UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034514 |
|---|---|
| Receipt number | R000039354 |
| Scientific Title | The study of changes in neutrophil function and physical stress during the perioperative period of endoscopic operation |
| Date of disclosure of the study information | 2018/10/16 |
| Last modified on | 2022/05/04 11:38:31 |
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Basic information
Public title
The study of changes in neutrophil function and physical stress during the perioperative period of endoscopic operation
Acronym
changes in serum opsonic activity during the perioperative period of endoscopic operation
Scientific Title
The study of changes in neutrophil function and physical stress during the perioperative period of endoscopic operation
Scientific Title:Acronym
changes in serum opsonic activity during the perioperative period of endoscopic operation
Region
| Japan |
Condition
Condition
gastric cancer, colorectal cancer, esophageal cancer, esophageal achalasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
invasiveness of endoscopic operation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes in serum opsonic activity on the next day and at 4 days after endoscopic operation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients who undergo endoscopic operation
2) written informed concent
Key exclusion criteria
patients who have a history of liver cirrhosis, are undergoing artificial dialysis, have other malignancies, and are using immunomodulatory drugs
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Chinda |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Gastroenterology and Hematology
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, Aomori
TEL
0172-33-5111
chinda@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Chinda |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Gastroenterology and Hematology
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, Aomori
TEL
0172-33-5111
Homepage URL
chinda@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-sourcing
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
Department of Gastroenterology and Hematology, Hirosaki University Graduate School of Medicine
Address
5 Zaifu-cho, Hirosaki, Aomori
Tel
0172335111
chinda@hirosaki-u.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
| 2018 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jcbn/64/2/64_18-93/_article
Number of participants that the trial has enrolled
Results
SOA to stimulate neutrophil ROS production was increased during the perioperative period of ESD for gastric cancer. SOA was the highest on the next day of ESD and continued to increase even at 4 days after ESD.
During the perioperative period of ESD for early-stage colorectal cancer, no SOA changes were found on the day after ESD. SOA increased 4 days after ESD when measured by LgCL, but not in other cases.
Results date posted
| 2019 | Year | 11 | Month | 03 | Day |
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
| 2015 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
patients who underwent ESD for gastric cancer, colorectal cancer and esophageal cancer and POEM for esophageal achalasia at Hirosaki University Hospital
Management information
Registered date
| 2018 | Year | 10 | Month | 16 | Day |
Last modified on
| 2022 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039354
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
