UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062999 |
|---|---|
| Receipt number | R000071445 |
| Scientific Title | Assessment of Gastroesophageal Reflux Disease (GERD) Before and After Sleeve Gastrectomy in Patients with Obesity |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/20 11:44:30 |
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Basic information
Public title
Assessment of Gastroesophageal Reflux Disease (GERD) Before and After Sleeve Gastrectomy in Patients with Obesity
Acronym
Assessment of Gastroesophageal Reflux Disease (GERD) Before and After Sleeve Gastrectomy in Patients with Obesity
Scientific Title
Assessment of Gastroesophageal Reflux Disease (GERD) Before and After Sleeve Gastrectomy in Patients with Obesity
Scientific Title:Acronym
Assessment of Gastroesophageal Reflux Disease (GERD) Before and After Sleeve Gastrectomy in Patients with Obesity
Region
| Japan |
Condition
Condition
patients with obesity undergoing sleeve gastrectomy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the severity of gastroesophageal reflux disease (GERD) before and after sleeve gastrectomy in patients with obesity and to assess the therapeutic efficacy of vonoprazan.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the symptom severity and endoscopic severity of gastroesophageal reflux disease (GERD) at 1 year after sleeve gastrectomy.
Key secondary outcomes
To evaluate the efficacy of a 4-week treatment with vonoprazan 20 mg in patients with GERD after sleeve gastrectomy.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
If patients are diagnosed with GERD, treatment with vonoprazan 20 mg once daily will be initiated and continued for 4 weeks.
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
Patients aged 20 years or older with obesity who meet the surgical criteria for sleeve gastrectomy.
Key exclusion criteria
1. Patients considered unsuitable for participation by the principal investigator or a sub-investigator.
2. Patients from whom informed consent cannot be obtained from the patient or their legally authorized representative (or family member, if applicable).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideharu |
| Middle name | |
| Last name | Okanobu |
Organization
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Division name
Department of Gastroenterology
Zip code
730-8619
Address
1-9-6, Sendamachi, Naka-ku, Hiroshima, Japan
TEL
+81-82-241-3111
okanobu.hrc.med@gmail.com
Public contact
Name of contact person
| 1st name | Hideharu |
| Middle name | |
| Last name | Okanobu |
Organization
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Division name
Department of Gastroenterology
Zip code
730-8619
Address
1-9-6, Sendamachi, Naka-ku, Hiroshima, Japan
TEL
+81-82-241-3111
Homepage URL
okanobu.hrc.med@gmail.com
Sponsor or person
Institute
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Address
1-9-6, Sendamachi, Naka-ku, Hiroshima, Japan
Tel
+81-82-241-3111
okanobu.hrc.med@gmail.com
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
| 2026 | Year | 10 | 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
54
Results
Postoperative GERD developed in 19 of the 54 patients. Of these, 16 had erosive esophagitis and 3 had non-erosive reflux disease (NERD). The median FSSG score increased significantly from 5 (range, 0-28) preoperatively to 29 (range, 8-45) postoperatively, indicating a marked worsening of symptom severity. All patients with erosive esophagitis were treated with vonoprazan 20 mg once daily, and endoscopic healing was confirmed in all cases.
Results date posted
| 2026 | Year | 08 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 54 patients were included, comprising 19 men and 35 women. The median age was 49.5 years (range, 22-64), and the median body mass index (BMI) was 39.1 kg/m2 (range, 29.3-57.2).
Participant flow
This study was registered retrospectively after the initiation of the study.
Patients who underwent sleeve gastrectomy were consecutively enrolled, and those who developed GERD after surgery were evaluated.
Adverse events
None
Outcome measures
Postoperative GERD developed in 19 of the 54 patients. Of these, 16 had erosive esophagitis and 3 had non-erosive reflux disease (NERD). The median FSSG score increased significantly from 5 (range, 0-28) preoperatively to 29 (range, 8-45) postoperatively, indicating a marked worsening of symptom severity. All patients with erosive esophagitis were treated with vonoprazan 20 mg once daily, and endoscopic healing was confirmed in all cases.
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 20 | Day |
Last modified on
| 2026 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071445
