Joon Seop Lee1, Hyun Seok Lee1, Eun Soo Kim2, Min Kyu Jung1, Jin Tae Jung3, Ho Gak Kim3, Dong Wook Lee3, Dae Jin Kim4, Yoo Jin Lee5, Chang Heon Yang6. 1. Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea. 2. Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea. dandy813@hanmail.net. 3. Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, South Korea. 4. Department of Internal Medicine, Fatima Hospital of Daegu, Daegu, South Korea. 5. Department of Internal Medicine, Keimyung University School of Medicine, Daegu, South Korea. 6. Department of Internal Medicine, Dongguk University School of Medicine, Gyeongju, South Korea.
Abstract
BACKGROUND: Stent migration is one of the main drawbacks of covered self-expandable metal stent (SEMSs), occurring in up to 40% of malignant colorectal obstruction management cases. Various types of covered SEMSs have been developed to reduce this risk. We aimed to compare the effectiveness and complication rates of the flare-type covered SEMS (Flare) with those of the double-layered covered SEMS (ComVi). METHODS: We performed a prospective, randomized study in four tertiary referral centers between July 2016 and April 2018. Patients with malignant colorectal obstruction were eligible for the study. The primary outcome was migration rate as observed within the first month. Rates of technical success, clinical success, and complications within the first month were also assessed. RESULTS: A total of 60 patients were included (mean age, 70.5 ± 12.5 years; male, 31 [51.7%]). Flare and ComVi stents were applied in 30 patients each. The Flare and ComVi groups showed comparable technical success rates (90% [27/30] vs. 96.7% [29/30], p = 0.605) and clinical success rates (85.2% [23/27] vs. 75.9% [22/29], p = 0.589). Migration occurred in three (11.1%) and four (13.8%) cases in the Flare and ComVi groups, respectively, without significant difference (p = 0.99), and the risk of other complications, including perforation and re-obstruction, did not differ between the two groups. CONCLUSIONS: Our study indicates that both flare-shape and double-layered covered SEMSs are equally effective options for the management of malignant colorectal obstruction with low migration rates when compared with previously reported migration risk of covered SEMS.
BACKGROUND: Stent migration is one of the main drawbacks of covered self-expandable metal stent (SEMSs), occurring in up to 40% of malignant colorectal obstruction management cases. Various types of covered SEMSs have been developed to reduce this risk. We aimed to compare the effectiveness and complication rates of the flare-type covered SEMS (Flare) with those of the double-layered covered SEMS (ComVi). METHODS: We performed a prospective, randomized study in four tertiary referral centers between July 2016 and April 2018. Patients with malignant colorectal obstruction were eligible for the study. The primary outcome was migration rate as observed within the first month. Rates of technical success, clinical success, and complications within the first month were also assessed. RESULTS: A total of 60 patients were included (mean age, 70.5 ± 12.5 years; male, 31 [51.7%]). Flare and ComVi stents were applied in 30 patients each. The Flare and ComVi groups showed comparable technical success rates (90% [27/30] vs. 96.7% [29/30], p = 0.605) and clinical success rates (85.2% [23/27] vs. 75.9% [22/29], p = 0.589). Migration occurred in three (11.1%) and four (13.8%) cases in the Flare and ComVi groups, respectively, without significant difference (p = 0.99), and the risk of other complications, including perforation and re-obstruction, did not differ between the two groups. CONCLUSIONS: Our study indicates that both flare-shape and double-layered covered SEMSs are equally effective options for the management of malignant colorectal obstruction with low migration rates when compared with previously reported migration risk of covered SEMS.
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