None listed
Conditions
Brief summary
Patients can develop strictures (narrowings) of the oesophagus (gullet) following therapy for head and neck cancers. These strictures can impair swallowing. They are treated by dilatation (stretching open) during endoscopy, but in some patients can recur frequently and lead to need for frequent and repeated procedures. We are examining the effect of patients self-dilating their strictures at home on the recurrence rate of such strictures. Our study hypothesis is that patients treated with self-dilatation have reduced clinically significant re-stricturing necessitating endoscopic dilatation, compared to those treated with endoscopic dilatation on-demand.
Interventions
Name: Self-dilatation Self-dilatation will be performed by the patient using a tungsten-filled weighted silicone dilator with a tapered tip (Maloney dilator; Getz Healthcare, Lane Cove, NSW, Australia). The subject will be appropriately educated by the study team; training sessions will include detailed verbal instructions, familiarisation with the dilatation equipment, and participants will be shown an instructional video. The first self-dilatation will be performed in the recovery room after endoscopic dilatation under the supervision of a member of the study team (either a physician, gastroenterology trainee or speech pathologist experienced in the management of self-dilatation patients). Subsequently, the patient will return for supervised self-dilatation for 1-3 sessions, depending on each patient’s ability to learn the technique. The supervised self-dilatation session(s) will be 5-10 minutes in duration. Thereafter education will continue via scheduled telephone calls from a member of the study team during which progress with self-dilatation will be assessed, problems troubleshooted, and schedule for reduction in dilatation frequency will be advised. The size of the Maloney dilator to be used will be 1-2mm smaller in diameter than the size reached during endoscopic dilatation. Initially, patients will be instructed to perform self-dilatation twice daily. The frequency of dilatation will be gradually reduced over time to once monthly over an average period of 6-12 months. The exact rate and extent to which reduction in dilation frequency occurs will be individualised and dependent on information obtained from the patient via the scheduled contact sessions with a member of the study team Based on findings at the endoscopy, a tape marker will be affixed to the dilator by a member of the study team to indicate to the patient the depth of insertion required. Patients will be advised to generously apply lubricant to the dilator and to apply topical anaesthesia to the oropharynx using 10% xylocaine spray, prior to passage of the dilator. Patients can choose to perform self-dilatation in either the sitting or standing position. The patient will then pass the dilator through the mouth, starting with tapered tip. Once the tip reaches the pharynx, the patient will attempt to swallow while gently advancing the dilator to facilitate further passage into the oesophagus. The dilator will then continue to be gently advanced by the patient, until the tape marker on the dilator reaches the mouth. The patient will be instructed not to advance the dilator if excessive resistance to its passage is found (what constitutes normal and excessive resistance will be taught to the patient during the hands-on education sessions). Once the dilator has been inserted to the adequate depth, it can then be immediately removed from the mouth in a single motion. Once the participant becomes proficient with the technique, it will take no more than 30s to perform.
Sponsors
Study design
Eligibility
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