POEM Versus Pneumatic Dilatation in Achalasia Cardia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Asian Institute of Gastroenterology, India
Sponsor:
Information provided by (Responsible Party):
Nageshwar Reddy D, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier:
NCT02025790
First received: December 31, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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


Condition Intervention
Achalasia Cardia
Procedure: Per Oral Endoscopic Myotomy (POEM)
Procedure: Pneumatic Dilatation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Trial Comparing POEM to Pneumatic Dilatation for Treatment of Achalasia Cardia

Resource links provided by NLM:


Further study details as provided by Asian Institute of Gastroenterology, India:

Primary Outcome Measures:
  • Clinical success [ Time Frame: 3 months post procedure ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 1 week post procedure ] [ Designated as safety issue: Yes ]
    All dilatation or POEM related adverse events, including type, required intervention, severity, time to resolution


Other Outcome Measures:
  • Cytokine levels [ Time Frame: Pre procedure and immediately and 6 hours post procedure ] [ Designated as safety issue: No ]
    Post procedural inflammation compared to baseline as measured by blood cytokine levels

  • Long term clinical success [ Time Frame: 6 and 12 months post procedure ] [ Designated as safety issue: No ]
    Long term clinical success at 6 and 12 months post procedure compared to baseline.

  • LES pressure [ Time Frame: 3, 6 and12 months post procedure ] [ Designated as safety issue: No ]
    Post procedure reduction in LES pressure at 3, 6 and 12 months compared to baseline.

  • Quality of life [ Time Frame: 3, 6 and 12 months post procedure ] [ Designated as safety issue: No ]
    Quality of Life (QOL) improvement at 3, 6 and 12 months post procedure compared to baseline using SF36 questionnaire


Estimated Enrollment: 140
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02025790

Contacts
Contact: D Nageshwar Reddy, MD +914023378888 aigindia@yahoo.co.in

Locations
India
Asian Institute of Gastroenterology Recruiting
Hyderabad, Andhra Pradesh, India, 500082
Contact: D Nageshwar Reddy, MD    +914023378888    aigindia@yahoo.co.in   
Contact: Mohan Ramchandani, MD    +914023378888    ramchandanimohan@gmail.com   
Sub-Investigator: Mohan Ramchandani, MD         
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
Principal Investigator: D Nageshwar Reddy, MD Asian Institute of Gastroenterology (AIG)
  More Information

No publications provided

Responsible Party: Nageshwar Reddy D, Chairman, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT02025790     History of Changes
Other Study ID Numbers: AIG-POEM-01
Study First Received: December 31, 2013
Last Updated: December 31, 2013
Health Authority: India: Ministry of Health

Keywords provided by Asian Institute of Gastroenterology, India:
Achalasia
POEM
Pneumatic dilatation
Eckardt score

Additional relevant MeSH terms:
Esophageal Achalasia
Dilatation, Pathologic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 22, 2014