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

NCT ID: NCT06870630

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-29

Study Completion Date

2025-07-30

Brief Summary

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\- 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.

Detailed Description

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. 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.

Conditions

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Esophageal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Per oral endoscopy myotomy for standard myotomy

Standard myotomy is muscle fibers cutting in esophagus more than 7 cms

Group Type ACTIVE_COMPARATOR

Per oral endoscopy myotomy

Intervention Type 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.

Per oral endoscopy myotomy for esophago gastric junction myotomy

Myotomy is muscle fibers cutting in esophagus less than 3 cms.

Group Type SHAM_COMPARATOR

Per oral endoscopy myotomy

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asian Institute of Gastroenterology, India

OTHER

Sponsor Role lead

Responsible Party

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Mohan Ramchandani

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohan Dr Ramchandani, MBBS MD

Role: STUDY_DIRECTOR

AIG Hospitals

Zaheer Dr Nabi, MBBS MD

Role: PRINCIPAL_INVESTIGATOR

AIG Hospitals

Pradev Dr Inovolu, MBBS MD

Role: PRINCIPAL_INVESTIGATOR

AIG Hospitals

Locations

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Asian Institute of Gastroenterology /Aig Hospitals

Hyderabad, Telangana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Rajesh Dr Goud, M.Pharm, MBA

Role: CONTACT

04023378888 ext. 204

Sreejith Dr OT, MBBS MD

Role: CONTACT

04023378888 ext. 500

Facility Contacts

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ZAHEER DR NABI, MBBS MDDNB

Role: primary

04023378888

Other Identifiers

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POEMUSM

Identifier Type: -

Identifier Source: org_study_id

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