Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients
1 other identifier
interventional
158
1 country
1
Brief Summary
\- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 29, 2023
CompletedFirst Submitted
Initial submission to the registry
March 6, 2025
CompletedFirst Posted
Study publicly available on registry
March 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2025
CompletedJune 10, 2025
March 1, 2025
1.5 years
March 6, 2025
June 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
3 months
Integrated Relaxation Pressure (IRP) at High resolution manometry test
IRP in mm Hg measures pressure in the esophagus
3 months
Study Arms (2)
Per oral endoscopy myotomy for standard myotomy
ACTIVE COMPARATORStandard myotomy is muscle fibers cutting in esophagus more than 7 cms
Per oral endoscopy myotomy for esophago gastric junction myotomy
SHAM COMPARATORMyotomy is muscle fibers cutting in esophagus less than 3 cms.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adult \>18 years
- Diagnosis of Type 2 Achalasia cardia based on High resolution manometry.
You may not qualify if:
- Patients with Type 1 \& 3 ACHALASIA CARDIA
- Patients with previous endoscopic or surgical treatment for achalasia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, Telangana, 500082, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
March 6, 2025
First Posted
March 11, 2025
Study Start
November 29, 2023
Primary Completion
June 14, 2025
Study Completion
July 30, 2025
Last Updated
June 10, 2025
Record last verified: 2025-03