Peroral Endoscopic Myotomy in Hypercontractile Esophageal motility disorders

Not Applicable

Recruiting

• Conditions: Hypercontractile esophageal motility disorders; K22.0; Achalasia of cardia

• Registration Number: DRKS00007793
• Lead Sponsor: Medizinische Klinik II, HELIOS Klinikum Krefeld

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

All consecutive recruited achalsia typ III and symptomatic hypercontractile esophageal motility disorders (Chicago Classifikation) vor
Eckardt Score > 3
18 – 80 years
ASA class 1 and 2

Exclusion Criteria

Patients < 18 years
Patients without consent
Patients with coagulation disturbances (Quick<50%, Thromboytes < 50.000/ul)
pregnancy
previous surgery esophagus and/or stomach
Liver cirrhosis with/without esophageal varices
Eosinophilic esophagitis
Barretts esophagus
Esophageal strictures
Premalignant and/or malignant Esophageal disorders
Extremly dilated esophagus (> 6cm)
Achalasia Type I und II (Chicago Classifikation)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of symptoms of at least 90%, Eckardt score < 3. Symptom reduction is measured by standardized questionaires (SF-36, Eckardt score, visuell-analogue scales) 3 weeks, 6 and 12 month after POEM.<br>

Secondary Outcome Measures

Name	Time	Method
Reduction of hypercontractile esophageal motility disordera, DCI < 5000 mmHg-s-cm, <br>< 20% preliminary contractions, reduced DL < 4,5 Sekunden <br>Achalasia Typ III: IRP4 < 10 mmHg or resting pressure lower esophageal sphincter < 5 mmHg<br><br>These Parameters will be measured by gastrografin swallow, high resolution esophageal manometry and 24h-pH-metry-impedance measurement 3 weeks after POEM.