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Trial registered on ANZCTR


Registration number
ACTRN12612000060842
Ethics application status
Approved
Date submitted
21/12/2011
Date registered
12/01/2012
Date last updated
12/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Difficult biliary cannulation: A randomized trial of early needle knife sphincterotomy.
Scientific title
In adult patients undergoing an ERCP procedure who have a difficult biliary cannulation, how does early needle knife cannulation techniques compare to standard cannulation techniques in the success and complications of the procedure
Secondary ID [1] 273313 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post ERCP pancreatitis 279086 0
Biliary cannulation success 285538 0
Post ERCP complications 285539 0
Condition category
Condition code
Oral and Gastrointestinal 279275 279275 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
Needle knife sphincterotomy
This technique involves cutting through the duodenal mucosa directly into the bile duct rather than directly cannulating the bile duct via the anatomical opening (Ampulla of Vater). It involves the use of a needle knife - a thin stiff wire that cuts through the use of diathermy. Typically the needle knife technique takes between 1 - 10 minutes to gain access. Once used to gain access, it is not used again during the procedure.
Intervention code [1] 283663 0
Treatment: Surgery
Intervention code [2] 284000 0
Other interventions
Comparator / control treatment
Standard treatment - persistence of standard cannulation techniques.
Standard techniques involve the use of a sphincterotome or thin catheter to directly cannulate the bile duct through the anatomical opening - the sphincter (ampulla) of Vater. A range of different catheters or sphincterotomes can be used incorporating different sized catheters and angulation/rotations.
Control group
Active

Outcomes
Primary outcome [1] 279896 0
Post ERCP pancreatitis
This outcome will be determined by blood tests - amylase and lipase at 24 hours.
In the event of post procedural pain, clinical assessment will be performed and blood tests may be performed at an earlier timepoint. A CT scan may be performed if acute pancreatitis is confirmed on blood tests and clinical assessment, as this can suggest the severity of the pancreatitis episode.
Patients will be contacted via phone within the first 5 days and again at day 30. Questions will relate to the symptoms of possible complications.
Timepoint [1] 279896 0
Immediate; at 24 hours; at day 30
Secondary outcome [1] 294717 0
Biliary cannulation success
This outcome is assessed at the time of the procedure and confirmed by the use of fluroscopy (XRay) and radio-opaque contrast and wires that identifies the bile duct and biliary tree.
Timepoint [1] 294717 0
Immediate
Secondary outcome [2] 294718 0
Post ERCP complications (non pancreatitis)
This outcome is assessed by a combination of clinical assessment, blood tests and imaging.
Complications typically occur within the first 14 days, predominantly in the first 24 hours. If there is a clinical suspicion of complications apart from pancreatitis - such as perforation or bleeding, the appropriate imaging and blood tests will be performed for confirmation of the diagnosis.
Timepoint [2] 294718 0
Immediate; at 24 hours; at day 30

Eligibility
Key inclusion criteria
Biliary indication for ERCP
Naive biliary sphincter
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Absence of active pancreatitis
Pancreatic malignancy
Ampullary malignancy
Previous sphincterotomy
Haemodynamically instability

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)
All eligible patients (biliary indication and naive sphincter) invited prior to the procedure to be involved. Consent obtained prior to the procedure.
Random number generation was performed by a clinician not involved in the study and the number concealed in an opaque envelope.
At prescribed time/criteria for randomization to occur, the next sequential envelope was opened by a medical team member not directly involved in the study.
The proceduralist was informed of the randomized group and the randomisation result was recorded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random computer generation number generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
152
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284147 0
Self funded/Unfunded
Name [1] 284147 0
Country [1] 284147 0
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Endoscopy Unit
Department of Gastroenterology
Hawkesbury Road
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 269109 0
None
Name [1] 269109 0
Address [1] 269109 0
Country [1] 269109 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272108 0
Sydney West area health service human ethics and research committee
Ethics committee address [1] 272108 0
Research Office
Clinical Sciences
Westmead Hospital Campus
Hawkesbury Road
Westmead NSW 2145
Ethics committee country [1] 272108 0
Australia
Date submitted for ethics approval [1] 272108 0
Approval date [1] 272108 0
01/03/2007
Ethics approval number [1] 272108 0
2007/3/4.3(2553)

Summary
Brief summary
Endoscopic retrograde cholangiopancreatoscopy (ERCP) is a procedure that can assist in the treatment and diagnosis of liver disease as well as gallstone disease.
Like all medical procedures, ERCP is associated with complications specifically infalmmation of the pancreas (pancreatitis). Pancreatitis is often associated with more difficult procedures that take longer than normal to complete. In these situations special techniques may be used to successfully complete the procedure, such as directly cutting into the drainage tube (bile duct)from the liver - this is called a needle knife cutting technique.
This study looks at whether the use of this needle knife cutting technique may prevent or reduce the risk of pancreatitis complications if performed at an earlier stage.
Trial website
Trial related presentations / publications
Interim analysis presented at
Digestive diseases week (DDW) New Orleans USA May 2010
Australian Gastroenterology week (AGW) Oct 2009
Public notes

Contacts
Principal investigator
Name 33343 0
Address 33343 0
Country 33343 0
Phone 33343 0
Fax 33343 0
Email 33343 0
Contact person for public queries
Name 16590 0
Michael Swan
Address 16590 0
Endoscopy Unit
Westmead Hospital
Hawkesbury Rd
Westmead, NSW 2145
Country 16590 0
Australia
Phone 16590 0
61 2 98459779
Fax 16590 0
61 2 98456213
Email 16590 0
[email protected]
Contact person for scientific queries
Name 7518 0
Michael Swan
Address 7518 0
Endoscopy Unit
Westmead Hospital
Hawkesbury Rd
Westmead, NSW 2145
Country 7518 0
Australia
Phone 7518 0
61 2 98459779
Fax 7518 0
61 2 98456213
Email 7518 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
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