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RecruitingNCT07875686Updated Oct 15, 2026

Full-thickness Versus Progressive Myotomy in Peroral Endoscopic Esophageal Myotomy in Achalasia: A Randomized Controlled Trial

A Phase 2 interventional study of Full thickness myotomy and Progressive thickness myotomy in Achalasia Cardia and Achalasia, sponsored by Cairo University. Recruiting at 2 sites in Egypt. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Cairo University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Peroral endoscopic esophageal myotomy (POEM) has been established as an effective therapy for Achalasia. It is still not known how deep the myotomy should be and if it should include the circular and longitudinal muscles or not. It is hypothesized that a complete full thickness myotomy could lead to higher rates of gastroesophageal reflux disease (GERD). In this study we compare performing a Full-thickness myotomy with a progressive myotomy (proximal half circular only, distal half full-thickness, and assessment the different outcomes including efficacy and the incidence of postprocedural GERD.

02

Conditions studied

  • Achalasia Cardia
  • Achalasia

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Keywords

  • Achalasia
  • POEM
  • Peroral endoscopic esophageal myotomy
03

In context

Esophageal Achalasia

141 studies on the registry are indexed under Esophageal Achalasia; 45 are open to participants now.

This study's planned enrollment of 70 is above the median of 60 across 94 interventional studies indexed under Esophageal Achalasia.

Browse Esophageal Achalasia studies →

Lead sponsor

Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Achalasia confirmed by manometry
  • Type 1 and type 2 Achalasia
  • Eckhart score >3
  • Fit to undergo anaesthesia

Exclusion criteria

Exclusion Criteria:

  • Type 3 achalasia and other esophageal motility Disorders
  • Hiatus hernia
  • Coagulopathy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    FULL THICKNESS MYOTOMY

    Procedure will include a full thickness myotomy including both the circular and longitudinal muscle layers throughout the whole length of the myotomy

    Procedure: Full thickness myotomy

  • Active comparator
    Progressive myotomy

    Procedure will include a progressive thickness myotomy where the proximal half of the myotomy will be selective cutting only the circular muscles, while the distal half will include both circular and longitudinal muscles.

    Procedure: Progressive thickness myotomy

Interventions

  • ProcedureFull thickness myotomy

    Full thickness myotomy

  • ProcedureProgressive thickness myotomy

    Progressive thickness myotomy

06

What researchers measure

Primary outcomes

  1. Presence of Esophagitis

    Any degree of esophagitis detected endoscopically

    Time frame: 6 months after the POEM procedure

Secondary outcomes

  1. Clinical improvement

    ECKHART score

    Time frame: 6 months after the POEM procedure

  2. Ph manometry

    Demeester score

    Time frame: 6 months after the POEM procedure

  3. Duration of myotomy

    Duration of myotomy

    Time frame: During the procedure

  4. Adverse events

    Any adverse events

    Time frame: up to 6 months after the POEM procedure

07

Study locations

2 of 2 sites recruiting
  • Cairo University
    Cairo, Egypt
    • Hany Shehab · Contact
    Recruiting
  • Theodore Bilharz Institute
    Cairo, Egypt
    • Khaled Ragab · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07875686
Lead sponsor
Cairo University
Responsible party
Hany Shehab (Professor, Cairo University) — Principal investigator
First posted
Oct 15, 2026
Start date
Aug 1, 2025
Primary completion
Jan 30, 2027 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Hany Shehab
Contact
h.shehab@kasralainy.edu.eg
+201111111071
Ahmed 3lbadry
Contact
+20 10 66860084

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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