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

NCT ID: NCT02259283

Last Updated: 2014-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-09-30

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.

Conditions

Achalasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Achalasia

Patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will undergo POEM with the hybrid knife.

Group Type: EXPERIMENTAL

Hybrid Knife

Intervention Type: DEVICE

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

Interventions

Hybrid Knife

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Michele Tedeschi

Chief of Clinical research Project

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandro Repici, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, Italy

Countries

Italy

References

Eckardt VF, Aignherr C, Bernhard G. Predictors of outcome in patients with achalasia treated by pneumatic dilation. Gastroenterology. 1992 Dec;103(6):1732-8. doi: 10.1016/0016-5085(92)91428-7.

Reference Type: BACKGROUND

PMID: 1451966 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20354937 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22982946 (View on PubMed)

Other Identifiers

POEM-ICH

Identifier Type: -

Identifier Source: org_study_id