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Recruiting NCT06687291

Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer

— Observational Gastroesophageal Cancer (GC) Postoperative Delirium (POD) Quality of Life (QOL) Frailty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Gastroesophageal Cancer (GC), Postoperative Delirium (POD), Quality of Life (QOL), Frailty. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The primary objective of this observational study is to investigate the incidence of Post Operative Delirium (POD) after gastroesophageal cancer surgery. Secondary objectives are to investigate the relationship between POD, preoperative depression, frailty, quality of life, malnutrition and sarcopenia. Participants identified with POD will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview, in order to understand the participant's experience of postoperative delirium. The main objective aims to answer: What is the incidence of POD after gastroesophageal cancer surgery.

Primary outcome measures

  • Incidence of postoperative delirium [Time frame: From enrollment to the follow up meeting after surgery, approximate 6 months.]
Secondary outcome measures (5)
  • Preoperative depression [Time frame: From enrollment to admission for surgery]
  • Preoperative frailty [Time frame: At admission for surgery]
  • Health-related quality of life [Time frame: From enrollment to the follow up meeting after surgery, approximate 6 months.]
  • Malnutrition [Time frame: At admission for surgery]
  • Sarcopenia [Time frame: From enrollment to admission for surgery]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with esophageal or gastric cancer, treated with (or without) chemotherapy and surgery.
  • Age ≥18 at the time for inclusion.
  • Participate on a voluntary basis and can (for any reason) end its participation during the study.
  • Capable of giving informed consent.

Exclusion criteria

  • Patients with preoperative cognitive dysfunction such as dementia.
  • Patients who are inoperable due to metastases.
  • Patients unable to communicate due to severely impaired hearing and/or - seeing.
  • Patients with ongoing drug and/or alcohol abuse.
  • Patients who cannot give informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Karolinska University Hospital, Huddinge — Huddinge

Publications

  • Tieges Z, Maclullich AMJ, Anand A, Brookes C, Cassarino M, O'connor M, Ryan D, Saller T, Arora RC, Chang Y, Agarwal K, Taffet G, Quinn T, Shenkin SD, Galvin R. Diagnostic accuracy of the 4AT for delirium detection in older adults: systematic review and meta-analysis. Age Ageing. 2021 May 5;50(3):733-743. doi: 10.1093/ageing/afaa224. PMID 33951145
  • Liu J, Li J, Wang J, Zhang M, Han S, Du Y. Associated factors for postoperative delirium following major abdominal surgery: A systematic review and meta-analysis. Int J Geriatr Psychiatry. 2023 Jun;38(6):e5942. doi: 10.1002/gps.5942. PMID 37260053
  • Loh KP, Janelsins MC, Mohile SG, Holmes HM, Hsu T, Inouye SK, Karuturi MS, Kimmick GG, Lichtman SM, Magnuson A, Whitehead MI, Wong ML, Ahles TA. Chemotherapy-related cognitive impairment in older patients with cancer. J Geriatr Oncol. 2016 Jul;7(4):270-80. doi: 10.1016/j.jgo.2016.04.008. Epub 2016 Jul 5. PMID 27197918
  • Hughes CG, Boncyk CS, Culley DJ, Fleisher LA, Leung JM, McDonagh DL, Gan TJ, McEvoy MD, Miller TE; Perioperative Quality Initiative (POQI) 6 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Delirium Prevention. Anesth Analg. 2020 Jun;130(6):1572-1590. doi: 10.1213/ANE.0000000000004641. PMID 32022748

Identifiers

NCT: NCT06687291 · Ethical approval 2024-00971-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗