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Trial registered on ANZCTR


Registration number
ACTRN12614000968673
Ethics application status
Approved
Date submitted
30/08/2014
Date registered
10/09/2014
Date last updated
17/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Unsedated gastroscopy – A study to identify which form of gastroscopy is tolerated best and preferred by patients
Scientific title
Unsedated oesophagogastroduodenoscopy (EGD) in patients referred for outpatient EGD and healthy volunteers - a RCT to assess and compare the tolerability of transnasal vs. small caliber per-oral vs. conventional approach.
Secondary ID [1] 285266 0
Nil known
Universal Trial Number (UTN)
U1111-1156-6879
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diseases of the upper gastrointestinal tract 292914 0
Condition category
Condition code
Oral and Gastrointestinal 293201 293201 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Unsedated oesophagogastroduodenoscopy (EGD)

Arm 1: Transnasal EGD followed by small-caliber per-oral EGD followed by conventional EGD

Arm 2: Small-caliber per oral EGD followed by transnasal EGD followed by conventional EGD

Arm 3: Conventional EGD followed by transnasal EGD followed by per-oral EGD

Three EGDs are performed during two sessions. The two small caliber EGDs (transnasal and per-oral approach) are performed during one session and the conventional EGD is performed during one session.

Conventional EGD uses a 9-10mm diameter scope that is passed through the mouth, oropharynx, bypassing the larynx into the oesophagus, stomach and proximal small bowel. The assessment of oesophagus, stomach and duodenum requires between 3-9mins.

Transnasal EGD uses a ~5mm diameter endoscope that is passed into the upper gastrointestinal tract via the nostrils, nasopharynx and thereafter the passage is similar to the conventional EGD (see above). The procedure time is in average longer (approx. one minute longer) due to the insertion through the nostril which also affects the handling throughout the procedure.

Small caliber per-oral EGD (SC-PO) uses the same endoscope that is used for the transnasal approach, however the insertion pathway is similar to the conventional approach. The procedure time is also similar to the conventional EGD with about 3-9minutes.

The session during which both small caliber approaches (TN and PO) are performed requires a 45 minute slot. Between the procedures and after the second procedure an approx. ten minute pause is planned to allow filling in of the participant questionnaire.

The session during which the conventional EGD will be performed requires a 30 minute slot.

We aim to perform the two sessions within two days to two weeks.

We use two different anesthetics which are applied through a nozzle into the pharynx and then swallowed or into each nostril:

For the conventional EGD and SC-PO EGD:
Oral pump spray (Xylocaine Pump Spray 10%/ trademark) lidocaine 10%. 5 squirts twice into the pharynx.

For the transnasal EGD:
Combination nasal spray (Co-Pheynylcaine Forte/ trademark) 5% lignocaine hydrochloride and 0.5% phenylephrine hydrochloride. 5 squirts per nostril.
Intervention code [1] 290144 0
Treatment: Devices
Intervention code [2] 290205 0
Diagnosis / Prognosis
Intervention code [3] 290206 0
Early detection / Screening
Comparator / control treatment
Conventional EGD (this is the current standard in unsedated EGD in New Zealand; conventional means a standard diameter gastroscope is used)
Control group
Active

Outcomes
Primary outcome [1] 293070 0
Participant preferences for unsedated EGD, comparing the three available endoscopic variants.
Timepoint [1] 293070 0
Directly following the completion of the interventions
(all three endoscopic variants are performed on each participant within two endoscopy sessions)
Secondary outcome [1] 310287 0
Tolerability of each intervention:
A questionnaire was designed which uses several 10 point visual analog scales in order to assess overall tolerability as well as coughing, nausea, gagging, anxiety (prior and during the procedure), pain.

Timepoint [1] 310287 0
Directly following completion of each intervention.
Secondary outcome [2] 310288 0
Complication rates:
Conventional and transnasal gastroscopy are very safe procedure and serious side effects such as perforation or non-self-limiting bleeding are extremely rare.

More common side effects that could possibly occur during gastroscopy are discomfort, gagging, coughing and choking sensation.

During transnasal gastroscopy, nasal discomfort and nose bleeding (usually minor and self-limited) could occur. These side effects are usually mild and limited to the short duration of the procedure.

Other possible rare side effects that could occur are allergic reactions to the topical anesthetics and injury to dentition or the voice box.

Any complication experienced by a participant will be assessed by a gastroenterologist who will also perform a targeted physical examination. Should a complication require further investigations or treatment then this will be discussed directly with the participants primary carer. Further required management steps will then be arranged by the primary carer or the gastroenterologists (research team) as appropriate and this will be decided on a case by case basis depending on the complication and it's severity.
Timepoint [2] 310288 0
Following each intervention and up to 24 hours following the final EGD. This will be assessed via a telephone call.
Secondary outcome [3] 310289 0
Endoscopist preference for unsedated EGD, comparing the three available endoscopic variants.
Timepoint [3] 310289 0
Directly following the completion of the interventions.

Eligibility
Key inclusion criteria
Age >15
We include healthy volunteers and patients that are referred to our service for the purpose of an outpatient EGD and patients that are under the Gastroenterology Department follow up requiring an EGD. No specific condition or symptom is targeted in the patient population other then the requirement for an outpatient EGD.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age < 16, acute illness that does not allow safe performance of EGD as per study protocol, pregnancy, acute nasal trauma, active epistaxis, active upper gastrointestinal bleeding, allergy to topical anaesthetic

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Sample size calculation using data from table 1 of the article Atar M et al. (2014) article (World J Gastrointst Endosc 2014 Feb 16; 6(2):41-48.

We took the mean difference between TOE and TNE (=4.8-2.6) to be 2.2 (approximately 2) and the standard deviation (SD) of the difference to be 3.2 (approximately 3) and then used these numbers in a power sample size calculation with 90% power. The results were we need an approximate sample size of around N=30-40 in each group to find a significance difference between the two methods at the 5% significance level (i.e. obtain a p-value of at least 0.05).

The data will be analyzed by a statistician assessing means, standard deviations, significance differences between the various methods at a 5% significance level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/09/2014
Actual
8/09/2014
Date of last participant enrolment
Anticipated
Actual
5/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 6329 0
New Zealand
State/province [1] 6329 0

Funding & Sponsors
Funding source category [1] 289885 0
Hospital
Name [1] 289885 0
Gastroenterology Department
North Shore Hospital
Country [1] 289885 0
New Zealand
Primary sponsor type
Hospital
Name
Gastroenterology Department North Shore Hospital
Address
124 Shakespeare Rd, Westlake 0622
Auckland
Country
New Zealand
Secondary sponsor category [1] 288565 0
None
Name [1] 288565 0
Address [1] 288565 0
Country [1] 288565 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291608 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 291608 0
Ministry of Health
C/- Medsafe, level 6
Deloitte House
10 Brandon Street
PO Box 6013
Wellington 6011
Ethics committee country [1] 291608 0
New Zealand
Date submitted for ethics approval [1] 291608 0
Approval date [1] 291608 0
28/08/2014
Ethics approval number [1] 291608 0
14/NTB/5

Summary
Brief summary
* The purpose of this study is to find out which form of unsedated gastroscopy is the most comfortable and preferred by patients.

* Gastroscopies are very safe standard procedures that are performed in most hospitals all over the world since many years. In our Gastroenterology Department we perform thousands of gastroscopies every year and we believe that this study may help us to directly to improve our patient care.

What is a Gastroscopy, what means unsedated and what different forms are there?

A gastroscopy is a very safe endoscopic procedure to assess the food pipe, stomach and the beginning of the small bowel. The complete procedure only takes three to nine minutes. The instrument used is called a gastroscope, which is essentially a long tube with a camera at the tip that can be passed through the mouth or the nose into your oesophagus and from there into the stomach and also a very short distance into the small bowel. A gastroscopy is required to investigate swallowing difficulties, heartburn, early satiety, chest and abdominal pain or bleeding from the oesophagus or stomach.

There are two different types of gastroscopes available differing essentially only in diameter:

* Conventional gastroscopes that have a diameter just below 10 mm (half the diameter of a 10 cent coin) and these are the current standard here in New Zealand.
1) Can only be passed through the mouth!

* Slim gastroscopes that have only a diameter of 5mm and these can be passed therefore also easily through the nose. Ear-nose-throat specialists commonly use such instruments here in New Zealand.
1) Can be passed through the mouth.
2) Can be passed through the nose (generally not requiring sedation).

Therefore three different forms of gastroscopy procedures are possible due to two different diameter scopes available. The conventional larger diameter scope can only be passed through the mouth and this is the current standard here in New Zealand for in and out patient procedures. The slim endoscopes with a diameter half the size can be passed through the mouth, but also through the nose and the latter can be performed with topical anesthetic in general. This approach is called transnasal gastroscopy and the procedure has been used in for many years in countries such as Japan and France. A further advantage of the transnasal gastroscopy is that it enables people to talk throughout the procedure.

Performing a gastroscopy unsedated/ without sedation means that prior to the gastroscopy only a topical anesthetic is sprayed into your mouth or nostrils. The topical anesthetic will cause reduced sensation for a short time in your nose and throat, which will decrease the chances of gagging and discomfort during the gastroscopy.

As the gastroscopy is performed through the mouth, a mouth guard is used to protect your teeth. Unfortunately, you cannot talk throughout the procedure due to the mouth guard and the gastroscope being in place.

In our current clinical practice, sedation is additionally used in approximately half of the gastroscopies performed with conventional gastroscopes. Sedation means that the doctor administers medication over a needle into a small superficial vein (blood vessel) in your arm that makes you sleepy, reduces anxiety and discomfort. This is usually due to patient or doctor preference or due to patients not tolerating this procedure with a conventional gastroscope without sedation due to gagging, coughing or anxiety.

In the Waitemata District Health Board region currently all outpatient gastroscopies are organized as a procedure that may be performed with sedation and only conventional size gastroscopes are used. Therefore all patients have to take a day off work and organize a family member or friend to pick them up, as you are not allowed to drive, use the public transport system or take a taxi following the administration of sedation.

In general, the big advantage of unsedated gastroscopy is that patients are allowed to drive and do not require an accompanying person. Furthermore, the time spent in the Endoscopy unit is a lot shorter as patients can leave directly after the procedure. Patients are also able to return to work the same day and this is not possible when a gastroscopy is performed under sedation.

Furthermore, complications such as blood pressure and breathing compromise, although rare, are usually associated with sedation.

Therefore, we believe offering unsedated gastroscopies and in turn alleviating the need for a support person and taking a day off work would be greatly appreciated in our community.


It is our goal that this service should offer the most comfortable form of gastroscopy to the patient. There is however conflicting evidence as to which form of unsedated gastroscopy is the most comfortable. As a result, we have designed this study to clarify what form of unsedated gastroscopy is the most comfortable and preferred by patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51134 0
Dr Alexander Huelsen
Address 51134 0
Gastroenterology Department
North Shore Hospital
124 Shakespeare Road
Westlake 0622
Auckland
Country 51134 0
New Zealand
Phone 51134 0
+64 9 486 8920 extension 2828
Fax 51134 0
Email 51134 0
[email protected]
Contact person for public queries
Name 51135 0
Alexander Huelsen
Address 51135 0
Gastroenterology Department
North Shore Hospital
124 Shakespeare Road
Westlake 0622
Auckland
Country 51135 0
New Zealand
Phone 51135 0
+64 9 486 8920 extension 2828
Fax 51135 0
Email 51135 0
[email protected]
Contact person for scientific queries
Name 51136 0
Alexander Huelsen
Address 51136 0
Gastroenterology Department
North Shore Hospital
124 Shakespeare Road
Westlake 0622
Auckland
Country 51136 0
New Zealand
Phone 51136 0
+64 9 486 8920 extension 2828
Fax 51136 0
Email 51136 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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