Difficult biliary cannulation: A randomized trial of early needle knife sphincterotomy.

Not Applicable

Completed

• Conditions: Post ERCP pancreatitis; Biliary cannulation success; Post ERCP complications; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12612000060842
• Lead Sponsor: Westmead Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Biliary indication for ERCP
Naive biliary sphincter

Exclusion Criteria

Absence of active pancreatitis
Pancreatic malignancy
Ampullary malignancy
Previous sphincterotomy
Haemodynamically instability

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post ERCP pancreatitis<br>This outcome will be determined by blood tests - amylase and lipase at 24 hours. <br>In the event of post procedural pain, clinical assessment will be performed and blood tests may be performed at an earlier timepoint. A CT scan may be performed if acute pancreatitis is confirmed on blood tests and clinical assessment, as this can suggest the severity of the pancreatitis episode. <br>Patients will be contacted via phone within the first 5 days and again at day 30. Questions will relate to the symptoms of possible complications.[Immediate; at 24 hours; at day 30]

Secondary Outcome Measures

Name	Time	Method
Biliary cannulation success<br>This outcome is assessed at the time of the procedure and confirmed by the use of fluroscopy (XRay) and radio-opaque contrast and wires that identifies the bile duct and biliary tree.[Immediate];Post ERCP complications (non pancreatitis)<br>This outcome is assessed by a combination of clinical assessment, blood tests and imaging.<br>Complications typically occur within the first 14 days, predominantly in the first 24 hours. If there is a clinical suspicion of complications apart from pancreatitis - such as perforation or bleeding, the appropriate imaging and blood tests will be performed for confirmation of the diagnosis.[Immediate; at 24 hours; at day 30]