Peroral Endoscopic Myotomy (POEM) for Esophageal Motility
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/21/2018 |
| Start Date: | May 2014 |
| End Date: | May 2015 |
Peroral Endoscopic Myotomy (POEM) for Esophageal Motility in Patients With a Clinical Diagnosis of Achalasia
The investigators wish to monitor the adoption of a new, incisionless approach to performing
a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic
Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally
providing similar if not better outcomes (safety and efficacy) as the Heller myotomy. The
investigators hope to enroll 10 patients with a clinical diagnosis of achalasia who meet
inclusion criteria.
The POEM procedure has been done in many hospitals without any research associated with it.
Dr. Ginsberg, Dr. Chandrasekhara and Dr. Kochman will perform the procedures after being
trained. Dr. Ginsberg has personally witnessed the performance of 10 POEM procedures and has
performed in a swine model. The PI is credentialed to initiate POEM at HUP with the first
case to be proctored by an experienced operator. The PI will then proctor the other adopters.
The investigators would like to evaluate the safety of it and the effectiveness of it. The
investigators will use their symptom scores and radiology tests pre- and post-POEM to
evaluate effectiveness.
a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic
Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally
providing similar if not better outcomes (safety and efficacy) as the Heller myotomy. The
investigators hope to enroll 10 patients with a clinical diagnosis of achalasia who meet
inclusion criteria.
The POEM procedure has been done in many hospitals without any research associated with it.
Dr. Ginsberg, Dr. Chandrasekhara and Dr. Kochman will perform the procedures after being
trained. Dr. Ginsberg has personally witnessed the performance of 10 POEM procedures and has
performed in a swine model. The PI is credentialed to initiate POEM at HUP with the first
case to be proctored by an experienced operator. The PI will then proctor the other adopters.
The investigators would like to evaluate the safety of it and the effectiveness of it. The
investigators will use their symptom scores and radiology tests pre- and post-POEM to
evaluate effectiveness.
An esophageal motility disorder is when muscular contractions become discoordinated or weak
and interfere with movement of food down the esophagus. Some esophageal motility disorders
persist long enough to cause severe problems requiring surgical intervention. Achalasia, one
subtype of esophageal motility disorder that is a rare disease, can be defined by the
esophageal sphincter and muscle unable to relax or dilate. Left untreated, symptoms such as
difficulty swallowing, regurgitation, heartburn, and chest pain may easily turn into
complications such as severe weight loss, malnutrition, coughing, pulmonary infection,
pneumonia, and perforation of the esophagus. Diagnosis of esophageal achalasia can be
determined by esophageal manometry and/or barium swallow esophagram. Treatment for achalasia
includes balloon dilation, botulinum toxin injection and surgical intervention. Balloon
dilation is performed by inserting a balloon through the esophageal sphincter, inflating the
balloon, disrupting the esophageal muscle. Botox has also been known to successfully relax
spastic muscle contractions of achalasia through direct injection into the esophageal muscle.
Unfortunately, each alternative to surgical treatment often requires repeated administration
to improve the symptoms of achalasia. Traditional treatment of achalasia has included open
abdominal or thoracic surgical procedures to cut valve muscles between the esophagus and
stomach (Heller Myotomy). Laparoscopic multi-port Heller myotomies have become the preferred
approach, requiring 4 smaller abdominal incisions for placement of laparoscope equipment.
Results of this laparoscopic technique have proven that although 2/3 of the patient
population was successfully treated, a subset of this group still need repeat surgical
procedures or balloon dilation. Recently, single-incision laparoscopic Heller myotomies have
produced favorable results, with a single umbilical incision preferential to
multiple-incision laparoscopy. We propose adoption of a new, incisionless approach to
performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral
Endoscopic Myotomy (POEM) is expected to provide a less-invasive treatment for esophageal
achalasia, ideally providing similar if not better outcomes as the Heller myotomy and can be
adopted safely and effectively at Penn Medicine.
and interfere with movement of food down the esophagus. Some esophageal motility disorders
persist long enough to cause severe problems requiring surgical intervention. Achalasia, one
subtype of esophageal motility disorder that is a rare disease, can be defined by the
esophageal sphincter and muscle unable to relax or dilate. Left untreated, symptoms such as
difficulty swallowing, regurgitation, heartburn, and chest pain may easily turn into
complications such as severe weight loss, malnutrition, coughing, pulmonary infection,
pneumonia, and perforation of the esophagus. Diagnosis of esophageal achalasia can be
determined by esophageal manometry and/or barium swallow esophagram. Treatment for achalasia
includes balloon dilation, botulinum toxin injection and surgical intervention. Balloon
dilation is performed by inserting a balloon through the esophageal sphincter, inflating the
balloon, disrupting the esophageal muscle. Botox has also been known to successfully relax
spastic muscle contractions of achalasia through direct injection into the esophageal muscle.
Unfortunately, each alternative to surgical treatment often requires repeated administration
to improve the symptoms of achalasia. Traditional treatment of achalasia has included open
abdominal or thoracic surgical procedures to cut valve muscles between the esophagus and
stomach (Heller Myotomy). Laparoscopic multi-port Heller myotomies have become the preferred
approach, requiring 4 smaller abdominal incisions for placement of laparoscope equipment.
Results of this laparoscopic technique have proven that although 2/3 of the patient
population was successfully treated, a subset of this group still need repeat surgical
procedures or balloon dilation. Recently, single-incision laparoscopic Heller myotomies have
produced favorable results, with a single umbilical incision preferential to
multiple-incision laparoscopy. We propose adoption of a new, incisionless approach to
performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral
Endoscopic Myotomy (POEM) is expected to provide a less-invasive treatment for esophageal
achalasia, ideally providing similar if not better outcomes as the Heller myotomy and can be
adopted safely and effectively at Penn Medicine.
Inclusion Criteria:
- Age > or = to 18 years of age
- Clinical diagnosis of achalasia
- A candidate for Heller myotomy
- Esophageal manometry and barium esophogram with findings supportive of achalasia
diagnosis
- Women of childbearing potential: negative urine pregnancy test
- Able to undergo general anesthesia
- Willing and able to give informed consent
Exclusion Criteria:
- < 18 years of age
- Pregnancy
- Previous mediastinal or esophageal surgery
- Contraindications for esophagogastroduodenoscopy
- Presence of malignancy
- Coagulopathy (INR 1.5)
- Thrombocytopenia (platelet count < 100K/microliter)
- ASA Score > Class II
- History of mental illness
- Any medical conditions as determined by the PI to be a contraindication to the
procedure
- Unable to give informed consent
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