Recruiting

POEM

Sponsor:

University Health Network, Toronto

Code:

NCT02425033

Conditions

Esophageal Achalasia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

POEM

Study Details

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.

Conditions

Esophageal Achalasia

Study ID

NCT02425033

Start date

Apr, 2015

Status verified date

Oct, 2016

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

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

Interventions

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.

Primary outcome measure

  • Effectiveness of intervention (Symptom severity relief according to pre- and post-operative quality of life questionnaire) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Eran Shlomovitz, MD

416-340-3287eran.shlomovitz@uhn.ca

Allan Okrainec, MD

416-603-5224allan.okrainec@uhn.ca

Locations

Toronto General Hospital, University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Eran Shlomovitz, MD

416-340-3287eran.shlomovitz@uhn.ca

Principal Investigator:

Eran Shlomovitz, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Oct 31, 2016

Last verified

Oct, 2016

Keywords

  • POEM
  • Minimally invasive surgery
  • Achalasia
  • Spastic esophageal disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2016-10-31.