Status:
COMPLETED
A Trial of 0.025 Wire Guided Cannulation Versus Current Practice 0.035 Wire Guided Cannulation
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Abdominal Pain
Post-ERCP Acute Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to determine whether using a smaller wire results in a higher success rate at endoscopic retrograde cholangiopancreatography (ERCP), and lower incidence of adverse events
Detailed Description
Cannulation of the bile duct is a prerequisite to successful therapeutic biliary endoscopy. Cannulation itself can carry substantial risk to the patient. Acute pancreatitis following ERCP can occur up...
Eligibility Criteria
Inclusion
- All patients referred for ERCP who have an intact naïve papilla are considered for inclusion
Exclusion
- Age \<18yrs
- Acute illness (hypotension: BP\<90mmHg, hypoxia: O2 \<95%, haemodynamic instability)
- Inability or refusal to give informed consent.
- Patients with previous sphincterotomy
- Pancreatic or ampullary cancer are excluded as post-ERCP pancreatitis (PEP) is very uncommon in these subgroups and tumour-related anatomical variation may alter cannulation technique.
- (consider substratify results for this subgroup, but exclude if duodenal stenosis precludes an attempt on the papilla)
- Patients with surgically altered anatomy (Bilroth II gastrectomy and Roux en Y anastomosis) are excluded as cannulation technique is fundamentally different from that in normal anatomy.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT01408264
Start Date
August 1 2010
End Date
December 1 2012
Last Update
July 31 2013
Active Locations (1)
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1
Endoscopy Centre, Prince of Wales Hospital
Hong Kong, China