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Ultra- Short vs Standard Length oesophageal myotomy in Per-Oral Endoscopic Myotomy: An International Multi-centre Randomised Controlled Trial

Ultra- Short vs Standard Length oesophageal myotomy in Per-Oral Endoscopic Myotomy in patients with achalasia- a study comparing functional and symptomatic outcomes

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001230448
Enrollment
198
Registered
2025-11-06
Start date
2025-11-17
Completion date
2027-11-01
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Achalasia is an uncommon disorder of oesophageal motility characterized by failure of relaxation of the Lower Oesophageal Sphincter (LES) resulting in regurgitation of undigested food; chest pain; and weight loss. The mainstay of treatment involves pneumatic dilation, laparoscopic Heller’s myotomy and more recently Per-Oral Endoscopic Myotomy (POEM). Confounders exist in current data comparing oesophageal myotomy length in POEM and optimizing technique. Therefore this study aims to assess myotomy length outcomes. Lay summary: Achalasia is a rare oesophageal disorder where the lower esophageal (feeding tube) sphincter muscle fails to relax, preventing food from entering the stomach properly. The main symptoms are difficulty swallowing (dysphagia), chest pain, and regurgitation of undigested food. It is treated through interventions such as surgery (like Heller myotomy) or endoscopic procedures like balloon dilation or POEM (per oral endoscopic myotomy). Regarding myotomy in particular, a shorter myotomy or cutting of the muscle may result in shorter procedure times. Therefore this study is researching whether this would be a safe approach with similar outcomes to the standard procedure.

Interventions

Patients will be prospectively randomised to ultrashort or standard length Per oral endoscopic myotomy. Patients undergo either short or standard poem (7cm myotomy or ultra short 4cm) with an average duration of 30-60 minutes. This will be performed by an expert gastroenterologist only. Medical records (reports) will demonstrate adherence to the intervention. There is no extra training required for the intervention.

Sponsors

St Vincent's Hospital Melbourne
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Achalasia diagnosis Eckardt score >3

Exclusion criteria

Previous Heller's myotomy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026