Prospective Study on the Feasibility and Results of POEM in Idiopathic Achalasia
Study Details
Study Description
Brief Summary
Treatment options for achalasia include endoscopic dilations and surgical myotomy. Recently the POEM (Per oral endoscopic myotoymy) technique has been described. Patients undergo myotomy under endoscopic control. It has advantage over endoscopic dilation since myotomy is performed, and has advantage over surgery because it is performed endoscopically, thus is less invasive. One potential disadvantage in respect to surgery may be that it may determine higher rates of post-operative reflux. The purpose of this study is to prospectively assess the feasibility of PEOM in our Center with the new hybrid knife, and clinical results at 1, 3 and 12 months.
This is a prospective, phase II study. Ten patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will be included for the POEM procedure.
This study will last about 2 years. The aim is the feasibility, security and success rate of POEM for achalasia. Patients will be followed for at least one year.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Achalasia Patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will undergo POEM with the hybrid knife. |
Device: Hybrid Knife
POEM (Per oral endoscopic myotoymy) technique performed with the hybrid knife which combines injection and cutting in the same device.
|
Outcome Measures
Primary Outcome Measures
- Feasibility [24 months]
Percentage of patients with successful POEM
- Clinical Success [24 months]
A reduction of 2 or more points in the Eckardt score, that determines a score of 3 or more in 24 months.
Secondary Outcome Measures
- Quality of Life [24 months]
Quality of life as measured by questionnaires (SF36 and l'EORTC QLQ-OES24) that will be administered to the patients at 3 and 12 months.
- Adverse events [24 months]
Post-operative adverse events (perforation, bleeding, infection, aspiration, etc)
- Reflux disease [24 months]
Reflux disase as diagnosed clinically (HRQL questionnarie) or by 24-hour pH-metry
- Treatment failure [24 months]
Percentages of patients in which other interventions for dysphagia are required after the first POEM.
- Efficacy [24 months]
Basal and post-treatment pressure of the lower esophageal sphincter, as measured by manometry and esophageal follow-through.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 to 75 years
-
Manometric diagnosis of achalasia
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Eckardt score more than 3
-
Informed consent
Exclusion Criteria:
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Increased surgical risk for important comorbidities,
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Pseudoachalasia
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Mega-esophagus (more than 7 cm) and or sigmoid esophagus,
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Previous esophageal or gastric surgery (with the exception of gastric perforation)
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Inability of completing the questionnarie
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Inability to keep a commitment for follow-up
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Esophageal diverticulum
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Endoscopy Unit, Humanitas Research Hospital | Rozzano | Milano | Italy | 20089 |
Sponsors and Collaborators
- Istituto Clinico Humanitas
Investigators
- Principal Investigator: Alessandro Repici, MD, Istituto Clinico Humanitas
Study Documents (Full-Text)
None provided.More Information
Publications
- Eckardt VF, Aignherr C, Bernhard G. Predictors of outcome in patients with achalasia treated by pneumatic dilation. Gastroenterology. 1992 Dec;103(6):1732-8.
- Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
- Swanstrom LL, Kurian A, Dunst CM, Sharata A, Bhayani N, Rieder E. Long-term outcomes of an endoscopic myotomy for achalasia: the POEM procedure. Ann Surg. 2012 Oct;256(4):659-67. doi: 10.1097/SLA.0b013e31826b5212.
- POEM-ICH