ArticleTrials2022
Fistulotomy versus standard cannulation as the primary technique for all patients undergoing ERCP with a native papilla: a protocol for a single center randomized controlled trial.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04559867 (Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial
Who cites it
1 citing paper in PubMed, 3 citations in OpenAlex.
- Cutting Edge Access: Needle Knife Fistulotomy for Difficult Biliary Cannulation.Current gastroenterology reports · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEndoscopic 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.
methodsA 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 registrationClinicalTrials.gov NCT04559867 . Registered on September 23, 2020.
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