NCT02025790

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 1, 2014

Status Verified

December 1, 2013

Enrollment Period

1.2 years

First QC Date

December 31, 2013

Last Update Submit

December 31, 2013

Conditions

Achalasia Cardia

Keywords

AchalasiaPOEMPneumatic dilatationEckardt score

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adverse events

    1 week post procedure

Other Outcomes (4)

  • Cytokine levels

    Pre procedure and immediately and 6 hours post procedure

  • Long term clinical success

    6 and 12 months post procedure

  • LES pressure

    3, 6 and12 months post procedure

  • +1 more other outcomes

Study Arms (2)

Group A - POEM

EXPERIMENTAL

Per Oral Endoscopic Myotomy for treatment of achalasia

Procedure: Per Oral Endoscopic Myotomy (POEM)

Group B - Dilatation

ACTIVE COMPARATOR

\- Pneumatic dilatation using a balloon for treatment of achalasia.

Procedure: Pneumatic Dilatation

Interventions

Per Oral Endoscopic Myotomy (POEM)PROCEDURE

* 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

Group A - POEM
Pneumatic DilatationPROCEDURE

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

Group B - Dilatation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Andhra Pradesh, 500082, India

RECRUITING

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • D Nageshwar Reddy, MD

    Asian Institute of Gastroenterology (AIG)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

D Nageshwar Reddy, MD

CONTACT

+914023378888aigindia@yahoo.co.in

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman

Study Record Dates

First Submitted

December 31, 2013

First Posted

January 1, 2014

Study Start

December 1, 2013

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

January 1, 2014

Record last verified: 2013-12

Locations

IN(1)