Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001437853
Ethics application status
Approved
Date submitted
18/02/2020
Date registered
25/10/2021
Date last updated
25/10/2021
Date data sharing statement initially provided
25/10/2021
Date results information initially provided
25/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A retrospective analysis of a prospectively collected database on the safety and effectiveness of preemptive esophageal dilatation in the management of high-grade food bolus obstruction in the upper esophagus
Scientific title
A retrospective analysis of a prospectively collected database on the safety and effectiveness of preemptive esophageal dilatation in the management of high-grade food bolus obstruction in the upper esophagus
Secondary ID [1] 300587 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food bolus obstruction 316322 0
Condition category
Condition code
Oral and Gastrointestinal 314589 314589 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We propose to assess the safety and effectiveness of esophageal dilation at the time of food bolus disimpaction in reducing the risk of recurrent FBO in a retrospective analysis of a prospective database from 2008 to 2017. We aim to compare patients who undergo concurrent esophageal dilation using Savary Gillard dilator catheters at the time of food bolus disimpaction and those who have elective esophageal dilation as an outpatient.
a) Participant requirement (no involvement, the following data will be collected from each case:
• Demographic data,
• Clinical presentations
• Underlying pathology
• Mucosal damage to the esophagus and larynx
• Complications after endoscopy such as aspiration, sore throat, GI bleeding.
• Hospital stay duration

b) the duration of observation/follow-up per participant (Up to 48 hours post-enrolment and 10 days post-enrolment)
Intervention code [1] 316892 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322918 0
Safety of esophageal dilation assessed through medical records and hospital admissions records.
Timepoint [1] 322918 0
48 hours after procedure
Primary outcome [2] 326739 0
Safety, devoid of any procedure related complications assessed through hospital records and patient reporting.
Adverse events or Complications are defined as procedure related complications from esophageal dilation which are bleeding and perforation.
-Bleeding is categorized into (i)“minor bleeding”- transient bleeding that spontaneously resolved without requirement of blood transfusion or intervention to stop bleeding OR (ii) “major bleeding”- persistent bleeding leading to hemodynamic instability and requirement of blood transfusion and intervention to cease bleeding such as radiologic embolization or endoscopic hemostasis.
-Perforation is defined as iatrogenic esophageal mucosal tear with direct communication with mediastinum or peritoneum the after esophageal dilation evident on endoscopic view
Timepoint [2] 326739 0
48 hours after procedure
Secondary outcome [1] 380240 0
Effectiveness of esophageal dilation in reducing recurrent FBO will be defined as the ability of the endoscope to traverse the esophageal stenosis after dilation and ability to reduce the number of recurrent food bolus obstruction, this will be assessed through medical records and hospital admissions.
Timepoint [1] 380240 0
Within 48 hours of procedure
Secondary outcome [2] 392530 0
-Esophageal Structural abnormalities defined as obvious esophageal pathologies including peptic stricture, eosinophilic esophagitis and schatzki rings that is evident during endoscopy
Timepoint [2] 392530 0
Within 48 hours of procedure
Secondary outcome [3] 401808 0
Total endoscopy time, this will be assessed through data-linkage to medical records.

-Total endoscopy time is defined as the time when the first endoscopic dilator is inserted into the oral cavity to the time when the last dilator is removed from the oral cavity
Timepoint [3] 401808 0
Within 48 hours of procedure

Eligibility
Key inclusion criteria
• Age 18-90 years
• Confirmed acute food bolus requiring endoscopy
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age <18
• Patients managed medically, not requiring endoscopic retrieval of food bolus

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/06/2018
Date of last participant enrolment
Anticipated
Actual
30/09/2019
Date of last data collection
Anticipated
Actual
30/09/2019
Sample size
Target
400
Accrual to date
Final
456
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 305009 0
Hospital
Name [1] 305009 0
Royal Adelaide Hospital
Country [1] 305009 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Department of Gastroenterology
Royal Adelaide Hospital
Port Road Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 305366 0
None
Name [1] 305366 0
Address [1] 305366 0
Country [1] 305366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305406 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 305406 0
CALHN Research Office
RAH Clinical Trial Centre
Level 3, Royal Adelaide Hospital
Port Road
ADELAIDE SA 5000
Ethics committee country [1] 305406 0
Australia
Date submitted for ethics approval [1] 305406 0
Approval date [1] 305406 0
15/06/2018
Ethics approval number [1] 305406 0

Summary
Brief summary
We propose to assess the safety and effectiveness of esophageal dilation at the time of food bolus disimpaction in reducing the risk of recurrent FBO in a retrospective analysis of a prospective database from 2008 to 2017. We aim to compare patients who undergo concurrent esophageal dilation using Savary Gillard dilator catheters at the time of food bolus disimpaction and those who have elective esophageal dilation as an outpatient.
We expect that the concurrent esophageal dilation at the time of initial removal of food bolus is safe and effective in reducing the risk of recurrent FBO given it will treat the underlying pathology and stretch the esophagus. As a consequence, the patient does not need to return to hospital for a second endoscopy or represent to hospital with recurrent FBO. This would not only reduce health care cost but also reduce the number of patients presenting to emergency department with recurrent FBO.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100270 0
A/Prof Nam Q Nguyen
Address 100270 0
Department of Gastroenterology
Royal Adelaide Hospital
Port Road Adelaide SA 5000
Country 100270 0
Australia
Phone 100270 0
+61 8 70742189
Fax 100270 0
Email 100270 0
[email protected]
Contact person for public queries
Name 100271 0
Mrs Romina Safaeian
Address 100271 0
Department of Gastroenterology
Royal Adelaide Hospital
Port Road Adelaide SA 5000
Country 100271 0
Australia
Phone 100271 0
+61 8 70742189
Fax 100271 0
Email 100271 0
[email protected]
Contact person for scientific queries
Name 100272 0
Mrs Romina Safaeian
Address 100272 0
Department of Gastroenterology
Royal Adelaide Hospital
Port Road Adelaide SA 5000
Country 100272 0
Australia
Phone 100272 0
+61 8 70742189
Fax 100272 0
Email 100272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.