Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine
About this trial
Peroral endoscopic myotomy (POEM) is an effective, minimally invasive treatment for achalasia, offering excellent rates of symptom relief. However, a significant drawback is the high incidence of gastroesophageal reflux disease (GERD) following the procedure. One proposed technical modification, the selective preservation of the sling fibers during gastric myotomy (SFP-POEM), may reduce this risk without compromising efficacy as compared to a conventional POEM procedure, which includes myotomy of the sling fibers. In this study, adults with achalasia will be randomly assigned to receive one of the two POEM technical approaches. Researchers will monitor whether preserving sling fibers reduces the rates of reflux esophagitis (classified as Los Angeles Grade B or higher) on follow-up endoscopy. Participants will be followed for up to 1 year after the procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Diagnosis of achalasia (Type I-III) per Chicago Classification v3.0
Deemed appropriate candidates for POEM
Ability to provide informed consent
Disqualifiers
Spastic motility disorders other than achalasia type I-III (e.g. diffuse esophageal spasm, jackhammer esophagus, EGJ outflow obstruction)
Sigmoid esophagus
Prior surgical myotomy (e.g., Heller myotomy)
Contraindications to endoscopy or general anesthesia
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional POEM
Procedure/SurgeryStandard posterior POEM with full-thickness myotomy, including both circular and gastric sling muscle fibers.
Sling Fiber-Preserving POEM
Procedure/SurgeryPosterior POEM with selective preservation of gastric sling fibers by limiting myotomy to the right of the second penetrating vessel.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Conventional POEMActive comparator 1 intervention
Group B: Sling Fiber-Preservation POEMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Significant Reflux Esophagitis (Los Angeles Grade B or Higher)
Reflux esophagitis will be assessed by upper endoscopy (EGD) at 3 months post-POEM. Grading will be based on the Los Angeles (LA) Classification. Significant reflux is defined as LA Grade B or higher.
Time frame
3 months post-procedureSecondary outcomes
1
Esophageal Acid Exposure
Esophageal acid exposure will be measured by 24-hour Bravo pH monitoring performed off PPIs for at least 2 weeks. Reflux severity is quantified using acid exposure time (%) and the DeMeester composite score. The DeMeester score has no fixed maximum; higher values indicate greater esophageal acid exposure. Pathologic reflux is defined as acid exposure time \>6% and/or a DeMeester score \>14.72.
Time frame
3 months post-procedure2
Symptomatic Gastroesophageal Reflux (GerdQ Score)
Symptom-based GERD assessment will be measured using the Gastroesophageal Reflux Disease Questionnaire (GerdQ), which ranges from 0 to 18. Higher scores indicate more frequent or severe reflux symptoms, while lower scores indicate fewer or no symptoms. A score \>7 is considered clinically significant.
Time frame
3, 6, 12 months post-procedure3
Proton Pump Inhibitor (PPI) Use
Assessment of ongoing PPI therapy and symptom-guided discontinuation based on reflux control.
Time frame
3, 6, 12 months post-procedure4
Clinical Success (Eckardt Symptom Score ≤ 3)
Symptom improvement will be measured using the Eckardt Symptom Score, which ranges from 0 to 12. Higher scores indicate more severe symptoms (dysphagia, chest pain, regurgitation, and weight loss), while lower scores indicate symptom improvement. A score ≤ 3 is considered a successful clinical outcome.
Time frame
3, 6 and 12 months post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Irvine
Lead sponsor
Hoag Memorial Hospital Presbyterian
Collaborator
University of Ottawa
Collaborator
Vancouver General Hospital
Collaborator
Cedars-Sinai Medical Center
Collaborator
Source ClinicalTrials.gov
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