Clinical Trial: Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) as Additional Endoscopic Treatment Options for Achalasia and Other Esophageal Motility Disorders

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.


Detailed Summary:
Sponsor: Medical University of Vienna

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: December 8, 2014
Date Started: June 2014
Date Completion: June 2027
Last Updated: August 7, 2015
Last Verified: August 2015