Needle-Knife Fistulotomy is Safe During ERCP, Even for Trainees
FROM TECHNIQUES AND INNOVATIONS IN GASTROINTESTINAL ENDOSCOPY
, based on results of a randomized trial.
Across procedures conducted predominantly by trainees, safety outcomes were similar between NKF and standard cannulation, and all patients were successfully cannulated, suggesting this is a broadly accessible technique, reported lead author Aleksey Novikov, MD, of the University of Florida College of Medicine, Gainesville, and colleagues, reported.
Writing in Techniques and Innovations in Gastrointestinal Endoscopy, the investigators noted that standard cannulation fails in 5-20% of cases, which has led to development of various alternative techniques, including NKF. To perform the technique, the endoscopist makes a small incision in the intraduodenal biliary segment 3-6mm above the papillary orifice, with cephalad extension until bili-ary access is achieved.
To date, four prospective studies have evaluated NKF in the hands of expert advanced endoscopists.
“These studies showed that NKF is a safe and useful technique that significantly reduces the risk of PEP in the hands of expert advanced endoscopists,” the investigators wrote. ‘The suggestion that NKF should be restricted to expert advanced endoscopists likely limits widespread use.”
To determine whether NKF is a suitable technique for less experienced endoscopists, the investigators conducted the present single-center, prospective randomized controlled trial at Thomas Jefferson University Hospital in Philadelphia.
Adults undergoing ERCP for biliary indications were randomly assigned in a 1:1 ratio to undergo primary cannulation via NKF or standard cannulation. Patients with prior sphincterotomy, ampullectomy, or unfavorable anatomy were excluded.
A total of 186 patients were randomized, with 137 ultimately included in the per-protocol analysis after exclusions for anatomic factors. Most procedures (72.3%) were performed by advanced endoscopy trainees under direct supervision, 26 procedures (19.0%) were performed by attending endoscopists without substantive prior NKF experience, and 12 (8.8%) by an attending endoscopist with NKF expertise.
“It is important to note that the majority of procedures performed in the context of this study were performed by an advanced endoscopy trainee with no NKF experience or an attending advanced endoscopist with minimal NKF experience,” the investigators wrote.
All patients received prophylactic rectal indomethacin, and cannulation attempts were capped at 20 minutes before crossover to another technique was permitted.
The primary endpoint was incidence of post-ERCP pancreatitis. Secondary endpoints included successful biliary access, time to access, and rates of bleeding and perforation.
Post-ERCP pancreatitis occurred at similar rate across groups: 6 cases (8.2%) in the standard cannulation arm and 5 cases (7.8%) in the NKF arm (P = .93). Rates of bleeding and perforation were also similar for both techniques.
Within the initial 20-minute window, biliary access rates were comparable between groups, at 75.3% and 82.2% for standard cannulation and NKF, respectively (P = .89). Allowing additional attempts or crossover, overall success rose to 100% in both arms.
Mean time to access was longer with NKF, averaging 380 seconds compared with 268 seconds for standard cannulation (P less than .05).
“NKF was essentially equivalent to standard cannulation in many aspects,” the investigators wrote, calling the two techniques “complementary.”
They also suggested that the relative equivalence between techniques “carries more weight” after considering the low level of NKF experience among participating endoscopists.
“Overall, our data support teaching advanced endoscopy trainees NKF as a primary method of biliary access in patients with favorable anatomy,” the investigators concluded.
The investigators disclosed relationships with Medtronic, Boston Scientific, and Olympus.