Clinical trial NCT01405469: Endoscopic Peroral Myotomy for Treatment of Achalasia
Official title: Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achalasia
Keywords: Achalasia
Heller myotomy
Dysphagia
Peroral Endoscopic Myotomy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3
timeFrame: 3 months after treatment
Secondary outcomes:
measure: mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure
timeFrame: manometry at 3 month after therapy
measure: Number of Participants With Reflux Symptoms
timeFrame: during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment
measure: Number of Participants With Procedure-related Adverse Events
timeFrame: procedure to 3 months post procedure
measure: Medication 3 Months After POEM
timeFrame: 3 months
measure: Duration Time Procedure
timeFrame: procedure
measure: Days Duration Hospitalization
timeFrame: days of hospitalization for POEM procedure, an average of 4 days
measure: cm Myotomy Length
timeFrame: POEM procedure
measure: Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Thomas Roesch, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
citation: von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.