UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040514 |
|---|---|
| Receipt number | 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 | 2021/05/28 14:32:27 |
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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
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
toriumi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046121
