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临床试验/KCT0004849
KCT0004849已完成未知

Endobiliary radiofrequency ablation of malignant hilar obstruction

Seoul National University Bundang Hospital0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
25

研究概览

简要总结

All procedures in the two groups were performed successfully in single session. In RFA group, the mean stricture length was 44.1 ± 12.2 mm from RAD to left IHD, which was ablated with 3 or 4 cycles from the left PTBD route. The stricture length from CBD to RPD was 48.7 ± 15.5 mm requiring 3–5 ablation cycles performed from the right PTBD route. In stent group, the mean stricture length was 41.8 ± 9.7 mm from RAD to left IHD and 43.7 ± 10.1 mm from CBD to RPD. The stricture lengths were not different between the two groups (p > 0.1). Two stents were successfully placed in criss-cross configuration in all patients. The stent patency was confirmed on completion cholangiogram in all patients. Bilateral drainage catheters were removed 2–5 days after the procedure. In all patients, cholangitis and fever were resolved within 3 days after the procedure. The value of laboratory tests significantly improved. The serum total bilirubin decreased after the procedure (from 7.4 ± 3.3 mg/dl to 1.6 ± 0.8 in the RFA group, p < 0.001, and from 6.9 ± 1.8 to 1.5 ± 0.9 mg/dl in the stent group, p < 0.001). The white blood cell count was normalized in all patients of the two groups (from 12.2 ± 4.1 mg/dl to 4.7 ± 2.2 in the RFA group, p < 0.001, and from 13.1 ± 4.1 to 5.1 ± 3.1 mg/dl in the stent group, p < 0.001). Procedure-related adverse events (AEs) included abdominal pain, skin infection at PTBD entry site, and mild hemobilia (Table 2). The pain and skin infection were resolved with oral analgesics and antibiotics. The hemobilia was suspected on cholangiogram during the procedure, but spontaneously disappeared on follow-up cholangiogram before PTBD removal. There was no difference in grade 1 or grade 2 AEs between the two groups. No AEs greater than grade 2 were observed in either group.

研究设计

研究类型
Interventional Study

入排标准

年龄范围
19(Year) 至 90(Year)(—)
性别
All

入选标准

  • radiologically or histologically proven malignant hilar obstruction
  • - patient who signed consent for biliary stent placement
  • - age 19-90

排除标准

  • - possible curative resection
  • - inability to biliary access due to previous surgery
  • - life expectancy <3 months
  • - uncontrolled ascites, INR>2.0, platelet<5k
  • - pregnancy, inability to obtain written consent

研究者

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