UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061991 |
|---|---|
| Receipt number | R000070937 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/06/21 |
| Last modified on | 2026/06/21 18:47:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
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
Acronym
MLM Gastrectomy Complication Prediction
Scientific Title
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
Scientific Title:Acronym
MLM Gastrectomy Complication Prediction
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of postoperative complications of Clavien-Dindo grade 2 or higher among patients aged 75 years or older undergoing gastrectomy for gastric cancer
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 75 | years-old | <= |
Age-upper limit
| 100 | 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 sample size
801
Research contact person
Name of lead principal investigator
| 1st name | Goshi |
| Middle name | |
| Last name | Fujimoto |
Organization
Kameda Medical Center
Division name
Gastroenterological Surgery
Zip code
296-0041
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture 296-8602, Japan
TEL
0470922211
g_chimera_7@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Goshi |
| Middle name | |
| Last name | Fujimoto |
Organization
Kameda Medical Center
Division name
Gastroenterological Surgery
Zip code
296-0041
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture 296-8602, Japan
TEL
0470922211
Homepage URL
g_chimera_7@yahoo.co.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Goshi Fujimoto
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kameda Medical Center
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture 296-8602, Japan
Tel
0470922211
g_chimera_7@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
静岡県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
801
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, retrospective cohort study of patients aged 75 years or older who underwent gastrectomy for gastric cancer at our institution between April 1, 2000 and March 31, 2025.
Using data extracted from electronic medical records, we developed machine learning models to predict the occurrence of postoperative complications of Clavien-Dindo grade 2 or higher. The study period was divided at April 1, 2019 into two cohorts: an earlier cohort (development cohort, 638 patients) used for model development, and a later cohort (temporal validation cohort, 163 patients) used for temporal validation of model performance.
Predictors were limited to variables confirmed preoperatively, including age, sex, body mass index, American Society of Anesthesiologists physical status, age-adjusted Charlson comorbidity index, prior laparotomy history, total gastrectomy, open surgical approach, Prognostic Nutritional Index, C-reactive protein-to-albumin ratio, and prothrombin time international normalized ratio. Postoperatively determined pathological variables were not included as predictors.
Management information
Registered date
| 2026 | Year | 06 | Month | 21 | Day |
Last modified on
| 2026 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070937
