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

NCT06872255 | Not Yet Recruiting DMC

• 1 other identifier: VADYSMA
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

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.

Conditions

Dysphagia; Dysphagia, Esophageal; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Eckardt score

  At baseline and after 3, 6 and 12 months

• Mellow - Pinkas score

  At baseline and after 3, 6 and 12 months

• PAGI-QOL score (Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life)

  At baseline and after 3, 6 and 12 months

• GERD-RHQL score (Gastroesophageal Reflux Disease Health-related Quality of Life)

  At baseline and after 3, 6 and 12 months

• Integrated Relaxation Pressure (IRP)

  At baseline and after 6 months

Study Arms (1)

POEM arm

EXPERIMENTAL

Patients, who will undergo peroral endoscopic myotomy for postfundoplication dysphagia

Procedure: Per Oral Endoscopic Myotomy (POEM)

Interventions

Per Oral Endoscopic Myotomy (POEM) PROCEDURE

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.

POEM arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

St. Anne's University Hospital Brno, Czech Republic

Brno, 60200, Czechia

Location

University Hospital Trnava

Trnava, 91701, Slovakia

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Jan Martínek, prof., MD

CONTACT

+420 723 708 839; jan.martinek@fnusa.cz

Martin Vašátko, MD

CONTACT

+420 739 476 451; martin.vasatko@fnusa.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroenterology and hepatology department

Model Details: 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)

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 12, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 12, 2025

Record last verified: 2025-02

Locations

SL (1); CZ (1)