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

NCT ID: NCT06872255

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-06-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

POEM arm

Patients, who will undergo peroral endoscopic myotomy for postfundoplication dysphagia

Group Type: EXPERIMENTAL

Per Oral Endoscopic Myotomy (POEM)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Trnava

NETWORK

Sponsor Role: collaborator

St. Anne's University Hospital Brno, Czech Republic

OTHER

Sponsor Role: collaborator

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Jan Martinek, MD, PhD, AGAF

Head of Gastroenterology and hepatology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St. Anne's University Hospital Brno, Czech Republic

Brno, , Czechia

University Hospital Trnava

Trnava, , Slovakia

Countries

Czechia; Slovakia

Central Contacts

Jan Martínek, prof., MD

Role: CONTACT

jan.martinek@fnusa.cz

+420 723 708 839

Martin Vašátko, MD

Role: CONTACT

martin.vasatko@fnusa.cz

+420 739 476 451

Facility Contacts

Martin Vašátko, MD

Role: primary

martin.vasatko@fnusa.cz

+420 739 476 451

Jan Martínek, prof., MD

Role: backup

jan.martinek@fnusa.cz

+420 723 708 839

Rastislav Husťak, MD

Role: primary

rhustak@gmail.com

+421 33/593 81 11

Ján Ušák, MD

Role: backup

jan.usak@gmail.com

+421 33/593 81 11

Other Identifiers

VADYSMA

Identifier Type: -

Identifier Source: org_study_id