Endoscopic cutting of the constrictor (sphincter) muscle of the bile ducts before placement of a metal tube (stent) to lower the risk of an inflammation of the pancreas

Endoscopic sphincterotomy before fully covered self-expandable metal stent placement for malignant extrahepatic biliary obstruction to prevent pancreatitis: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21209

Enrollment

518

Registered

2015-07-09

Start date

2016-05-03

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Malignant biliary obstruction Endoscopic biliary sphincterotomy Post-ERCP pancreatitis

Interventions

ERCP met sfincterotomie en gecoverde metalen stent&nbsp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Indication for fully covered self-expandable metal stent placement - (Suspected) malignant biliary outflow obstruction - Biliary stenosis located = 2 cm distal from the hilum - Age = 18 years - Written informed consent for the procedure and study participation

Exclusion criteria

Exclusion criteria: - Hilar biliary obstruction, defined as stenosis located within 2 cm of the hilum - Biliary SEMS or more than 1 plastic endoprothesis in situ - Precut sphincterotomy or standard sphincterotomy - Prophylactic pancreatic duct stent, even when the PD-stent is subsequently removed - Continued use of anticoagulants or antiplatelet drugs with the exception of low-dose aspirin (max. 100mg/day) - Known clotting disorder - Patients unable to provide written consent for the study

Design outcomes

Primary

Measure	Time frame
Incidence of post-ERCP pancreatitis	—

Secondary

Measure	Time frame
- 30-days ERCP-related morbidity - 30 days stent-related morbidity - 30 days mortality - Technical success of stent placement	—

Contacts

Public ContactE.E. Halsema, van

e.e.halsemavan@amc.nl+31(0)205668708

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)