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van CCT (UK)

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

- candidate number17097
- NTR NumberNTR4501
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-apr-2014
- Secondary IDsNL48223.018.14 Dossiernummer ABR
- Public TitlePneumodilation versus Per-Oral Endoscopic Myotomy in Achalasia patients with recurrent symptoms after Laparoscopic Heller Myotomy
- Scientific TitlePneumodilation versus Per-Oral Endoscopic Myotomy in Achalasia patients with recurrent symptoms after Laparoscopic Heller Myotomy
- hypothesisWe hypothesize that per-oral endoscopic myotomy has a higher long-term efficacy than pneumodilation in treatment of patients with recurrent symptoms after Heller myotomy
- Healt Condition(s) or Problem(s) studiedAchalasia, Pneumodilation, Relapse, Laparoscopic Heller Myotomy, Per-oral endoscopic myotomy
- Inclusion criteria1. Presence of achalasia as shown on oesophageal manometry at least once
2. Previous Heller myotomy
3. Eckardt score > 3
4. Significant stasis (stasis of >2 cm on barium oesophagogram after two minutes)
5. Age between 18-80 years
6. Signed written informed consent
- Exclusion criteria1. Previous pneumodilations after the Heller myotomy (pneumodilations before the Heller myotomy are allowed)
2. Previous (attempt at) POEM
3. Previous surgery of the stomach or oesophagus, except Heller myotomy
4. Known coagulopathy
5. Presence of liver cirrhosis and/or oesophageal varices
6. Presence of eosinophilic oesophagitis
7. Pregnancy at time of treatment
8. Presence of a stricture of the oesophagus
9. Presence of malignant or premalignant oesophageal lesions
10. Presence of one or more large esophageal diverticuli
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2014
- planned closingdate1-mei-2020
- Target number of participants45
- Interventionsper-oral endoscopic myotomy (intervention)
- Primary outcome- Treatment success at one year, defined as: An Eckardt score of 3 or less in the absence of additional retreatment after the allocated treatment (patients in the pneumodilation arm undergo 2 pneumodilations, with 30 and 35 mm and another one or two pneumodilations are allowing up to 40 mm in case of symptom recurrence within 1 year), patients in the POEM arm undergo POEM and no subsequent treatments)
- Secondary outcome Quality of life and achalasia-specific quality of life
Stasis in the oesophagus, measured with a timed barium oesophagogram
Complications of the treatment, defined as any unwanted events that arise following treatment and/or that are secondary to the treatment. Complications are classified as 'severe' when these result in admission > 24 hours or prolongation of an already planned admission of >24 hours, admission to a medium or intensive care unit, additional endoscopic procedures, or blood transfusion or death. Other complications are classified as 'mild'.
Treatment success after two and five years follow up
The use of acid-suppressant drugs and the presence of reflux symptoms using the GerdQ questionnaire
The presence of reflux oesophagitis, as observed during upper endoscopy
- Timepoints3 months, 1, 2 and 5 years
- Trial web site
- statusplanned
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Gastroenterology
- Publications
- Brief summarySummary POEMA-2 trial
Idiopathic achalasia is a rare motility disorder of the oesophagus with an annual incidence rate of 1 per 100,000 persons. Achalasia i caused by progressive destruction and degeneration of the neurons in the myenteric plexus. This leads to subsequent retention of food and saliva in the oesophagus, resulting in the typical symptoms of achalasia such as dysphagia, chest pain, regurgitation of undigested food and weight loss. On the long term, incomplete oesophageal emptying and reflux result in an increased risk for development of squamous cell carcinoma of the oesophagus. The cause of the neuronal degeneration found in achalasia is unknown.
Treatment procedures include: endoscopic pneumodilations (PD) and laparoscopic Heller myotomy. Unfortunately, some patients experience recurrent or persistent symptoms after pneumodilations and Heller myotomy. Patients with recurrent symptoms after undergoing a laparoscopic Heller myotomy are usually treated with pneumodilation . However, the success rates of pneumodilation after laparscopic Heller myotomy are only between 50-67% leaving a substantial proportion of these patients with recurrent symptoms.
Recently, a new procedure has been introduced, the per-oral endoscopic myotomy. During per-oral endoscopic myotomy the circular muscle layers of the lower oesophageal sphincter are cut similar to the Heller myotomy, but the approach is through the wall of the esophagus with the endoscope instead of laparoscopically.
This study compares the efficacy of POEM to the efficacy of pneumodilation for the treatment of recurrent symptoms in patients with idiopathic achalasia that previously underwent Heller myotomy. This study is a multicenter randomized clinical trial, including adult patient with persistent or recurrent symptomatic idiopathic achalasia after Heller myotomy.
- Main changes (audit trail)
- RECORD1-apr-2014 - 1-mei-2014

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