Prospective Study on the Feasibility and Results of POEM in Idiopathic Achalasia

Achalasia Clinical Trial

— POEM  

Official title:

Prospective Study on the Feasibility and Results of the Treatment of Idiopathic Achalasia With the POEM (Per Oral Endoscopic Myotomy) Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259283
• Other study ID #: POEM-ICH
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2014
• Last updated: October 3, 2014
• Start date: December 2012
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18 to 75 years

• Manometric diagnosis of achalasia

• Eckardt score more than 3

• Informed consent

Exclusion Criteria:

• Increased surgical risk for important comorbidities,

• Pseudoachalasia

• Mega-esophagus (more than 7 cm) and or sigmoid esophagus,

• Previous esophageal or gastric surgery (with the exception of gastric perforation)

• Inability of completing the questionnarie

• Inability to keep a commitment for follow-up

• Esophageal diverticulum

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

Device:
• Hybrid Knife
POEM (Per oral endoscopic myotoymy) technique performed with the hybrid knife which combines injection and cutting in the same device.

Locations

Country	Name	City	State
Italy	Endoscopy Unit, Humanitas Research Hospital	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Eckardt VF, Aignherr C, Bernhard G. Predictors of outcome in patients with achalasia treated by pneumatic dilation. Gastroenterology. 1992 Dec;103(6):1732-8. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Percentage of patients with successful POEM	24 months	Yes
Primary	Clinical Success	A reduction of 2 or more points in the Eckardt score, that determines a score of 3 or more in 24 months.	24 months	Yes
Secondary	Quality of Life	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.	24 months	No
Secondary	Adverse events	Post-operative adverse events (perforation, bleeding, infection, aspiration, etc)	24 months	Yes
Secondary	Reflux disease	Reflux disase as diagnosed clinically (HRQL questionnarie) or by 24-hour pH-metry	24 months	Yes
Secondary	Treatment failure	Percentages of patients in which other interventions for dysphagia are required after the first POEM.	24 months	Yes
Secondary	Efficacy	Basal and post-treatment pressure of the lower esophageal sphincter, as measured by manometry and esophageal follow-through.	24 months	No