Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia (POETA)
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|ClinicalTrials.gov Identifier: NCT02518542|
Recruitment Status : Recruiting
First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Achalasia is an esophageal motility disorder, which leads to clinical symptoms such as dysphagia, regurgitation, chest pain and consecutive weight loss.
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Achalasia||Procedure: Endoscopic intervention A Procedure: Endoscopic intervention B Procedure: Endoscopic intervention C Procedure: Laparoscopic Surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) as Additional Endoscopic Treatment Options for Achalasia and Other Esophageal Motility Disorders|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2027|
Active Comparator: Per oral endoscopic therapy A
Per oral endoscopic myotomy
Procedure: Endoscopic intervention A
POEM: Per oral endoscopic myotomy
Active Comparator: Per oral endoscopic therapy B
Prolonged dilatation by implantation of large diameter stents.
Procedure: 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.
Active Comparator: Per oral endoscopic therapy C
Procedure: Endoscopic intervention C
Endoscopic balloon dilatation
Active Comparator: Laparoscopic surgery
Laparoscopic Heller myotomy
Procedure: Laparoscopic Surgery
Laparoscopic Heller myotomy
- Achalasia specific symptoms according to the Eckardt score (0-12) [ Time Frame: 6 mo post-op ]Eckardt score: Weight loss 0kg (0), less than 5kg (1), 5-10 kg (2), more than 10 kg (3); Dysphagia none(0), occasional (1), daily (2), every meal (3); Regurgitation none(0), occasional (1), daily (2), every meal (3); Retrosternal pain none(0), occasional (1), daily (2), every meal (3)
- Barium column height (cm) in esophagogram [ Time Frame: 6 mo post-op ]
- Resting pressure (mmHg) at the lower esophageal sphincter [ Time Frame: 6 mo post-op ]
- Stent migration [ Time Frame: p.o. day 1 ]Analysis: On the first postoperative day a routine esophagogram will be used to evaluate the appropriate location of the esophageal stent. Early distal stent dislocation/migration into the stomach will be registered.
- Percent of time (min)/24h that the pH is less than 4.0 in pH-metry [ Time Frame: 6 mo post-op ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518542
|Contact: Department of Surgery, Medical University of Vienna||+43 1 40400 ext email@example.com; firstname.lastname@example.org|
|Department of Surgery, Medical University of Vienna||Recruiting|
|Vienna, Austria, 1090|
|Contact: Sebastian F Schoppmann, MD +43 1 40400 ext 5621 email@example.com|
|Contact: Erwin Rieder, MD +43 1 40400 ext 5621 firstname.lastname@example.org|