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Trial registered on ANZCTR


Registration number
ACTRN12620000290998
Ethics application status
Approved
Date submitted
18/02/2020
Date registered
4/03/2020
Date last updated
4/03/2020
Date data sharing statement initially provided
4/03/2020
Date results information initially provided
4/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Advantages of cap-assisted device in the endoscopic management of food bolus obstruction in the esophagus. A multicenter randomized, controlled trial.
Scientific title
Advantages of cap-assisted device in the endoscopic management of food bolus obstruction in the esophagus. A multicenter randomized, controlled trial.
Secondary ID [1] 300575 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Bolus Obstruction 316305 0
Condition category
Condition code
Oral and Gastrointestinal 314573 314573 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Injuries and Accidents 314574 314574 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with confirmed acute food bolus obstruction in the upper esophagus will be recruited in to the study. Using a computer-generated program, patients will be randomised into one of two groups:
(a) Cap Assisted Group. In this group, a transparent cap will be fixed to the tip of the scope. The endoscopic procedure will be performed with the cap in-situ. Once the scope is intubated into the esophagus, standard examination will be performed to identify and characterize the food bolus. To extract the food bolus, the scope will be maneuvered so that the food bolus is engaged and sucked into the cap. Once the bolus is completely engaged inside the cap with constant suction, the scope is gently withdrawn with the bolus sucked against the cap. The procedure can take between 5-15 minutes.

(b) Conventional Group: In this group, the traditional established techniques without the use of the suction cap, will be performed to extract the food bolus with various devices such as snare, Rothnet, basket, or forceps for food bolus extraction. The choice of the devices will be at the discretion of the endoscopist. The procedure can take between 5-15 minutes.

If either the cap-assisted or conventional method fail after 15 mins of trialing the patient will be crossed over to the other technique and this will ensure the removal of the food bolus.
Intervention code [1] 316880 0
Treatment: Other
Comparator / control treatment
Control treatments will consists of currently established techniques without the use of the suction cap to retrieve the food bolus (e.g. Snamre, Rothnet, Basket, Foreceps). The choice of device will be at the discretion of the endoscopist.
Control group
Active

Outcomes
Primary outcome [1] 322905 0
Compare procedure times between the two groups of successful food bolus removal. Calculated from the start of anesthetic induction to the time of endotracheal extubation and included the time taken to evaluate the upper esophageal tract and to assemble the endoscopic device (Recorded using a stopwatch),
Timepoint [1] 322905 0
Assessed at the end of the procedure
Secondary outcome [1] 380198 0
Compare the rates of en bloc removal of food bolus between the two groups (Using data-linkage of medical records and recorded endoscope video).
Timepoint [1] 380198 0
Assessed within 48 hours post-procedure
Secondary outcome [2] 380199 0
Compare the rates of procedure-related adverse events between the two groups. Examples may include mucosal tear or damage, perforation, or bleeding. Following the procedure, patients will undergo endoscopic assessment to evaluate for any underlying complications.
Timepoint [2] 380199 0
Assessed within 48 hours post-procedure

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

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
Completed
Date of first participant enrolment
Anticipated
Actual
17/07/2017
Date of last participant enrolment
Anticipated
Actual
1/07/2019
Date of last data collection
Anticipated
Actual
20/02/2020
Sample size
Target
150
Accrual to date
Final
315
Recruitment in Australia
Recruitment state(s)
QLD,SA

Funding & Sponsors
Funding source category [1] 304992 0
Hospital
Name [1] 304992 0
Royal Adelaide Hospital
Country [1] 304992 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Port Road,
Adelaide,
SA, 5000
Country
Australia
Secondary sponsor category [1] 305351 0
None
Name [1] 305351 0
Address [1] 305351 0
Country [1] 305351 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305394 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 305394 0
Royal Adelaide Hospital
Port Road.
Adelaide,
SA 5000
Ethics committee country [1] 305394 0
Australia
Date submitted for ethics approval [1] 305394 0
Approval date [1] 305394 0
03/05/2017
Ethics approval number [1] 305394 0

Summary
Brief summary
What is the problem?
Esophageal food bolus is a common emergency. Majority of food boluses pass spontaneously or can be managed medically. However, in 10-20% of cases, endoscopic retrieval is necessary. However, endoscopic removal of food bolus can be challenging, due to limitation of working space within the esophagus, direct visualization of food bolus, the type or size of the food bolus and the endoscopic devices utilized. As a result, this may lead of failure or incomplete removal of food bolus and increase patient’s morbidity, even mortality.

What is this study?
We propose to assess the effectiveness of the transparent cap- assisted device, as a novel endoscopic technique in the management of food impaction in the esophagus in comparison to conventional endoscopic methods, given its usefulness has not been formally assessed in large randomized controlled studies to date.

What is the significance of this study?
We aim to compare a new technique for removing a piece of food which has become stuck in the esophagus using a transparent cap-assisted device and compare this to the established endoscopic method. We hope that this new technique will assist in complete removal of food bolus in one single piece rather than in pieces. This would reduce the time taken with patient’s safety unaltered, but this will not be known until we have completed with this research study.
We hypothesized the use of a transparent cap allows complete en-bloc removal of food bolus in a shorter amount of time and less trauma to the mucosa, as compared to the conventional techniques.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100226 0
A/Prof Nam Nguyen
Address 100226 0
Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital,
Port Road,
Adelaide,
SA, 5000
Country 100226 0
Australia
Phone 100226 0
+61 8 7074 2189
Fax 100226 0
+61 8 7074 6192
Email 100226 0
quocnam.nguyen@sa.gov.au
Contact person for public queries
Name 100227 0
Dr Marie Ooi
Address 100227 0
Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital,
Port Road,
Adelaide,
SA, 5000
Country 100227 0
Australia
Phone 100227 0
+61 8 7074 2189
Fax 100227 0
+61 8 7074 6192
Email 100227 0
marie.ooi@sa.gov.au
Contact person for scientific queries
Name 100228 0
Dr Marie Ooi
Address 100228 0
Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital,
Port Road,
Adelaide,
SA, 5000
Country 100228 0
Australia
Phone 100228 0
+61 8 7074 2189
Fax 100228 0
+61 8 7074 6192
Email 100228 0
marie.ooi@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval was not obtained to make IPD available. Individual information will be de-identified and will not be disclosed to the public.


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
SourceTitleYear of PublicationDOI
EmbaseComparison of Cap-Assisted vs Conventional Endoscopic Technique for Management of Food Bolus Impaction in the Esophagus: Results of a Multicenter Randomized Controlled Trial.2021https://dx.doi.org/10.14309/ajg.0000000000001484
N.B. These documents automatically identified may not have been verified by the study sponsor.