Per-Oral Endoscopic Esophagomyotomy (POEM)

NCT ID: NCT01635374

Last Updated: 2015-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-01-31

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.

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 1 week post-op.

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.

Conditions

Achalasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Per-Oral Endoscopic Esophagomyotomy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

POEM

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Eric Hungness

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric S Hungness, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00030841

Identifier Type: -

Identifier Source: org_study_id