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

Completed

• Conditions: Post-ERCP pancreatitis; 10017969; 10017991

• Registration Number: NL-OMON55849
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 511

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

• 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. 100 mg/day)
• Known clotting disorder
• Patients unable to provide written consent for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of post-ERCP pancreatitis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- 30-day morbidity related to ERCP (with or without sphincterotomy)<br /><br>- Technical success of stent placement<br /><br>- Stent-related 30-day morbidity<br /><br>- 30-day mortality</p><br>