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. 2021 Nov 12;9(11):E1801-E1810.
doi: 10.1055/a-1526-1208. eCollection 2021 Nov.

Common bile duct size in malignant distal obstruction and lumen-apposing metal stents: a multicenter prospective study

Mihai Rimbaş  1   2 , Andrea Anderloni  3 , Bertrand Napoléon  4 , Andrada Seicean  5 , Edoardo Forti  6 , Stefano Francesco Crinò  7 , Ilaria Tarantino  8 , Paolo Giorgio Arcidiacono  9 , Carlo Fabbri  10 , Gianenrico Rizzatti  1   11 , Arnaldo Amato  12 , Theodor Voiosu  13   2 , Alessandro Fugazza  3 , Ofelia Moșteanu  5 , Àngels Ginès  14 , Germana de Nucci  15 , Pietro Fusaroli  16 , Nam Quoc Nguyen  17 , Roberto Di Mitri  18 , Leonardo Minelli Grazioli  19 , Massimiliano Mutignani  6 , Livia Archibugi  9 , Cecilia Binda  10 , Anna Cominardi  16 , Carmelo Barbera  20 , Glòria Fernández-Esparrach  14 , Laurent Palazzo  21 , Maxime Palazzo  22 , Jan Werner Poley  23 , Cristiano Spada  1   19 , Giorgio Valerii  20 , Takao Itoi  24 , Yukitoshi Matsunami  24 , Radu Bogdan Mateescu  13   2 , Cristian Băicuș  2 , Guido Costamagna  1   11 , Alberto Larghi  1   11
Affiliations

Common bile duct size in malignant distal obstruction and lumen-apposing metal stents: a multicenter prospective study

Mihai Rimbaş et al. Endosc Int Open. .

Abstract

Background and study aims Feasibility of EUS-guided choledochoduodenostomy (EUS-CDS) using available lumen-apposing stents (LAMS) is limited by the size of the common bile duct (CBD) (≤ 12 mm, cut-off for experts; 15 mm, cut-off for non-experts). We aimed to assess the prevalence and predictive factors associated with CBD size ≥ 12 and 15 mm in naïve patients with malignant distal biliary obstruction (MDBO). Patients and methods This was a prospective cohort study involving 22 centers with assessment of CBD diameter and subjective feasibility of the EUS-CDS performance in naïve jaundiced patients undergoing EUS evaluation for MDBO. Results A total of 491 patients (mean age 69 ± 12 years) with mean serum bilirubin of 12.7 ± 6.6 mg/dL entered the final analysis. Dilation of the CBD ≥ 12 and 15 mm was detected in 78.8 % and 51.9 % of cases, respectively. Subjective feasibility of EUS-CDS was expressed by endosonographers in 91.2 % for a CBD ≥ 12 mm and in 96.5 % for a CBD ≥ 15 mm. On multivariate analysis, age ( P < 0.01) and bilirubin level ( P ≤ 0.001) were the only factors associated with both CBD dilation ≥ 12 and ≥ 15 mm. These variables were poorly associated with the extent of duct dilation; however, based on them a prediction model could be constructed that satisfactorily predicted CBD size ≥ 12 mm in patients at least 70 years and a bilirubin level ≥ 7 mg/dL. Conclusions Our study showed that at presentation in a large cohort of patients with MDBO, EUS-CDS can be potentially performed in three quarters to half of cases by expert and less experienced endosonographers, respectively. Dedicated stents or devices with different designs able to overcome the limitations of existing electrocautery-enhanced LAMS for EUS-CDS are needed.

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Conflict of interest statement

Competing interests Dr. Anderloni is a consultant for Boston Scientific, Olympus Medical and Medtronic. Dr. Fabbri is a consultant for Boston Scientific. Dr. Napoleon has held supported teaching sessions and had research collaboration with Boston Scientific. Dr. Poley served as a consultant for and received speaker and travel fees from Boston Scientific, Cook Endoscopy, and Pentax. Dr. Mutignani had a research collaboration with Boston Scientific. Dr. Palazzo is a consultant for Boston Scientific. Dr. Itoi is a speaker for Boston Scientific. Dr. Costamagna received research support from Cook Endoscopy and he currently is a member of Advisory Committees or review panels for Olympus Medical and Boston Scientific. Dr. Larghi received educational fees from Boston Scientific and Pentax.

Figures

Fig. 1
Fig. 1
Measurement of the common bile duct (CBD) diameter at the theoretical site of choledochoduodeno-anastomosis with the AXIOS Stent and Electrocautery Enhanced Delivery System. a Identification of the obstructive tumor (arrow). b, c Tracing of the common bile duct from the obstructive tumor upwards (*). d Identification of the suitable site for EUS-guided choledocoduodenostomy where measurement of the CBD diameter is performed ( a ).
Fig. 2
Fig. 2
Flowchart of the study.
Fig. 3
Fig. 3
Chart detailing the distribution of patients per extent of common bile duct (CBD) dilation.
See this image and copyright information in PMC

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