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

NCT ID: NCT07178821

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-01-01

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.

Conditions

Achalasia, Esophageal; GERD (Gastroesophageal Reflux Disease)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional POEM

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

Group Type: ACTIVE_COMPARATOR

Conventional POEM

Intervention Type: PROCEDURE

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

Sling Fiber-Preservation POEM

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.

Group Type: EXPERIMENTAL

Sling Fiber-Preserving POEM

Intervention Type: PROCEDURE

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

Interventions

Conventional POEM

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

SFP-POEM

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoag Memorial Hospital Presbyterian

OTHER

Sponsor Role: collaborator

University of Ottawa

OTHER

Sponsor Role: collaborator

Vancouver General Hospital

OTHER

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Frances Dang

Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Samarasena, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine - UCI Medical Center

Orange, California, United States

Countries

United States

Central Contacts

Frances Dang, MD, MSc

Role: CONTACT

dangf1@hs.uci.edu

714-456-6745

Jason Samarasena, MD

Role: CONTACT

jsamaras@hs.uci.edu

714-456-7447

Facility Contacts

Frances Dang, MD

Role: primary

dangf1@hs.uci.edu

714-456-7447

References

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.

Reference Type: BACKGROUND

PMID: 37598863 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39586589 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31373050 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34716481 (View on PubMed)

Other Identifiers

7028

Identifier Type: -

Identifier Source: org_study_id