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POEM Versus Pneumatic Dilatation in Achalasia Cardia

Primary Purpose

Achalasia Cardia

Status

Unknown status

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Per Oral Endoscopic Myotomy (POEM)

Pneumatic Dilatation

About this trial

This is an interventional treatment trial for Achalasia Cardia focused on measuring Achalasia, POEM, Pneumatic dilatation, Eckardt score

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Achalasia with Eckardt score at least 3 (0-12 scale achalasia least-most severe)
Age 18-75 years
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:

Severe comorbid illness
Previous esophageal or gastric surgery
Pseudo achalasia
Achalasia with esophageal diverticula
Pregnancy or lactation

Sites / Locations

Asian Institute of GastroenterologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A - POEM

Group B - Dilatation

Arm Description

Per Oral Endoscopic Myotomy for treatment of achalasia

- Pneumatic dilatation using a balloon for treatment of achalasia.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse events

All dilatation or POEM related adverse events, including type, required intervention, severity, time to resolution

Full Information

NCT ID

NCT02025790

First Posted

December 31, 2013

Last Updated

December 31, 2013

Sponsor

Asian Institute of Gastroenterology, India

1. Study Identification

Unique Protocol Identification Number

NCT02025790

Brief Title

POEM Versus Pneumatic Dilatation in Achalasia Cardia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

December 2013 (undefined)

Primary Completion Date

March 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asian Institute of Gastroenterology, India

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Achalasia Cardia

Keywords

Achalasia, POEM, Pneumatic dilatation, Eckardt score

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A - POEM

Arm Type

Experimental

Arm Description

Per Oral Endoscopic Myotomy for treatment of achalasia

Arm Title

Group B - Dilatation

Arm Type

Active Comparator

Arm Description

- Pneumatic dilatation using a balloon for treatment of achalasia.

Intervention Type

Procedure

Intervention Name(s)

Per Oral Endoscopic Myotomy (POEM)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Pneumatic Dilatation

Intervention Description

Pneumatic dilatation using a Rigiflex balloon up to 35 mm at 8 psi for 1 minute.

Primary Outcome Measure Information:

Title

Clinical success

Description

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

Time Frame

3 months post procedure

Secondary Outcome Measure Information:

Title

Adverse events

Description

All dilatation or POEM related adverse events, including type, required intervention, severity, time to resolution

Time Frame

1 week post procedure

Other Pre-specified Outcome Measures:

Title

Cytokine levels

Description

Post procedural inflammation compared to baseline as measured by blood cytokine levels

Time Frame

Pre procedure and immediately and 6 hours post procedure

Title

Long term clinical success

Description

Long term clinical success at 6 and 12 months post procedure compared to baseline.

Time Frame

6 and 12 months post procedure

Title

LES pressure

Description

Post procedure reduction in LES pressure at 3, 6 and 12 months compared to baseline.

Time Frame

3, 6 and12 months post procedure

Title

Quality of life

Description

Quality of Life (QOL) improvement at 3, 6 and 12 months post procedure compared to baseline using SF36 questionnaire

Time Frame

3, 6 and 12 months post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Achalasia with Eckardt score at least 3 (0-12 scale achalasia least-most severe) Age 18-75 years 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: Severe comorbid illness Previous esophageal or gastric surgery Pseudo achalasia Achalasia with esophageal diverticula Pregnancy or lactation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

D Nageshwar Reddy, MD

Phone

+914023378888

aigindia@yahoo.co.in

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

D Nageshwar Reddy, MD

Organizational Affiliation

Asian Institute of Gastroenterology (AIG)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asian Institute of Gastroenterology

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500082

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

D Nageshwar Reddy, MD

Phone

+914023378888

aigindia@yahoo.co.in

First Name & Middle Initial & Last Name & Degree

Mohan Ramchandani, MD

Phone

+914023378888

ramchandanimohan@gmail.com

First Name & Middle Initial & Last Name & Degree

Mohan Ramchandani, MD

12. IPD Sharing Statement

Learn more about this trial

POEM Versus Pneumatic Dilatation in Achalasia Cardia

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