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

Not Applicable

Not yet recruiting

• Conditions: Dysphagia; Dysphagia, Esophageal; Healthy

• Registration Number: NCT06872255
• Lead Sponsor: Institute for Clinical and Experimental Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12
• Study Start: 2025-04-01
• Primary Completion: 2027-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy and safety of POEM in patients with postfundoplication dysfagia	6 months	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

Secondary Outcome Measures

Name	Time	Method
Eckardt score	At and after 3 and 12 months	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.
Mellow - Pinkas score	At baseline and after 3, 6 and 12 months	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)
PAGI-QOL score (Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life)	At baseline and after 3, 6 and 12 months	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.
GERD-RHQL score (Gastroesophageal Reflux Disease Health-related Quality of Life)	At baseline and after 3, 6 and 12 months	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.
Integrated Relaxation Pressure (IRP)	At baseline and after 6 months	High resolution manometry - Median IRP recorded from 10 supine swallows, measured in mmHg. A value \>15 mmHg indicates EGJ outflow obstruction.
Endoluminal planimetry (Endoflip)	At baseline and after 6 months	Pyloric distensibility measured by impedance planimetry (EndoFLIP device)
Esophagogram	At baseline and after 6 months	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.
GERD	At baseline and after 3, 6 and 12 months	Presence of reflux esophagitis based on endoscopy findings.
Esophageal 24h-Hour pH metry	At 3 months after procedure	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
PPI/H2 antagonists	At baseline and after 3, 6 and 12 months	PPI's and/or H2 antagonists use before and after procedure (POEM).

Trial Locations

Locations (2)

St. Anne's University Hospital Brno, Czech Republic; 🇨🇿 Brno, Czech Republic

University Hospital Trnava; 🇸🇰 Trnava, Slovakia