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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021843
Receipt No. R000025082
Scientific Title A novel endoscopic submucosal dissection technique for proton pump inhibitor-refractory gastroesophageal reflux disease
Date of disclosure of the study information 2016/04/09
Last modified on 2016/04/14

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Basic information
Public title A novel endoscopic submucosal dissection technique for proton pump inhibitor-refractory gastroesophageal reflux disease
Acronym ESD for GERD
Scientific Title A novel endoscopic submucosal dissection technique for proton pump inhibitor-refractory gastroesophageal reflux disease
Scientific Title:Acronym ESD for GERD
Region
Japan

Condition
Condition gastroesophageal reflux disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We devised an endoscopic fundoplication procedure using endoscopic submucosal dissection (ESD) for the treatment of GERD (ESD-G). The aim of this study was to clarify
the effect and safety of ESD-G.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary endpoint was the improvement in
the rate of heartburn experienced by the patients following ESD-G.
Key secondary outcomes The secondary endpoints were comparisons of the frequency scale for the symptoms
of GERD (FSSG), before and 6 months after the procedure, oral medication dose, LA classification of the endoscopic findings, and esophageal 24-h pH monitoring. The safety of ESD-G was also assessed.

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 encoscopic submucosal dissection
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Males or females aged 20 years or older
2. Patients complaining of symptoms of gastroesophageal reflux disease on an inquiry sheet despite receiving PPI therapy for 8 weeks or more
3. Those with reflux esophagitis involving <3/4 of the circumference on endoscopy
4. Those in whom intra-esophageal pressure measurement and 24-hour esophageal pH monitoring were performed before surgery, and endoscopy, intra-esophageal pressure testing, and 24-hour esophageal pH monitoring are possible 1 month after surgery
5. Those from whom written informed consent regarding this procedure was obtained
Key exclusion criteria 1. Patients aged 19 years or younger
2. Those with reflux esophagitis involving more than 3/4 of the circumference on endoscopy
3. Those with a history of portal hypertension or esophageal varices
4. Those who have undergone gastric or esophageal surgery
5. Those with esophagostenosis or dysphagia
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Higuchi Kazuhide
Organization Osaka Medical College
Division name Second Department of Internal Medicine
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
TEL 072-683-1221
Email higuchi@osaka-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Toshihisa Takeuchi
Organization Osaka Medical College
Division name Endoscopy Center
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
TEL 072-683-1221
Homepage URL
Email in2097@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
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
Address
Tel
Email

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
2016 Year 04 Month 09 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
2016 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 09 Day
Last modified on
2016 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025082

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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