To compare 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.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
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
Background summary
Achalasia is a rare motility disorder of he oesophagus that is characterised by
aperistalsis of the oesophageal body and dysrelaxation of the lower oesophageal
sphincer caused by progressive destruction and degenaration 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. The
cause of the neuronal degeneration found in achalasia in still unknown.
Study objective
To compare 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.
Study design
Multicenter randomised clinical trial
Intervention
Study subjects undergo a POEM or endoscopic pneumodilation
Per-oral submucosal myotomy (POEM): the POEM is entirely endoscopic. Using and
endoscopic knife, an entry o he submucosal space is made in the oesophagus and
after creaing a submucosal tunnel towars the lower oesophageal sphincter the
cicular muscle layers are cut. At the end of he pocedure the mucoal opening is
closed with clips.
Endoscopic pneumodilation: endoscopic dilation of the lower oesophageal spincer
is performen by a Rigiflex balloon of 30 mm and after 1-3 weeks of 35 mm. A
third dilation with a 40mm balloon is performed, if patients suffer from
persistent or recurrent symptoms wihing 3 months. If symptoms return with 3-12
months, two additional dilations will be performed using a 35 and 40 mm
balloon.
Study burden and risks
For this study patients will be treated with per-oral endoscopic submucosal
myotomy (POEM) or endoscopic pneumodilation for the treatment of persistent or
recurent symptoms of achalasie. Both procedures are associated with risks,
including bleeding during or after treatment, a perforation of the oesophagus
or stomach during the treatment and infection after treatment. These
complications could be severe and are, in some cases, in need of immediate
care. This may imply additional endoscopic of surgical procedures with
extension of admission time.
To determine long term effectiveness patients are followed fo a period of 5
years and need to undergo different eosophageal examinations like a
gastroscopy, a timed barium oesophagram, high resolution manometry and a 24
hour ph-impedance measuremet. Furthermore, the need to fill out questionnaires
regularly. After the procedures subjecs need to visit the outpatient clinic at
least 5 times or follow-up.
The first resuls of the POEM are very promising and suggest at this treatmen is
beter than he endoscopic pneumodilation. The risks of both procedures are
equal. Furthermore, patients that are not participating in the trial will also
undergo a treament, in most cases this will be endoscopic pneumodilation.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL48223.018.14 |
| OMON | NL-OMON25721 |