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A novel endoscopic submucosal dissection technique for proton pump inhibitor-refractory gastroesophageal reflux disease

A novel endoscopic submucosal dissection technique for proton pump inhibitor-refractory gastroesophageal reflux disease - ESD for GERD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021843
Enrollment
20
Registered
2016-04-09
Start date
2016-04-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastroesophageal reflux disease

Interventions

encoscopic submucosal dissection

Sponsors

Osaka Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The primary endpoint was the improvement in the rate of heartburn experienced by the patients following ESD-G.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactToshihisa Takeuchi

Osaka Medical College Endoscopy Center

in2097@osaka-med.ac.jp072-683-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026