UMIN-CTR Clinical Trial

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
Email	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
Email	kentaro231616@gmail.com

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053512