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Covered metal biliary stents and risk of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis

Covered metal biliary stents and risk of post-ERCP pancreatitis in patients with biliary disease: A multicenter retrospective cohort study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622001390774
Enrollment
2269
Registered
2022-10-31
Start date
2020-06-01
Completion date
2020-08-01
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 proph

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).

Sponsors

Liverpool Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients undergoing ERCP for biliary indications between October 2016 and October 2019

Exclusion criteria

Patients undergoing ERCP for primary pancreatic indications (such as pancreatic duct strictures or stones) Procedures aborted prior to attempted biliary cannulation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026