Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis
Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis
复制标题
DOI：
10.1055/s-0034-1391331
复制
发表时间：
2015-07-01
期刊：
影响因子：
9.3
通讯作者：
Halttunen, Jorma
中科院分区：
文献类型：
--
作者：
Haapamaki, Carola;Kylanpaa, Leena;Halttunen, Jorma
背景和研究目的：覆盖自膨胀金属支架（cems）在良性胆道适应症中的应用正在不断发展。本研究的目的是评估cems与多个塑料支架治疗慢性胰腺炎引起的良性胆道狭窄（BBS）的安全性和可行性。患者和方法：这是一项前瞻性，多中心，随机研究60例慢性胰腺炎引起的BBS患者。在随机分组之前，所有患者都接受了初始塑料支架。在随机分组时，用单个cems或三个塑料支架代替支架。3个月后检查cems的位置或再添加3个塑料支架。在随机分组后6个月，所有支架均被移除。临床随访包括在支架取出后6个月和2年进行腹部超声和实验室检查。结果：2例患者在支架取出前退出cems组。2014年4月，中位随访时间为40个月（范围1-66个月）。塑料支架组2年无狭窄成功率为90%(95%可信区间[CI] 72%-97%)， cems组为92%(95%可信区间[CI] 70%-98%) （P = 0.405）。塑料支架组在取出支架后50个月有一例晚期复发。塑料支架组发生支架移位3次（10%），cems组发生2次（7%;P = 1.000）。结论：采用6个10-Fr塑料支架或1个10-mm cems治疗6个月，可较好地缓解慢性胰腺炎引起的胆道狭窄。
Background and study aims: The use of covered self-expandable metallic stents (cSEMS) in benign biliary indications is evolving. The aim of the study was to assess the safety and feasibility of cSEMS compared with multiple plastic stents in the treatment of benign biliary stricture (BBS) caused by chronic pancreatitis.Patients and methods: This was a prospective, multicenter, randomized study of 60 patients with BBS caused by chronic pancreatitis. All patients received an initial plastic stent before randomization. At randomization, the stent was replaced either with a single cSEMS or three plastic stents. After 3 months, the position of the cSEMS was checked or another three plastic stents were added. At 6months after randomization, all stents were removed. Clinical follow-up including abdominal ultrasound and laboratory tests were performed at 6 months and 2 years after stent removal.Results: Two patients dropped out of the cSEMS group before stent removal. In April 2014, the median follow-up was 40 months (range 1-66 months). The 2-year, stricture-free success rate was 90% (95% confidence interval [CI] 72%-97%) in the plastic stent group and 92% (95 % CI 70%-98%) in the cSEMS group (P = 0.405). There was one late recurrence in the plastic stent group 50 months after stent removal. Stent migration occurred three times (10 %) in the plastic stent group and twice in the cSEMS group (7 %; P = 1.000).Conclusion: A 6-month treatment with either six 10-Fr plastic stents or with one 10-mm cSEMS produced good long-term relief of biliary stricture caused by chronic pancreatitis.