Clinical Trial: Development and Temporal Validation of Machine Learning Models for Predicting Postoperative Complications After Gastrectomy in Patients Aged 75 Years or Older: A Single-Center Retrospective Cohort Study (Japan)

Tokyo, June 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061991) titled 'Development and Temporal Validation of Machine Learning Models for Predicting Postoperative Complications After Gastrectomy in Patients Aged 75 Years or Older: A Single-Center Retrospective Cohort Study' on June 21.

Study Type: Observational

Primary Sponsor: Institute - Kameda Medical Center

Condition: Condition - Gastric cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study aimed to develop and temporally validate machine learning models for predicting grade 2 or higher complications after gastrectomy in patients aged 75 years or older using exclusively preoperative variables, quantify optimism bias, and evaluate incremental predictive value over single-predictor baselines, in accordance with the TRIPOD+AI statement and PROBAST+AI guidelines. Basic objectives2 - Safety

Eligibility: Age-lower limit - 75 years-old = Gender - Male and Female Key inclusion criteria - Patients aged 75 years or older who underwent gastrectomy (distal gastrectomy, total gastrectomy, or proximal gastrectomy) for gastric cancer at our institution between April 1, 2000 and March 31, 2025, regardless of the extent of lymphadenectomy (D0-D2), resection margin status (R0-R2), simultaneous resection of other organs, or prior neoadjuvant chemotherapy. Key exclusion criteria - Patients meeting any of the following criteria were excluded: 1) concurrent malignancies other than gastric cancer; 2) insufficient data required for this study; 3) exploratory laparotomy; 4) bypass procedures; 5) local gastric resection, gastric segmentectomy, or pylorus-preserving gastrectomy; 6) gastrostomy or jejunostomy formation alone. Target Size - 801

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2026 Year 06 Month 04 Day Date of IRB - 2026 Year 06 Month 04 Day Anticipated trial start date - 2026 Year 06 Month 04 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070937

Disclaimer: Curated by HT Syndication.