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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040514
Receipt No. R000046121
Scientific Title Evaluation of gastroesophageal reflux using high-resolution manometry and pH monitor after proximal gastrectomy
Date of disclosure of the study information 2020/07/01
Last modified on 2020/05/25

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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 Preinitiation
Date of protocol fixation
2020 Year 05 Month 17 Day
Date of IRB
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
2020 Year 05 Month 25 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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