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Achalasia, EsophagealSFP-POEMNCT07178821

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

A study testing Conventional POEM and Sling Fiber-Preserving POEM in people with Achalasia, Esophageal and GERD (Gastroesophageal Reflux Disease), run by University of California, Irvine at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Conventional POEM and Sling Fiber-Preserving POEM
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
1 Dec 2025to 1 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Frances Dang, MD, MSc contact

714-456-6745

dangf1@hs.uci.edu

Jason Samarasena, MD contact

714-456-7447

jsamaras@hs.uci.edu

United States1 site

  • University of California, Irvine - UCI Medical Center

    Orange, California, 92868

    Frances Dang, MD, 714-456-7447, dangf1@hs.uci.edu

    Jason Samarasena, MD, MBA

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Conventional POEM, Sling Fiber-Preserving POEM
Keywords
Achalasia, POEM, Peroral Endoscopic Myotomy, Sling Fiber Preservation, SFP-POEM, Gastroesophageal Reflux, GERD, Reflux Esophagitis, Randomized Controlled Trial
Medical subject headings
Esophageal Achalasia, Gastroesophageal Reflux, Esophagitis, Peptic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional POEMProcedure or surgery

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

  • Sling Fiber-Preserving POEMProcedure or surgery

    Also called SFP-POEM

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

Study groups in NCT07178821
Study groupRoleWhat they receive
Conventional POEMActive comparatorParticipants in this arm will undergo standard peroral endoscopic myotomy (POEM), including myotomy of circular and sling muscle fibers at the gastric side.
Receives: Procedure: Conventional POEM
Sling Fiber-Preservation POEMExperimentalParticipants 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.
Receives: Procedure: Sling Fiber-Preserving POEM

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months post-procedure

Secondary outcomes (6)

  1. Esophageal Acid Exposure

    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.

    Measured: 3 months post-procedure

  2. Symptomatic Gastroesophageal Reflux (GerdQ Score)

    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.

    Measured: 3, 6, 12 months post-procedure

  3. Proton Pump Inhibitor (PPI) Use

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

    Measured: 3, 6, 12 months post-procedure

  4. Clinical Success (Eckardt Symptom Score ≤ 3)

    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.

    Measured: 3, 6 and 12 months post-procedure

  5. Technical Success

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

    Measured: During procedure

  6. Adverse Events

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

    Measured: Within 1 month post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07178821
Sponsor's protocol ID
7028
Acronym
SFP-POEM
Status last verified
Oct 2025
First submitted
10 Sep 2025
Last updated
22 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared outside the study team. The current protocol does not include provisions for public or external data sharing.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 34716481

Questions about this trial

What is this clinical trial studying?

A study testing Conventional POEM and Sling Fiber-Preserving POEM in people with Achalasia, Esophageal and GERD (Gastroesophageal Reflux Disease), run by University of California, Irvine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Frances Dang, MD, MSc (714-456-6745, dangf1@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Significant Reflux Esophagitis (Los Angeles Grade B or Higher) (time frame: 3 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07178821, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.

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