Endolumenal Partial Myotomy for Esophageal Motility Disorders

NCT ID: NCT01302301

Last Updated: 2011-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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Achalasia and esophageal spasm are primary esophageal motility disorders where the lower esophageal sphincter fails to relax in response to swallowing with no well understood underlying cause. Surgical myotomy represents an appropriate therapeutic option. The purpose of this study is to evaluate flexible endoscopic myotomy a novel therapeutic approach to overcome the need for invasive surgery.

Detailed Description

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In this study, the investigators propose the use of a recent endolumenal technique for partial myotomy in patients suffering from primary esophageal motility disorders.

Under general anesthesia patients will have upper endoscopy. Submucosal injection and mucosal incision is created for entry into the submucosal space. A submucosal tunnel is then created using a needle knife or blunt dissection as appropriate. Dissection will continue distally beyond the lower esophageal sphincter. The inner circular muscle fibers will then be divided to achieve an adequate myotomy length. The mucosal entry is then closed appropriately.

Results will be compared to historical data of conventional Heller myotomies.

Conditions

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Esophageal Motility Disorders

Keywords

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endolumenal myotomy, per oral endoscopic myotomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Per oral endolumenal myotomy

flexible endoscopic submucosal esophageal partial myotomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Candidate for elective Heller myotomy
* Ability to undergo general anesthesia
* Ability to give informed consent

Exclusion Criteria

* Previous mediastinal or esophageal surgery
* Contraindications for EGD
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Oregon Clinic

OTHER

Sponsor Role lead

Responsible Party

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The Oregon Clinic

Locations

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Providence Portland Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lee L Swanstrom, MD

Role: CONTACT

Phone: 503 281 0561

Email: [email protected]

Facility Contacts

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Lee L Swanstrom, MD

Role: primary

References

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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)

Other Identifiers

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PROV10-117A

Identifier Type: -

Identifier Source: org_study_id