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ClinicalTrials.gov ID

NCT06872255

Lead Sponsor

Institute for Clinical and Experimental MedicineOTHER_GOV

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

30Estimated

Last Update Posted

Mar 12, 2025Actual

Start Date

Apr 1, 2025Estimated

Primary Completion Date

Jun 1, 2027Estimated

Completion Date

Jun 1, 2027Estimated

Official Title

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

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.

• Dysphagia
• Dysphagia, Esophageal
• Healthy

• Per Oral Endoscopic Myotomy (POEM)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Institute for Clinical and Experimental MedicineOTHER_GOV

Collaborators

University Hospital TrnavaNETWORK

St. Anne's University Hospital Brno, Czech RepublicOTHER

rhustak@gmail.com+421 33/593 81 11