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

Launched by INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called Per-oral Endoscopic Myotomy (POEM) for patients who experience severe swallowing difficulties (dysphagia) after having surgery for acid reflux called fundoplication. Fundoplication can sometimes lead to ongoing swallowing problems, which is frustrating for many patients. The researchers want to see if POEM can help these individuals improve their swallowing ability and overall quality of life.

To participate in this study, patients must be at least 18 years old and have had fundoplication surgery within the last 10 years. They should have severe swallowing issues that have lasted for more than six months, along with specific findings from their medical tests. Participants can expect to receive treatment using the POEM technique, which is a minimally invasive procedure, and they will be monitored closely throughout the study. This trial is important because it aims to provide a better solution for those who have not found relief from their swallowing difficulties after previous treatments.

Gender

ALL

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