UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056081 |
|---|---|
| Receipt number | R000064082 |
| Scientific Title | A multicenter observational prospective study to evaluate the efficacy of a thin therapeutic endoscope in per-oral endoscopic myotomy (POEM) |
| Date of disclosure of the study information | 2024/11/06 |
| Last modified on | 2024/11/06 22:04:20 |
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Basic information
Public title
A multicenter observational prospective study to evaluate the efficacy of a thin therapeutic endoscope in per-oral endoscopic myotomy (POEM)
Acronym
Study to evaluate the efficacy of thin therapeutic endoscope in POEM
Scientific Title
A multicenter observational prospective study to evaluate the efficacy of a thin therapeutic endoscope in per-oral endoscopic myotomy (POEM)
Scientific Title:Acronym
Study to evaluate the efficacy of thin therapeutic endoscope in POEM
Region
| Japan |
Condition
Condition
Esophageal achalasia and related disorders
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of treatment with a thin therapeutic endoscope in cases of esophageal motility disorders (esophageal achalasia and related disorders) diagnosed as indications for peroral endoscopic myotomy (POEM).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Procedural success rate of POEM performed with a thin therapeutic endoscope
Key secondary outcomes
Procedure time, submucosal tunnel creation time, muscle layer incision time, number of clips required for entry closure, postoperative pain, postoperative inflammation, perioperative adverse event incidence, symptom improvement rate (using Eckardt score), incidence of gastroesophageal reflux disease after POEM, difference in treatment outcome between the normal therapeutic endoscopy treatment group
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
| 18 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with esophageal achalasia and related diseases by high resolution manometry (HRM), esophagography, or esophagogastroduodenoscopy.
2. Patients must be at least 18 years old and less than 95 years old at the time of consent.
3. Patients must have a performance status (ECOG) of 0, 1, or 2.
4. Patients may or may not have received prior treatment for esophageal achalasia.
5. Patients must be able to follow their progress from 49 to 98 days after treatment.
6. Patients whose participation in the study has been fully explained and whose written consent has been obtained from the study subjects themselves.
Key exclusion criteria
1. Cases in which general anesthesia is difficult to administer
2. Patients with infectious diseases requiring systemic treatment
3. Patients who are pregnant, may become pregnant, or are breastfeeding.
4. patients with psychosis, psychiatric symptoms, or dementia that would make participation in the study difficult
5. patients with respiratory disease requiring continuous oxygen administration
6. patients with uncontrolled hypertension
7. Patients with uncontrolled diabetes mellitus. 8.
8. Other cases that the investigator deems inappropriate
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Hiasa |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime, Japan
TEL
089-960-5308
hiasa@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideomi |
| Middle name | |
| Last name | Tomida |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime, Japan
TEL
089-960-5308
Homepage URL
hideomi.tomida.epch@hotmail.com
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Yoichi Hiasa
Funding Source
Organization
None
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
Ehime University Hospital Clinical Research Ethics Review Committee
Address
454 Shitsukawa, Toon, Ehime, Japan
Tel
089-960-5172
cttc@m.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
自治医科大学附属病院、昭和大学江東豊洲病院、慶應義塾大学病院、信州大学医学部附属病院、愛知医科大学病院、大阪公立大学医学部附属病院、鳥取大学医学部附属病院、愛媛大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 06 | 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
| 2024 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the usefulness of using a thin therapeutic endoscopic procedure in cases of esophageal motility disorders (esophageal achalasia and related disorders) diagnosed as an indication for peroral endoscopic myotomy (POEM).
Primary endpoint: success rate of POEM procedures
Secondary endpoint: operative time, submucosal tunnel creation time, muscle layer incision time, number of clips required for entry closure, postoperative pain, postoperative inflammation, perioperative adverse event rate, symptom improvement rate (Eckardt score), incidence of gastroesophageal reflux disease after POEM, and difference in outcomes between the standard therapeutic endoscope treatment groups.
Management information
Registered date
| 2024 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064082
