None listed
Conditions
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.
Interventions
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 ex
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.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Confirmed acute food bolus requiring endoscopy.
Exclusion criteria
Age less than 18 years; Patients managed medically, not requiring endoscopic retrieval of food bolus.
Outcome results
None listed