Overview

This trial is active, not recruiting.

Condition achalasia
Treatment peroral endoscopic myotomy
Sponsor Universitätsklinikum Hamburg-Eppendorf
Start date November 2010
End date June 2011
Trial size 16 participants
Trial identifier NCT01405469, UKE Hamburg Endoscopy PV3725

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
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 Outcomes

Measure
Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3
time frame: 3 months after treatment

Secondary Outcomes

Measure
Pressure of the Lower Esophageal Sphincter 3 Months After POEM Procedure
time frame: manometry at 3 month after therapy
Reflux Symptoms
time frame: during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment
Procedure-related Adverse Events
time frame: procedure to 3 months post procedure
Medication 3 Months After POEM
time frame: 3 months
Duration Time Procedure
time frame: procedure
Duration Hospitalization
time frame: hospitalization for POEM procedure
Myotomy Length
time frame: POEM procedure
Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment
time frame: 3 months after treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study
Principal investigator Thomas Roesch, Prof. Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf.