UMIN-CTR Clinical Trial

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

Public contact
Name of contact person	1st name Toshihisa Middle name Last name Takeuchi
Organization	Osaka Medical College
Division name	Endoscopy Center
Zip code	569-8686
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	Osaka Medical College
Address	2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
Tel	072-683-1221
Email	rinri@osaka-med.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	2016 Year 04 Month 09 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://bmcgastroenterol.biomedcentral.com/track/pdf/10.1186/s12876-021-02022-x.pdf
Number of participants that the trial has enrolled	35
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	Completed
Date of protocol fixation	2016 Year 03 Month 07 Day
Date of IRB	2016 Year 03 Month 07 Day
Anticipated trial start date	2016 Year 04 Month 15 Day
Last follow-up date	2022 Year 03 Month 06 Day
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	2022 Year 04 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025082