Dysphagia in Oculopharyngeal Muscular Dystrophy (OPMD)- Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up

Phase 1

• Conditions: Dysphagia
• Interventions: Procedure: Upper esophageal sphincter myotomy

• Registration Number: NCT01167439
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

The investigators aimed to review the natural history of dysphagia and dysphonia in OPMD in order to identify the best candidates and the proper timing to perform dysphagia alleviating procedures in both heterozygote and homozygote patients from the large pool of cases with this disease in Israel.

Detailed Description

Clinical evaluation of patients suspected of having OPMD. Genetic confirmatory tests (diagnostic DNA test) at the genetic unit in Afula Hospital. Clinical follow-up with endoscopic fiber optic evaluation of swallowing. Pre-operative assessment. Crycopharyngeal myotomy intervention in selected patients. Nutrition follow-up.

Study Timeline

• Study Start: 2009-07
• Status Verified: 2009-12
• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-21
• Last Update Submitted: 2010-07-21
• Study First Posted: 2010-07-22
• Last Update Posted: 2010-07-22
• Primary Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• heterozygote and homozygote OPMD patients

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Severe dysphagia	Upper esophageal sphincter myotomy	-

Primary Outcome Measures

Name	Time	Method
Dysphagia, quality of life. Proper intervention timing in OPMD based on knowledge about the natural history of the feeding difficulty.	at least 3 years	Dysphagia, quality of life. Proper intervention timing in OPMD patients is very important and must be based on deep knowledge about the natural history of the feeding difficulty.

Trial Locations

Locations (1)

Israel National Center for OPMD and Dysphagia, HYMC; 🇮🇱 POB 169, Hadera, Israel