Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia
NCT ID: NCT02518542
Last Updated: 2015-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2014-06-30
2027-06-30
Brief Summary
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Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon dilatation (BD) can provide sufficient symptom relief in many patients, both interventions have their individual drawbacks. Additionally, treatment after failed LHM or BD can be challenging and in few might even lead to esophagectomy.
Per oral endoscopic myotomy (POEM) and prolonged dilatation (PRD) are two novel endoscopically performed therapeutic options for achalasia and other esophageal motility disorders. Both not only appear to provide good results, when performed as initial treatment but also might be an excellent option after e.g failed LHM.
The purpose of this study is to evaluate the long-term efficacy of four different treatment options, such as POEM, PRD with stent-fixation, PD and conventional LHM for achalasia in an individualized treatment setting.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Per oral endoscopic therapy A
Per oral endoscopic myotomy
Endoscopic intervention A
POEM: Per oral endoscopic myotomy
Per oral endoscopic therapy B
Prolonged dilatation by implantation of large diameter stents.
Endoscopic intervention B
PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options.
Per oral endoscopic therapy C
Dilatation
Endoscopic intervention C
Endoscopic balloon dilatation
Laparoscopic surgery
Laparoscopic Heller myotomy
Laparoscopic Surgery
Laparoscopic Heller myotomy
Interventions
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Endoscopic intervention A
POEM: Per oral endoscopic myotomy
Endoscopic intervention B
PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options.
Endoscopic intervention C
Endoscopic balloon dilatation
Laparoscopic Surgery
Laparoscopic Heller myotomy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Erwin Rieder
Priv. Doz. Dr. Erwin Rieder
Locations
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Department of Surgery, Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Department of Surgery, Medical University of Vienna
Role: CONTACT
Facility Contacts
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Other Identifiers
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POETA
Identifier Type: -
Identifier Source: org_study_id
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