NCT02259283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
Last Updated

October 8, 2014

Status Verified

October 1, 2014

Enrollment Period

1.5 years

First QC Date

September 29, 2014

Last Update Submit

October 3, 2014

Conditions

Achalasia

Keywords

achalasiaper oral endoscopic myotoymyendoscopy

Outcome Measures

Primary Outcomes (2)

  • Feasibility

    Percentage of patients with successful POEM

    24 months

  • 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

Secondary Outcomes (5)

  • Quality of Life

    24 months

  • Adverse events

    24 months

  • Reflux disease

    24 months

  • Treatment failure

    24 months

  • Efficacy

    24 months

Study Arms (1)

Achalasia

EXPERIMENTAL

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

Interventions

Hybrid KnifeDEVICE

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

Achalasia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 75 years
  • Manometric diagnosis of achalasia
  • Eckardt score more than 3
  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

Related 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. doi: 10.1016/0016-5085(92)91428-7.

    PMID: 1451966BACKGROUND

  • 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.

    PMID: 20354937BACKGROUND

  • 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.

    PMID: 22982946BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Alessandro Repici, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Clinical research Project

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 8, 2014

Study Start

December 1, 2012

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

October 8, 2014

Record last verified: 2014-10

Locations

IT(1)