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Gut Liver. 2018 Sep 15;12(5):597-605. doi: 10.5009/gnl17572.

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

Author information

1
Department of Internal Medicine, Soonchunhyang University School of Medicine, Cheonan, Korea.
2
Department of Biostatistics, Soonchunhyang University School of Medicine, Seoul, Korea.
3
Department of Internal Medicine, Soonchunhyang University School of Medicine, Bucheon, Korea.
4
Department of Internal Medicine, Soonchunhyang University School of Medicine, Seoul, Korea.

Abstract

Background/Aims:

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.

Methods:

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.

Results:

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).

Conclusions:

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.

KEYWORDS:

Biliary; Cannulation; Iso-Tome; Needle-knife; Precut

PMID:
29730907
PMCID:
PMC6143454
DOI:
10.5009/gnl17572
[Indexed for MEDLINE]
Free PMC Article

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