Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients

Last updated: June 9, 2025
Sponsor: Asian Institute of Gastroenterology, India
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Achalasia

Gastrointestinal Diseases And Disorders

Treatment

Per oral endoscopy myotomy

Clinical Study ID

NCT06870630
POEMUSM
  • Ages 18-75
  • All Genders

Study Summary

  • Consecutive eligible patients will be randomized in a 1:1 ratio to esophagogastric complex only myotomy or standard myotomy groups. Randomization is done according to the computer-generated algorithm. A clinical research coordinator will prepare the sealed randomization envelops and will hand over to the operating endoscopists before the beginning of the procedure. Written informed consent will be obtained from all participants. In this study, the participants and the care-provider assessing the clinical response to the POEM procedure at 3months will be blinded to the allocation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult >18 years

  • Diagnosis of Type 2 Achalasia cardia based on High resolution manometry.

Exclusion

Exclusion Criteria:

  • Patients with Type 1 & 3 ACHALASIA CARDIA

  • Patients with previous endoscopic or surgical treatment for achalasia

  • Patients with standard exclusion criteria for POEM procedure such ascontraindication to general anesthesia, coagulopathy (international normalized ratio > 1.5, platelet count < 50 000/μL), portal hypertension, pregnancy, breast feedingwomen, and diffuse scarring in the esophagus due to previous surgery or radiation.

Study Design

Total Participants: 158
Treatment Group(s): 1
Primary Treatment: Per oral endoscopy myotomy
Phase:
Study Start date:
November 29, 2023
Estimated Completion Date:
July 30, 2025

Study Description

. Primary objective -

• To study the incidence of true reflux on 24 hour pH analysis with manual study.

Secondary objective -

  • To analyse treatment success which is defined as Eckdart score < 3 at follow up assessment ( 3rd month)

  • To analyse the recovery of peristalsis after POEM using High resolution manometry

  • To study total procedure time , intra operative adverse effects and duration of hospital stay.

  • Severity of oesophagitis

  • Presence of GERD symptoms based on GERD questionnaire & Quality of life questionaire post procedure.

Connect with a study center

  • Asian Institute of Gastroenterology /Aig Hospitals

    Hyderabad, Telangana 500082
    India

    Active - Recruiting

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