Trial document




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  DRKS00007793

Trial Description

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Title

Peroral Endoscopic Myotomy in Hypercontractile Esophageal motility disorders

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Trial Acronym

POEM-HYPE

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URL of the Trial

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Brief Summary in Lay Language

Patients with symptomatic hypercontractile esophageal motility disorders may have chest pain, retrosternal pressure, dysphagia and/or regurgitation. Established treatment is often with limited effect (medication, balloon distension, botulinum toxin injection, laparocopic myotomy). Peroral endoscopic myotomy (POEM) of the esophageal circular muscle is an established therapy that could be also effective in hypercontractile esophageal motility disorders. This view is supported by studies indicating effectivness in achalasia (type III, Chicago classification) and case reports in hypercontractile esophageal motility disorders. However, systematic investigations are not available yet. In this prospective open study, patients with symptomatic hypercontractile esophageal motility disorders will be investigates systematically. The patients receive standardized questionaires about their symptoms and quality of life, upper GI endoscopy with esophageal biopsies, 24h-pH-metry-impedance measurement, gastrografin swallow and POEM. Treatment effectivity will be controlled by repeated questionairs and investigations 3 weeks after treatment and by repeated questionaires 6 an 12 month after treatment.

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Brief Summary in Scientific Language

Prospective, open, non randomized clinical study with upper GI endoscopy, biopsy, gastrografin-swallow, high resolution manometry, esophageal 24h-pH-metry-impedance measurement and peroral endoscopic myotomy (POEM) in patients with achalasia type III and hypercontractile esophageal motility disorders (esophageal spasm, hypercontractile esophagus)

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00007793
  •   2015/02/11
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  •   yes
  •   Approved
  •   14-359, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   K22.0 -  Achalasia of cardia
  •   Hypercontractile esophageal motility disorders
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Interventions/Observational Groups

  •   All consecutive patients with symptomatic achalasia type III and hypercontractile esophageal motility disorders (Chicago classification) receive standardized questionaires, upper GI endoscopy, biopsy, gastrografin-swallow, high resolution manometry, esophageal 24h-pH-metry-impedance measurement and peroral endoscopic myotomy (POEM)
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

Reduction of hypercontractile esophageal motility disordera, DCI < 5000 mmHg-s-cm,
< 20% preliminary contractions, reduced DL < 4,5 Sekunden
Achalasia Typ III: IRP4 < 10 mmHg or resting pressure lower esophageal sphincter < 5 mmHg

These Parameters will be measured by gastrografin swallow, high resolution esophageal manometry and 24h-pH-metry-impedance measurement 3 weeks after POEM.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/03/01
  •   70
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional 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

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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)

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Addresses

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    • Medizinische Klinik II, HELIOS Klinikum Krefeld
    • Mr.  Prof. Dr. med.  Thomas  Frieling 
    • Lutherplatz 40
    • 47805  Krefeld
    • Germany
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    • Klinik für Innere Medizin und GastroenterologieElisabeth-Krankenhaus
    • Ms.  Priv. Doz. Dr. med.  Brigitte  Schumacher 
    • Klara-Kopp-Weg 3
    • 45138  Essen
    • Germany
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    • Medizinische Klinik II, HELIOS Klinikum Krefeld
    • Mr.  Prof. Dr. med.  Thomas  Frieling 
    • Lutherplatz 40
    • 47805  Krefeld
    • Germany
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    • Medizinische Klinik II, HELIOS Klinikum Krefeld
    • Mr.  Prof. Dr. med.  Thomas  Frieling 
    • Lutherplatz 40
    • 47805  Krefeld
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Klinik II, HELIOS Klinikum Krefeld
    • Mr.  Prof. Dr. med.  Thomas  Frieling 
    • Lutherplatz 40
    • 47805  Krefeld
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.