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Not yet recruiting NCT06872255

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

No phase Interventional Dysphagia Dysphagia, Esophageal Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Per Oral Endoscopic Myotomy (POEM).
Who it may be relevant to
Registry conditions: Dysphagia, Dysphagia, Esophageal, Healthy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia, Slovakia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Prospective Pilot Trial of Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia (VADYSMA Trial)

Overview

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.

Interventions

  • Procedure Per Oral Endoscopic Myotomy (POEM)
    All procedures will be performed by an experienced endoscopist, with a sufficient experience in "third space" endoscopy (at least 100 POEMs) under general anesthesia (internal preoperative examination is necessary) with a high-definition endoscope, fitted with a plastic distal attachment. Before the procedure, the patients will be administered intravenous antibiotics. Exclusively CO2 will be used for insufflation. POEM will be performed in a similar way as in patients with achalasia - the proced

Primary outcome measures

  • Efficacy and safety of POEM in patients with postfundoplication dysfagia [Time frame: 6 months]
Secondary outcome measures (11)
  • Eckardt score [Time frame: At baseline and after 3, 6 and 12 months]
  • Mellow - Pinkas score [Time frame: At baseline and after 3, 6 and 12 months]
  • PAGI-QOL score (Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life) [Time frame: At baseline and after 3, 6 and 12 months]
  • GERD-RHQL score (Gastroesophageal Reflux Disease Health-related Quality of Life) [Time frame: At baseline and after 3, 6 and 12 months]
  • Integrated Relaxation Pressure (IRP) [Time frame: At baseline and after 6 months]
  • Endoluminal planimetry (Endoflip) [Time frame: At baseline and after 6 months]
  • Esophagogram [Time frame: At baseline and after 6 months]
  • Eckardt score [Time frame: At and after 3 and 12 months]
  • GERD [Time frame: At baseline and after 3, 6 and 12 months]
  • Esophageal 24h-Hour pH metry [Time frame: At 3 months after procedure]
  • PPI/H2 antagonists [Time frame: At baseline and after 3, 6 and 12 months]

Eligibility criteria

Inclusion criteria

  • 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)
  • Age above 18 years
  • Signed informed consent form

Exclusion criteria

  • 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
  • Active peptic ulcer disease
  • Esophageal stricture (peptic, malignant, other)
  • Partial or complete supradiaphragmatic migration of the wrap and/or stomach (Hinder Type III - IV), Large hiatal hernia more than 5 cm
  • Known eosinophilic esophagitis
  • Severe coagulopathy
  • Esophageal or gastric varices
  • Advanced liver cirrhosis (Child B or Child C)
  • Pregnancy or puerperium
  • Malignant or pre-malignant esophageal diseases (dysplasia): patients with a history of such disease after its cure are eligible for enrolment
  • Any other condition, which in the opinion of the investigator would interfere with study requirements
  • Known gastroparesis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • St. Anne's University Hospital Brno, Czech Republic — Brno
Slovakia · 1 center
  • University Hospital Trnava — Trnava

Identifiers

NCT: NCT06872255 · VADYSMA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗