Sling-Fiber Preservation vs. Conventional POEM for Achalasia

(SFP-POEM Trial)

Overseen By Frances Dang, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Spastic motility disorders, Sigmoid esophagus, Prior surgical myotomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: Day of procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods of performing peroral endoscopic myotomy (POEM) for individuals with achalasia, a condition that makes swallowing difficult. Researchers aim to determine if preserving certain muscle fibers during the procedure can reduce the risk of developing acid reflux afterward. One group will undergo the standard POEM (Conventional POEM), while the other will receive a modified version that preserves specific muscle fibers (Sling Fiber-Preserving POEM). This study suits adults diagnosed with achalasia who can undergo endoscopy and consent to participate. As an unphased trial, it offers a unique opportunity to contribute to medical knowledge and potentially improve future treatment options for achalasia.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Sling Fiber-Preserving POEM (SFP-POEM) is generally safe and successful, with about a 90% success rate. This method may also reduce the risk of severe erosive esophagitis, which involves damage and inflammation of the esophagus lining, compared to traditional methods. By avoiding the cutting of certain muscle fibers in the stomach, SFP-POEM seems to help prevent reflux problems. In contrast, studies indicate that while the conventional POEM treatment is technically successful, about 49% of patients may experience reflux esophagitis, which means irritation or damage to the esophagus after the procedure. Both treatments have been studied for safety, but SFP-POEM might have an advantage in reducing some side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Sling Fiber-Preserving POEM for achalasia because it offers a unique approach by selectively preserving the gastric sling fibers. Unlike conventional POEM, which involves cutting both circular and sling muscle fibers, this new method aims to spare the sling fibers, potentially reducing side effects and improving recovery. This technique employs a double scope method to ensure precision, which could lead to better long-term outcomes for patients. By targeting the right of the second penetrating vessel, it innovates on the traditional approach, promising a more refined treatment option for achalasia sufferers.

What evidence suggests that this trial's treatments could be effective for achalasia?

This trial will compare two procedures for treating achalasia: Conventional POEM and Sling Fiber-Preserving POEM (SFP-POEM). Studies have shown that the traditional POEM procedure effectively treats achalasia, a condition that makes swallowing difficult, with less invasiveness. Although it provides excellent symptom relief, it often results in a high rate of acid reflux, where stomach acid irritates the esophagus. Research suggests that SFP-POEM, which participants in this trial may receive, might reduce the risk of severe reflux while maintaining effectiveness. One study found that preserving the sling fibers during the procedure can reduce severe erosive esophagitis (a serious form of reflux) and has a success rate of 90%. This suggests that SFP-POEM could be a safer option with fewer side effects related to acid reflux. ^{1 2 3 4 6}

Who Is on the Research Team?

Jason Samarasena, MD, MBA

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for adults with achalasia, a condition that affects the esophagus and causes difficulty swallowing. Participants should not have other complications like severe reflux esophagitis or previous treatments for achalasia. They must be able to undergo endoscopy.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with achalasia type I, II, or III.

I am considered a good candidate for the POEM procedure.

Exclusion Criteria

I have had a Heller myotomy surgery.

I cannot have endoscopy or general anesthesia due to health reasons.

I have heart or lung conditions that make endoscopy unsafe for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either conventional POEM or sling fiber-preservation POEM procedure

Day of procedure

Initial Follow-up

Participants are monitored for reflux esophagitis and other outcomes

3 months

Endoscopy at 3 months post-procedure

Extended Follow-up

Participants are monitored for ongoing reflux symptoms and PPI use

12 months

Assessments at 3, 6, and 12 months post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• Conventional POEM
• Sling Fiber-Preserving POEM

Trial Overview The study compares two types of POEM procedures: conventional POEM and Sling Fiber-Preserving POEM (SFP-POEM). It aims to see if SFP-POEM reduces post-procedure acid reflux without affecting treatment success. Patients are randomly chosen for one method and tracked for a year.

How Is the Trial Designed?

Group I: Sling Fiber-Preservation POEM Experimental Treatment 1 Intervention

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 II: Conventional POEM Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Hoag Memorial Hospital Presbyterian

Collaborator

Trials

37

Recruited

17,200+

Vancouver General Hospital

Collaborator

Trials

42

Recruited

19,700+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

University of Ottawa

Collaborator

Trials

231

Recruited

267,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07178821

Sling-Fiber Preservation POEM vs. Conventional ... Peroral endoscopic myotomy (POEM) is an effective, minimally invasive treatment for achalasia, offering excellent rates of symptom relief.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34716481/

Safety and effectiveness of sling fiber preservation POEM ... SP-POEM is safe and effective, with a success rate of 90%. The rate of severe erosive esophagitis can be decreased by preserving sling fibers.

3. journals.lww.com journals.lww.com/ajg/fulltext/2024/10001/s1510_peroral_endoscopic_myotomy_for_achalasia.1511.aspx

S1510 Peroral Endoscopic Myotomy for Achalasia With ... This study suggests that SFP-POEM might reduce the incidence of symptomatic GERD (a subjective outcome) without affecting GERD-related objective outcomes.

4. giejournal.org giejournal.org/article/S0016-5107(25)01837-1/abstract

a systematic review and meta-analysis Safety and effectiveness of sling fiber preservation POEM to reduce severe post-procedural erosive esophagitis. Surg Endosc. 2022; 36:4255 ...

5. withpower.com withpower.com/trial/phase-esophagitis-peptic-11-2025-43b32

Sling-Fiber Preservation vs. Conventional POEM for ... Peroral endoscopic myotomy (POEM) is an effective, minimally invasive treatment for achalasia, offering excellent rates of symptom relief.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510723028286

Conventional versus oblique fiber-sparing endoscopic ... POEM was technically successful in all patients. Overall, reflux esophagitis was found in 56 patients (48.7%). The incidence of at least grade B esophagitis was ...