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Endoscopic Peroral Myotomy for Treatment of Achalasia (POEM)

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ClinicalTrials.gov Identifier: NCT01405469
Recruitment Status : Completed
First Posted : July 29, 2011
Results First Posted : December 2, 2014
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
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 or disease Intervention/treatment Phase
Achalasia Other: Peroral Endoscopic Myotomy Not Applicable

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 eckhardt symptom score 3 month after therapy.

Primary outcome:

-eckhardt 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, esophagal-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. An electric generator 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study
Study Start Date : November 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Peroral Endoscopic Myotomy
Patients with achalasia who are designed to either get balloon dilatation or have botulinum toxin 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. An electric generator 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



Primary Outcome Measures :
  1. Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3 [ Time Frame: 3 months after treatment ]
    eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. "with every meal" giving 3 points," daily" (2 points), "sometimes" (1 Point) or "no" (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms.


Secondary Outcome Measures :
  1. mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure [ Time Frame: manometry at 3 month after therapy ]
    esophageal manometry is done 3 months after POEM procedure to evaluate resting lower esophageal sphincter pressure

  2. Number of Participants With Reflux Symptoms [ Time Frame: during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment ]
    Number of Participants with Reflux Symptoms during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment

  3. Number of Participants With Procedure-related Adverse Events [ Time Frame: procedure to 3 months post procedure ]
    procedure-related adverse events per protocol

  4. Medication 3 Months After POEM [ Time Frame: 3 months ]
    proton pump inhibitor (PPI) use at 3 months after POEM procedure

  5. Duration Time Procedure [ Time Frame: procedure ]
    duration time of POEM procedures in minutes

  6. Days Duration Hospitalization [ Time Frame: days of hospitalization for POEM procedure, an average of 4 days ]
    participants were followed for the duration of hospital stay, an average of 4 days

  7. cm Myotomy Length [ Time Frame: POEM procedure ]
    myotomy length in cm

  8. Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment [ Time Frame: 3 months after treatment ]
    eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. "with every meal" giving 3 points," daily" (2 points), "sometimes" (1 Point) or "no" (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms. Post-myotomy eckhardt score ≤ 3 n individuals has been reached in 15 individuals.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagal-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01405469     History of Changes
Other Study ID Numbers: UKE Hamburg Endoscopy PV3725
First Posted: July 29, 2011    Key Record Dates
Results First Posted: December 2, 2014
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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