None listed
Conditions
Brief summary
The purpose of this study is to assess the safety and efficacy of an endoscopic procedure called “POEM” (Per Oral Endoscopic Myotomy). The POEM procedure is a novel endoscopic treatment used for motility disorders of the oesophagus. POEM is a minimally-invasive endoscopic therapy with similar clinical responses to current surgical treatments, and shown to have shorter recovery time and less post-operative pain. Who is it for? You may be eligible for this study if you are 18 years or older and have been diagnosed with the oesophageal motility disorder “Achalasia”. Study Details All participants will undergo the POEM procedure; performed with deep sedation administered by an anaesthetist (you are not likely to feel the entire process). The procedure itself involves an endoscope entering through your mouth into the oesophagus, and then a special tiny knife in the endoscope is used to cut away specific muscle fibers in the oesophagus. When this is done the endoscope will come back up through the mouth. You will be asked to return to the Gastroenterology clinic at 3 months, 6 months, 12 months, and 24 months following your procedure for follow-up visits. Because POEM has not been formally assessed in South Australia, we are interested to see how well this procedure compares to the current established treatments. We hope this research will help provide information on the safety and usefulness of POEM as a potential replacement for current treatments options for achalasia and other motility disorders of the oesophagus.
Interventions
The per oral endoscopic myotomy (POEM) procedure involves 4 major steps:
1) Mucosal incision and entry into the submucosal space;
The endoscope enters through the mouth into the oesophagus. A small incision will be made into the oesophagus wall lining, so the endoscope will enter the submucosal space.
2) Creation of submucosal tunnel;
A special knife will be used to tunnel a new pathway within the submucosal layer, to reach the underlying muscle fibres.
3) Myotomy or cutting the circular musc
The per oral endoscopic myotomy (POEM) procedure involves 4 major steps: 1) Mucosal incision and entry into the submucosal space; The endoscope enters through the mouth into the oesophagus. A small incision will be made into the oesophagus wall lining, so the endoscope will enter the submucosal space. 2) Creation of submucosal tunnel; A special knife will be used to tunnel a new pathway within the submucosal layer, to reach the underlying muscle fibres. 3) Myotomy or cutting the circular muscle fibres; A special knife will be used to partially remove and loosen muscles from the sides of the oesophagus, lower oesophageal sphincter, and upper part of the stomach. 4) Closure of the mucosal defects with clips; Special endoscopic clips will be used to close of the incision lining of the oesophagus, and the endoscopic tube will be removed by coming back up through the mouth. The investigator/endoscopist will be administering the POEM procedure. Clinical observation during and after the procedure will be used to monitor fidelity to the intervention (clinical observation and medical notes prior to the procedure will be taken into account). POEM procedure was first introduced in 2008 for the treatment of achalasia and has become an established endoscopic procedure that utilizes the submucosal space to perform myotomy for the treatment of achalasia. This procedure requires anaesthesia support with airway intubation, and can be performed in an endoscopy unit. This procedure is similar to other endoscopic procedures and does not require a sterile environment such as in theatre. The procedure will take up to approximately 1 - 1.5 hours to complete.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
American Society of Anaesthesiologists (ASA) III or less. Confirmed diagnosis of achalasia on high resolution manometry. Not on anticoagulant or antiplatelet.
Exclusion criteria
American Society of Anaesthesiologists (ASA) IV On uninterrupted anticoagulation or antiplatelet medication Patient with pseudoachalasia from cardiac cancer
Outcome results
None listed