Per-Oral Endoscopic Esophagomyotomy (POEM)

NCT01635374 | Completed

• 1 other identifier: STU00030841
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Achalasia

Outcome Measures

Primary Outcomes (1)

• Change in Eckardt symptom score

  a brief 4 question survey will be filled out

  inital pre-op surgical evaluation and one-year postoperative

Secondary Outcomes (1)

• Number and frequency of intraoperative and postoperative complications

  day of operation to one-year postoperative

Study Arms (1)

Per-Oral Endoscopic Esophagomyotomy

EXPERIMENTAL

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.

Procedure: Per-Oral Endoscopic Esophagomyotomy

Interventions

Per-Oral Endoscopic Esophagomyotomy PROCEDURE

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 2 to rule out esophageal leak. A standardized symptom checklist will be used to assess patient's prior to hospital discharge and on post-op days 4 and 7. All patient will have a 2 week post-op appointment.

Also known as: POEM

Per-Oral Endoscopic Esophagomyotomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Eric S Hungness, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: July 9, 2012
• Study Start: July 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: January 1, 2014
• Last Updated: January 6, 2015

Record last verified: 2015-01

Locations

US (1)