Endoscopic Peroral Myotomy for Treatment of Achalasia

Achalasia Clinical Trial

Official title:

Endoscopic Peroral Myotomy for Treatment of Achalasia: Multicenter Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01405417
• Other study ID #: UKE HH Endoscopy PV3725mc
• Status: Terminated
• Phase: N/A
• Start date: April 2011
• Est. completion date: September 2017

Study information

• Verified date: April 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center s

70 patients will be enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the Eckardt symptom score at 3 month after peroral endoscopic myotomy.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: September 2017
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

Procedure:
• Endoscopic Peroral Myotomy
Endoscopic peroral 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.

Locations

Country	Name	City	State
Canada	Clinic for Visceral- and Thoracic Surgery, McGill University Health Centre	Montreal	Quebec
Germany	Clinic for Visceral-, Vasular- and Thoracic Surgery, Markus-Krankenhaus	Frankfurt am Main
Germany	Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie	Hamburg
Netherlands	Department of Gastroenterology and Hepatology, Academic Medical Center	Amsterdam
Switzerland	Klinik für Gastroenterologie, USZ	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Countries where clinical trial is conducted

Canada,  Germany,  Netherlands,  Switzerland, 

References & Publications (5)

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. — View Citation

Von Renteln D, Fuchs KH, Fockens P, Bauerfeind P, Vassiliou MC, Werner YB, Fried G, Breithaupt W, Heinrich H, Bredenoord AJ, Kersten JF, Verlaan T, Trevisonno M, Rösch T. Peroral endoscopic myotomy for the treatment of achalasia: an international prospect — View Citation

von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rösch 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. — View Citation

Werner YB, Costamagna G, Swanström LL, von Renteln D, Familiari P, Sharata AM, Noder T, Schachschal G, Kersten JF, Rösch T. Clinical response to peroral endoscopic myotomy in patients with idiopathic achalasia at a minimum follow-up of 2 years. Gut. 2016 — View Citation

Werner YB, von Renteln D, Noder T, Schachschal G, Denzer UW, Groth S, Nast JF, Kersten JF, Petzoldt M, Adam G, Mann O, Repici A, Hassan C, Rösch T. Early adverse events of per-oral endoscopic myotomy. Gastrointest Endosc. 2017 Apr;85(4):708-718.e2. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eckhard symptom score at 3 month after peroral endoscopic myotomy	Validated symptom score based on dysphagia, pain, regurgitation and weight loss	Score is evaluated at 3 month after peroral endoscopic myotomy
Secondary	Lower esophageal sphincter pressure	Manometry study	Lower esophageal sphincter pressure is determined by manometry at 3 month after peroral endoscopic myotomy
Secondary	Reflux Symptoms	Symptoms as reported by the patient	Reflux Symptoms are evaluated at 3 month after peroral endoscopic myotomy

External Links

•   University Hospital Hamburg-Eppendorf, Endoscopy Department