Is the Isolated-Tip Needle-Knife Precut as Effective as Conventional Precut Fistulotomy in Difficult Biliary Cannulation?

• Published in: Gut and liver Vol. 12; no. 5; pp. 597 - 605
• Main Authors: Lee, Tae Hoon, Park, Sang-Heum, Yang, Jae Kook, Han, Su Jung, Park, Suyeon, Choi, Hyun Jong, Lee, Yun Nah, Cha, Sang-Woo, Moon, Jong Ho, Cho, Young Deok
• Format: Journal Article
• Language: English
• Published: Korea (South) Editorial Office of Gut and Liver 01.09.2018; Gastroenterology Council for Gut and Liver; 거트앤리버 소화기연관학회협의회
• Subjects: Aged; Ampulla of Vater - surgery; biliary; cannulation; Catheterization - instrumentation; Catheterization - methods; Cholangiopancreatography, Endoscopic Retrograde - instrumentation; Cholangiopancreatography, Endoscopic Retrograde - methods; Feasibility Studies; Female; Humans; iso-tome; Male; Middle Aged; needle-knife; Needles; Original; precut; Prospective Studies; Sphincterotomy, Endoscopic - instrumentation; Sphincterotomy, Endoscopic - methods; Surgical Instruments; Treatment Outcome; 내과학; Cannulation; Needle-knife; Iso-Tome; Precut; Biliary
• ISSN: 1976-2283; 2005-1212
• DOI: 10.5009/gnl17572

Needle-knife precut fistulotomy (NK-F) is a well-known freehand technique for difficult biliary cannulation (DBC). Another approach involves the use of Iso-Tome , a modified precutting device with an insulated needle tip to prevent direct thermal injury. This comparative study aimed to evaluate the efficacy of the Iso-Tome precut (IT-P) compared to that of NK-F for DBC. Patients with a naïve papilla who underwent early IT-P or NK-F for DBC were enrolled. DBC was defined as failure to achieve selective biliary access by wire-guided cannulation despite 5 minutes of attempted cannulation, ≥5 papillary contacts, or a hooknose-shaped papilla. The primary endpoint was the primary technical success rate, which was based on a noninferiority model. A total of 239 DBC cases were enrolled. The primary technical success rates were 74.7% (89/119) in the IT-P group and 91.6% (110/120) in the NK-F group (lower limit of 90% confidence interval, -0.23; p=0.927 for a noninferiority margin of 10%). The total technical success rates were 87.4% and 95.0%, respectively (p=0.038). The mean precutting times for successful biliary access were 11.2 minutes for IT-P and 7.3 minutes for NK-F (p<0.01). The procedure-related adverse event rates were 9.2% for IT-P and 5.8% for NK-F (p=0.318). The rates of post-endoscopic retrograde cholangiopancreatography pancreatitis were 4.2% and 2.5%, respectively (p=0.499). IT-P failed to exhibit noninferiority compared with NK-F regarding the primary technical success rate of DBC, but there was no difference in the frequency of adverse events.