Per-Oral Endoscopic Esophagomyotomy (POEM)
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 2/7/2015 |
| Start Date: | July 2010 |
| End Date: | July 2017 |
| Contact: | Eric S Hungness, M.D. |
| Email: | ehungness@nmh.org |
| Phone: | 312-695-0641 |
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.
(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.
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.
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.
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
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