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NCT Number: NCT06870630

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

- 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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Key information

Conditions

Esophageal Diseases Digestive System Diseases Gastrointestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Institute of Gastroenterology /Aig Hospitals

Hyderabad, Telangana, 500082, India

Location status: Recruiting

Location contact

ZAHEER DR NABI, MBBS MDDNB

CONTACT

[email protected]

04023378888

About this study

. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. Integrated Relaxation Pressure (IRP) at High resolution manometry test

    Time frame: 3 months

    IRP in mm Hg measures pressure in the esophagus

Study contacts

Contact information is provided by the study sponsor or research team.

Rajesh Dr Goud, M.Pharm, MBA

CONTACT

[email protected]

04023378888 ext. 204

Sreejith Dr OT, MBBS MD

CONTACT

[email protected]

04023378888 ext. 500

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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