Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000096752
Ethics application status
Not yet submitted
Date submitted
18/01/2013
Date registered
24/01/2013
Date last updated
24/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A study on the effectiveness of Indomethacin in preventing post Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
Scientific title
Among patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP), does a single dose of Indomethacin reduce the incidence of Post-ERCP Pancreatitis?
Secondary ID [1] 281804 0
NIL
Universal Trial Number (UTN)
U1111-1138-6774
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis 288139 0
Condition category
Condition code
Oral and Gastrointestinal 288511 288511 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
Indomethacin is a Non-Steroidal Anti-inflammatory Drug (NSAID), which is commonly used to treat fever, headaches, and bone, muscular or joint pain. It works by inhibiting the production of prostaglandins (known to cause such symptoms). It is marketed under several names, including Indocid and Arthrexin.
In our study, participants will be given an Indomethacin suppository (dose given rectally) 5 minutes before the commencement of the ERCP.
We will then be monitoring our patients for 90 minutes post procedure for symptoms, which would suggest pancreatitis (in particular abdominal pain).
Intervention code [1] 286351 0
Prevention
Comparator / control treatment
Currently there are no wide accepted methods used for the prevention of post-ERCP pancreatitis.
The control group will be using a placebo suppository (glucose).
Control group
Placebo

Outcomes
Primary outcome [1] 288667 0
The primary outcome will be Post-ERCP Pancreatitis, which is defined as:
-new-onset abdominal pain
-elevation of serum amylase (greater than 3 times the upper limit of normal) after 24 hours
-requiring more than 2 days hospitalization
Timepoint [1] 288667 0
Patients will be observed for 90 minutes post-procedure and then reassessed at the 24 hour mark
Secondary outcome [1] 300732 0
Acute renal impairment (via serum creatinine measurement 24 hours post procedure)
Timepoint [1] 300732 0
24 hours post procedure

Eligibility
Key inclusion criteria
All patients undergoing Endoscopic Retrograde Cholangiopancreatography
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Those with active pancreatitis
-Renal impairment
-known allergy to non-steroidal anti-inflammatory drugs (including NSAID induced asthma)
-patients with concomitant NSAID therapy (excluding Aspirin)
-patients without a native papilla
-Active peptic ulcer disease

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 442 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 443 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 444 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [4] 445 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 6204 0
5000 - Adelaide
Recruitment postcode(s) [2] 6205 0
5011 - Woodville
Recruitment postcode(s) [3] 6206 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 6207 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 286590 0
Hospital
Name [1] 286590 0
Department of Gastroenterology and Hepatology
Country [1] 286590 0
Australia
Primary sponsor type
Individual
Name
Vinh-An Phan
Address
Department of Gastroenterology and Hepatology
Ward Q7
Royal Adelaide Hospital
North Terrace
Adelaide CBD
South Australia 5000
Country
Australia
Secondary sponsor category [1] 285373 0
Individual
Name [1] 285373 0
Mark Schoeman
Address [1] 285373 0
Department of Gastroenterology and Hepatology
Ward Q7
Royal Adelaide Hospital
North Terrace
Adelaide CBD
South Australia 5000
Country [1] 285373 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288664 0
Research Ethics Committee
Ethics committee address [1] 288664 0
Ethics committee country [1] 288664 0
Australia
Date submitted for ethics approval [1] 288664 0
25/01/2013
Approval date [1] 288664 0
Ethics approval number [1] 288664 0

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

Contacts
Principal investigator
Name 37182 0
Dr Vinh-An Phan
Address 37182 0
Department of Gastroenterology and Hepatology
Ward Q7
Royal Adelaide Hospital
North Terrace
Adelaide CBD
SA 5000
Country 37182 0
Australia
Phone 37182 0
+61 08 82224000
Fax 37182 0
Email 37182 0
[email protected]
Contact person for public queries
Name 37183 0
Vinh-An Phan
Address 37183 0
Department of Gastroenterology and Hepatology
Ward Q7
Royal Adelaide Hospital
North Terrace
Adelaide CBD
SA 5000
Country 37183 0
Australia
Phone 37183 0
+61 08 82224000
Fax 37183 0
Email 37183 0
[email protected]
Contact person for scientific queries
Name 37184 0
Vinh-An Phan
Address 37184 0
Department of Gastroenterology and Hepatology
Ward Q7
Royal Adelaide Hospital
North Terrace
Adelaide CBD
SA 5000
Country 37184 0
Australia
Phone 37184 0
+61 08 82224000
Fax 37184 0
Email 37184 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.