POEM Versus Pneumatic Dilatation in Achalasia Cardia

Achalasia Cardia Clinical Trial

Official title:

A Prospective Trial Comparing POEM to Pneumatic Dilatation for Treatment of Achalasia Cardia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02025790
• Other study ID #: AIG-POEM-01
• Status: Recruiting
• Phase: N/A
• First received: December 31, 2013
• Last updated: December 31, 2013
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2013
• Source: Asian Institute of Gastroenterology, India
• Contact: D Nageshwar Reddy, MD
• Phone: +914023378888
• Email: aigindia[@]yahoo.co.in
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of achalasia cardia.

Description:

Achalasia is an esophageal motility disorder which involves smooth muscle of the esophagus and the lower esophageal sphincter (LES). Achalasia causes difficulty swallowing, regurgitation, and sometimes chest pain and weight loss. Endoscopic treatments of achalasia can be provided in the form of dilatation of the LES or cutting of muscle fibers (myotomy) of the esophagus and of the LES under endoscopic viewing. Dilatation in this trial is accomplished with rigiflex balloons and myotomy via Per Oral Endoscopic Myotomy (POEM). The effectiveness of treatment of achalasia using each method will be compared in this trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Achalasia with Eckardt score at least 3 (0-12 scale achalasia least-most severe)

2. Age 18-75 years

3. Willing and able to comply with the study procedures and provide written informed consent form to participate in the study written informed consent form to participate in the study

Exclusion Criteria:

1. Severe comorbid illness

2. Previous esophageal or gastric surgery

3. Pseudo achalasia

4. Achalasia with esophageal diverticula

5. Pregnancy or lactation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achalasia Cardia
• Esophageal Achalasia

Intervention

Procedure:
• Per Oral Endoscopic Myotomy (POEM)
Mucosal incision - After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 12 cm proximal to the gastroesophageal junction (GEJ). Submucosal tunneling. A long submucosal tunnel is created to 3 cm distal to the GEJ. Endoscopic myotomy is begun at 3 cm distal to the mucosal entry point, and is carried out in a proximal to distal direction to a total length of 10 cm. Long endoscopic myotomy is performed 10 cm proximal to GEJ extending Closure of mucosal entry: the mucosal incision is closed using hemostatic clips
• Pneumatic Dilatation
Pneumatic dilatation using a Rigiflex balloon up to 35 mm at 8 psi for 1 minute.

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology	Hyderabad	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cytokine levels	Post procedural inflammation compared to baseline as measured by blood cytokine levels	Pre procedure and immediately and 6 hours post procedure	No
Other	Long term clinical success	Long term clinical success at 6 and 12 months post procedure compared to baseline.	6 and 12 months post procedure	No
Other	LES pressure	Post procedure reduction in LES pressure at 3, 6 and 12 months compared to baseline.	3, 6 and12 months post procedure	No
Other	Quality of life	Quality of Life (QOL) improvement at 3, 6 and 12 months post procedure compared to baseline using SF36 questionnaire	3, 6 and 12 months post procedure	No
Primary	Clinical success	Clinical success defined as reduction of Eckardt score (0-12 scale achalasia least-most severe) of achalasia to an Eckardt score of 3 or less post procedure	3 months post procedure	No
Secondary	Adverse events	All dilatation or POEM related adverse events, including type, required intervention, severity, time to resolution	1 week post procedure	Yes