Per-Oral Endoscopic Esophagomyotomy (POEM)
(POEM Trial)

Recruiting in Palo Alto (17 mi)

Overseen byEric S Hungness, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eric S Hungness, M.D.

Principal Investigator

Northwestern University

Eligibility Criteria

Inclusion Criteria

Age > 18 yrs. of age and < 85 yrs. of age

Ability to undergo general anesthesia

Ability to give informed consent

See 1 more

Treatment Details

Interventions

Per-Oral Endoscopic Esophagomyotomy (Procedure)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Per-Oral Endoscopic EsophagomyotomyExperimental Treatment1 Intervention

Patients will have a standard pre-operative work-up that may include upper endoscopy (EGD), endoscopic ultrasound (EUS), upper GI X-rays, high-resolution manometry, pH, FLIP and impedance measurement studies. Once a diagnosis of esophageal motility disorder is confirmed, patients will be offered POEM or standard treatment. Patients undergoing POEM will review and sign the study consent prior to their procedure. Patients will return and be evaluated two weeks following their procedure. At this visit, any post-operative complications will be noted in the patient's medical record. Also, at this visit and at the preoperative visit, patients will complete a standardized Quality of Life assessment. Perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record. Patients will then return at 6 weeks post-op to complete a second set of questionnaires and have a high resolution manometry performed to assess residual LES pressure.