Unique ID issued by UMIN | UMIN000021843 |
---|---|
Receipt number | 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 | 2022/04/14 11:17:57 |
A novel endoscopic submucosal dissection technique for proton pump inhibitor-refractory gastroesophageal reflux disease
ESD for GERD
A novel endoscopic submucosal dissection technique for proton pump inhibitor-refractory gastroesophageal reflux disease
ESD for GERD
Japan |
gastroesophageal reflux disease
Gastroenterology |
Others
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
The primary endpoint was the improvement in
the rate of heartburn experienced by the patients following ESD-G.
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
encoscopic submucosal dissection
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
20
1st name | Kazuhide |
Middle name | |
Last name | Higuchi |
Osaka Medical College
Second Department of Internal Medicine
569-8686
2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
072-683-1221
higuchi@osaka-med.ac.jp
1st name | Toshihisa |
Middle name | |
Last name | Takeuchi |
Osaka Medical College
Endoscopy Center
569-8686
2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
072-683-1221
in2097@osaka-med.ac.jp
Osaka Medical College
Osaka Medical College
Other
Osaka Medical College
2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
072-683-1221
rinri@osaka-med.ac.jp
NO
2016 | Year | 04 | Month | 09 | Day |
Published
https://bmcgastroenterol.biomedcentral.com/track/pdf/10.1186/s12876-021-02022-x.pdf
35
Completed
2016 | Year | 03 | Month | 07 | Day |
2016 | Year | 03 | Month | 07 | Day |
2016 | Year | 04 | Month | 15 | Day |
2022 | Year | 03 | Month | 06 | Day |
2016 | Year | 04 | Month | 09 | Day |
2022 | Year | 04 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025082