Clinical trial NCT06872255: Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia
Official title: A Prospective Pilot Trial of Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia (VADYSMA Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysphagia
Dysphagia, Esophageal
Healthy
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital Trnava
name: St. Anne's University Hospital Brno, Czech Republic
First posted: 2025-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with refractory (\> 6 months) and severe dysphagia after fundoplication procedure defined as an Eckardt score ≥3 and Mellow - Pinkas score ≥2 at baseline, with proven obstruction of gastroesofageal junction (EGJOO)
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

1. 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.
2. Refractory (\> 6 months) and severe dysphagia after fundoplication procedure defined as an Eckardt score ≥3 and Mellow - Pinkas score ≥2 at baseline.
3. 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
4. Endoluminal planimetry: EGJ-DI \< 3 mm2/mmHg (with 40ml)
5. Age above 18 years
6. Signed informed consent form

Exclusion Criteria:

1. No previous attempt with at least one prokinetic drug
2. Previous esophageal myotomy (open, laparoscopic or endoscopic)
3. Primary esophageal motility disorder (achalasia etc.)
4. Active erosive esophagitis
5. Active peptic ulcer disease
6. Esophageal stricture (peptic, malignant, other)
7. Partial or complete supradiaphragmatic migration of the wrap and/or stomach (Hinder Type III - IV), Large hiatal hernia more than 5 cm
8. Known eosinophilic esophagitis
9. Severe coagulopathy
10. Esophageal or gastric varices
11. Advanced liver cirrhosis (Child B or Child C)
12. Pregnancy or puerperium
13. Malignant or pre-malignant esophageal diseases (dysplasia): patients with a history of such disease after its cure are eligible for enrolment
14. Any other condition, which in the opinion of the investigator would interfere with study requirements
15. Known gastroparesis

Primary outcomes:
measure: Efficacy and safety of POEM in patients with postfundoplication dysfagia
timeFrame: 6 months
Secondary outcomes:
measure: Eckardt score
timeFrame: At baseline and after 3, 6 and 12 months
measure: Mellow - Pinkas score
timeFrame: At baseline and after 3, 6 and 12 months
measure: PAGI-QOL score (Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life)
timeFrame: At baseline and after 3, 6 and 12 months
measure: GERD-RHQL score (Gastroesophageal Reflux Disease Health-related Quality of Life)
timeFrame: At baseline and after 3, 6 and 12 months
measure: Integrated Relaxation Pressure (IRP)
timeFrame: At baseline and after 6 months
measure: Endoluminal planimetry (Endoflip)
timeFrame: At baseline and after 6 months
measure: Esophagogram
timeFrame: At baseline and after 6 months
measure: Eckardt score
timeFrame: At and after 3 and 12 months
measure: GERD
timeFrame: At baseline and after 3, 6 and 12 months
measure: Esophageal 24h-Hour pH metry
timeFrame: At 3 months after procedure
measure: PPI/H2 antagonists
timeFrame: At baseline and after 3, 6 and 12 months
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: St. Anne's University Hospital Brno, Czech Republic
city: Trnava
country: Slovakia
facility: University Hospital Trnava
Study officials:
References: