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

Asian Institute of Gastroenterology, India

Status: Enrolling

Conditions: Esophageal Diseases

Treatments: Device: Per oral endoscopy myotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06870630

POEMUSM

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 158 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

158 participants in 2 patient groups

Per oral endoscopy myotomy for standard myotomy

Active Comparator group

Description:

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

Treatment:

Device: Per oral endoscopy myotomy

Per oral endoscopy myotomy for esophago gastric junction myotomy

Sham Comparator group

Description:

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

Treatment:

Device: Per oral endoscopy myotomy