations on pancreatic exocrine function after pancreaticoduodenectomy. World J Gastrointest Oncol. 2014 Sep 15;6(9):325-9. doi: 10.4251/wjgo.v6.i9.325. — View Citation

Palumbo C, Pecoraro A, Knipper S, Rosiello G, Tian Z, Shariat SF, Simeone C, Briganti A, Saad F, Berruti A, Antonelli A, Karakiewicz PI. Survival and Complication Rates of Metastasectomy in Patients With Metastatic Renal Cell Carcinoma Treated Exclusively With Targeted Therapy: A Combined Population-based Analysis. Anticancer Res. 2019 Aug;39(8):4357-4361. doi: 10.21873/anticanres.13604. — View Citation

Piltz S, Meimarakis G, Wichmann MW, Hatz R, Schildberg FW, Fuerst H. Long-term results after pulmonary resection of renal cell carcinoma metastases. Ann Thorac Surg. 2002 Apr;73(4):1082-7. doi: 10.1016/s0003-4975(01)03602-5. — View Citation

Raveenthiran S, Esler R, Yaxley J, Kyle S. The use of 68Ga-PET/CT PSMA in the staging of primary and suspected recurrent renal cell carcinoma. Eur J Nucl Med Mol Imaging. 2019 Oct;46(11):2280-2288. doi: 10.1007/s00259-019-04432-2. Epub 2019 Jul 23. — View Citation

Saginala K, Barsouk A, Aluru JS, Rawla P, Padala SA, Barsouk A. Epidemiology of Bladder Cancer. Med Sci (Basel). 2020 Mar 13;8(1):15. doi: 10.3390/medsci8010015. — View Citation

Santoni M, Conti A, Partelli S, Porta C, Sternberg CN, Procopio G, Bracarda S, Basso U, De Giorgi U, Derosa L, Rizzo M, Ortega C, Massari F, Iacovelli R, Milella M, Di Lorenzo G, Buti S, Cerbone L, Burattini L, Montironi R, Santini D, Falconi M, Cascinu S. Surgical resection does not improve survival in patients with renal metastases to the pancreas in the era of tyrosine kinase inhibitors. Ann Surg Oncol. 2015;22(6):2094-100. doi: 10.1245/s10434-014-4256-7. Epub 2014 Dec 4. — View Citation

Sellner F, Thalhammer S, Klimpfinger M. Isolated Pancreatic Metastases of Renal Cell Cancer: Genetics and Epigenetics of an Unusual Tumour Entity. Cancers (Basel). 2022 Mar 17;14(6):1539. doi: 10.3390/cancers14061539. — View Citation

Shin TJ, Song C, Jeong CW, Kwak C, Seo S, Kang M, Chung J, Hong SH, Hwang EC, Park JY, Lee H. Metastatic renal cell carcinoma to the pancreas: Clinical features and treatment outcome. J Surg Oncol. 2021 Jan;123(1):204-213. doi: 10.1002/jso.26251. Epub 2020 Oct 12. — View Citation

Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12. — View Citation

Sperti C, Pozza G, Brazzale AR, Buratin A, Moletta L, Beltrame V, Valmasoni M. Metastatic tumors to the pancreas: a systematic review and meta-analysis. Minerva Chir. 2016 Oct;71(5):337-44. Epub 2016 Jul 14. — View Citation

Sun M, Meyer CP, Karam JA, de Velasco G, Chang SL, Pal SK, Trinh QD, Choueiri TK. Predictors, utilization patterns, and overall survival of patients undergoing metastasectomy for metastatic renal cell carcinoma in the era of targeted therapy. Eur J Surg Oncol. 2018 Sep;44(9):1439-1445. doi: 10.1016/j.ejso.2018.05.026. Epub 2018 Jun 5. — View Citation

Sweeney AD, Fisher WE, Wu MF, Hilsenbeck SG, Brunicardi FC. Value of pancreatic resection for cancer metastatic to the pancreas. J Surg Res. 2010 May 15;160(2):268-76. doi: 10.1016/j.jss.2008.04.012. — View Citation

Tosoian JJ, Cameron JL, Allaf ME, Hruban RH, Nahime CB, Pawlik TM, Pierorazio PM, Reddy S, Wolfgang CL. Resection of isolated renal cell carcinoma metastases of the pancreas: outcomes from the Johns Hopkins Hospital. J Gastrointest Surg. 2014 Mar;18(3):542-8. doi: 10.1007/s11605-013-2278-2. Epub 2013 Oct 26. — View Citation

Vig SVL, Zan E, Kang SK. Imaging for Metastatic Renal Cell Carcinoma. Urol Clin North Am. 2020 Aug;47(3):281-291. doi: 10.1016/j.ucl.2020.04.005. Epub 2020 Jun 11. — View Citation

Wiechno P, Kucharz J, Sadowska M, Michalski W, Sikora-Kupis B, Jonska-Gmyrek J, Poniatowska G, Nietupski K, Ossolinski K, Demkow T. Contemporary treatment of metastatic renal cell carcinoma. Med Oncol. 2018 Oct 27;35(12):156. doi: 10.1007/s12032-018-1217-1. — View Citation

Williamson TJ, Pearson JR, Ischia J, Bolton DM, Lawrentschuk N. Guideline of guidelines: follow-up after nephrectomy for renal cell carcinoma. BJU Int. 2016 Apr;117(4):555-62. doi: 10.1111/bju.13384. Epub 2016 Jan 8. — View Citation

Young J, Thompson A, Tait I, Waugh L, McPhillips G. Centralization of services and reduction of adverse events in pancreatic cancer surgery. World J Surg. 2013 Sep;37(9):2229-33. doi: 10.1007/s00268-013-2108-4. — View Citation

* Note: There are 38 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival observational 1. January 2011 to 31. December 2022
Primary disease free survival observational 1. January 2011 to 31. December 2022
Secondary complications observational 1. january 2011 to 31. December 2022
See also
  Status Clinical Trial Phase
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT03213314 - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies N/A
Enrolling by invitation NCT05534490 - Surgery and Functionality in Older Adults N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Terminated NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Recruiting NCT06397287 - PROM Project Urology
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03432429 - Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Recruiting NCT05370404 - Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain: N/A
Not yet recruiting NCT05467319 - Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS Phase 3
Recruiting NCT04602429 - Children's Acute Surgical Abdomen Programme
Completed NCT03124901 - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor N/A
Completed NCT04595695 - The Effect of Clear Masks in Improving Patient Relationships N/A
Recruiting NCT06103136 - Maestro 1.0 Post-Market Registry
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT04059328 - Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
Recruiting NCT03697278 - Monitoring Postoperative Patient-controlled Analgesia (PCA) N/A