Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001390774
Ethics application status
Approved
Date submitted
4/10/2022
Date registered
31/10/2022
Date last updated
31/10/2022
Date data sharing statement initially provided
31/10/2022
Date results information initially provided
31/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Covered metal biliary stents and risk of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis
Scientific title
Covered metal biliary stents and risk of post-ERCP pancreatitis in patients with biliary disease: A multicenter retrospective cohort study
Secondary ID [1] 308112 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatitis 327816 0
Biliary disease 327817 0
Condition category
Condition code
Oral and Gastrointestinal 324890 324890 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a multicenter retrospective cohort study involving tertiary referral centers in Australia. Consecutive adult patients who underwent ERCP for biliary indications between October 2016 and October 2019 were included in the study. Primary pancreatic indications (such as pancreatic duct strictures or stones) and procedures aborted prior to attempted cannulation were excluded. Procedural decisions including endoscopic biliary sphincterotomy, stent choice and use of post-ERCP pancreatitis prophylaxis were at the discretion of the treating endoscopist.
Data was collected by electronic chart review only, with no participant involvement required. Clinical characteristics, procedural information, and any post-procedural adverse events were collected from electronic chart review at each center. The primary endpoint was rate of post-ERCP pancreatitis (within 30 days post-procedure). Secondary endpoints included severity of pancreatitis, other procedure-related adverse events (bleeding, perforation, cholangitis; occurring within 30 days post-procedure) and stent-related adverse events occurring within 90 days post-procedure (stent migration or stent occlusion).
Intervention code [1] 324561 0
Diagnosis / Prognosis
Comparator / control treatment
Patients who underwent ERCP with use of fully-covered self-expanding metal stents will be compared to the following groups
- Patients who underwent ERCP without placement of stents
- Patients who underwent ERCP with placement of plastic stents
- Patients who underwent ERCP with placement of uncovered self-expanding metal stents
Control group
Active

Outcomes
Primary outcome [1] 332695 0
Rate of post-ERCP pancreatitis
This will be determined by review of electronic medical record and defined according to Cotton criteria (new or worsened abdominal pain and amylase >3 times normal limit)
Timepoint [1] 332695 0
Occurring within 30 days post-procedure
Secondary outcome [1] 414387 0
Severity of pancreatitis as determined by electronic medical record review and defined by Cotton criteria
Timepoint [1] 414387 0
Within 30 days post-procedure
Secondary outcome [2] 414388 0
Procedure related adverse events (bleeding, perforation, cholangitis) as determined by electronic medical record review
Timepoint [2] 414388 0
Within 30 days post-procedure
Secondary outcome [3] 414389 0
Stent-related adverse events (stent migration or stent occlusion) as determined by electronic medical record review
Timepoint [3] 414389 0
Occurring within 90 days post-procedure

Eligibility
Key inclusion criteria
Adult patients undergoing ERCP for biliary indications between October 2016 and October 2019
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing ERCP for primary pancreatic indications (such as pancreatic duct strictures or stones)
Procedures aborted prior to attempted biliary cannulation

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2020
Date of last participant enrolment
Anticipated
Actual
1/08/2020
Date of last data collection
Anticipated
Actual
1/08/2020
Sample size
Target
2000
Accrual to date
Final
2269
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 312367 0
Hospital
Name [1] 312367 0
Liverpool Hospital
Country [1] 312367 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
75 Elizabeth St, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 313932 0
None
Name [1] 313932 0
Address [1] 313932 0
Country [1] 313932 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311727 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 311727 0
Liverpool Hospital Eastern Campus
52 Scrivener Street
LIVERPOOL NSW 2170
Ethics committee country [1] 311727 0
Australia
Date submitted for ethics approval [1] 311727 0
Approval date [1] 311727 0
20/05/2020
Ethics approval number [1] 311727 0

Summary
Brief summary
Biliary fully-covered self-expanding metal stents are increasingly used over plastic or uncovered self-expanding metal stents due to their long-term patency and removability. However, there is concern that their placement across the papilla may lead to post-ERCP pancreatitis. Thus, this study aimed to assess the rates of post-ERCP pancreatitis with and without the use of fully-covered self-expanding metal stents for both benign and malignant indications. Our hypothesis for this study was that the use of fully-covered self-expanding metal stents would be associated with a higher risk of post-ERCP pancreatitis.
This is a retrospective study involving three Australian tertiary referral centers. Consecutive adults who underwent ERCP for biliary indications between October 2016-October 2019 were included. We analysed the rate of post-ERCP pancreatitis, severity of pancreatitis, other procedure- and stent-related adverse events occurring within 90 days.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122150 0
Dr Milan Bassan
Address 122150 0
Liverpool Hospital
75 Elizabeth St, Liverpool NSW 2170
Country 122150 0
Australia
Phone 122150 0
+61 02 8738 4085
Fax 122150 0
Email 122150 0
milan.bassan@health.nsw.gov.au
Contact person for public queries
Name 122151 0
Dr Milan Bassan
Address 122151 0
Liverpool Hospital
75 Elizabeth St, Liverpool NSW 2170
Country 122151 0
Australia
Phone 122151 0
+61 02 8738 4085
Fax 122151 0
Email 122151 0
milan.bassan@health.nsw.gov.au
Contact person for scientific queries
Name 122152 0
Dr Milan Bassan
Address 122152 0
Liverpool Hospital
75 Elizabeth St, Liverpool NSW 2170
Country 122152 0
Australia
Phone 122152 0
+61 02 8738 4085
Fax 122152 0
Email 122152 0
milan.bassan@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.