Trial reportGut and liver2018
Is the Isolated-Tip Needle-Knife Precut as Effective as Conventional Precut Fistulotomy in Difficult Biliary Cannulation?
Trial report in Gut and liver, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.
- Meta-analysis of the effectiveness of early endoscopic treatment of Acute biliary pancreatitis based on lightweight deep learning model.BMC gastroenterology · 2024Pooled it
- Rescue cannulation techniques in difficult biliary access-A comprehensive review.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2025Review
- Efficacy of a Newly Developed Guidewire for Selective Biliary Cannulation: A Multicenter Randomized Controlled Trial.Journal of clinical medicine · 2023Article
- Success and Safety of Needle Knife Papillotomy and Fistulotomy Based on Papillary Anatomy: A Prospective Controlled Trial.Digestive diseases and sciences · 2022Article
- Cannulation procedure optimization for patients with duodenal papillary tumors.Surgical endoscopy · 2021Article
- Primary needle-knife fistulotomy for preventing post-endoscopic retrograde cholangiopancreatography pancreatitis: Importance of the endoscopist's expertise level.World journal of clinical cases · 2021Article
- Risk Factors for Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: Evidence from 1786 Cases.Medical science monitor : international medical journal of experimental and clinical research · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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 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.
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