UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062964 |
|---|---|
| Receipt number | R000072092 |
| Scientific Title | Temporal Validation of Prediction Models for Prolonged Postoperative Stay After Gastrectomy: Impact of DPC-Based Outcome Definitions |
| Date of disclosure of the study information | 2026/09/17 |
| Last modified on | 2026/09/17 16:10:10 |
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Basic information
Public title
Validation of prediction models for prolonged hospital stay after gastrectomy
Acronym
Gastrectomy Stay Prediction Study
Scientific Title
Temporal Validation of Prediction Models for Prolonged Postoperative Stay After Gastrectomy: Impact of DPC-Based Outcome Definitions
Scientific Title:Acronym
Temporal Validation of Stay Prediction
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop machine learning models predicting prolonged postoperative stay after gastrectomy for gastric cancer, and to evaluate their discrimination, calibration, and clinical utility using internal cross-validation and temporal validation (development cohort 1996-2015, test cohort 2016-2026). To additionally examine how DPC (Diagnosis Procedure Combination)-based outcome definitions affect model performance.
Basic objectives2
Others
Basic objectives -Others
Development and validation of a prediction model (observational study)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discharge on or after postoperative day 14 (day of surgery defined as postoperative day 0)
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent distal gastrectomy, proximal gastrectomy, or total gastrectomy for gastric cancer at Kameda Medical Center between April 1996 and March 2026, with recorded postoperative length of stay
Key exclusion criteria
Patients with postoperative length of stay exceeding 300 days
Target sample size
2663
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, Chiba
TEL
0470922211
Homepage URL
g_chimera_7@yahoo.co.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
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, Chiba
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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 17 | 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
2663
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 | 08 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study includes a long-term cohort spanning periods before and after DPC (Diagnosis Procedure Combination) implementation, and incorporates a sensitivity analysis using a patient-specific outcome based on DPC Period II thresholds, in addition to the primary fixed outcome (discharge on or after postoperative day 14).
Management information
Registered date
| 2026 | Year | 09 | Month | 17 | Day |
Last modified on
| 2026 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072092
