Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2015-04-30
2018-12-31
Brief Summary
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The investigators hypothesize that POEM is a safe and effective technique for the surgical management of such disorders at our institution.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
Patients undergoing POEM for spastic esophageal disorders such as achalasia at the University Health Network, Toronto, Canada
POEM
Under general anesthesia, patient undergoes upper endoscopy and a small longitudinal submucosal incision is created and a dilating balloon is inserted submucosally via the created incision. The balloon is slightly inflated to allow entrance of the endoscope. The gastroscope is advanced into the submucosal space and the tunnel is created via endoscopic or blunt dissection as appropriate. The tunnel is created distally and is stopped several centimeters beyond the lower esophageal sphincter (LES), which can easily be identified using endoscopic landmarks. Using a dissection knife, the clearly visible circular muscles are divided. The longitudinal layer is left intact and the mucosal entry is closed.
Interventions
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POEM
Under general anesthesia, patient undergoes upper endoscopy and a small longitudinal submucosal incision is created and a dilating balloon is inserted submucosally via the created incision. The balloon is slightly inflated to allow entrance of the endoscope. The gastroscope is advanced into the submucosal space and the tunnel is created via endoscopic or blunt dissection as appropriate. The tunnel is created distally and is stopped several centimeters beyond the lower esophageal sphincter (LES), which can easily be identified using endoscopic landmarks. Using a dissection knife, the clearly visible circular muscles are divided. The longitudinal layer is left intact and the mucosal entry is closed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 elective Heller myotomy
* BMI \> 45
* Currently pregnant
* Refusing to participate in the study or without informed consent
* Concomitant participation in other clinical trial
18 Years
85 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Eran Shlomovitz, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Toronto General Hospital, University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Eran Shlomovitz, MD
Role: primary
References
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Pellegrini C, Wetter LA, Patti M, Leichter R, Mussan G, Mori T, Bernstein G, Way L. Thoracoscopic esophagomyotomy. Initial experience with a new approach for the treatment of achalasia. Ann Surg. 1992 Sep;216(3):291-6; discussion 296-9. doi: 10.1097/00000658-199209000-00008.
Ortega JA, Madureri V, Perez L. Endoscopic myotomy in the treatment of achalasia. Gastrointest Endosc. 1980 Feb;26(1):8-10. doi: 10.1016/s0016-5107(80)73249-2.
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.
Pasricha PJ, Hawari R, Ahmed I, Chen J, Cotton PB, Hawes RH, Kalloo AN, Kantsevoy SV, Gostout CJ. Submucosal endoscopic esophageal myotomy: a novel experimental approach for the treatment of achalasia. Endoscopy. 2007 Sep;39(9):761-4. doi: 10.1055/s-2007-966764.
Luketich JD, Fernando HC, Christie NA, Buenaventura PO, Keenan RJ, Ikramuddin S, Schauer PR. Outcomes after minimally invasive esophagomyotomy. Ann Thorac Surg. 2001 Dec;72(6):1909-12; discussion 1912-3. doi: 10.1016/s0003-4975(01)03127-7.
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.
Minami H, Isomoto H, Yamaguchi N, Matsushima K, Akazawa Y, Ohnita K, Takeshima F, Inoue H, Nakao K. Peroral endoscopic myotomy for esophageal achalasia: clinical impact of 28 cases. Dig Endosc. 2014 Jan;26(1):43-51. doi: 10.1111/den.12086. Epub 2013 Apr 14.
Pescarus R, Shlomovitz E, Swanstrom LL. Per-oral endoscopic myotomy (POEM) for esophageal achalasia. Curr Gastroenterol Rep. 2014 Jan;16(1):369. doi: 10.1007/s11894-013-0369-6.
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.
Sharata AM, Dunst CM, Pescarus R, Shlomovitz E, Wille AJ, Reavis KM, Swanstrom LL. Peroral endoscopic myotomy (POEM) for esophageal primary motility disorders: analysis of 100 consecutive patients. J Gastrointest Surg. 2015 Jan;19(1):161-70; discussion 170. doi: 10.1007/s11605-014-2610-5. Epub 2014 Sep 3.
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.
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.
Yang D, Wagh MS. Peroral endoscopic myotomy for the treatment of achalasia: an analysis. Diagn Ther Endosc. 2013;2013:389596. doi: 10.1155/2013/389596. Epub 2013 Oct 27.
Ren Z, Zhong Y, Zhou P, Xu M, Cai M, Li L, Shi Q, Yao L. Perioperative management and treatment for complications during and after peroral endoscopic myotomy (POEM) for esophageal achalasia (EA) (data from 119 cases). Surg Endosc. 2012 Nov;26(11):3267-72. doi: 10.1007/s00464-012-2336-y. Epub 2012 May 19.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
Other Identifiers
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14-8327
Identifier Type: -
Identifier Source: org_study_id