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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
207
Cannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices
CHA Bundang Medical Center
Seongnam, Bundang-gu, South Korea
Gangnam Severance Hospital
Seoul, Gangnam-gu, South Korea
Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, South Korea
In Ha University Hospital
Incheon, Jung-gu, South Korea
Soon Chun Hyang University Hospital, Cheonan
Cheonan, Namdong-gu, South Korea
Gachon University Gil Medical Center
Incheon, Namdong-gu, South Korea
Pusan National University Hospital
Busan, Seo-gu, South Korea
Incidence rate of post-endoscopic retrograde cholangiopancreatography
Time frame: 1 week
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
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