None listed
Conditions
Brief summary
Cricopharyngeal (CP) achalasia is a motility disorder where the upper oesophageal sphincter does not relax completely to allow passage of swallowed food and water from the pharynx into the oesophagus. It is associated with several neurological disorders including Parkinson's Disease, Lateral Medullary Stroke, and brain stem tumour. Patients with this condition suffer from troublesome swallowing, often resulting in both reduced quality of life and increase risk for malnourishment and chest infection. Conventional treatment (cricopharyngeal myotomy) is a morbid open surgery that carries significant risk, thus often not offered to patients. Per-oral endoscopic myotomy (POEM) is a minimally invasive endoscopic technique initially designed to treat lower oesophageal sphincter dysfunction (achalasia cardia). This technique has potentially to be adapted in the treatment of CP achalasia while mimimising the risk associated with conventional open surgery.. In this pilot study, we aim to gather preiliminary clinical efficacy and safety of cricopharyngeal POEM in the treatment of swallowing difficulties related to upper oesophageal sphincter dysfunction.
Interventions
Dysphagic patients with manometric evidence of inadequate upper oesophageal sphincter relaxation will undergo cricopharyngeal per-oral endoscopic myotomy (C-POEM). C-POEM is a minimally invasive endoscopic technique designed to perform oesophageal sphincterotomy; its safety and efficacy are well-established in the treatment of achalasia cardia. C-POEM is performed under general anaesthesia, and the anticipated average duration of the procedure will be 60 minutes. Clinical efficacy is objectively
Dysphagic patients with manometric evidence of inadequate upper oesophageal sphincter relaxation will undergo cricopharyngeal per-oral endoscopic myotomy (C-POEM). C-POEM is a minimally invasive endoscopic technique designed to perform oesophageal sphincterotomy; its safety and efficacy are well-established in the treatment of achalasia cardia. C-POEM is performed under general anaesthesia, and the anticipated average duration of the procedure will be 60 minutes. Clinical efficacy is objectively determined by 1) patient-reported outcome - dysphagia questionnaire; 2) intra-procedural upper oesophageal sphincter distensibility measurement; and 3) upper oesophageal sphincter relaxation pressure by high-resolution manometry. C-POEM will be performed by experienced therapeutic gastrointestinal endoscopists (Principal Investigator Dr Peter Wu; co-investigator Prof Philip Chiu). All standard of care monitoring for endoscopic procedures will be applied, including nursing and anaesthetic documentation. Endoscopy reports will also be generated as part of medical record.
Sponsors
The Chinese University of Hong Kong
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed