Cola Trial

Rationale: Cola as a treatment option for complete oesophageal food bolus obstruction has
been promulgated for more than 20 years. Cola has been advocated as safe for patients in
whom endoscopic removal of a food bolus is judged to be too risky. However, evidence on
safety and efficacy of cola as initial treatment is lacking. The current guidelines recommend
an emergent endoscopy for removal of the food bolus. This treatment gives discomfort and
risk of aspiration and perforation. If cola were successful in removal of the food bolus, this
would greatly improve patient comfort and health care utilisation, since cola is cheap and
globally available.
We hypothesize that cola can resolve a substantial percentage of complete oesophageal
obstructions.

Objective: To assess the efficacy and safety of cola as the initial treatment of complete
oesophageal food bolus impactions.

Study design: a multi-centre randomised clinical trial

Study population: Adult patients with symptomatic complete oesophageal food bolus
impaction

Intervention: patients in the cola-arm will drink 25 millilitre sips of Coca-Cola with an interval
of 1 minute and a maximum of 8 sips.

Main study parameters/endpoints: the percentage of complete or partial resolution of the
oesophageal food bolus obstruction after drinking cola. We also evaluate intervention
complications.

Nature and extent of the burden and risks associated with participation, benefit and
group relatedness: Drinking cola during complete oesophageal obstruction can be
uncomfortable, however no significant complications have been reported in previous studies
on cola use. Patients in the control group will be treated following current guidelines, so for
them there will be no burden or extra risk

We hypothesize that cola can resolve a substantial percentage of complete oesophageal
obstructions

The following will be recorded using questionnaires in Castor:

Baseline:
At baseline, the following will be recorded for all patients in both study arms:
Gender, age, nature of food bolus, impaction duration, time of presentation to the ED, rem- edies tried before coming to hospital, whether a GP was contacted and what advise they gave, at how many centimetres below the suprasternal notch the patient indicates the loca- tion of the bolus (if able to indicate), previous history of impactions (including number), pre- vious endoscopic procedures and diagnoses.

During treatment:
For all patients (both study arms), the following will be recorded:
􏰀
When the patient has passed the food bolus:
Time of bolus passage, whether the bolus passed distally or came out orally, whether the patient thinks there is complete or partial resolution of the bolus, whether the patient aspirated, bled, still experiences pain/discomfort after passage or experiences dysp- noea. Booking of follow-up elective diagnostic endoscopy must be recorded. If this is deemed unnecessary by the gastroenterologist on call, the reason why.

􏰀When the patient has not passed the food bolus 30 minutes after enrolment (i.e. at
the end of the study protocol):
Whether the patient aspirated, bled, still experiences pain/discomfort or feels dyspnoeic and whether the patient is still unable to pass fluids and saliva.

For the patients in the cola arm of the study only, the following will be recorded: Time of first sip of cola, how many sips in total, total amount drunk in millilitres.

In the endoscopy suite
The following information will be extracted from the endoscopy report by the site investiga- tors: Presence, nature and location of food bolus. Manoeuvres and techniques required to dislodge the bolus. Time of bolus passage. Oral or distal passage. Complications (oesoph- ageal perforation, mucosal laceration, bleeding, aspiration or any other complication) seen before removal and again after removal. Endoscopic diagnosis. Treatment advice, if any.

General follow up
Patients will be contacted by telephone to check for the occurrence of adverse events after discharge from the hospital after one week.

Patients who will have passed their food bolus pre-endoscopically will not need urgent en- doscopy. They will however, per current guidelines, need elective diagnostic endoscopy, unless they are known to the department of gastroenterology and the gastroenterologist on call decides that endoscopy is not indicated in the patient. Results of this elective diagnostic endoscopy will be followed up through the endoscopy report.

Treatment with cola while waiting for emergent endoscopic removal will be compared to the standard treatment according to the current ESGE guidelines: no pre-endoscopic treatment while waiting for emergent endoscopic
removal. Timing of endoscopy will be minimally affected by this study: for both study arms,
endoscopic removal will be planned 30 minutes after being enrolled in the study

Intervention:
Canned Coca-Cola will be kept uncooled in an appropriate place at the Emergency Department. For every new patient, a new can will be opened. The patient will be given a bowl or will be placed by the sink because of likely regurgitation and drooling. Access to suctioning will be ensured. The patient will be asked by the treating physician or emergency medicine nurse to swallow a 25ml sip of Coca-Cola from a standard medication measuring cup. The patient will always maintain an upright (sitting or standing) position. They will be asked to wait for 1 minute and if unsuccessful, to continue swallowing 25ml sips at 1-minute intervals. If still unsuccessful after 4 sips, they will ‘rest’ for 10 minutes in an upright position and then resume 15mins after the initial sip, repeating the same protocol. If unsuccessful after the second series of 4 sips, the protocol will be discontinued. In total, the patient will drink a maximum of 200mls of cola. Dependant of the crowding at the Emergency Department, it is not always possible to let the patient drink cola under the supervision of a nurse or physician. Therefore, in some cases the patient will be asked to keep track of time theirselves.