Cognitive effects of stomach or esophagus cancer surgery
Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer
This study will see how often people who have surgery for stomach or esophagus cancer develop postoperative delirium and whether it is linked to preoperative depression, frailty, malnutrition, sarcopenia, or lower quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Huddinge) |
| Trial ID | NCT06687291 on ClinicalTrials.gov |
What this trial studies
This observational study will measure the incidence of postoperative delirium (POD) in adults undergoing surgery for gastric or esophageal cancer and examine relationships with preoperative depression, frailty, malnutrition, sarcopenia and quality of life. Clinical data and routine follow-up assessments will be used, and participants identified with POD will be invited to a qualitative interview to describe their experience. Common exclusions include preexisting dementia, inoperable metastatic disease, severe communication impairments, ongoing substance abuse, and inability to consent. The study is conducted at Karolinska University Hospital, Huddinge, in collaboration with Region Stockholm.
Who should consider this trial
Good fit: Adults (age ≥18) diagnosed with gastric or esophageal cancer who are treated with or without chemotherapy and who can give informed consent and communicate are the intended participants.
Not a fit: Patients with preoperative dementia, inoperable metastatic disease, severe hearing or vision impairment preventing communication, ongoing drug or alcohol abuse, or inability to consent are excluded and unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the results could help identify patients at higher risk for postoperative delirium so clinicians can target screening and preoperative or postoperative support to reduce delirium and improve recovery.
How similar studies have performed: Previous observational work in major abdominal and oncologic surgery has linked frailty, malnutrition and depression to postoperative delirium, but focused data specifically in gastroesophageal cancer surgery are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Huddinge
- Karolinska University Hospital, Huddinge — Huddinge, Sweden (Recruiting)
Study contacts
- Principal investigator: Maria Lampi, PhD — Karolinska Institutet
- Study coordinator: Marcus Nömm, PhD-student
- Email: marcus.nomm@ki.se
- Phone: 0733765652
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.