Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD

Official title

Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD: A Randomized Control Trial

Overview

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

• Procedure Conventional POEM
  Standard posterior POEM with full-thickness myotomy, including both circular and gastric sling muscle fibers.
• Procedure Sling Fiber-Preserving POEM
  Posterior POEM with selective preservation of gastric sling fibers by limiting myotomy to the right of the second penetrating vessel.

Primary outcome measures

• Incidence of Significant Reflux Esophagitis (Los Angeles Grade B or Higher) [Time frame: 3 months post-procedure]

Secondary outcome measures (6)

• Esophageal Acid Exposure [Time frame: 3 months post-procedure]
• Symptomatic Gastroesophageal Reflux (GerdQ Score) [Time frame: 3, 6, 12 months post-procedure]
• Proton Pump Inhibitor (PPI) Use [Time frame: 3, 6, 12 months post-procedure]
• Clinical Success (Eckardt Symptom Score ≤ 3) [Time frame: 3, 6 and 12 months post-procedure]
• Technical Success [Time frame: During procedure]
• Adverse Events [Time frame: Within 1 month post-procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of California, Irvine - UCI Medical Center — Orange

Publications

• Nabi Z, Chandran V, Basha J, Ramchandani M, Inavolu P, Kalpala R, Goud R, Jagtap N, Darisetty S, Gupta R, Tandan M, Lakhtakia S, Kotla R, Devarasetty R, Rao GV, Reddy DN. Conventional versus oblique fiber-sparing endoscopic myotomy for achalasia cardia: a randomized controlled trial (with videos). Gastrointest Endosc. 2024 Jan;99(1):1-9. doi: 10.1016/j.gie.2023.08.007. Epub 2023 Aug 19. PMID 37598863
• Fujiyoshi Y, Fujiyoshi MRA, Khalaf K, May GR, Teshima CW. Sling fiber preservation during POEM reduces incidence of postoperative reflux symptoms. Dis Esophagus. 2025 Jan 7;38(1):doae097. doi: 10.1093/dote/doae097. PMID 39586589
• Tanaka S, Toyonaga T, Kawara F, Watanabe D, Hoshi N, Abe H, Ariyoshi R, Ohara Y, Takao T, Morita Y, Umegaki E, Kodama Y. Novel per-oral endoscopic myotomy method preserving oblique muscle using two penetrating vessels as anatomic landmarks reduces postoperative gastroesophageal reflux. J Gastroenterol Hepatol. 2019 Dec;34(12):2158-2163. doi: 10.1111/jgh.14814. Epub 2019 Aug 23. PMID 31373050
• Shiwaku H, Inoue H, Shiwaku A, Okada H, Hasegawa S. Safety and effectiveness of sling fiber preservation POEM to reduce severe post-procedural erosive esophagitis. Surg Endosc. 2022 Jun;36(6):4255-4264. doi: 10.1007/s00464-021-08763-w. Epub 2021 Oct 29. PMID 34716481

Identifiers

NCT: NCT07178821 · 7028

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗