None listed
Conditions
Interventions
Behavioral : Patients participating in the study are randomly assigned to either the experimental group or the control group after undergoing the peroral endoscopic myotomy(POEM) procedure. Both group
Sponsors
Yonsei University Health System, Gangnam Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age between 19 and 75 years at the time of obtaining written informed consent - Patients diagnosed with achalasia who are scheduled to undergo Peroral endoscopic myotomy or have undergone Peroral endoscopic myotomy within the past 7 days - Able to understand and comply with instructions and participate for the entire duration of the clinical trial - Voluntarily decide to participate and provide written informed consent to the clinical trial - For participants of childbearing potential, agreement to use medically appropriate contraception throughout the study period
Exclusion criteria
Exclusion criteria: - Inability to undergo upper gastrointestinal endoscopy - Presence of esophageal stricture, ulcer stricture, esophagogastric varices, Barrett’s esophagus exceeding 3 cm (long-segment Barrett’s esophagus), active peptic ulcer, gastrointestinal bleeding, malignancy, or eosinophilic esophagitis as confirmed by upper gastrointestinal endoscopy - History of surgical procedures involving the esophagus, stomach, or duodenum (except for simple perforation repair or endoscopic tumor resection) - History of hypersensitivity to antacids, proton pump inhibitors, or potassium competitive acid blockers - Current psychiatric disorder under treatment with medication - History of psychiatric disease within the past 5 years - Pregnant or breastfeeding women - Patients scheduled to undergo surgery requiring hospitalization within 3 months of trial participation or requiring surgical treatment - Any other clinically significant findings deemed by the investigator to make the participant inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of esophagitis of LA grade B or higher at 8 weeks after Peroral endoscopic myotomy in each group | — |
Secondary
| Measure | Time frame |
|---|---|
| A difference in treatment response (Reflux Disease Questionnaire score) between groups at 4 and 8 weeks;The presence of inspiratory augmentation on high-resolution manometry performed at 8 weeks in each group | — |
Countries
Korea, Republic of
Contacts
Public ContactCheal Wung Huh
Yonsei University Yongin Severance Hospital
Outcome results
None listed