Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07178821

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Achalasia, Esophageal Deglutition Disorders Digestive System Diseases Duodenal Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Esophagitis Esophagitis, Peptic GERD (Gastroesophageal Reflux Disease) Gastroenteritis Gastroesophageal Reflux Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine - UCI Medical Center

Orange, California, 92868, United States

Location contact

Frances Dang, MD

CONTACT

[email protected]

714-456-7447

Frances Dang, MD

SUB_INVESTIGATOR

Jason Samarasena, MD, MBA

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional POEM

Procedure

Standard posterior POEM with full-thickness myotomy, including both circular and gastric sling muscle fibers.

Sling Fiber-Preserving POEM

Procedure

Posterior POEM with selective preservation of gastric sling fibers by limiting myotomy to the right of the second penetrating vessel.

Other names: SFP-POEM

Primary outcomes

  1. Incidence of Significant Reflux Esophagitis (Los Angeles Grade B or Higher)

    Time frame: 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 outcomes

  1. Esophageal Acid Exposure

    Time frame: 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.

  2. Symptomatic Gastroesophageal Reflux (GerdQ Score)

    Time frame: 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.

  3. Proton Pump Inhibitor (PPI) Use

    Time frame: 3, 6, 12 months post-procedure

    Assessment of ongoing PPI therapy and symptom-guided discontinuation based on reflux control.

  4. Clinical Success (Eckardt Symptom Score ≤ 3)

    Time frame: 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.

  5. Technical Success

    Time frame: During procedure

    Technical success defined as completion of full-length myotomy as planned.

  6. Adverse Events

    Time frame: Within 1 month post-procedure

    Monitoring of intra- and post-procedural complications, including bleeding, perforation, capno-peritoneum, leak, infection, and other unexpected events.

Study contacts

Contact information is provided by the study sponsor or research team.

Frances Dang, MD, MSc

CONTACT

[email protected]

714-456-6745

Jason Samarasena, MD

CONTACT

[email protected]

714-456-7447

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Cedars-Sinai Medical Center
  • Hoag Memorial Hospital Presbyterian
  • University of Ottawa
  • Vancouver General Hospital

Registry information

Official study title

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

Acronym: SFP-POEM

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 17, 2025
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.