Clinical Impact of Peroral Endoscopic Myotomy for Esophageal Achalasia

July 22, 2012 updated by: Shanghai Zhongshan Hospital
Achalasia is a rare esophageal motility disorder, which is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. These symptoms are primarily caused by incomplete relaxation of a frequently hypertensive lower esophageal sphincter (LES) and to some extent by a lack of peristalsis in the tubular esophagus. Unfortunately, no therapy returns normal esophageal function. Treatment is therefore directed at lowering the LES pressure, with the aim of reducing the functional obstruction to bolus transit at this site. Current treatments can be endoscopic or surgical. Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia in some centers. The investigators purpose was to further evaluate the efficacy and the feasibility of POEM for patients with achalasia in a prospective larger study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Patients were eligible for enrollment in the study if they had an Eckardt symptom score ≥ 4. The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy (EGD)). Exclusion criteria were severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk, pseudoachalasia, and megaesophagus (diameter of > 7 cm).
  2. All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry. Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires.
  3. The primary outcome of the study was therapeutic success (a reduction in the Eckardt score to ≤3) at the follow-up assessment. The secondary outcomes included procedure-related adverse events, LES pressure on manometry pre- and post POEM, reflux symptoms and medication use before and after POEM, and procedure-related parameters such as procedure time, hospital stay, and myotomy length.

Study Type

Interventional

Enrollment (Anticipated)

450

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

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University
        • Contact:

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

6 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • with an Eckardt symptom score ≥ 4
  • The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy)
  • Informed patient consent was obtained

Exclusion Criteria:

  • Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk
  • Pseudoachalasia
  • megaesophagus (diameter of > 7 cm)

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EA
Patients were eligible for enrollment in the study if they had an Eckardt symptom score ≥ 4. The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy (EGD)).
Procedure: POEM
Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia in some centers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Therapeutic success (a reduction in the Eckardt score to ≤3)
Time Frame: Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires during follow-up, an expected average of 2 years.
Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires during follow-up, an expected average of 2 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedure-related adverse events
Time Frame: All patients were scheduled for a follow-up visit at 1 month after POEM for EGD.
All patients were scheduled for a follow-up visit at 1 month after POEM for EGD.
Lower esophageal sphincter (LES) pressure on manometry
Time Frame: All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry
All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry
Reflux symptoms and medication use before and after POEM
Time Frame: Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires during follow-up, an expected average of 2 years.
Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires during follow-up, an expected average of 2 years.

Collaborators and Investigators

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

Sponsor

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 22, 2012

First Posted (ESTIMATE)

July 25, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2012

Last Update Submitted That Met QC Criteria

July 22, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endoscopycenter-POEM

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.

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