16 - Advancing The Paradigm: Ultra-Early Fistulotomy In Biliary Access During ERCP

João Fernandes, MD¹, Rita Ribeiro, MD², Alda Andrade, MD², Isabel Tarrio, MD², Tarcísio Araújo, MD², Patrício Costa, PhD³, Jorge Canena, MD, PhD⁴, Luís Lopes, MD, PhD, MBA^5
1ULS Alto Minho; ICVS – Life and Health Sciences Research Institute and ICVS/3B’s; ULS Cova da Beira, Viseu, Viseu, Portugal; ²ULS Alto Minho, Viana do Castelo, Viana do Castelo, Portugal; ³ICVS – Life and Health Sciences Research Institute and ICVS/3B’s, Viana do Castelo, Viana do Castelo, Portugal; ⁴University Department of Gastroenterology - CUF Tejo Hospital - Nova Medical School; Amadora Sinta Hospital, Lisbon, Lisboa, Portugal; ⁵ULS Alto Minho; ICVS – Life and Health Sciences Research Institute and ICVS/3B’s, Viana do Castelo, Viana do Castelo, Portugal

Introduction: A recent randomized trial (RCT) with no post-ERCP pancreatitis (PEP) prevention suggested superiority of primary needle-knife fistulotomy (NKF) for PEP rate and canulation rate when compared to conventional cannulation methods (CCM). However, in the real clinical scenario, most of endoscopists try to use CCM in all naïve papillae at least for one/two attempts before switching for NKF (ultra-early NKF). The aim of this study was to compare UE-NKF versus CCM for biliary access in a population with different risk factors for PEP.

Methods: 370 patients were prospectively and randomly allocated to one of two groups accordingly with the technique of cannulation: ultra-early NKF (UE-NKF) versus CCM. All patients in UE-NKF group were allowed a real-life scenario effect (up to two CCM attempts and lasting less than two minutes before switching to NKF). Patients with flat papillae or diverticular papillae were excluded from the study. PEP prevention was used in all cases. We compared incidence of adverse events, including PEP, biliary access rates and procedural times.

Results: There were no differences in mean number of PEP risk factors between groups (UE-NKF 1,34+1,02; CCM 1,51+1.03). The cannulation success rate was 70.62% for the CCM strategy, compared to 94.19% for the UE-NKF strategy (p< 0.001). The average cannulation time for the CCM strategy was 3 minutes and 19 seconds, compared to 5 minutes and 10 seconds for the UE-NKF strategy. The overall adverse event rate was 17.52% for the CCM group, compared to 13.5% for the UE-NKF strategy. The PEP rate was 9.49% for the CCM strategy and 6.13% for the UE-NKF strategy (p< 0.01).

Discussion: The UE-NKF strategy is associated with a significant higher rate of biliary access and a lower rate of complications namely PEP. The use of UE-NKF may be recommended as a future strategy of biliary cannulation.

ClinicalTrials.gov ID NCT04492137


Disclosures:


João Fernandes, MD¹, Rita Ribeiro, MD², Alda Andrade, MD², Isabel Tarrio, MD², Tarcísio Araújo, MD², Patrício Costa, PhD³, Jorge Canena, MD, PhD⁴, Luís Lopes, MD, PhD, MBA⁵, 16, Advancing The Paradigm: Ultra-Early Fistulotomy In Biliary Access During ERCP, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.