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Trial record 2 of 24 for:    Recruiting, Not yet recruiting, Available Studies | "Esophageal Achalasia"

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
Sponsor:
Information provided by (Responsible Party):
Erwin Rieder, Medical University of Vienna

Brief Summary:

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Endoscopy

Arm Intervention/treatment
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
Dilatation
Procedure: Endoscopic intervention C
Endoscopic balloon dilatation

Active Comparator: Laparoscopic surgery
Laparoscopic Heller myotomy
Procedure: Laparoscopic Surgery
Laparoscopic Heller myotomy




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Barium column height (cm) in esophagogram [ Time Frame: 6 mo post-op ]
  2. Resting pressure (mmHg) at the lower esophageal sphincter [ Time Frame: 6 mo post-op ]
  3. 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.

  4. Percent of time (min)/24h that the pH is less than 4.0 in pH-metry [ Time Frame: 6 mo post-op ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm

Exclusion Criteria:

  • Contraindication for EGD

Information from the National Library of Medicine

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


Contacts
Contact: Department of Surgery, Medical University of Vienna +43 1 40400 ext 5621 sebastian.schoppmann@meduniwien.ac.at; erwin.rieder@meduniwien.ac.at

Locations
Austria
Department of Surgery, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Sebastian F Schoppmann, MD    +43 1 40400 ext 5621    sebastian.schoppmann@meduniwien.ac.at   
Contact: Erwin Rieder, MD    +43 1 40400 ext 5621    erwin.rieder@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna

Responsible Party: Erwin Rieder, Priv. Doz. Dr. Erwin Rieder, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02518542     History of Changes
Other Study ID Numbers: POETA
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases