Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute for Clinical and Experimental Medicine

About this trial

Laparoscopic fundoplication represents the standard antireflux procedure, when conservative measures fail. However, any type of fundoplication may be accompanied by adverse events. Postfundoplication dysphagia (PFD) may hamper results of anti-reflux surgery. Endoscopic pneumatic dilation has been considered as the first line treatment option for persistent PFD. However, studies have not confirmed its effectiveness in this indication. Peroral endoscopic myotomy (POEM) became a standard treatment for the management of esophageal achalasia and moreover has also been assessed in a small cohort of patients with refractory PFD and some patients achieved significant treatment success. We plan to perform a prospective international cohort multicenter study assessing the efficacy of POEM in patients with persistent and severe PFD.

Eligibility criteria

Qualifiers

Patients after laparoscopic fundoplication procedure by Nissen (total, 360°), Dor (anterior, 180°) or Toupet (posterior, 270°) for gastroesophageal reflux disease no later than 10 years before enrolment.

Refractory (> 6 months) and severe dysphagia after fundoplication procedure defined as an Eckardt score ≥3 and Mellow - Pinkas score ≥2 at baseline.

X-ray (contrasted radiographic examination of the esophagus) characterized by both: a.) tapered narrowing of the distal esophagus and GEJ; b.) partial/total stagnation of the contrast solution above the GEJ

Endoluminal planimetry: EGJ-DI < 3 mm2/mmHg (with 40ml)

Disqualifiers

No previous attempt with at least one prokinetic drug

Previous esophageal myotomy (open, laparoscopic or endoscopic)

Primary esophageal motility disorder (achalasia etc.)

Active erosive esophagitis

Trial design

Treatments tested in this trial

  • Per Oral Endoscopic Myotomy (POEM)

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Institute for Clinical and Experimental Medicine

Lead sponsor

St. Anne's University Hospital Brno, Czech Republic

Sponsor institution

University Hospital Trnava

Collaborator

St. Anne's University Hospital Brno, Czech Republic

Collaborator