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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAsian Institute of Gastroenterology, India

About this trial

\- 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

This trial does not accept healthy volunteers

Qualifiers

Adult >18 years

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Per oral endoscopy myotomy

    Device

    Poem procedure is meant for cutting of circular and longitudinal muscle fibers in esophagus to reduce the symptoms of dysphagia, regurgitation and chestpain, weight loss.

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: Per oral endoscopy myotomy for standard myotomyActive comparator 1 intervention
Group B: Per oral endoscopy myotomy for esophago gastric junction myotomySham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of true reflux based on 24-hour pH impedence

Reflux parameters in percent are noted in impedence report like acidic and non acidic refluxes

Time frame
3 months
2

Integrated Relaxation Pressure (IRP) at High resolution manometry test

IRP in mm Hg measures pressure in the esophagus

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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