Pneumodilation Or Endoscopic Myotomy in Achalasia trial

Completed

Conditions: Achalasia
Oesophageal motility disorder
10017977

Registration Number: NL-OMON39025

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 65

Inclusion Criteria

- Presence of achalasia, as shown on oesophageal manometry
- Eckardt score > 3
- Age between 18-80 years
- Signed written informed consent
- ASA class I or II

Exclusion Criteria

- Previous endoscopic or surgical treatment for achalasia, except botulinium toxin
injections
- Previous surgery of the stomach or oesophagus
- Patients with known coagulopathy
- Presence of liver cirrhosis and/or oesophageal varices
- Presence of eosinophilic oesophagitis
- Presence of Barrett*s oesophagus
- Pregnancy at time of treatment
- Presence of a stricture of the oesophagus
- Presence of malignant or premalignant oesophageal lesions
- Presence of an extensive, tortuous dilated oesophageal body (S-shape)
- Presence of a diverticula in the distal oesophagus

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is treatment success, defined as an Eckardt score of 3 or less<br /><br>in the absence of the need for endoscopic or surgical retreatment and the<br /><br>absence of severe complications associated with treatment. The primary endpoint<br /><br>is measured after two years, but follow up is continued up to 5 years. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Quality of life and achalasia-specific quality of life<br /><br>- Stasis in the oesophagus, measured with a timed barium oesophagogram<br /><br>- Presence of reflux symptoms, reflux oesophagitis and excessive oesophageal<br /><br>acid exposure<br /><br>- Lower oesophageal sphincter pressure and integrative relaxation pressure<br /><br>(IRP4), as measured with high-resolution manometry<br /><br>- Complications of the treatment, defined as any unwanted events that arise<br /><br>following treatment and/or that are secondary to the treatment. Complications<br /><br>are classified as severe when these result in admission > 24 hours or<br /><br>prolongation of an already planned admission of >24 hours, admission to a<br /><br>medium or intensive care unit, additional endoscopic procedures, or blood<br /><br>transfusion or death. Other complications are classified as mild.<br /><br>- The need for endoscopic or surgical retreatment after the initial treatment<br /><br>session</p><br>