Clinical trial NCT02425033: POEM for Spastic Esophageal Disorders
Official title: Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter in Patients With Spastic Esophageal Disorders Such as Achalasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Achalasia
Keywords: POEM
Minimally invasive surgery
Achalasia
Spastic esophageal disorders
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and safety of the Per-Oral Endoscopic Myotomy (POEM) technique for lower esophageal sphincter myotomy in patients suffering from spastic esophageal disorders such as achalasia at a Canadian institution.

The investigators hypothesize that POEM is a safe and effective technique for the surgical management of such disorders at our institution.

Detailed description: Standard surgical care for spastic esophageal disorders such as achalasia includes a procedure called Heller myotomy.

The treatment in our study, called endoscopic myotomy (also known as peroral endoscopic myotomy - POEM) is different from standard surgery (Heller myotomy) because it is less invasive, is less likely to cause reflux, and usually requires shorter operative times with less loss of blood during the surgery. Although POEM has been adopted worldwide and has proven to be successful, the experience in Canada is very limited to date.

Eligibility criteria: Inclusion Criteria:

* Symptomatic achalasia or similar spastic esophageal disorder and pre-op barium swallow, manometry, and esophagogastroduodenoscopy being consistent with the diagnosis
* Ability to undergo general anesthesia
* Age \> 18 yrs and \< 85 yrs. of age
* Ability to give informed consent
* Candidate for elective Heller myotomy

Exclusion Criteria:

* Contraindications for esophagogastroduodenoscopy
* Contraindications for elective Heller myotomy
* BMI \> 45
* Currently pregnant
* Refusing to participate in the study or without informed consent
* Concomitant participation in other clinical trial

Primary outcomes:
measure: Effectiveness of intervention (Symptom severity relief according to pre- and post-operative quality of life questionnaire)
timeFrame: 1 year
Secondary outcomes:
measure: Surgical complications
timeFrame: 30 days
measure: LES pressure (according to manometry)
timeFrame: 6 months
measure: pH test (pH level in esophagus)
timeFrame: 6 months
measure: Diameter of the esophageal body
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Eran Shlomovitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hungness ES, Teitelbaum EN, Santos BF, Arafat FO, Pandolfino JE, Kahrilas PJ, Soper NJ. Comparison of perioperative outcomes between peroral esophageal myotomy (POEM) and laparoscopic Heller myotomy. J Gastrointest Surg. 2013 Feb;17(2):228-35. doi: 10.1007/s11605-012-2030-3. Epub 2012 Sep 28.
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citation: Kumta NA, Mehta S, Kedia P, Weaver K, Sharaiha RZ, Fukami N, Minami H, Casas F, Gaidhane M, Lambroza A, Kahaleh M. Peroral endoscopic myotomy: establishing a new program. Clin Endosc. 2014 Sep;47(5):389-97. doi: 10.5946/ce.2014.47.5.389. Epub 2014 Sep 30.
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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, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study. Gastroenterology. 2013 Aug;145(2):309-11.e1-3. doi: 10.1053/j.gastro.2013.04.057. Epub 2013 May 9.
citation: Saleem AM, Hennessey H, von Renteln D, Vassiliou MC. Atrial fibrillation as an unexpected complication after peroral endoscopic myotomy (POEM): a case report. Surg Laparosc Endosc Percutan Tech. 2014 Oct;24(5):e196-9. doi: 10.1097/SLE.0000000000000094.
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