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

June 9, 2025 updated by: Mohan Ramchandani, Asian Institute of Gastroenterology, India
- 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Recruiting
        • Asian Institute of Gastroenterology /Aig Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Per oral endoscopy myotomy for standard myotomy
Standard myotomy is muscle fibers cutting in esophagus more than 7 cms
Device: Per oral endoscopy myotomy
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.
Sham Comparator: Per oral endoscopy myotomy for esophago gastric junction myotomy
Myotomy is muscle fibers cutting in esophagus less than 3 cms.
Device: Per oral endoscopy myotomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of true reflux based on 24-hour pH impedence
Time Frame: 3 months
Reflux parameters in percent are noted in impedence report like acidic and non acidic refluxes
3 months
Integrated Relaxation Pressure (IRP) at High resolution manometry test
Time Frame: 3 months
IRP in mm Hg measures pressure in the esophagus
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Investigators

  • Study Director: Mohan Dr Ramchandani, MBBS MD, AIG Hospitals
  • Principal Investigator: Zaheer Dr Nabi, MBBS MD, AIG Hospitals
  • Principal Investigator: Pradev Dr Inovolu, MBBS MD, AIG Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2023

Primary Completion (Estimated)

June 14, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 9, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POEMUSM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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