NCT02916199

Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method

Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method in Patients With High Risk of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicenter Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

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 biliary disease 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 description

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.

Conditions

• Common Bile Duct Stone
• Malignant Hepatobiliary Neoplasm
• Biliary Stricture
• Pancreatic Diseases
• Sphincter of Oddi Dysfunction

Interventions

Type	Name	Description
DEVICE	cannulation of ampulla of Vater	Cannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices

Timeline

• Start date: 2016-10-04
• Primary completion: 2017-11-28
• Completion: 2017-11-28
• First posted: 2016-09-27
• Last updated: 2019-01-30

Locations

7 sites across 1 country: South Korea