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Procedure

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

N/A
Waitlist Available
Led By Eric S Hungness, M.D.
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up inital pre-op surgical evaluation and one-year postoperative
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Achalasia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~inital pre-op surgical evaluation and one-year postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and inital pre-op surgical evaluation and one-year postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Eckardt symptom score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Per-Oral Endoscopic Esophagomyotomy
2010
N/A
~400

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,115 Total Patients Enrolled
1 Trials studying Achalasia
60 Patients Enrolled for Achalasia
Eric S Hungness, M.D.Principal InvestigatorNorthwestern University
1 Previous Clinical Trials
4 Total Patients Enrolled
~26 spots leftby Jan 2026