A Prospective Multi-center Study Comparing Endoscopic Pneumodilation and Per Oral Endoscopic Myotomy (POEM) as Treatment of Idiopathic Achalasia
The aim of the study is to compare the efficacy of per-oral endoscopic myotomy (POEM) to the efficacy of pneumodilation as the initial treatment of symptomatic idiopathic achalasia. It is hypothesized that POEM has a higher long-term efficacy than pneumodilation in treatment of therapy-naive patients with idiopathic achalasia.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Multi-center Study Comparing Endoscopic Pneumodilation and Per Oral Endoscopic Myotomy (POEM) as Treatment of Idiopathic Achalasia|
- therapeutic succes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
The time till failure is the primary outcome parameter. The time is measured from date of pneumatic dilation (last session) or POEM to date of relapse of symptoms (date of establishment). Symptoms will be evaluated using the Eckardt scoring system (Table 1.). Therapeutic success is defined as a drop in Eckardt score to ≤ 3 after treatment and symptom control at yearly follow-up which is also defined as an Eckardt score of ≤ 3.
If symptoms recur within patients randomized for pneumatic dilation, retreatment with pneumatic dilation is allowed according to the protocol. If retreatment does not result in reduction of the symptom score below 4, the patient will be considered as a treatment failure.
- quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]The quality of life is determined using a general QoL questionnaire, namely the SF36 questionnaire. In addition, a more disease specific questionnaire, i.e. the EORTC QLQ-OES24 questionnaire, is filled out. These questionnaires have scored the QoL at fixed time points during follow-up (1 month, 3 months and yearly).
- complication rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complications (perforation, bleeding, etc) occurring during or immediately following the procedure are recorded by the attending phycisian.
In addition, gastroesophageal reflux is measured using 24h pHmetry after 3 months and 1 year. The number of patients with pathological acid exposure (>4.5% of time a pH<4) will be assessed. Endoscopy is performed after 1 year to detect esophagitis. Esophagitis rates and LA grades of esophagitis will be assessed.
- need for retreetment [ Time Frame: 2 years ] [ Designated as safety issue: No ]Retreatment is allowed in the pneumodilation group when symptoms recur, which is defined as an Eckardt score of > 3. Symptom scores are assessed after one month, three months and then yearly.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||January 2023|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Active Comparator: PD
Active Comparator: POEM
peroral endoscopic myotomy
peroral endoscopic myotomy