Clinical Trial: Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method in Patients With High Risk of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicenter Randomized Control
Brief Summary: The aim of this study are to evaluate the feasibility of needle knife fistulotomy (NKF) as an initial procedure for biliary access in patients with common bile duct stones who are at increased risk for post-endoscopic retrograde endoscopic retrograde cholangiopancreatography (PEP) and to assess the incidence rate of complications including PEP between NKF and conventional cannulation methods.
Detailed Summary: Endoscopic retrograde endoscopic retrograde cholangiopancreatography (ERCP) is widely used for the diagnosis and treatment of pancreatic and biliary tract disease. However, post-ERCP pancreatitis (PEP) is the most common adverse event following the procedure, ranging from 2% to 10% in nonselective cases, and it can cause substantial morbidity, mortality, or high medical costs. Recent advances in cannulation technique and accessories for biliary cannulation have contributed to reduce the incidence of PEP, but biliary cannulation can fail in 5% to 20% of cases of ERCP. Suprapapillary needle-knife fistulotomy (NKF), with or without large-diameter balloon dilation, has been used as a rescue method in cases of difficult biliary cannulation, and NKF was recommended as an initial approach to selective biliary cannulation in cases of repetitive unintentional pancreatic cannulation.9 Moreover, difficult biliary cannulation is known to be a risk factor for PEP, and it has been reported that NKF is associated with a low risk of PEP. Thus, we hypothesized that NKF may reduce the risk of PEP in patients who are at increased risk for PEP.
Sponsor: Hallym University Kangnam Sacred Heart Hospital
Current Primary Outcome: Incidence rate of post-endoscopic retrograde cholangiopancreatography [ Time Frame: 1 week ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence rate of complications including bleeding, perforation and infection [ Time Frame: 1 week ]
- Success rate of cannulation [ Time Frame: 1 day ]
- Success rate of stone removal [ Time Frame: 1 day ]
Original Secondary Outcome: Same as current
Information By: Hallym University Kangnam Sacred Heart Hospital
Dates:
Date Received: September 24, 2016
Date Started: September 2016
Date Completion: December 2017
Last Updated: September 25, 2016
Last Verified: September 2016
