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Pneumodilation versus Per-Oral Endoscopic Myotomy in Achalasia patients with recurrent symptoms after Laparoscopic Heller Myotomy trial

Recruiting
Conditions
Achalasia
oesophageal motiliy disorder
10017977
Registration Number
NL-OMON50756
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
45
Inclusion Criteria

Presence of achalasia as shown on oesophageal manometry at least once
Previous Heller myotomy
Eckardt score > 3
Significant stasis (stasis of >=2 cm on barium oesophagogram after two minutes)
Age between 18-80 years
Signed written informed consent

Exclusion Criteria

Previous pneumodilations after the Heller myotomy (pneumodilations before the
Heller myotomy are allowed)
Previous (attempt at) POEM
Previous surgery of the stomach or oesophagus, except Heller myotomy
Known coagulopathy
Presence of liver cirrhosis and/or oesophageal varices
Presence of eosinophilic oesophagitis
Pregnancy at time of treatment
Presence of a stricture of the oesophagus
Presence of malignant or premalignant oesophageal lesions
Presence of one or more large esophageal diverticuli

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>- Treatment success at one year, defined as: An Eckardt score of 3 or less in<br /><br>the absence of additional retreatment after the allocated treatment (patients<br /><br>in the pneumodilation arm undergo 2 pneumodilations, with 30 and 35 mm and<br /><br>another one or two pneumodilations are allowing up to 40 mm in case of symptom<br /><br>recurrence within 1 year), patients in the POEM arm undergo POEM and no<br /><br>subsequent treatments) </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Quality of life and achalasia-specific quality of life<br /><br>- Stasis in the oesophagus, measured with a timed barium oesophagogram<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>- Treatment success after two and five years follow up<br /><br>- The use of acid-suppressant drugs and the presence of reflux symptoms using<br /><br>the GerdQ questionnaire<br /><br>- The presence of reflux oesophagitis, as observed during upper endoscopy</p><br>
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