Comparison of dilatation via endoscopy or by the patient themselves for the treatment of recurrent strictures (narrowings) of the pharyngo-oesophageal junctio

Not Applicable

• Conditions: gastrointestinal tract stricture; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620000193976
• Lead Sponsor: South Eastern Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-19
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

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

Inclusion Criteria

Age greater than or equal to 18 years
-Completion of radiotherapy with or without adjuvant chemotherapy
-Pharyngeal dysphagia symptoms defined as Sydney Swallow Questionnaire > 234 (upper limit of normal).
-At least two dilatations in the preceding six months with the most recent dilatation no more than three months prior, and clinical indication for endoscopic dilatation demonstrating a pharyngo-oesophageal junction stricture (test)

Exclusion Criteria

-Individuals who cannot provide informed consent due to any reason (language barrier, impaired cognitive function)
-Recurrence or persistent disease following head and neck cancer treatment.
-Pre-existing disorder known to cause pharyngeal dysphagia such as: MVA, MND, Parkinson’s, inflammatory myopathy.
-Pre-existing oesophageal disease known to cause dysphagia such as eosinophilic oesophagitis, achalasia, oesophageal cancer.
-Either current pregnancy, intended pregnancy or breastfeeding during the study
-Concomitant use of Warfarin or other anticoagulant drug, or impaired blood clotting.
-Significant impairment of renal or hepatic function or other co-morbid conditions which in the opinion of the investigators preclude inclusion in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrent dysphagia necessitating endoscopic dilatation of a stricture – binary outcome, analysed as difference in proportions between treatment groups. I.e. the percentage of subjects with recurrent dysphagia necessitating endoscopic dilatation of a stricture.*<br><br>*During endoscopy for dysphagia recurrence, a recurrent stricture will be determined to have occurred unless the endoscopist is able to pass a dilator of a comparable size (within 1mm) as was reached on the initial series of dilatations with no mucosal disruption. It follows that recurrent stricture will be determined to be present if the same comparably sized dilator cannot be passed or if it is passed and causes a mucosal tear.[6 months post commencement of intervention]

Secondary Outcome Measures

Name	Time	Method
Safety, reported as the number of non-serious adverse events and serious adverse events. Known or possible adverse events include serious perforation, bleeding, pain and reflux symptoms. Adverse events will be participant self-reported.[6 months post-randomisation];Dysphagia symptom severity, as measured by Sydney Swallow Questionnaire[Baseline before intervention, at 3 months, and at 6 months (secondary timepoint)];Quality of life, measured by MD Anderson Dysphagia Inventory[Baseline before intervention, 3 months, and 6 months (secondary timepoint)];Patient acceptability of treatment modality – binary outcome[6 months or at time of reaching primary endpoint if that occurs earlier];Patient preference of treatment modality (for patients experienced in both modalities) – binary outcome[6 months post-randomisation]