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Fistulotomy versus standard cannulation as the primary technique for all patients undergoing ERCP with a native
Lawrence Hookey1, Mandip Rai1, Robert Bechara2
1Department of Medicine, Division of Gastroenterology, Queen's University, Kingston, Ontario, Canada.
Insights
This study will compare the needle-knife fistulotomy (NKF) technique to standard cannulation for Endoscopic Retrograde Cholangiopancreatography (ERCP). The goal is to determine if NKF reduces the risk of post-ERCP pancreatitis (PEP).
Area of Science:
- Gastroenterology
- Endoscopy
- Surgical Innovation
Background:
- Post-ERCP pancreatitis (PEP) is a significant risk following Endoscopic Retrograde Cholangiopancreatography (ERCP).
- Difficulty in achieving biliary access is a known risk factor for PEP.
- The needle-knife fistulotomy (NKF) technique offers a novel approach to biliary access, potentially minimizing thermal damage and PEP risk.
Purpose of the Study:
- To compare the efficacy and safety of initial NKF versus standard cannulation for biliary access in ERCP.
- To evaluate NKF as a primary technique for gaining biliary access.
- To assess the potential of NKF to reduce the incidence of PEP.
Main Methods:
- A randomized controlled trial involving 538 non-selective patients undergoing ERCP.
- Patients will be randomized to either standard cannulation or the NKF technique.
- Primary outcome is the incidence of PEP; secondary outcomes include cannulation success rates, time, and complication incidence.
Main Results:
- This section is to be filled after the study's completion.
Conclusions:
- This randomized controlled trial is expected to provide critical data on the effectiveness and safety of the NKF technique.
- Results could potentially lead to a shift in ERCP practices, aiming to reduce PEP incidence.
- The study will clarify the role of NKF as an initial approach for biliary access in ERCP.
Background:
Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable procedure for the management of pancreaticobiliary diseases. Post-ERCP pancreatitis (PEP) is the most common serious adverse event. One risk factor of PEP is difficulty achieving biliary access. The conventional ERCP technique involves the cannulation of the bile duct via the ampulla of Vater, followed by sphincter incision using electrocautery. Conventionally, if the standard method fails then, precut techniques have been utilized as an alternative means of gaining biliary access. The needle-knife fistulotomy (NKF) technique involves identifying the intra-duodenal segment of the bile duct and uses a needle knife to incise directly into the bile duct. This is done above and away from the natural office, thus minimizing thermal damage which may result in PEP. Our recent prospective study of 50 patients demonstrated the safety and feasibility of the NKF precut technique as a primary means of gaining biliary access. The next step is to conduct a randomized controlled trial to compare the efficacy and safety of initial NKF to the standard cannulation in a non-selective patient population undergoing ERCP.
Methods:
A randomized control trial of 538 consecutive, non-selective patients with pancreaticobiliary disease undergoing ERCP at a tertiary care center in Kingston, Ontario, Canada, will be conducted. Patients will be randomized to one of two treatment groups, standard cannulation or NKF. The primary outcome of the study will be the incidence of PEP. Secondary outcomes will include rate of successful cannulation of the common bile duct (CBD), time to successful cannulation, total procedure time, difficulty of cannulation, and incidence of complications.
Discussion:
This RCT will yield important answers regarding the efficacy and safety of initial NKF to the standard cannulation in a non-selective patient population undergoing ERCP. The results of our study could alter ERCP practices and outcomes if NKF is shown to reduce PEP risk.
Trial Registration:
ClinicalTrials.gov NCT04559867 . Registered on September 23, 2020.
