ANZCTR - Registration

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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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Food Bolus Obstruction

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Injuries and Accidents

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 Once the bolus is completely engaged inside the cap with constant suction, the scope is gently withdrawn with the bolus sucked against the cap.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]

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]

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]

Assessed at the end of the procedure

Secondary outcome [1]

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]

Assessed within 48 hours post-procedure

Secondary outcome [2]

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]

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?

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]

Hospital

Name [1]

Royal Adelaide Hospital

Address [1]

Port Road,
Adelaide,
SA, 5000

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Adelaide Hospital

Address

Port Road,
Adelaide,
SA, 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital Human Research Ethics Committee

Ethics committee address [1]

Royal Adelaide Hospital
Port Road.
Adelaide,
SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/05/2017

Ethics approval number [1]

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

A/Prof Nam Nguyen

Address

Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital,
Port Road,
Adelaide,
SA, 5000

Country

Australia

Phone

+61 8 7074 2189

Fax

+61 8 7074 6192

quocnam.nguyen@sa.gov.au

Contact person for public queries

Name

Marie Ooi

Address

Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital,
Port Road,
Adelaide,
SA, 5000

Country

Australia

Phone

+61 8 7074 2189

Fax

+61 8 7074 6192

marie.ooi@sa.gov.au

Contact person for scientific queries

Name

Marie Ooi

Address

Department of Gastroenterology and Hepatology,
Royal Adelaide Hospital,
Port Road,
Adelaide,
SA, 5000

Country

Australia

Phone

+61 8 7074 2189

Fax

+61 8 7074 6192

marie.ooi@sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Comparison of Cap-Assisted vs Conventional Endoscopic Technique for Management of Food Bolus Impaction in the Esophagus: Results of a Multicenter Randomized Controlled Trial.	2021	https://dx.doi.org/10.14309/ajg.0000000000001484

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically