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Completed

NCT Number: NCT01405469

Endoscopic Peroral Myotomy for Treatment of Achalasia

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.

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Key information

Conditions

Achalasia Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peroral Endoscopic Myotomy

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study

Acronym: POEM

Important dates

Study start
2010
Primary completion
2011
Study completion
2016
First posted
Jul 29, 2011
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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