UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046904 |
|---|---|
| Receipt number | R000053512 |
| Scientific Title | Intragastric pressure measurement study for evaluation of the invasion depth of early gastric cancer |
| Date of disclosure of the study information | 2022/02/21 |
| Last modified on | 2022/02/14 14:58:22 |
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Basic information
Public title
Intragastric pressure measurement study for evaluation of the invasion depth of early gastric cancer
Acronym
Intragastric pressure measurement study
Scientific Title
Intragastric pressure measurement study for evaluation of the invasion depth of early gastric cancer
Scientific Title:Acronym
Intragastric pressure measurement study
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to obtain the intragastric pressure necessary for determining the invasion depth of early gastric cancer for preoperative endoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endopoint of this study is to obtain the intragastric pressure necessary for determining the invasion depth of early gastric cancer for preoperative endoscopy
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 with an Eastern Cooperative Oncology Group performance status score of 0 or 1 [1].
2. Patients with an age at registration over 20 years old.
3. Patients who provided written informed consent for study participation.
4. Patients with biopsy histopathological examination of the lesion diagnosed as Vienna Classification Category 4 or 5 [2].
5. Patients with a tumor size of 10 mm or greater.
1. Oken, M.M., Creech, R.H., Tormey, et al: Toxicity And Response Criteria Of The Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655, 1982.
2. R J Schlemper, R H Liddell, Kato Y, et al: The Vienna classification of gastrointestinal epithelial neoplasia. Gut. 2000; 47: 251-255.
Key exclusion criteria
1. Patients with previous gastric surgery and those with a gastric tube.
2. Patients with pedunculated type lesion [3].
3. Patients who would have difficulty participating in this study due to psychiatric disorders or symptoms.
4. Patients whom doctor decide not to register to this study.
3. Participants in the Paris Workshop. The Paris endoscopic classification of superficial neoplastic lesions : esophagus, stomach, and colon-November 30 to December 1, 2002. Gastrointestinal Endosc 58 (suppl): S3-43, 2003
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino City, Fukuoka 818-8502, Japan
TEL
+81-(0)92-921-1011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Imamura |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino City, Fukuoka 818-8502, Japan
TEL
+81-(0)92-921-1011
Homepage URL
kentaro231616@gmail.com
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi Hospital
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
Fukuoka University-Medical Ethics Review Board
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka City, Fukuoka Prefecture
Tel
092-801-1011
fumed-ethics@fukuoka-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
福岡大学筑紫病院（福岡県）
Fukuoka University Chikushi Hospital (Fukuoka prefecture, Japan)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 21 | 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 | 09 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research to begin at Fukuoka University Chikushi Hospital
Management information
Registered date
| 2022 | Year | 02 | Month | 14 | Day |
Last modified on
| 2022 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053512
