AzTrials
AzTrials

SurgeryNCT05882747

Renal Cell Carcinoma Metastases to Pancreas

An observational study of Surgery, run by Copenhagen University Hospital, Rigshospitalet.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgery
How many people
25 participants
Where
No sites listed yet
Study dates
1 Jan 2011to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Both sex living in Denmark and operated at Rigshospitalet Copenhagen from 1. January 2011 to 31. December 2021.

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.

-

About this study

Official title: The Results of Surgery for Renal Cell Carcinoma Metastases in the Pancreas

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.

Read the detailed 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.

Conditions
Surgery
Keywords
Pancreatic resection, pancreatic metastase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    observational

    Measured: 1. January 2011 to 31. December 2022

  2. disease free survival

    observational

    Measured: 1. January 2011 to 31. December 2022

Secondary outcomes (1)

  1. complications

    observational

    Measured: 1. january 2011 to 31. December 2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2023
  2. Study start1 Jan 2011
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05882747
Sponsor's protocol ID
RH-2023-3
Status last verified
May 2023
First submitted
21 May 2023
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: there is no plan to make IPD available

Publications

  • 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.

    PubMed 32183076

  • 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.

    PubMed 35020204

  • 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.

    PubMed 22147975

  • 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.

    PubMed 21890909

  • 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.

    PubMed 27412234

  • 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.

    PubMed 30368624

  • 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.

    PubMed 26032863

  • 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.

    PubMed 29935840

  • 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.

    PubMed 31366530

  • 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.

    PubMed 31672281

  • 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.

    PubMed 31345661

  • 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.

    PubMed 33047324

  • 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.

    PubMed 23756771

  • 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.

    PubMed 28379871

  • 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.

    PubMed 25232457

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery, run by Copenhagen University Hospital, Rigshospitalet.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: 1. January 2011 to 31. December 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05882747, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.

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