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

NCT07287787 | Not Yet Recruiting

• 1 other identifier: 04-2025-100435
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

• 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:
• Primary (main):
• 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.

Conditions

Achalasia, Esophageal

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (3)

• - Technical success

  1 day ( the day of the procedure )

• procedure time

  1 day ( the day of the procedure)

• Intraoperative & post operative complications

  up to 6 months after the procedure

Study Arms (2)

Group I (Naïve group): Patients undergoing POEM as primary therapy.

ACTIVE COMPARATOR

Procedure: per-oral endoscopic myotomy (POEM)

- Group II (Prior Pneumatic Dilation group):Patients undergoing POEM after failed pneumatic dilation

ACTIVE COMPARATOR

Procedure: per-oral endoscopic myotomy (POEM)

Interventions

per-oral endoscopic myotomy (POEM) PROCEDURE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at internal medicine department - faculty of medicine - Assiut university

Model Details: randomized control trial

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 17, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12