Clinical trial NCT01873300: Endoscopic Myotomy for the Treatment of Achalasia (Motility Disorder) of the Esophagus - POEM Procedure
Official title: Endoscopic Esophageal Myotomy for the Treatment of Achalasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Achalasia
Keywords: Achalasia
Dysphagia
Endoscopic
Myotomy
Heller
NOTES
POEM
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions (belly area cuts), by using an endoscope to create a small cut at the most inner layer of the esophagus to expose the esophageal sphincter muscle fibers from the inside of the esophagus. The investigators are studying whether subjects who undergo Endoscopic Esophageal Myotomy will have similar functional outcome, and at the same time less pain, scar formation and wound infection than with laparoscopic or open surgery.

Detailed description: The purpose of this research study is to find out more about a less invasive way of doing the surgical procedure (esophageal myotomy) to treat Achalasia.

Achalasia is a disease of the esophagus, where the lower esophageal sphincter fails to relax, causing difficulty in swallowing.

Esophageal myotomy (Heller myotomy) is surgically cutting the muscle fibers of the esophageal sphincter to allow passage of food into the stomach.

Esophageal myotomy is routinely done either by laparoscopic or open surgery. Laparoscopic surgery requires several (about 4 to 5) small incisions in the abdomen to allow the camera and surgical instruments to be introduced into the abdominal cavity to perform the myotomy. In open surgery, a 6- to 8-inch abdominal incision is made to gain access to the abdominal cavity to perform the myotomy.

Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions.

The researchers are investigating how safe Endoscopic Esophageal Myotomy is and how well it works. Additionally, the researchers will assess the level of pain and the amount of scarring subjects has after this surgery.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of achalasia
* Age 18-65
* ASA class 1-2

Exclusion Criteria:

* Pregnant women
* Any prior surgical or endoscopic treatment for achalasia except dilation less than 20 mm
* Patients who are taking immunosuppressive medications or are immunocompromised Patients on blood thinners or aspirin or with history of bleeding disorders
* ASA class III patients

Primary outcomes:
measure: Improvement of quality of life and dysphagia symptoms
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Masschusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David W Rattner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Masschusetts General Hospital / Harvard Medical School
name: Ozanan R Meireles, MD
role: STUDY_DIRECTOR
References:
citation: Inoue H, Kudo SE. [Per-oral endoscopic myotomy (POEM) for 43 consecutive cases of esophageal achalasia]. Nihon Rinsho. 2010 Sep;68(9):1749-52. Japanese.
citation: Inoue H, Tianle KM, Ikeda H, Hosoya T, Onimaru M, Yoshida A, Minami H, Kudo SE. Peroral endoscopic myotomy for esophageal achalasia: technique, indication, and outcomes. Thorac Surg Clin. 2011 Nov;21(4):519-25. doi: 10.1016/j.thorsurg.2011.08.005.
citation: von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.