Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia (POETA)

August 7, 2015 updated by: Erwin Rieder, Medical University of Vienna

Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) as Additional Endoscopic Treatment Options for Achalasia and Other Esophageal Motility Disorders

Achalasia is an esophageal motility disorder, which leads to clinical symptoms such as dysphagia, regurgitation, chest pain and consecutive weight loss.

Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon dilatation (BD) can provide sufficient symptom relief in many patients, both interventions have their individual drawbacks. Additionally, treatment after failed LHM or BD can be challenging and in few might even lead to esophagectomy.

Per oral endoscopic myotomy (POEM) and prolonged dilatation (PRD) are two novel endoscopically performed therapeutic options for achalasia and other esophageal motility disorders. Both not only appear to provide good results, when performed as initial treatment but also might be an excellent option after e.g failed LHM.

The purpose of this study is to evaluate the long-term efficacy of four different treatment options, such as POEM, PRD with stent-fixation, PD and conventional LHM for achalasia in an individualized treatment setting.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm

Exclusion Criteria:

  • Contraindication for EGD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Per oral endoscopic therapy A
Per oral endoscopic myotomy
Procedure: Endoscopic intervention A
POEM: Per oral endoscopic myotomy
Active Comparator: Per oral endoscopic therapy B
Prolonged dilatation by implantation of large diameter stents.
Procedure: Endoscopic intervention B
PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options.
Active Comparator: Per oral endoscopic therapy C
Dilatation
Procedure: Endoscopic intervention C
Endoscopic balloon dilatation
Active Comparator: Laparoscopic surgery
Laparoscopic Heller myotomy
Procedure: Laparoscopic Surgery
Laparoscopic Heller myotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achalasia specific symptoms according to the Eckardt score (0-12)
Time Frame: 6 mo post-op
Eckardt score: Weight loss 0kg (0), less than 5kg (1), 5-10 kg (2), more than 10 kg (3); Dysphagia none(0), occasional (1), daily (2), every meal (3); Regurgitation none(0), occasional (1), daily (2), every meal (3); Retrosternal pain none(0), occasional (1), daily (2), every meal (3)
6 mo post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barium column height (cm) in esophagogram
Time Frame: 6 mo post-op
6 mo post-op
Resting pressure (mmHg) at the lower esophageal sphincter
Time Frame: 6 mo post-op
6 mo post-op
Stent migration
Time Frame: p.o. day 1
Analysis: On the first postoperative day a routine esophagogram will be used to evaluate the appropriate location of the esophageal stent. Early distal stent dislocation/migration into the stomach will be registered.
p.o. day 1
Percent of time (min)/24h that the pH is less than 4.0 in pH-metry
Time Frame: 6 mo post-op
6 mo post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2027

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

August 7, 2015

First Posted (Estimate)

August 10, 2015

Study Record Updates

Last Update Posted (Estimate)

August 10, 2015

Last Update Submitted That Met QC Criteria

August 7, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POETA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Achalasia

Clinical Trials on Endoscopic intervention A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe