POEM Versus Pneumatic Dilatation in Achalasia Cardia

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

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

Study Overview

• Status: Unknown
• Conditions: Achalasia Cardia
• Intervention / Treatment: Procedure: Per Oral Endoscopic Myotomy (POEM); Procedure: Pneumatic Dilatation

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: D Nageshwar Reddy, MD; Phone Number: +914023378888; Email: aigindia@yahoo.co.in

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500082
      • Recruiting
      • Asian institute of Gastroenterology
      • Contact: D Nageshwar Reddy, MD; Phone Number: +914023378888; Email: aigindia@yahoo.co.in
      • Contact: Mohan Ramchandani, MD; Phone Number: +914023378888; Email: ramchandanimohan@gmail.com
      • Sub-Investigator: Mohan Ramchandani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A - POEM; Per Oral Endoscopic Myotomy for treatment of achalasia	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
ACTIVE_COMPARATOR: Group B - Dilatation; - Pneumatic dilatation using a balloon for treatment of achalasia.	Procedure: Pneumatic Dilatation; Pneumatic dilatation using a Rigiflex balloon up to 35 mm at 8 psi for 1 minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	All dilatation or POEM related adverse events, including type, required intervention, severity, time to resolution	1 week post procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytokine levels	Post procedural inflammation compared to baseline as measured by blood cytokine levels	Pre procedure and immediately and 6 hours post procedure
Long term clinical success	Long term clinical success at 6 and 12 months post procedure compared to baseline.	6 and 12 months post procedure
LES pressure	Post procedure reduction in LES pressure at 3, 6 and 12 months compared to baseline.	3, 6 and12 months post procedure
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

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: D Nageshwar Reddy, MD, Asian Institute of Gastroenterology (AIG)

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ANTICIPATED): March 1, 2015
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: December 31, 2013
• First Submitted That Met QC Criteria: December 31, 2013
• First Posted (ESTIMATE): January 1, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): January 1, 2014
• Last Update Submitted That Met QC Criteria: December 31, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Achalasia; POEM; Pneumatic dilatation; Eckardt score
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophageal Achalasia; Dilatation, Pathologic
• Other Study ID Numbers: AIG-POEM-01