Comparative Study of Per-oral Endoscopic Myotomy (POEM) in Treatment - naïve Achalasia Patients Versus Patients With Previous Pneumatic Dilation

The aim of this study is to compare the clinical efficacy, safety, and technical outcomes of per-oral endoscopid myotomy( POEM )in treatment-naïve achalasia patients versus patients with previous pneumatic dilation.

• Study subjects:

  1. Inclusion criteria: Adult patients diagnosed with achalasia (Chicago classification types I-III by High resolution manometry (HRM) ).

  2. Exclusion criteria:

     1. Children below 18 yr.
     2. Prior surgical myotomy.

     3. pregnancy

        Groups:

• Group I (Naïve group): Patients undergoing POEM as primary therapy.
• Group II (Prior Pneumatic Dilation group): Patients undergoing POEM after failed or relapsed pneumatic dilation.

Data analyzed included the following:

• Baseline: basic demographic information, Eckardt score , manometry(HRM) , timed barium esophagogram and history of pneumatic dilation .
• Perioperative parameters (Disease duration, Surgical time, Length of hospital stay, mucosal edema, and mucosal injuries).
• Intraoperative (mucosal perforation ,bleeding in submucosal space ,pneumoperitoneum ,pneumomediastinum,pneumothorax or incompelet myotomy )and postoperative complications (Infections,esophageal leak ,subcutaneous emphysema, GERD,esophagitis ) .
• Post procedure symptoms evaluation (Eckardt score) at 1, 3&6 months after the procedure .

Eckardt score :

It is a 12-point score which is as following :

0 1 2 3 Recent weight loss (kg) none <5 kg 5-10 kg >10 kg Dysphagia none occasional daily each meal Retrosternal chest pain none occasional daily each meal Regurgitation none occasional daily each meal

A score of ≥3 is suggestive of active achalasia.

POEM technique :

Briefly, the procedure included submucosal injection at the 5-6-o'clock position entry point, and mucosal incision at the posterior wall about 8-10 cm above the esophageal-gastric junction (EGJ), entry into the tunnel by clearing submucosal fibers, and then myotomy initiating about 2 cm down from the mucosal incision and extending 2-4 cm into the cardia. Afterwards, the mucosal incision will be closed using endoclips. In special circumstances, when fibrosis or adhesions present because of prior PD, the myotomy will be located in an area of normal (fibrosis-free) tissue, and a long myotomy will be made.

Technical success was defined as a successful completion of the entire POEM procedure. Clinical success was defined as a post-POEM Eckardt score of 3.

• Research outcome measures:

  1. Primary (main):

     Clinical success at 3 and 6 months (Eckardt score ≤ 3 )

  2. Secondary (subsidiary):
• Technical success
• Procedure time
• Intra- and post-operative complications.

Data management and analysis :

Data will be collected first in sheets, and then will be in Master sheet. Data of every patient will be coded. This will be done using SPSS. Categorical data were presented as number and percentage. Continuous data is presented as mean and standard deviation (SD) if normally distributed or median and interquartile range (IQR) if non normal distributed. Other test will be used according to the results and relations needed to be studied.

Study Overview

• Status: Not yet recruiting
• Conditions: Achalasia, Esophageal
• Intervention / Treatment: Procedure: per-oral endoscopic myotomy (POEM)

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients diagnosed with achalasia (Chicago classification types I-III by High resolution manometry (HRM) ).

Exclusion Criteria:

• Children below 18 yr.
• Prior surgical myotomy.
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I (Naïve group): Patients undergoing POEM as primary therapy.	Procedure: per-oral endoscopic myotomy (POEM); Briefly, the procedure included submucosal injection at the 5-6-o'clock position entry point, and mucosal incision at the posterior wall about 8-10 cm above the esophageal-gastric junction (EGJ), entry into the tunnel by clearing submucosal fibers, and then myotomy initiating about 2 cm down from the mucosal incision and extending 2-4 cm into the cardia. Afterwards, the mucosal incision will be closed using endoclips. In special circumstances, when fibrosis or adhesions present because of prior PD, the myotomy will be located in an area of normal (fibrosis-free) tissue, and a long myotomy will be made.
Active Comparator: - Group II (Prior Pneumatic Dilation group):Patients undergoing POEM after failed pneumatic dilation	Procedure: per-oral endoscopic myotomy (POEM); Briefly, the procedure included submucosal injection at the 5-6-o'clock position entry point, and mucosal incision at the posterior wall about 8-10 cm above the esophageal-gastric junction (EGJ), entry into the tunnel by clearing submucosal fibers, and then myotomy initiating about 2 cm down from the mucosal incision and extending 2-4 cm into the cardia. Afterwards, the mucosal incision will be closed using endoclips. In special circumstances, when fibrosis or adhesions present because of prior PD, the myotomy will be located in an area of normal (fibrosis-free) tissue, and a long myotomy will be made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical success at 3 and 6 months (Eckardt score ≤ 3 )	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- Technical success	the procedure will be done completely or need to do premature myotomy or to be aborted due to fibrosis or any technical problem	1 day ( the day of the procedure )
procedure time	compare the procedure time between the 2 groups	1 day ( the day of the procedure)
Intraoperative & post operative complications	define intraoperative complications ( pneumoperitoneum, pneumothorax , mucosal perforation or bleeding ) and post operative complications ( Infections,esophageal leak ,subcutaneous emphysema, GERD,esophagitis ) and compare these complications between the 2 gruops.	up to 6 months after the procedure

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Achalasia
• Other Study ID Numbers: 04-2025-100435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No