UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of gastroesophageal reflux using high-resolution manometry and pH monitor after proximal gastrectomy
Acronym	Evaluation of gastroesophageal reflux using high-resolution manometry and pH monitor after proximal gastrectomy
Scientific Title	Evaluation of gastroesophageal reflux using high-resolution manometry and pH monitor after proximal gastrectomy
Scientific Title:Acronym	Evaluation of gastroesophageal reflux using high-resolution manometry and pH monitor after proximal gastrectomy
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the esophageal reflux after proximal gastrectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The difference of internal pressure at the anastomotic site between the types of reconstructions at more than 1 year after proximal gastrectomy.
Key secondary outcomes	The difference of DeMeester score between the types of reconstructions at more than 1 year after surgery. The change of internal pressure and DeMeester score before and after proximal gastrectomy. The associations between internal pressure or DeMeester score and quality of life. The associations between internal pressure or DeMeester score and body weight change or prognostic nutritional index.

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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	<Patients after proximal gastrectomy> 1) Patients who underwent proximal gastrectomy for gastric cancer at the University of Tokyo hospital 2) Patients who are 20-85 years old at the time of consent 3) Patients who do not receive chemotherapy or radiotherapy 4) Patients without recurrence 5) Patients who do not have other malignancy 6) Patients who are not hospitalized 7) Patients with the written consent <Preoperative patients> 1) Patients with gastric cancer who is planed to perform proximal gastrectomy and do not receive neoadjuvant treatment. 2) Patients who are 20-85 years old at the time of consent 3) Patients without other organ malignancy 4) Patients who are not hospitalized 5) Patients with the written consent
Key exclusion criteria	1) Patients within 1 year after proximal gastrectomy (except preoperative patients) 2) Patients who are expected to be difficult to complete the examination 3) Patients who can not suspend anti-acid drugs. 4) Patients who have already joined this trial 5) Patients with contraindication for esophagogastroduodenoscopy. a) hemodynamic and respiratory instability b) hemorrhagic (except anti-coagulant drugs) c) severe anastomotic stenosis d) stenosis or obstruction of the bowel distal to the duodenum e) intolerant to esophagogastroduodenoscopy 6) Patients who have difficulty in swallowing with the catheter inserted 7) Patients with allergy to the drugs we plan to use 8) Patients who are pregnant 9) Patients whom researchers regard as invalid
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiroharu Middle name Last name Yamashita
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastrointestinal Surgery
Zip code	113-8655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	hyamashi-tky@umin.net

Public contact
Name of contact person	1st name Tetsuro Middle name Last name Toriumi
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastrointestinal Surgery
Zip code	113-8655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	toriumi-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Office for Human Research Studies, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel	03-5841-0818
Email	ethics@m.u-tokyo.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	2020 Year 07 Month 01 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	Open public recruiting
Date of protocol fixation	2020 Year 05 Month 17 Day
Date of IRB	2020 Year 06 Month 12 Day
Anticipated trial start date	2020 Year 07 Month 01 Day
Last follow-up date	2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 05 Month 25 Day
Last modified on	2021 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046121