Per-Oral Endoscopic Esophagomyotomy (POEM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Eric Hungness, Northwestern University
ClinicalTrials.gov Identifier:
NCT01635374
First received: April 10, 2012
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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 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

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.


Condition Intervention
Achalasia
Procedure: Per-Oral Endoscopic Esophagomyotomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Per-Oral Endoscopic Esophagomyotomy (POEM)

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in Eckardt symptom score [ Time Frame: inital pre-op surgical evaluation and one-year postoperative ] [ Designated as safety issue: No ]
    a brief 4 question survey will be filled out


Secondary Outcome Measures:
  • Number and frequency of intraoperative and postoperative complications [ Time Frame: day of operation to one-year postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: July 2010
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Per-Oral Endoscopic Esophagomyotomy
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
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.
Other Name: POEM

Detailed Description:

In this study, the investigators propose to use a surgical technique that eliminates skin incisions in patients undergoing esophagomyotomy. All patients will have a standard pre-operative esophageal 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 the diagnosis of achalasia is confirmed, patients will be offered POEM or standard treatment for achalasia. All patients undergoing POEM will review and sign the study consent prior to their procedure.

Operative and recovery room times as well as hospital length of stay will be collected. During the hospital stay, severity of pain, use of pain medications and complications will be recorded. Patients will remain NPO for 1 day. Post-op day 1, all patient will receive an esophagram to rule out esophageal perforation. If normal, patients will be started on clear liquids and advanced to a full liquid diet for 2 weeks post-op. All study patients will receive a call from a surgery clinic nurse on post-op day 4 and 7. The investigators will develop a check list that will contain the following (yes/no) elements to be used prior to discharge, on the post-op day 4 and 7 phone calls, and the 2 week post-op clinic visit: pain controlled with meds, nausea, emesis, fever, chills, shortness of breath, chest pain. If there are any "yes" responses to this checklist prior to discharge, the patient will not be discharged from the hospital. If there are any "yes" responses to this checklist at the post-op day 4 or 7 phone call, the patient will be advised to immediately come to the GI surgery clinic or go to the nearest emergency room. If there are any "yes" responses to this checklist at the 2 week clinic visit, the patient will undergo the necessary standard of care medical evaluation (labs, tests, etc.) and may be admitted to the hospital. These checklists will be reviewed by one of the investigators, collected and stored in a locked file cabinet.

Patients will return and be evaluated by their surgeon two weeks following their procedure. At this visit, any post-operative complications will be noted in the patient's medical record. Additionally at this visit and at the preoperative visit, patients will complete a standardized Quality of Life (QOL) assessment (i.e., SF-36). 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.

The potential advantages to the patients entered into this study include those mentioned above regarding elimination of post-operative wound infection and hernia but also the lack of abdominal incisions may reduce pain and recovery time and likely have a cosmetic advantage as well. Potential risks of this study include those associated with use of flexible endoscopic instruments include esophageal perforation, bleeding and sore throat. In addition, there is the possibility that there may be new, unanticipated complications from this modified surgical technique. Patient risks will be mitigated by having the procedure performed by a surgeon with expertise in laparoscopic esophageal surgery, flexible endoscopy and NOTES, as well as having involvement of a skilled interventional gastroenterologist if deemed necessary. The principle investigator (who will be the primary surgeon for all procedures) has performed multiple pre-clinical animal and cadaver POEM procedures and has traveled to Yokohama, Japan to observe human POEM cases performed by Dr. Haru Inoue.

This feasibility study will initially evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in 20 patients. Once a standardized technique is established and risks are shown to be low, a prospective comparative evaluation is planned to compare this modified technique to the standard laparoscopic approach.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Contraindicated for EGD
  • Pregnancy
  • Barrett esophagus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635374

Contacts
Contact: Eric S Hungness, M.D. 312-695-0641 ehungness@nmh.org

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Eric S Hungness, M.D.    312-695-0641    ehungness@nmh.org   
Contact: Nathaniel Soper, M.D.    312-926-4962    nsoper@nmh.org   
Principal Investigator: Eric S Hungness, M.D.         
Sub-Investigator: Nathaniel Soper, M.D.         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Eric S Hungness, M.D. Northwestern University
  More Information

No publications provided

Responsible Party: Eric Hungness, Assistant Professor of Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT01635374     History of Changes
Other Study ID Numbers: STU00030841
Study First Received: April 10, 2012
Last Updated: August 27, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 20, 2014