Is the Isolated-Tip Needle-Knife Precut as Effective as Conventional Precut Fistulotomy in Difficult Biliary Cannulation?
- 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.
- All Author(s)
- T. H. Lee
; S. H. Park
; J. K. Yang
; S. J. Han
; S. Park
; H. J. Choi
; Y. N. Lee
; S. W. Cha
; J. H. Moon
; Y. D. Cho
- Issued Date
- 2018
- Type
- Article
- Keyword
- Cannulation; Biliary; Precut; Iso-Tome; Needle-knife
- Publisher
- 대한소화기학회
- ISSN
- 1976-2283
- Citation Title
- Gut and Liver
- Citation Volume
- 12
- Citation Number
- 5
- Citation Start Page
- 597
- Citation End Page
- 605
- Language(ISO)
- eng
- DOI
- 10.5009/gnl17572
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/2972
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