Per-Oral Endoscopic Esophagomyotomy (POEM)
Completed · Not applicable
Conditions studied: Achalasia
In brief
Achalasia is an esophageal motility disease that usually requires surgical intervention (esophagomyotomy). Laparoscopic techniques have reduced the morbidity associated with myotomy, but post-op GERD, wound infection, hernia and incisional pain are common. A new NOTES based procedure, per-oral endoscopic esophagomyotomy (POEM), has been developed that eliminates the need for skin incisions. All patients enrolled in this study, will have a thorough pre-op workup (including upper endoscopy, upper GI radiographs, high resolution esophageal manometry) confirming the diagnosis of achalasis at the Northwestern Esophageal Center. In this procedure, performed in the operating room under general anesthesia, a flexible endoscope is passed into the esophagus, a mucosal flap and a submucosal tunnel is created. This tunnel extends onto the stomach. The inner circular muscle layer of the lower esophagus and sphincter (LES) is identified and a myotomy is started 3-4cm distal to the mucosal flap and carried all the way onto the stomach. The mucosal opening is then closed with standard endoscopic clips. Patients will be admitted to the hospital and a gastrograffin esophagram will be performed on post-op day 1 to rule out esophageal leak. All patient will have a 2-3 week post-op appointment Patients with a confirmed diagnosis of achalasia may be offered POEM. The investigators hypothesize that POEM is feasible and safe and can effectively reduce residual LES pressure (as determined by manometry) and improve patients symptoms and quality of life.
Key facts
- Study ID
- NCT01635374
- Run by
- Northwestern University
- People needed
- 400
- Starts
- 2010-07-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2015-01-06
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ability to undergo general anesthesia
- Age > 18 yrs. of age and < 85 yrs. of age
- Ability to give informed consent
- Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm
You may not qualify if…
- Contraindicated for EGD
- Pregnancy
- Barrett esophagus
Where it is running
- Northwestern University — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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