UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056025 |
|---|---|
| Receipt number | R000064026 |
| Scientific Title | Study on the usefulness of endoscopic hiatal suture in patients with hiatal hernia of the esophagus with refractory reflux esophagitis |
| Date of disclosure of the study information | 2024/11/02 |
| Last modified on | 2024/11/02 12:26:45 |
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Basic information
Public title
Study on the usefulness of endoscopic hiatal suture in patients with hiatal hernia of the esophagus with refractory reflux esophagitis
Acronym
endoscopic hiatal suture
Scientific Title
Study on the usefulness of endoscopic hiatal suture in patients with hiatal hernia of the esophagus with refractory reflux esophagitis
Scientific Title:Acronym
endoscopic hiatal suture
Region
| Japan |
Condition
Condition
hiatal hernia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Esophageal hiatal hernia is a very common disorder, and reflux esophagitis is frequently observed due to gastric acid reflux into the esophagus. Acid secretion inhibitors such as proton pump inhibitors are mainly used, but when there is little improvement, surgical procedures such as the Nissen procedure or endoscopic procedures such as endoscopic anti-reflux mucosectomy (ARMS) are used. However, invasiveness and postoperative stricture are sometimes a problem, and some patients require long-term postoperative acid secretion inhibitors. The purpose of this study was to clarify the efficacy and safety of endoscopic suture in the lumen as a new treatment for hiatal hernia. Through this study, we aim to establish a new treatment method for hiatal hernia of the esophagus, which will contribute to improving the quality of life of patients and reducing medical costs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity in the Los Angeles Classification, an objective severity assessment of reflux esophagitis.
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
1. treat a hiatal hernia of the esophagus with reflux esophagitis
2. apply a ring thread clip to the hiatal hernia.
3. The pulled clip is detached with a cutter.
4. apply the clip to the contralateral side by pulling the remaining thread of the clip with thread in the same manner as in 3. Repeat this operation.
5. create a total of four mucosal defects. Suture the contralateral side with ZeoSure M, using two sutures on each of the two contralateral sides.
6. confirm that the gap between the lacunae has been narrowed by suturing and that the endoscope can pass through without any problem.
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 diagnosed with hiatal hernia with reflux esophagitis who have residual reflux esophagitis after 4 weeks of proton pump inhibitor therapy.
Patients who have given written informed consent.
Key exclusion criteria
Patients with severe cardiac or pulmonary diseases that are considered high risk for endoscopic treatment.
Patients with metal allergies.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Okada |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Advanced and Innovative Endoscopy
Zip code
7910295
Address
Sitsukawa Toon, Ehime, Japan
TEL
+81-89-960-5308
okada.masaya.ev@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Okada |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Advanced and Innovative Endoscopy
Zip code
791-0295
Address
Sitsukawa Toon, Ehime, Japan
TEL
+81-89-960-5308
Homepage URL
okada.masaya.ev@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Ehime University
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
Department of Advanced and Innovative Endoscopy, Ehime University Graduate School of Medicine
Address
454 Sitsukawa, Toon, Ehime 791-0295, Japan
Tel
+81 89-960-5308
okada.masaya.ev@ehime-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 02 | 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
| 2024 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 11 | Month | 02 | Day |
Last modified on
| 2024 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064026
