AzTrials
AzTrials

Pancreatic CancerNCT04893408

Pancreatic Surgery in Elderly Patients

An observational study of Pancreatic Cancer, 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

Pancreatic cancer is mainly seen among elderly subjects as more than 85 % of all patients are diagnosed after 60 years of age. Pancreatic surgery in the elderly is usually well tolerated, and the postoperative mortality has decreased and today is less than 5 % in high-volume centers. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
observational study
How many people
1,556 participants
Where
No sites listed yet
Study dates
1 Jan 2010to 31 Dec 2019
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Danish population operated for pancreatic tumors including ductal adenocarcinoma

Who may be able to join

  • all patients with pancreatic resection aged 18 years and older

Who cannot join

  • patients younger than 18 years

About this study

Official title: Postoperative and Long-term Survival in Relation to Life-expectancy After Pancreatic Surgery in Elderly Patients

Pancreatic cancer is mainly seen among elderly subjects as more than 85 % of all patients are diagnosed after 60 years of age. Pancreatic surgery in the elderly is usually well tolerated, and the postoperative mortality has decreased and today is less than 5 % in high-volume centers. When offering an old patient pancreatic surgery for a malignant disease it is important to evaluate not only the probability that the patient may survive the operation, but also the relevance of an operation in relation to the patient's remnant life expectancy and other treatment options than surgery. This problem has not been addressed in most studies on pancreatic surgery in the elderly, in which the outcome after surgery was the end point. The endpoints of the present study are the post-operative survival and surgical complications after major pancreatic surgery in all patients operated in the study period, and the long-term survival of patients operated for adenocarcinomas. These endpoints were set from the assumption that the postoperative mortality is related to age and comorbidity, while the long-term survival is influenced by the primary disease.

Read the detailed description

Study design The study is a retrospective, descriptive register study based on data from a prospectively maintained database. Data recruitment include all patients from the age of 18 with adenocarcinoma in the pancreas, papilla of vater and duodenum operated between January 1, 2010 and December 31, 2019 with a minimum of one year post-operative follow-up. Study completion date will be December 31, 2020. Patients are divided into two cohorts, patients younger than 75 years and patients 75 years and older. Moreover, data are divided into patients with malignant and non-malignant tumors. The study is reported according to the STROCSS guidelines (www.strocssguideline.com).

Study population The study includes 1,556 consecutive patients, 1,296 patients between 18 and 75 years and 260 patients aged 75 years and older. There are 1,208 patients with malignant tumours of whom 1,020 have adenocarcinoma. The remaining 348 patients have benign or no pathologic findings but were operated for pre-malignant diseases or on suspicion of a malignant tumor.

Data collection Data are collected from our 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. Patients from the Faroe Islands and Greenland are excluded, as they are not recorded in the Danish death register.

Outcomes Relevant postoperative complications are recorded in the study and include leakage from the pancreatic, bile or gastrojejunal anastomosis, intraabdominal hemorrhage and abscess formation or other complications with severe or fatal outcome. Outcomes are defined as postoperative complications and mortality assessed during 30- and 90-days and overall survival (OS) defined as the time from surgery to death from any cause or censoring at time of last follow-up. Hospitalization is defined as postoperative stay until discharge. In-hospital mortality is defined as all deaths from time of admission until discharge. Cancer specific mortality is defined as death from adenocarcinoma after other causes are censured. Recorded years of life lost are defined as lost years compared to the expected remnant life of an age-matched standard population. The recorded years of life lost are the number of deprived years that could have been saved, if patient had not developed an event that had shortened life.

Statistics Data are presented as median and range if not otherwise stated. Categorial data are presented as numbers or percentage and are analyzed with Fisher's exact test. Non-parametric continuous data between subgroups are analyzed with the Mann-Whitney test. The Kaplan-Meier method and the cumulative incidence function with correction for competing risks are used to estimate OS and the log-rank test to examine the differences between curves. The expected years of life lost are calculated as the difference between the area under the survival curve of the reference population and the patient population. The reference population is an age and sex matched Danish standard population. A p < 0.05 is considered statistically significant. Statistical analysis is performed with GraphPad Prism software version 6.05. (GraphPad, La Jolla, CA).

Ethics The study is a descriptive study and conducted in accordance with the principles stated in the Declaration of Helsinki. No approval is required according to the Danish National Health Board. The use of register data follows the General Data Protection Regulation of the European Union and is approved by the Danish Data Protection Agency (RH -2015-07, nr. 03616) and patients' consent. Consent for using health data was obtained before operation.

Being tested
observational study
Keywords
pancreatic cancer, surgery, old patients
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • observational studyOther

What is being measured

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

  1. postoperative mortality

    data base study

    Measured: 1. January 2010 to 31. December 2019

  2. long time survival in patients operated for pancreatic cancer

    data base study

    Measured: 1. January 2010 to 31. December 2019

Timeline

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

  1. First posted19 May 2021
  2. Study start1 Jan 2010
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

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
Other
Time perspective
Retrospective
Enrolment
1,556 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04893408
Sponsor's protocol ID
RH-C-2021-1
Status last verified
May 2021
First submitted
15 May 2021
Last updated
30 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.

    PubMed 33433946

  • van Roessel S, Mackay TM, Tol JAMG, van Delden OM, van Lienden KP, Nio CY, Phoa SSKS, Fockens P, van Hooft JE, Verheij J, Wilmink JW, van Gulik TM, Gouma DJ, Busch OR, Besselink MG. Impact of expanding indications on surgical and oncological outcome in 1434 consecutive pancreatoduodenectomies. HPB (Oxford). 2019 Jul;21(7):865-875. doi: 10.1016/j.hpb.2018.10.020. Epub 2018 Dec 31.

    PubMed 30606684

  • 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

  • Grobmyer SR, Kooby D, Blumgart LH, Hochwald SN. Novel pancreaticojejunostomy with a low rate of anastomotic failure-related complications. J Am Coll Surg. 2010 Jan;210(1):54-9. doi: 10.1016/j.jamcollsurg.2009.09.020. Epub 2009 Oct 28.

    PubMed 20123332

  • Valle JW, Palmer D, Jackson R, Cox T, Neoptolemos JP, Ghaneh P, Rawcliffe CL, Bassi C, Stocken DD, Cunningham D, O'Reilly D, Goldstein D, Robinson BA, Karapetis C, Scarfe A, Lacaine F, Sand J, Izbicki JR, Mayerle J, Dervenis C, Olah A, Butturini G, Lind PA, Middleton MR, Anthoney A, Sumpter K, Carter R, Buchler MW. Optimal duration and timing of adjuvant chemotherapy after definitive surgery for ductal adenocarcinoma of the pancreas: ongoing lessons from the ESPAC-3 study. J Clin Oncol. 2014 Feb 20;32(6):504-12. doi: 10.1200/JCO.2013.50.7657. Epub 2014 Jan 13.

    PubMed 24419109

  • Neoptolemos JP, Palmer DH, Ghaneh P, Psarelli EE, Valle JW, Halloran CM, Faluyi O, O'Reilly DA, Cunningham D, Wadsley J, Darby S, Meyer T, Gillmore R, Anthoney A, Lind P, Glimelius B, Falk S, Izbicki JR, Middleton GW, Cummins S, Ross PJ, Wasan H, McDonald A, Crosby T, Ma YT, Patel K, Sherriff D, Soomal R, Borg D, Sothi S, Hammel P, Hackert T, Jackson R, Buchler MW; European Study Group for Pancreatic Cancer. Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial. Lancet. 2017 Mar 11;389(10073):1011-1024. doi: 10.1016/S0140-6736(16)32409-6. Epub 2017 Jan 25.

    PubMed 28129987

  • Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.

    PubMed 30575490

  • Ducreux M, Cuhna AS, Caramella C, Hollebecque A, Burtin P, Goere D, Seufferlein T, Haustermans K, Van Laethem JL, Conroy T, Arnold D; ESMO Guidelines Committee. Cancer of the pancreas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v56-68. doi: 10.1093/annonc/mdv295. No abstract available.

    PubMed 26314780

  • Kim HT. Cumulative incidence in competing risks data and competing risks regression analysis. Clin Cancer Res. 2007 Jan 15;13(2 Pt 1):559-65. doi: 10.1158/1078-0432.CCR-06-1210.

    PubMed 17255278

  • Jindal M, Zheng C, Quadri HS, Ihemelandu CU, Hong YK, Smith AK, Dudeja V, Shara NM, Johnson LB, Al-Refaie WB. Why Do Long-Distance Travelers Have Improved Pancreatectomy Outcomes? J Am Coll Surg. 2017 Aug;225(2):216-225. doi: 10.1016/j.jamcollsurg.2017.04.003. Epub 2017 Apr 14.

    PubMed 28414114

  • van der Geest LG, Besselink MG, Busch OR, de Hingh IH, van Eijck CH, Dejong CH, Lemmens VE. Elderly Patients Strongly Benefit from Centralization of Pancreatic Cancer Surgery: A Population-Based Study. Ann Surg Oncol. 2016 Jun;23(6):2002-9. doi: 10.1245/s10434-016-5089-3. Epub 2016 Jan 21.

    PubMed 26795767

  • Huang L, Jansen L, Balavarca Y, Molina-Montes E, Babaei M, van der Geest L, Lemmens V, Van Eycken L, De Schutter H, Johannesen TB, Fristrup CW, Mortensen MB, Primic-Zakelj M, Zadnik V, Becker N, Hackert T, Magi M, Cassetti T, Sassatelli R, Grutzmann R, Merkel S, Goncalves AF, Bento MJ, Hegyi P, Lakatos G, Szentesi A, Moreau M, van de Velde T, Broeks A, Sant M, Minicozzi P, Mazzaferro V, Real FX, Carrato A, Molero X, Besselink MG, Malats N, Buchler MW, Schrotz-King P, Brenner H. Resection of pancreatic cancer in Europe and USA: an international large-scale study highlighting large variations. Gut. 2019 Jan;68(1):130-139. doi: 10.1136/gutjnl-2017-314828. Epub 2017 Nov 20.

    PubMed 29158237

  • Shamali A, De'Ath HD, Jaber B, Abuawad M, Barbaro S, Hamaday Z, Abu Hilal M. Elderly patients have similar short term outcomes and five-year survival compared to younger patients after pancreaticoduodenectomy. Int J Surg. 2017 Sep;45:138-143. doi: 10.1016/j.ijsu.2017.07.106. Epub 2017 Aug 4.

    PubMed 28782662

  • Adham M, Bredt LC, Robert M, Perinel J, Lombard-Bohas C, Ponchon T, Valette PJ. Pancreatic resection in elderly patients: should it be denied? Langenbecks Arch Surg. 2014 Apr;399(4):449-59. doi: 10.1007/s00423-014-1183-9. Epub 2014 Mar 27.

    PubMed 24671518

  • Turrini O, Paye F, Bachellier P, Sauvanet A, Sa Cunha A, Le Treut YP, Adham M, Mabrut JY, Chiche L, Delpero JR; French Surgical Association (AFC). Pancreatectomy for adenocarcinoma in elderly patients: postoperative outcomes and long term results: a study of the French Surgical Association. Eur J Surg Oncol. 2013 Feb;39(2):171-8. doi: 10.1016/j.ejso.2012.08.017. Epub 2012 Sep 19.

    PubMed 22999411

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Cancer, 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?

The sponsor lists 1 inclusion and 1 exclusion criteria. 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 30 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?

postoperative mortality (time frame: 1. January 2010 to 31. December 2019). 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 NCT04893408, which also lists 25 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 30 Nov 2023; AzTrials last refreshed its copy on 29 Oct 2026.

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