1. One-step versus two-step distal self-expandable metal stent placement: A multicenter prospective randomized trial
- Author
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Yuji Nishi, Hiroki Takada, Itaru Naitoh, Hiromi Kataoka, Katsuyuki Miyabe, Michihiro Yoshida, Hiromu Kondo, Kazuki Hayashi, Kaiki Anbe, Atsuyuki Hirano, Shuya Shimizu, Kenichi Haneda, Fumihiro Okumura, and Hitoshi Sano
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Two step ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Pancreatic cancer ,Medicine ,Humans ,Prospective Studies ,Adverse effect ,Chemotherapy ,Cholestasis ,Hepatology ,business.industry ,Gastroenterology ,Stent ,Bilirubin ,medicine.disease ,Surgery ,Clinical trial ,Stent placement ,030220 oncology & carcinogenesis ,030211 gastroenterology & hepatology ,Stents ,Neoplasm Recurrence, Local ,business - Abstract
BACKGROUND AND AIM Two methods of transpapillary covered self-expandable metal stent (SEMS) placement are used for distal malignant biliary obstruction (MBO): after initial drainage by plastic stent (two-step method) and without previous drainage (one-step method). METHODS In total, 90 patients with unresectable pancreatic cancer and distal MBO were enrolled in this prospective multicenter randomized study and allocated to one-step (n = 45) and two-step (n = 45) groups. The main outcome was the time to recurrent biliary obstruction (TRBO). Secondary outcomes were the rates of early and late adverse events, survival time, the time required for bilirubin level reduction, and cost-effectiveness. RESULTS The median TRBO did not differ significantly between the one-step and two-step groups (not available vs 314 days, P = 0.134). SEMS migration occurred significantly more frequently in the two-step group (14.3% vs 0%, P = 0.026). No significant difference was observed between groups in early (7.3% vs 14.3%, P = 0.483) or late (12.2% and 11.9%, P = 1) adverse events other than RBO, survival time (P = 0.104), or the median number of days required to reach a bilirubin level considered to be acceptable for chemotherapy administration (
- Published
- 2020