Clinical Trial: A Prospective Observational Study on the Prediction of Functional Outcomes Using Multifaceted Geriatric Assessment Tools (CGA7, G8, CFS) in Patients Aged 75 Years or Older Undergoing Endoscopic Submucosal Dissection (ESD) for Early Gastrointestinal Cancer (Japan)

Tokyo, Aug. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062689) titled 'Frailty Assessment for Predicting Outcomes after Endoscopic Treatment of Early Gastrointestinal Cancer in Elderly Patients Aged 75 Years or Older' on Aug. 25.

Study Type: Observational

Primary Sponsor: Institute - Tokyo University

Condition: Condition - Esophageal cancer, Stomach cancer, Colorectal cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - With the aging of the population, endoscopic submucosal dissection (ESD) is increasingly being performed in late-elderly patients aged 75 years and older. Although ESD is minimally invasive, in elderly patients the principal concern is not the procedure itself but rather the systemic complications it may precipitate, such as pneumonia and delirium. Even when the cancer is curatively resected, a situation in which discharge to home becomes difficult owing to an irreversible decline in activities of daily living (ADL) should be avoided; however, objective preoperative indices for predicting such outcomes have not yet been established. We hypothesize that systemic vulnerability (frailty) in late-elderly patients is a predictor of "functional breakdown." In this study, using three indices that can be assessed within a short time - CGA7, G8, and CFS - we examine whether preoperative frailty classification is independently associated with major adverse functional events (MAFE) within 30 days after the procedure. We also compare the three indices to determine which most precisely predicts prognosis. Basic objectives2 - Safety

Eligibility: Age-lower limit - 75 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who meet all of the following criteria are eligible for inclusion in the study. 1 Men and women aged 75 years or older 2 Patients scheduled to undergo elective ESD (esophageal, gastric, or colorectal) 3 Patients from whom written informed consent for participation in this study has been obtained, either from the patient or a legally authorized representative Key exclusion criteria - Patients who meet any of the following criteria are excluded from the study.

1 Patients with severe dementia or psychiatric illness that makes it difficult to obtain informed consent for study participation 2 Patients in whom assessment using CGA7, G8, or CFS is judged to be infeasible owing to their physical condition at baseline (e.g., complete bed rest, severe paralysis) 3 Patients with a malignancy or severe organ failure for whom life expectancy is estimated to be less than 6 months 4 Patients who have already been enrolled in this study for another ESD procedure during the enrollment period (i.e., a second or subsequent procedure in the same patient) Target Size - 330

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 02 Month 21 Day Date of IRB - 2026 Year 03 Month 19 Day Anticipated trial start date - 2026 Year 05 Month 29 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070497

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