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POEM for Spastic Esophageal Disorders

Primary Purpose

Esophageal Achalasia

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

POEM

About this trial

This is an interventional treatment trial for Esophageal Achalasia focused on measuring POEM, Minimally invasive surgery, Achalasia, Spastic esophageal disorders

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Toronto General Hospital, University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Patients undergoing POEM for spastic esophageal disorders such as achalasia at the University Health Network, Toronto, Canada

Outcomes

Primary Outcome Measures

Effectiveness of intervention (Symptom severity relief according to pre- and post-operative quality of life questionnaire)

Secondary Outcome Measures

Surgical complications

Based on Clavien-Dindo classification of surgical complications

LES pressure (according to manometry)

Lower esophageal sphincter (LES) pressure according to manometry pre and post intervention

pH test (pH level in esophagus)

pre and post intervention

Diameter of the esophageal body

Change in diameter of the esophageal body according to upper endoscopy findings

Full Information

NCT ID

NCT02425033

First Posted

April 2, 2015

Last Updated

October 27, 2016

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT02425033

Brief Title

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

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Achalasia

Keywords

POEM, Minimally invasive surgery, Achalasia, Spastic esophageal disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Patients undergoing POEM for spastic esophageal disorders such as achalasia at the University Health Network, Toronto, Canada

Intervention Type

Procedure

Intervention Name(s)

POEM

Other Intervention Name(s)

Peroral endoscopic myotomy, Endoscopic myotomy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Effectiveness of intervention (Symptom severity relief according to pre- and post-operative quality of life questionnaire)

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Surgical complications

Description

Based on Clavien-Dindo classification of surgical complications

Time Frame

30 days

Title

LES pressure (according to manometry)

Description

Lower esophageal sphincter (LES) pressure according to manometry pre and post intervention

Time Frame

6 months

Title

pH test (pH level in esophagus)

Description

pre and post intervention

Time Frame

6 months

Title

Diameter of the esophageal body

Description

Change in diameter of the esophageal body according to upper endoscopy findings

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eran Shlomovitz, MD

Phone

416-340-3287

eran.shlomovitz@uhn.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Allan Okrainec, MD

Phone

416-603-5224

allan.okrainec@uhn.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eran Shlomovitz, MD

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toronto General Hospital, University Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eran Shlomovitz, MD

Phone

416-340-3287

eran.shlomovitz@uhn.ca

First Name & Middle Initial & Last Name & Degree

Eran Shlomovitz, MD

First Name & Middle Initial & Last Name & Degree

Allan Okrainec, MD

First Name & Middle Initial & Last Name & Degree

Gail Darling, MD

First Name & Middle Initial & Last Name & Degree

David Urbach, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Undecided

Citations:

PubMed Identifier

1417178

Citation

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.

Results Reference

result

PubMed Identifier

7358270

Citation

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.

Results Reference

result

PubMed Identifier

20354937

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.

Results Reference

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PubMed Identifier

17703382

Citation

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.

Results Reference

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PubMed Identifier

11789770

Citation

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.

Results Reference

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PubMed Identifier

23054897

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.

Results Reference

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PubMed Identifier

23581563

Citation

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.

Results Reference

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PubMed Identifier

24362953

Citation

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.

Results Reference

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PubMed Identifier

25324996

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.

Results Reference

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PubMed Identifier

25183406

Citation

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.

Results Reference

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PubMed Identifier

23665071

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.

Results Reference

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PubMed Identifier

25222714

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.

Results Reference

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PubMed Identifier

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Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

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Citation

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POEM for Spastic Esophageal Disorders

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