NCT04893408

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,556

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
Last Updated

November 30, 2023

Status Verified

May 1, 2021

Enrollment Period

10 years

First QC Date

May 15, 2021

Last Update Submit

November 26, 2023

Conditions

Keywords

pancreatic cancer, surgery, old patients

Outcome Measures

Primary Outcomes (2)

  • postoperative mortality

    data base study

    1. January 2010 to 31. December 2019

  • long time survival in patients operated for pancreatic cancer

    data base study

    1. January 2010 to 31. December 2019

Interventions

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Danish population operated for pancreatic tumors including ductal adenocarcinoma

You may qualify if:

  • all patients with pancreatic resection aged 18 years and older

You may not qualify if:

  • patients younger than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (25)

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    PMID: 30575490BACKGROUND
  • 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.

    PMID: 26314780BACKGROUND
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    PMID: 17255278BACKGROUND
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    PMID: 28414114BACKGROUND
  • 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.

    PMID: 26795767BACKGROUND
  • 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.

    PMID: 29158237BACKGROUND
  • 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.

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  • 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.

    PMID: 24671518BACKGROUND
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    PMID: 22999411BACKGROUND
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    PMID: 22882194BACKGROUND
  • Hatzaras I, Schmidt C, Klemanski D, Muscarella P, Melvin WS, Ellison EC, Bloomston M. Pancreatic resection in the octogenarian: a safe option for pancreatic malignancy. J Am Coll Surg. 2011 Mar;212(3):373-7. doi: 10.1016/j.jamcollsurg.2010.10.015. Epub 2011 Jan 12.

    PMID: 21227721BACKGROUND
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    PMID: 20824366BACKGROUND
  • Hardacre JM, Simo K, McGee MF, Stellato TA, Schulak JA. Pancreatic resection in octogenarians. J Surg Res. 2009 Sep;156(1):129-32. doi: 10.1016/j.jss.2009.03.047. Epub 2009 May 3.

    PMID: 19592032BACKGROUND
  • Makary MA, Winter JM, Cameron JL, Campbell KA, Chang D, Cunningham SC, Riall TS, Yeo CJ. Pancreaticoduodenectomy in the very elderly. J Gastrointest Surg. 2006 Mar;10(3):347-56. doi: 10.1016/j.gassur.2005.12.014.

    PMID: 16504879BACKGROUND
  • Renz BW, Khalil PN, Mikhailov M, Graf S, Schiergens TS, Niess H, Boeck S, Heinemann V, Hartwig W, Werner J, Bruns CJ, Kleespies A. Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head is justified in elderly patients: A Retrospective Cohort Study. Int J Surg. 2016 Apr;28:118-25. doi: 10.1016/j.ijsu.2016.02.064. Epub 2016 Feb 21.

    PMID: 26906329BACKGROUND
  • Sultana A, Smith CT, Cunningham D, Starling N, Neoptolemos JP, Ghaneh P. Meta-analyses of chemotherapy for locally advanced and metastatic pancreatic cancer. J Clin Oncol. 2007 Jun 20;25(18):2607-15. doi: 10.1200/JCO.2006.09.2551.

    PMID: 17577041BACKGROUND
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MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • carsten p hansen, MD, DMSc

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant

Study Record Dates

First Submitted

May 15, 2021

First Posted

May 19, 2021

Study Start

January 1, 2010

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

November 30, 2023

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share