Achalasia, Esophageal, GERD (Gastroesophageal Reflux Disease)
Conditions
Keywords
Achalasia, POEM, Peroral Endoscopic Myotomy, Sling Fiber Preservation, SFP-POEM, Gastroesophageal Reflux, GERD, Reflux Esophagitis, Randomized Controlled Trial
Brief summary
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.
Detailed description
Achalasia is a rare esophageal motility disorder treated effectively with peroral endoscopic myotomy (POEM). However, post-procedure gastroesophageal reflux disease (GERD) is a common complication, reported in up to 65% of cases. One proposed technical modification - the selective preservation of gastric sling fibers - may help reduce reflux by maintaining part of the native anti-reflux mechanism. This is a single-blinded, multicenter randomized controlled trial comparing sling fiber preservation (SFP) POEM versus conventional POEM in adult patients with achalasia. Patients are randomized 1:1 to either technique. The primary endpoint is the incidence of significant reflux esophagitis (LA esophagitis grade B or higher) at 3 months post-procedure endoscopy. Secondary outcomes include acid exposure time on pH impedence monitoring, symptomatic reflux (GerdQ), PPI usage, technical and clinical success, and adverse events. Follow-up continues for 12 months. The study aims to determine whether the SFP-POEM technique reduces acid reflux without compromising treatment efficacy.
Interventions
PROCEDUREConventional POEM
Standard posterior POEM with full-thickness myotomy, including both circular and gastric sling muscle fibers.
PROCEDURESling Fiber-Preserving POEM
Posterior POEM with selective preservation of gastric sling fibers by limiting myotomy to the right of the second penetrating vessel.
Sponsors
Hoag Memorial Hospital Presbyterian
University of Ottawa
Vancouver General Hospital
Cedars-Sinai Medical Center
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are blinded to the intervention group. Endoscopists performing the procedure cannot be blinded.
Intervention model description
Participants are randomized in a 1:1 ratio to receive either sling fiber-preservation POEM or conventional POEM. Each participant undergoes only one assigned intervention and is followed for 12 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(Participants must meet all of the following): * Age ≥ 18 years * Diagnosis of achalasia (Type I-III) per Chicago Classification v3.0 * Deemed appropriate candidates for POEM * Ability to provide informed consent
Exclusion criteria
(Participants will be excluded if any of the following apply): * 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 * Pregnancy or actively breastfeeding * Significant cardiopulmonary comorbidities that preclude safe endoscopic intervention * Coagulopathy or portal hypertension * Unwillingness or inability to complete follow-up assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Significant Reflux Esophagitis (Los Angeles Grade B or Higher) | 3 months post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic Gastroesophageal Reflux (GerdQ Score) | 3, 6, 12 months post-procedure | 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. |
| Proton Pump Inhibitor (PPI) Use | 3, 6, 12 months post-procedure | Assessment of ongoing PPI therapy and symptom-guided discontinuation based on reflux control. |
| Esophageal Acid Exposure | 3 months post-procedure | 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. |
| Technical Success | During procedure | Technical success defined as completion of full-length myotomy as planned. |
| Adverse Events | Within 1 month post-procedure | Monitoring of intra- and post-procedural complications, including bleeding, perforation, capno-peritoneum, leak, infection, and other unexpected events. |
| Clinical Success (Eckardt Symptom Score ≤ 3) | 3, 6 and 12 months post-procedure | 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. |
Countries
United States
Contacts
Primary ContactFrances Dang, MD, MSc
Backup ContactJason Samarasena, MD
Outcome results
None listed