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

NCT07178821 | Not Yet Recruiting

• 1 other identifier: 7028
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Achalasia, Esophageal; GERD (Gastroesophageal Reflux Disease)

Keywords

Achalasia; POEM; Peroral Endoscopic Myotomy; Sling Fiber Preservation; SFP-POEM; Gastroesophageal Reflux; GERD; Reflux Esophagitis; Randomized Controlled Trial

Outcome Measures

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.

  3 months post-procedure

Secondary Outcomes (6)

• Esophageal Acid Exposure

  3 months post-procedure

• Symptomatic Gastroesophageal Reflux (GerdQ Score)

  3, 6, 12 months post-procedure

• Proton Pump Inhibitor (PPI) Use

  3, 6, 12 months post-procedure

• Clinical Success (Eckardt Symptom Score ≤ 3)

  3, 6 and 12 months post-procedure

• Technical Success

  During procedure

Study Arms (2)

Conventional POEM

ACTIVE COMPARATOR

Participants in this arm will undergo standard peroral endoscopic myotomy (POEM), including myotomy of circular and sling muscle fibers at the gastric side.

Procedure: Conventional POEM

Sling Fiber-Preservation POEM

EXPERIMENTAL

Participants in this arm will undergo posterior POEM with selective preservation of the gastric sling fibers. Myotomy is performed to the right of the second penetrating vessel to spare the sling fibers. The double scope technique will be employed to confirm that the tunnel ends on the lesser curve, which confirms sparing of the sling fibers.

Procedure: Sling Fiber-Preserving POEM

Interventions

Conventional POEM PROCEDURE

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

Conventional POEM

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.

Also known as: SFP-POEM

Sling Fiber-Preservation POEM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosis of achalasia (Type I-III) per Chicago Classification v3.0
• Deemed appropriate candidates for POEM
• Ability to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Hoag Memorial Hospital Presbyterian: collaborator
• University of Ottawa: collaborator
• Vancouver General Hospital: collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

University of California, Irvine - UCI Medical Center

Orange, California, 92868, United States

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia; Gastroesophageal Reflux; Esophagitis, Peptic

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Study Officials

• Jason Samarasena, MD, MBA

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frances Dang, MD, MSc

CONTACT

714-456-6745; dangf1@hs.uci.edu

Jason Samarasena, MD

CONTACT

714-456-7447; jsamaras@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to the intervention group. Endoscopists performing the procedure cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)