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Trial registered on ANZCTR


Registration number
ACTRN12620000193976
Ethics application status
Approved
Date submitted
4/02/2020
Date registered
19/02/2020
Date last updated
19/02/2020
Date data sharing statement initially provided
19/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of dilatation via endoscopy or by the patient themselves for the treatment of recurrent strictures (narrowings) of the pharyngo-oesophageal junction
Scientific title
Endoscopic versus self-dilatation for recurrent pharyngo-oesophageal strictures
Secondary ID [1] 300400 0
None
Universal Trial Number (UTN)
U1111-1247-5038
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastrointestinal tract stricture 316032 0
Condition category
Condition code
Oral and Gastrointestinal 314309 314309 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 316690 0
Treatment: Other
Comparator / control treatment
Endoscopic dilatation on-demand:
Following randomisation to this group, patients will be observed for symptoms of recurrent dysphagia suggesting stricture recurrence and offered repeat endoscopic dilatation if this occurs. This is current standard of care and this serves as the control group.
Control group
Active

Outcomes
Primary outcome [1] 322695 0
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.*

*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.
Timepoint [1] 322695 0
6 months post commencement of intervention
Secondary outcome [1] 379330 0
Dysphagia symptom severity, as measured by Sydney Swallow Questionnaire
Timepoint [1] 379330 0
Baseline before intervention, at 3 months, and at 6 months (secondary timepoint)
Secondary outcome [2] 379331 0
Quality of life, measured by MD Anderson Dysphagia Inventory
Timepoint [2] 379331 0
Baseline before intervention, 3 months, and 6 months (secondary timepoint)
Secondary outcome [3] 379332 0
Patient acceptability of treatment modality – binary outcome
Timepoint [3] 379332 0
6 months or at time of reaching primary endpoint if that occurs earlier
Secondary outcome [4] 379333 0
Patient preference of treatment modality (for patients experienced in both modalities) – binary outcome
Timepoint [4] 379333 0
6 months post-randomisation
Secondary outcome [5] 379334 0
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.
Timepoint [5] 379334 0
6 months post-randomisation

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304825 0
Self funded/Unfunded
Name [1] 304825 0
n/a
Country [1] 304825 0
Primary sponsor type
Government body
Name
South Eastern Sydney Local Health District
Address
G71 East Wing Edmund Blacket Building, Prince of Wales Hospital, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 305155 0
None
Name [1] 305155 0
n/a
Address [1] 305155 0
n/a
Country [1] 305155 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305236 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 305236 0
G71 East Wing Edmund Blacket Building, Prince of Wales Hospital, Randwick NSW 2031
Ethics committee country [1] 305236 0
Australia
Date submitted for ethics approval [1] 305236 0
Approval date [1] 305236 0
24/01/2010
Ethics approval number [1] 305236 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99714 0
Dr Santosh Sanagapalli
Address 99714 0
St Vincent's Hospital Sydney
390 Victoria ST Darlinghurst NSW 2010
Country 99714 0
Australia
Phone 99714 0
+61 283821111
Fax 99714 0
Email 99714 0
[email protected]
Contact person for public queries
Name 99715 0
Santosh Sanagapalli
Address 99715 0
St Vincent's Hospital Sydney
390 Victoria ST Darlinghurst NSW 2010
Country 99715 0
Australia
Phone 99715 0
+61 283821111
Fax 99715 0
Email 99715 0
[email protected]
Contact person for scientific queries
Name 99716 0
Santosh Sanagapalli
Address 99716 0
St Vincent's Hospital Sydney
390 Victoria ST Darlinghurst NSW 2010
Country 99716 0
Australia
Phone 99716 0
+61 283821111
Fax 99716 0
Email 99716 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
A request to obtain data can be made by emailing the Principal Investigator ([email protected]). Access is subject to approval by Principal Investigator.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.