Trial record 5 of 52 for:    "Achalasia"

Endoscopic Peroral Myotomy for Treatment of Achalasia (POEM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01405469
First received: May 26, 2011
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.


Condition Intervention
Achalasia
Other: Peroral Endoscopic Myotomy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Successful symptom relief based after Peroral Endoscopic Myotomy. [ Time Frame: Eckhard score at 3 month after therapy ] [ Designated as safety issue: No ]
    Achalasia symptom score based on regurgitation, dysphagia, weight loss and pain


Secondary Outcome Measures:
  • Resting pressure of the lower esophageal sphincter [ Time Frame: Manometry at 3 month after therapy ] [ Designated as safety issue: No ]
    Manometry study (Resting pressure of the lower esophageal sphincter)

  • Reflux Symptoms [ Time Frame: Reflux symptoms at 3 month after therapy ] [ Designated as safety issue: No ]
    Reflux symptoms as reported by the patient


Enrollment: 16
Study Start Date: November 2010
Estimated Study Completion Date: November 2015
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peroral Endoscopic Myotomy
Patients with achalasia who are designed to either get balloon dilatation or have botulinum toxine injection, or to have surgical intervention (Heller myotomy)for treatment
Other: Peroral Endoscopic Myotomy
A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips

Detailed Description:

This pilot study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.

16 patients are enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the Eckhard symptom score 3 month after therapy.

Primary outcome:

-Eckhard symptom score 3 month after therapy.

Secondary outcomes:

  • Lower esophageal sphincter pressure at 3 month after therapy.
  • Reflux symptoms at 3 month after therapy.

For this prospective study, inclusion criteria are achalasia, as diagnosed by established methods (contrast fluoroscopy, manometry, esophago-gastro-duodenoscopy) and age greater than 18 years. Previous therapy, such as esophageal surgery or previous myotomy are exclusion criterion.

A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophago-gastro-duodenoscopy which are consistent with the diagnosis
  • persons of age > 18 years with medical indication for surgical myotomy or Endoscopic balloon dilatation
  • Signed written informed consent.

Exclusion criteria:

  • Patients with previous surgery of the stomach or esophagus
  • Patients with known coagulopathy
  • Previous achalasia-treatment with surgery
  • Patients with liver cirrhosis and/or esophageal varices
  • Active esophagitis
  • Eosinophilic esophagitis
  • Barrett's esophagus
  • Pregnancy
  • Stricture of the esophagus
  • Malignant or premalignant esophageal lesion
  • Candida esophagitis
  • Hiatal hernia > 2cm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405469

Locations
Germany
Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Thomas Roesch, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
  More Information

Additional Information:
Publications:
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01405469     History of Changes
Other Study ID Numbers: UKE Hamburg Endoscopy PV3725
Study First Received: May 26, 2011
Last Updated: November 2, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Achalasia
Heller myotomy
Dysphagia
Peroral Endoscopic Myotomy

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014