Cricopharyngeal peroral endoscopic myotomy for cricopharyngeal achalasia: a pilot study on feasibility, efficacy, and safety

Not Applicable

• Conditions: Pharyngeal dysphagia; Upper oesophageal sphincter dysfunction; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Surgery - Surgical techniques; Neurological - Other neurological disorders

• Registration Number: ACTRN12619000927123
• Lead Sponsor: The Chinese University of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-03
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) Known underlying neurological disorders that would result in upper oesophageal sphincter dysfunction, and
2) Self-reported pharyngeal dysphagia symptoms, and
3) Manometric evidence of upper oesophageal sphincter dysfunction

Exclusion Criteria

1. Oesophageal disorders known to cause dysphagia (e.g. achalasia cardia, peptic oesopahgeal stricture)
2. Known hypopharyngeal structural disorders (e.g. radiotherapy-induced stricture)
3. Unwilling or unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dysphagia symptoms measured by Swallow Quality-of-Life questionnaire (Swal-QOL) [1-month post-endoscopic myotomy]

Secondary Outcome Measures

Name	Time	Method
pper oesophageal sphincter distensibility measured by the endoluminal functional lumen imaging probe[distensibility is measure intra-procedurally immediately before and after per-oral endoscopic myotomy];Patients will be observed in the hospital for a minimum of 24 hours after the procedure for major procedure-related complications, including (but not exclusive of) 1) Lumen perforation; 2) Would infection; 3) Bleeding requiring transfusion and/or intervention. Following discharge, weekly phone calls and 1-month clinic follow-up will be conducted by investigators to monitor for delayed complications such as bleeding and symptoms of infection.[Up to 30-day from the procedure]