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

Hillel Yaffe Medical Center

Status and phase: Unknown; Phase 1

Conditions: Dysphagia

Treatments: Procedure: Upper esophageal sphincter myotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01167439

0027-09-HYMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• heterozygote and homozygote OPMD patients

Exclusion criteria

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Mild dysphagia

No Intervention group

Severe dysphagia

Active Comparator group

Treatment:

Procedure: Upper esophageal sphincter myotomy