UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048021 |
|---|---|
| Receipt number | R000054541 |
| Scientific Title | Effect of gastrointestinal surgery on body protein decay and nutrient metabolism dynamics. |
| Date of disclosure of the study information | 2022/06/10 |
| Last modified on | 2024/08/24 15:15:05 |
* 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
Effect of gastrointestinal surgery on body protein decay and nutrient metabolism dynamics.
Acronym
Effect of gastrointestinal surgery on body protein decay and nutrient metabolism dynamics.
Scientific Title
Effect of gastrointestinal surgery on body protein decay and nutrient metabolism dynamics.
Scientific Title:Acronym
Effect of gastrointestinal surgery on body protein decay and nutrient metabolism dynamics.
Region
| Japan |
Condition
Condition
Malignant tumors of the upper gastrointestinal tract (including GIST)
Liver malignancies
Pancreatic malignancies
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the perioperative muscle protein disruption status and changes in oral intake status of patients who underwent upper gastrointestinal tract (esophagus and stomach) resection and hepatopancreatectomy, and to study their postoperative nutritional status.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in body protein decay (urinary titin), nutritional intake changes and nutritional status and bio-metabolic changes
Key secondary outcomes
Sarcopenia evaluation index, and its relationship with nutritional intake
Changes in nutritional metabolic composition of blood due to surgical procedures
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
(1) 20 years of age or older
(2) Persons who understand the content of this study and have given written consent
(3) Patients who underwent surgery at the Department of Gastroenterological Surgery, Kitano Hospital, Tazuke Kofukai Medical Research Institute
Key exclusion criteria
(1) Patients who cannot give consent to participate in this study
(2) Patients with muscular dystrophy or other chronic diseases that may cause muscle atrophy or collapse
(3) Patients on dialysis
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Tanaka |
Organization
Tazuke Kofukai, Medical Research Institute, Kitano Hospital
Division name
Department of Gastroenterological Surgery
Zip code
530-8480
Address
2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN
TEL
06-6312-1221
eiji-tanaka@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Momoko |
| Middle name | |
| Last name | Kyomen |
Organization
Tazuke Kofukai, Medical Research Institute, Kitano Hospital
Division name
Department of Clinical Nutrition
Zip code
530-8480
Address
2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN
TEL
06-6312-1221
Homepage URL
m-kyoumen@kitano-hp.or.jp
Sponsor or person
Institute
Tazuke Kofukai, Medical Research Institute, Kitano Hospital
Institute
Department
Personal name
Funding Source
Organization
Tazuke Kofukai, Medical Research Institute, Kitano Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Metabolism and Nutrition, Graduate School of Medical, Dental and Pharmaceutical Sciences, The University of Tokushima
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitano Hospital Medical Ethics Committee
Address
2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN
Tel
06-6131-2792
rinshou@kitano-hp.or.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 | 06 | Month | 10 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe the progress from preoperative to 1 year postoperative
Management information
Registered date
| 2022 | Year | 06 | Month | 10 | Day |
Last modified on
| 2024 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054541
