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NCT Number: NCT06687291

Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer

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.

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Key information

Conditions

Gastroesophageal Cancer (GC) Atrophy Behavior Behavioral Symptoms Chemically-Induced Disorders Chemobrain Chemotherapy Chemotherapy-Related Cognitive Impairment Cognition Disorders Cognitive Dysfunction Confusion Delirium Depression Drug-Related Side Effects and Adverse Reactions Emergence Delirium Frailty Malnutrition Mental Disorders Muscular Atrophy Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Delirium (POD) Quality of Life (QOL) Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of postoperative delirium

    Time frame: From enrollment to the follow up meeting after surgery, approximate 6 months.

    The assessment of cognitive function will be performed using the validated 4AT Test (4AT).

    Cognitive impact will be assessed at baseline before neoadjuvant chemotherapy (if chemotherapy is indicated) and at patient admission for surgery, postoperative day 1, 3 and 7, and at follow-up 4-8 weeks after surgery.

Secondary outcomes

  1. Preoperative depression

    Time frame: From enrollment to admission for surgery

    A risk factor for postoperative delirium is preoperative depression. Depression will be measured preoperatively with the Patient Health Questionnaire (PHQ-9).

  2. Preoperative frailty

    Time frame: At admission for surgery

    Frailty is a risk factor for post operative delirium. Frailty will be measured preoperatively with Clinical Frailty Scale (CFS-9).

  3. Health-related quality of life

    Time frame: From enrollment to the follow up meeting after surgery, approximate 6 months.

    Low score in quality of life is a risk factor for delirium. Patients will report health-related quality of life using the validated European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQC-C30) and EORTC validated Quality of Life Questionnaire for Oesophago-Gastric cancer (QLQ-OG25).

  4. Malnutrition

    Time frame: At admission for surgery

    Patients with malnutrition before surgery have a higher risk of developing post-operative delirium. Malnutrition is assessed by using Patient-Generated Subjective Global Assessment (PG-SGA) before surgery.

  5. Sarcopenia

    Time frame: From enrollment to admission for surgery

    There is association between preoperative sarcopenia and postoperative delirium in patients undergoing gastrointestinal cancer surgery. Sarcopenia is assessed by using CT-scan in clinical routine.

Other outcomes

  1. Patients experience of Postoperative delirium

    Time frame: The interview takes place 2 weeks after follow up-meeting

    All participants that suffered from POD will be invited to participate in an interview, with a maximum number of 25 participants. A semi-structured one-on-one interview with the aim to describe patient experiences of POD will be used. The semi-structured interview technique allows the interviewer to ask probing questions for clarification when necessary. An interview guide will be used to ensure covering issues such as cognition, memory loss, attention, awareness and orientation to the environment. The participant will be asked for participation at the follow-up meeting after surgery. The interview takes place 2 weeks after follow up-meeting after surgery at the location (or via that media) that best serve the participant. The interview will be recorded and transcribed, then analysed using qualitative content analysis with an inductive and latent approach.

Study contacts

Contact information is provided by the study sponsor or research team.

Marcus Nömm, PhD-student

CONTACT

[email protected]

0733765652

Maria Lampi, PhD

CONTACT

[email protected]

0852483721

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Acronym: CASE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 13, 2024
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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