Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06870630

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

Led by Asian Institute of Gastroenterology, India · Updated on 2025-06-10

158

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

\- 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult older than 18 years
  • Diagnosed with Type 2 Achalasia cardia based on High resolution manometry
Not Eligible

You will not qualify if you...

  • Patients with Type 1 or Type 3 Achalasia cardia
  • Patients who had previous endoscopic or surgical treatment for achalasia
  • Patients with contraindications to general anesthesia
  • Patients with coagulopathy (INR > 1.5, platelet count < 50,000/bcL)
  • Patients with portal hypertension
  • Pregnant or breastfeeding women
  • Patients with diffuse scarring in the esophagus due to prior surgery or radiation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Asian Institute of Gastroenterology /Aig Hospitals

Hyderabad, Telangana, India, 500082

Actively Recruiting

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Research Team

R

Rajesh Dr Goud, M.Pharm, MBA

CONTACT

S

Sreejith Dr OT, MBBS MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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