Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061561) titled 'Minimal Important Change of the Six-Minute Walk Distance in Patients with Esophageal Cancer Following Surgery' on June 1.
Study Type:
Observational
Primary Sponsor:
Institute - Nagasaki University
Condition:
Condition - Esophageal cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To determine the minimal important change in the longitudinal changes of the six-minute walk distance from before surgery to 3 weeks after surgery in patients with esophageal cancer.
Basic objectives2 - Bio-availability
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients diagnosed with esophageal cancer or esophagogastric junction cancer
Patients aged 20 years or older at the time of informed consent
Patients able to walk independently preoperatively
Patients scheduled to undergo elective esophagectomy
Key exclusion criteria - Patients who underwent reoperation within 3 weeks after surgery
Patients with comorbidities that could affect the 6-minute walk test (6MWT) (e.g., musculoskeletal or neurological disorders causing gait impairment, such as pain or impaired balance ability)
Patients unable to understand the QLQ-C30 questionnaire due to visual or hearing impairment, or cognitive dysfunction
Patients with missing data for the 6-minute walk distance and QLQ-C30 physical functioning score at both preoperative assessment and 3 weeks postoperatively
Target Size - 67
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 13 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2027 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070438
Disclaimer: Curated by HT Syndication.
