Tae Jun Song1, Jae Hoon Lee2, Sang Soo Lee1, Ji Woong Jang3, Jung Wook Kim4, Tae Jin Ok1, Dong Wook Oh1, Do Hyun Park1, Dong Wan Seo1, Sung Koo Lee1, Myung-Hwan Kim1, Song Cheol Kim2, Chul Nam Kim5, Sung Cheol Yun6. 1. Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea. 2. Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea. 3. Department of Internal Medicine, Eulgi University College of Medicine, Daejeon, Korea. 4. Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea. 5. Department of Surgery, Inje University Ilsan Paik Hospital, Goyang, Korea. 6. Department of Epidemiology and Biostatistics, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Abstract
BACKGROUND AND AIMS: Preoperative biliary drainage (PBD) with stent placement has been commonly used for patients with malignant biliary obstruction. In PBD, the placement of fully covered self-expandable metal stents (FCSEMSs) may provide better patency duration and a lower incidence of cholangitis compared with plastic stents. We aimed to evaluate which type of stent showed better outcomes in PBD. METHODS: In this multicenter, prospective randomized trial, we compared PBD with FCSEMSs versus plastic stents in 86 patients with malignant biliary obstruction between January 2012 and December 2014. Patients with obstructive jaundice were randomly assigned to undergo PBD either with plastic stents or FCSEMS placement. RESULTS: Baseline characteristics were not significantly different between the 2 groups. Endoscopic stent placement was technically successful in all patients. Procedure-related adverse events were not significantly different between the 2 groups (plastic vs FCSEMS group; 16.3% vs 16.3%, P = 1.0). Reintervention was required in 16.3% of the plastic stent group and 14.0% of the FCSEMS group (P = .763). The interval to surgery after PBD (plastic vs FCSEMS group; 14.2 ± 8.3 vs 12.3 ± 6.9 days, P = .426) was not significantly different between groups. Surgery-related adverse events occurred in 43.6% of the plastic stent group and 40.0% of the FCSEMS group (P = .755). CONCLUSIONS: In patients with resectable malignant biliary obstruction, the outcomes of PBD with plastic stents and FCSEMSs were similar. Considering the cost-effectiveness, PBD with plastic stents may be preferable to FCSEMS placement. (Clinical trial registration number: NCT01789502.).
RCT Entities:
BACKGROUND AND AIMS: Preoperative biliary drainage (PBD) with stent placement has been commonly used for patients with malignant biliary obstruction. In PBD, the placement of fully covered self-expandable metal stents (FCSEMSs) may provide better patency duration and a lower incidence of cholangitis compared with plastic stents. We aimed to evaluate which type of stent showed better outcomes in PBD. METHODS: In this multicenter, prospective randomized trial, we compared PBD with FCSEMSs versus plastic stents in 86 patients with malignant biliary obstruction between January 2012 and December 2014. Patients with obstructive jaundice were randomly assigned to undergo PBD either with plastic stents or FCSEMS placement. RESULTS: Baseline characteristics were not significantly different between the 2 groups. Endoscopic stent placement was technically successful in all patients. Procedure-related adverse events were not significantly different between the 2 groups (plastic vs FCSEMS group; 16.3% vs 16.3%, P = 1.0). Reintervention was required in 16.3% of the plastic stent group and 14.0% of the FCSEMS group (P = .763). The interval to surgery after PBD (plastic vs FCSEMS group; 14.2 ± 8.3 vs 12.3 ± 6.9 days, P = .426) was not significantly different between groups. Surgery-related adverse events occurred in 43.6% of the plastic stent group and 40.0% of the FCSEMS group (P = .755). CONCLUSIONS: In patients with resectable malignant biliary obstruction, the outcomes of PBD with plastic stents and FCSEMSs were similar. Considering the cost-effectiveness, PBD with plastic stents may be preferable to FCSEMS placement. (Clinical trial registration number: NCT01789502.).
Authors: Muhammad Nadeem Yousaf; Hamid Ehsan; Ahsan Wahab; Ahmad Muneeb; Fizah S Chaudhary; Richard Williams; Christopher J Haas Journal: World J Gastrointest Endosc Date: 2020-10-16