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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Dysphagia; Dysphagia, Esophageal
• Intervention / Treatment: Procedure: Per Oral Endoscopic Myotomy (POEM)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Martínek, prof., MD; Phone Number: +420 723 708 839; Email: jan.martinek@fnusa.cz
• Study Contact Backup: Name: Martin Vašátko, MD; Phone Number: +420 739 476 451; Email: martin.vasatko@fnusa.cz

Study Locations

• Czech Republic
  • Brno, Czech Republic, 60200
    • St. Anne's University Hospital Brno, Czech Republic
    • Contact: Jan Martínek, prof., MD; Phone Number: +420 723 708 839; Email: jan.martinek@fnusa.cz
    • Contact: Martin Vašátko, MD; Phone Number: +420 739 476 451; Email: martin.vasatko@fnusa.cz
• Slovakia
  • Trnava, Slovakia, 91701
    • University Hospital Trnava
    • Contact: Rastislav Husťak, MD; Phone Number: +421 33/593 81 11; Email: rhustak@gmail.com
    • Contact: Ján Ušák, MD; Phone Number: +421 33/593 81 11; Email: jan.usak@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: POEM arm; Patients, who will undergo peroral endoscopic myotomy for postfundoplication dysphagia

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 procedure consists of 4 steps: (1) mucosal incision and tunnel entry, (2) submucosal tunneling, (3) myotomy, and (4) closure of the mucosal entry with endoscopic clips or other closure devices. Perioperative protocol might differ according the usual way of performing POEM in a given center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy and safety of POEM in patients with postfundoplication dysfagia	The primary outcome will be proportion of patients with treatment success defined as Eckardt score ≤ 2 and its decrease by at least 1 point after POEM at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eckardt score	The Eckardt score is the grading system used for the evaluation of severity of symptoms in patients with esophageal achalasia. Four symptoms are assessed (dysphagia, regurgitation, chest pain and weight loss) and their severity ranges from 0 (no symptom) to 3 (with every meal). Total score is their sum and ranges from 0 to 12	At baseline and after 3, 6 and 12 months
Mellow - Pinkas score	The Mellow - Pinkas score is used to assess dysphagia grade before and after the interventions. Total score ranges from 0 to 3 (0 = able to eat normal diet, 1 = able to swallow some solid foods, 2 = able to swallow only semi solid foods, 3 = able to swallow liquids only)	At baseline and after 3, 6 and 12 months
PAGI-QOL score (Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life)	The PAGI-QoL questionnaire contains of 30 items with five subscales: (1) daily activities; (2) clothing; (3) diet/food habits; (4) relationship; and (5) psychological well-being and distress. Each item is scored on a 6-point Likert scale, with response options ranging from 0 (none) to 5 (severe problem all of the time). Subscale scores are calculated by averaging the item responses. A total score is calculated by averaging subscale scores. Higher score means impairment in quality of life.	At baseline and after 3, 6 and 12 months
GERD-RHQL score (Gastroesophageal Reflux Disease Health-related Quality of Life)	The GERD-HRQL questionnaire was developed and validated to measure changes of typical GERD symptoms such as heartburn and regurgitation in response to surgical or medical treatment. Higher (greater) possible score means worst symptoms - ranging from 0 to 75.	At baseline and after 3, 6 and 12 months
Integrated Relaxation Pressure (IRP)	High resolution manometry - Median IRP recorded from 10 supine swallows, measured in mmHg. A value >15 mmHg indicates EGJ outflow obstruction.	At baseline and after 6 months
Endoluminal planimetry (Endoflip)	Pyloric distensibility measured by impedance planimetry (EndoFLIP device)	At baseline and after 6 months
Esophagogram	Esophagogram provides valuable information of the fundoplication, better appreciate a paraesophageal hernia and information on esophageal emptying. Patients will be advised overnight fasting prior to timed barium esophagogram. A contrast agent (e.g. barium, usually 100 to 250 mL) is ingested orally within 15-20 seconds. Left posterior oblique X-ray will be taken 2 and 5 minutes after contrast agent ingestion. Maximum esophageal width and column hights will be recorded at 2 and 5 minutes.	At baseline and after 6 months
Eckardt score	The Eckardt score is used to assess the severity of achalasia symptoms. It is based on the four main symptoms of achalasia: dysphagia, regurgitation, chest pain and weight loss. Each symptom has four levels of severity: none = 0 point, occasional = 1 point, daily = 2 points, each meal = 3 points. The sum of the points gives the final score. Final score scale: 0 (best) - 12 (worst). Treatment success is defined as a decrease of Eckardt score by at least 1 point and an overall Eckardt score ≤ 2.	At and after 3 and 12 months
GERD	Presence of reflux esophagitis based on endoscopy findings.	At baseline and after 3, 6 and 12 months
Esophageal 24h-Hour pH metry	An esophageal pH test measures how often stomach acid enters to the esophagus. It also measures how long the acid stays there. The test involves placing a catheter into the esophagus. The catheter or device will measure an acid level (known as pH level) for 24 hours. Post-POEM Esophageal acid exposure (DeMeester score, proportion of time with pH below 4)After	At 3 months after procedure
PPI/H2 antagonists	PPI's and/or H2 antagonists use before and after procedure (POEM).	At baseline and after 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Institute for Clinical and Experimental Medicine
• Collaborators: St. Anne's University Hospital Brno, Czech Republic; University Hospital Trnava

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders
• Other Study ID Numbers: VADYSMA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No