Journal of gastroenterology and hepatology · 2026
Prospective Clinical Evaluation of a Novel Repositionable Plastic Stent for Endosonography-Guided Hepaticogastrostomy With or Without Antegrade Stenting (With Videos).
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Mukai Shuntaro, Sofuni Atsushi, Tsuchiya Takayoshi, Tanaka Reina, Tonozuka Ryosuke, Matsunami Yukitoshi, Nagai Kazumasa, Kojima Hiroyuki, Minami Hirohito, Hirakawa Noriyuki, Asano Kyoko, Shionoya Kento, Itoi Takao
Аннотация
BACKGROUND AND STUDY AIMS: A repositionable plastic stent (PS), developed to overcome the limitations of conventional pusher-type PS in endosonography-guided hepaticogastrostomy (EUS-HGS), minimizes the gap between the inner sheath and stent to improve insertability. This prospective single-center study evaluated its feasibility, safety, and clinical effectiveness in malignant and benign biliary diseases.
PATIENTS AND METHODS: Between August 2022 and August 2024, 100 consecutive patients undergoing EUS-HGS using the repositionable PS were enrolled. Mechanical tract dilation was performed, and antegrade metal stenting was added when feasible.
RESULTS: Trainees performed 76% of the procedures. The median bile duct diameter was 4.3 mm. Technical and functional success rates were 99% and 93.9%, respectively, without need for cautery dilation. Initial PS advancement failed in two benign cases with rigid bile ducts; the stent system was pulled back for additional dilation, enabling successful placement. Adverse events occurred in 10% of cases (biliary peritonitis, 6; cholangitis, 2; biloma from early stent bending, 1; bleeding, 1), all manageable, with intervention required in two cases. No stent migration occurred during the first month after insertion. Recurrent biliary obstruction developed in 24 cases, all with successful reintervention. Median time to recurrence of biliary obstruction was significantly longer for EUS-HGS combined with antegrade stenting than for EUS-HGS alone (389 vs. 168 days, p < 0.001).
CONCLUSIONS: This repositionable PS enables safe, effective EUS-HGS using mechanical dilation alone and corrective pullback for difficult cases. Its controlled deployment and reliable reintervention support its usefulness in both malignant and benign biliary diseases.
PATIENTS AND METHODS: Between August 2022 and August 2024, 100 consecutive patients undergoing EUS-HGS using the repositionable PS were enrolled. Mechanical tract dilation was performed, and antegrade metal stenting was added when feasible.
RESULTS: Trainees performed 76% of the procedures. The median bile duct diameter was 4.3 mm. Technical and functional success rates were 99% and 93.9%, respectively, without need for cautery dilation. Initial PS advancement failed in two benign cases with rigid bile ducts; the stent system was pulled back for additional dilation, enabling successful placement. Adverse events occurred in 10% of cases (biliary peritonitis, 6; cholangitis, 2; biloma from early stent bending, 1; bleeding, 1), all manageable, with intervention required in two cases. No stent migration occurred during the first month after insertion. Recurrent biliary obstruction developed in 24 cases, all with successful reintervention. Median time to recurrence of biliary obstruction was significantly longer for EUS-HGS combined with antegrade stenting than for EUS-HGS alone (389 vs. 168 days, p < 0.001).
CONCLUSIONS: This repositionable PS enables safe, effective EUS-HGS using mechanical dilation alone and corrective pullback for difficult cases. Its controlled deployment and reliable reintervention support its usefulness in both malignant and benign biliary diseases.