UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061670 |
|---|---|
| Receipt number | R000070563 |
| Scientific Title | The G-PMI Score: A Composite of the Geriatric Nutritional Risk Index and Psoas Muscle Index for Predicting Long-Term Outcomes After Esophagectomy in Male Patients with Esophageal Cancer- A Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/05/23 |
| Last modified on | 2026/05/23 21:21:35 |
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Basic information
Public title
A retrospective cohort study of the G-PMI score for predicting long-term outcomes after curative-intent esophagectomy for esophageal cancer
Acronym
G-PMI score study
Scientific Title
The G-PMI Score: A Composite of the Geriatric Nutritional Risk Index and Psoas Muscle Index for Predicting Long-Term Outcomes After Esophagectomy in Male Patients with Esophageal Cancer- A Retrospective Cohort Study
Scientific Title:Acronym
The G-PMI Score in Male Esophageal Cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to develop and evaluate the G-PMI score, a composite index combining the Geriatric Nutritional Risk Index (GNRI) and the psoas muscle index (PMI), in patients who underwent curative-intent esophagectomy for esophageal cancer. The study aims to assess the prognostic stratification ability of the G-PMI score for overall survival and disease-free survival, with particular attention to sex differences in the prognostic relevance of GNRI and PMI.
Basic objectives2
Others
Basic objectives -Others
Prognostic prediction and risk stratification
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival, defined as the time from surgery to death from any cause or last follow-up. Survival status and date of death during follow-up were assessed using medical records.
Key secondary outcomes
Disease-free survival, defined as the time from surgery to recurrence, death, or last follow-up. Recurrence status and date of recurrence were assessed using medical records, imaging studies, and endoscopic findings. Short-term postoperative outcomes, including postoperative complications, severe complications, anastomotic leakage, pneumonia, reoperation, in-hospital mortality, and length of postoperative hospital stay, were also evaluated. Postoperative complications were graded according to the Clavien-Dindo classification, and severe complications were defined as grade IIIb or higher.
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
| 18 | years-old | < |
Age-upper limit
| 999 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with primary esophageal cancer who underwent curative-intent esophagectomy at Hokkaido University Hospital between January 2010 and December 2024.
2.Patients with available preoperative laboratory and anthropometric data required for calculation of the Geriatric Nutritional Risk Index.
3.Patients with available preoperative CT images required for measurement of the psoas muscle index.
Key exclusion criteria
1.Patients who did not undergo surgery with curative intent.
2.Patients who underwent surgery for malignancies other than primary esophageal cancer.
3.Patients with missing data required for calculation of the Geriatric Nutritional Risk Index or measurement of the psoas muscle index.
Target sample size
216
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Nitta |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterological Surgery II
Zip code
060-8648
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8648, Japan
TEL
09075128303
cdv05300@par.odn.ne.jp
Public contact
Name of contact person
| 1st name | Takeo |
| Middle name | |
| Last name | Nitta |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterological Surgery II
Zip code
060-8648
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8648, Japan
TEL
09075128303
Homepage URL
cdv05300@par.odn.ne.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
No external funding
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
Hokkaido University Hospital Clinical Research Administration Center
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.ac.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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Not available
Publication of results
Unpublished
Result
URL related to results and publications
Not available
Number of participants that the trial has enrolled
216
Results
This retrospective study evaluated the association of the Geriatric Nutritional Risk Index, psoas muscle index, and the composite G-PMI score with long-term outcomes in 216 patients with primary esophageal cancer who underwent curative-intent esophagectomy at Hokkaido University Hospital between January 2010 and December 2024. The main results are currently being prepared for journal submission and have not yet been published. Result information will be updated after publication.
Results date posted
| 2026 | Year | 05 | Month | 23 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The main results of this study are currently being prepared for submission to a peer-reviewed journal. Result information in UMIN-CTR will be updated after publication.
Date of the first journal publication of results
Baseline Characteristics
This study included 216 patients with primary esophageal cancer who underwent curative-intent esophagectomy at Hokkaido University Hospital between January 2010 and December 2024. The cohort comprised 170 men and 46 women.
Participant flow
Consecutive patients who underwent surgical treatment for esophageal malignancy between January 2010 and December 2024 were screened. Patients who did not undergo curative-intent surgery, those with malignancies other than primary esophageal cancer, and those with missing data required for calculation of the Geriatric Nutritional Risk Index or psoas muscle index were excluded. A total of 216 patients were included in the final analysis.
Adverse events
This was a retrospective observational study using existing clinical data, and no study-specific intervention was performed; therefore, no study-related adverse events occurred. Short-term postoperative outcomes, including postoperative complications, severe complications, anastomotic leakage, pneumonia, reoperation, and in-hospital mortality, were retrospectively assessed using medical records.
Outcome measures
The primary outcome was overall survival, defined as the time from surgery to death from any cause or last follow-up. The secondary outcome was disease-free survival, defined as the time from surgery to recurrence, death, or last follow-up. Short-term postoperative outcomes included postoperative complications, severe complications, anastomotic leakage, pneumonia, reoperation, in-hospital mortality, and length of postoperative hospital stay. Postoperative complications were graded according to the Clavien-Dindo classification, and severe complications were defined as grade IIIb or higher.
Plan to share IPD
Individual participant data will not be publicly available.
IPD sharing Plan description
The datasets used in this study contain clinical information and will not be publicly available because of privacy protection and institutional regulations. Anonymized data may be considered upon reasonable request and with permission from the Institutional Review Board of Hokkaido University Hospital.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 04 | Day |
Date of closure to data entry
| 2026 | Year | 05 | Month | 04 | Day |
Date trial data considered complete
| 2026 | Year | 05 | Month | 04 | Day |
Date analysis concluded
| 2026 | Year | 05 | Month | 05 | Day |
Other
Other related information
This is a single-center retrospective cohort study of consecutive patients with primary esophageal cancer who underwent curative-intent esophagectomy at Hokkaido University Hospital between January 2010 and December 2024. No study-specific intervention was performed. Data obtained during routine clinical practice, including medical records, preoperative laboratory data, anthropometric data, preoperative CT images, pathological findings, postoperative outcomes, recurrence, and survival status, were retrospectively collected.
The main variables assessed were the Geriatric Nutritional Risk Index, psoas muscle index, and the composite G-PMI score integrating these two indices. The primary outcome was overall survival, and the secondary outcomes were disease-free survival and short-term postoperative outcomes. Sex differences in the prognostic relevance of GNRI and PMI were assessed, and the prognostic stratification ability of the G-PMI score was evaluated primarily in male patients.
Sampling was not random; all consecutive eligible patients during the study period were included. This study was approved by the Institutional Review Board of Hokkaido University Hospital (approval number: 024-0235). This registration is a retrospective registration performed after completion of the study and before journal submission, and it is not a prospective registration.
Management information
Registered date
| 2026 | Year | 05 | Month | 23 | Day |
Last modified on
| 2026 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070563
