Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000219583
Ethics application status
Approved
Date submitted
17/02/2015
Date registered
5/03/2015
Date last updated
5/03/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the patient's position whilst undergoing ERCP (Endoscopic Retrograde Cholangiopancreatography) affect ease of the procedure and complication rates
Scientific title
Randomised trial comparing efficacy and complications of left lateral decubitus versus prone position in patients undergoing ERCP (Endoscopic Retrograde Cholangiopancreatography)
Secondary ID [1] 286185 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Position of performing ERCP 294214 0
Condition category
Condition code
Oral and Gastrointestinal 294532 294532 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
ERCP is commonly performed in either the left lateral decubitus or prone position.
The left lateral decubitus position for performing ERCP will be in half of the randomised group.
Measurement of time to biliary cannulation and complication rates will be recorded.
Intervention code [1] 291198 0
Treatment: Other
Intervention code [2] 291315 0
Diagnosis / Prognosis
Comparator / control treatment
Comparator group will be active group of patients undergoing ERCP but those that have been randomised to the prone position.
Similar parameters as outlined in the "active/intervention" group will be assessed.
Control group
Active

Outcomes
Primary outcome [1] 294438 0
Time to biliary cannulation for left lateral decubitus position versus prone position
Timepoint [1] 294438 0
At time of procedure
Primary outcome [2] 294439 0
Number of pancreatic duct cannulations
Timepoint [2] 294439 0
At time of procedure
Primary outcome [3] 294440 0
Needle knife usage due to difficult biliary cannulation
Timepoint [3] 294440 0
At time of procedure
Secondary outcome [1] 313009 0
The secondary objective is other complications including perioperative cardio-respiratory anaesthetic complications and other complications directly as the result of ERCP - this will be assessed by reviewing the vital signs recorded during the procedure, reviewing the patient's electronic medical records, and where apropriate - a phone call to the patient at 4 weeks post procedure
Timepoint [1] 313009 0
immediate and 4 weeks

Eligibility
Key inclusion criteria
1. Adults over 18 years of age
2. Require a diagnostic or therapeutic ERCP for their medical management
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous ERCP
2. Critically unwell patients
3. Patients intubated prior to ERCP
4. Patients unable to lie in the required positions due to physical limitations
5. Pregnant
6. Inability to provide informed consent

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)
A suitable subject will be randomised to a position as determined by the position allocation concealed within a sealed opaque envelop e.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation was performed to ensure equal numbers of both genders are enrolled, and that half of each gender cohort will be randomised to one of two positions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Parallel with crossover.
Subjects are randomised to an initial position for performing the procedure. If the procedure is unsuccessful in that position, they will be repositioned to the other position, but they are not acting as control for themselves.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
If there is no significant difference between the standard and the experimental treatment groups, then 194 patients are required to be 90% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference in favour of the standard group of more than 10%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
15/04/2014
Date of last participant enrolment
Anticipated
1/02/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3454 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 9225 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 290757 0
Self funded/Unfunded
Name [1] 290757 0
nil
Country [1] 290757 0
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 289444 0
None
Name [1] 289444 0
Address [1] 289444 0
Country [1] 289444 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292389 0
HREC Monash Health
Ethics committee address [1] 292389 0
Ethics committee country [1] 292389 0
Australia
Date submitted for ethics approval [1] 292389 0
Approval date [1] 292389 0
11/04/2014
Ethics approval number [1] 292389 0
14038A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54966 0
Dr Michael Swan
Address 54966 0
Monash Health Department of Gastroenterology
246 Clayton Road
Clayton VIC 3168
Country 54966 0
Australia
Phone 54966 0
+61395946666
Fax 54966 0
Email 54966 0
[email protected]
Contact person for public queries
Name 54967 0
Alvin Ting
Address 54967 0
Monash Health Department of Gastroenterology
246 Clayton Road
Clayton VIC 3168
Country 54967 0
Australia
Phone 54967 0
+61395946666
Fax 54967 0
Email 54967 0
[email protected]
Contact person for scientific queries
Name 54968 0
Alvin Ting
Address 54968 0
Monash Health Department of Gastroenterology
246 Clayton Road
Clayton VIC 3168
Country 54968 0
Australia
Phone 54968 0
+61395946666
Fax 54968 0
Email 54968 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.