UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047005 |
|---|---|
| Receipt number | R000053624 |
| Scientific Title | Association between sarcopenia and a prognosis in patients undergoing percutaneous endoscopic gastrostomy |
| Date of disclosure of the study information | 2022/02/25 |
| Last modified on | 2025/02/27 11:20:40 |
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Basic information
Public title
Association between sarcopenia and a prognosis in patients undergoing percutaneous endoscopic gastrostomy
Acronym
Association between sarcopenia and a prognosis in patients undergoing percutaneous endoscopic gastrostomy
Scientific Title
Association between sarcopenia and a prognosis in patients undergoing percutaneous endoscopic gastrostomy
Scientific Title:Acronym
Association between sarcopenia and a prognosis in patients undergoing percutaneous endoscopic gastrostomy
Region
| Japan |
Condition
Condition
Patients undergoing percutaneous endoscopic gastrostomy
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between sarcopenia and prognosis in patients undergoing percutaneous endoscopic gastrostomy
Basic objectives2
Others
Basic objectives -Others
To evaluate whether the relationship between sarcopenia defined with skeletal muscle mass index at the third lumbar level (L3-SMI) and prognosis in patients undergoing percutaneous endoscopic gastrostomy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Overall survival between low and high groups of skeletal muscle mass index at the level of the third lumbar vertebra (L3-SMI)
Key secondary outcomes
1) Overall survival between low and high groups of psoas muscle mass index at the level of the third lumbar vertebra (L3-PMI)
2) Overall survival between low and high groups of skeletal muscle radiation attenuation at the level of the third lumbar vertebra (L3-MRA)
3) Overall survival between low and high group of L3-SMI in the covariate-balancing propensity score-matched subgroup
[Cut-off values]
L3-SMI: female, 29.6 cm2/m; male, 36.2 cm2/ m2
L3-PMI: female, 3.92 cm2/m2; male, 6.36 cm2/ m2
L3-MRA: female, 39.3 cm2/m2; male, 44.4 cm2/m2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who meet all of the following inclusion criteria
1. Consecutive patients who underwent PEG between March 2008 to April 2020 at the Jikei University Hospital (Tokyo, Japan)
2. 20 years of age or older
Key exclusion criteria
Those who meet at least one of the following inclusion criteria
1. Patients with advanced cancer
2. Patients who underwent PEG for the purpose of decompression of the gastrointestinal tract
3. Patients in which the cross-sectional CT images at the third lumber vertebra level were not available
4. Patients with missing body height data
5. Patients who refused to participate by opting out
Target sample size
127
Research contact person
Name of lead principal investigator
| 1st name | Shigo |
| Middle name | |
| Last name | Ono |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
1058471
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
0336331111
ms04furuhashi@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Furuhashi |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
1058471
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
0336331111
Homepage URL
ms04furuhashi@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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
The Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
Tel
0336331111
rinri@jikei.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 25 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2077-0383/12/10/3360
Number of participants that the trial has enrolled
127
Results
Of 127 patients (99 men, 28 women), 71 (56%) were diagnosed with sarcopenia, and 64 patients died during the observation period. The median follow-up period did not differ between patients with and without sarcopenia (p = 0.5). The median survival time after PEG was 273 days in patients with sarcopenia and 1133 days in those without (p < 0.001). Sarcopenia was associated with poor prognosis in patients having undergone PEG.
Results date posted
| 2025 | Year | 02 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients who underwent PEG consecutively from March 2008 to April 2020
Participant flow
We analyzed preoperative sarcopenia and the prognosis of patients after PEG. We defined sarcopenia as a skeletal muscle index at the level of the third lumbar vertebra of <29.6 cm2/m2 for women and <36.2 cm2/m2 for men
Adverse events
None
Outcome measures
The primary outcome was the difference in overall survival after PEG based on the status of sarcopenia.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes
Management information
Registered date
| 2022 | Year | 02 | Month | 25 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053624
