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

RecruitingNAAges 18 Years - 75 YearsAllAsian Institute of Gastroenterology, India
NCT06870630 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

\- 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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult \>18 years * Diagnosis of Type 2 Achalasia cardia based on High resolution manometry. 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 as contraindication to general anesthesia, coagulopathy (international normalized ratio \> 1.5, platelet count \< 50 000/μL), portal hypertension, pregnancy, breast feeding women, and diffuse scarring in the esophagus due to previous surgery or radiation.
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What it tests

  • Per oral endoscopy myotomy
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Where

1 site
Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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