KCT0004087已完成未知
A prospective, muti-center, randomized, comparative study to evaluate the efficacy and safety of a novel electrocautery-enhanced LAMS (Niti-S HOT SPAXUSTM Stent) versus plastic stent (Compass BDS™ biliary double pigtail plastic stent) used in the endoscopic-guided transmural drainage of walled-off necrosis
Hallym University Medical Center-Dongtan0 个研究点目标入组 46 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 46
研究概览
简要总结
The novel electrocautery-enhanced LAMS with a simple one-step deployment and the ability to perform DEN with minimal migration is safe and effective for the treatment of infected WON. The novel LAMS is a safe and reasonable option in terms of bleeding risk if a sufficient treatment duration is required
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •? patients with age =19 years who are needed EUS guided transmural drainage for walled-off necrosis confirmed by CT, MRI, EUS or other diagnostic modality
- •? at least one of the following criteria
- •- maximal WON size of 6cm or size of less than 6cm with infectious symptom and sign (fever, abdominal pain) requiring drainage procedure on judgement of physicians,
- •- persistant WON at least 4 weeks or more
- •- possible location on EUS for drainage of fluid collection by trans-mural approach,
- •? the patient accept to participate in the study or provide informed consent
排除标准
- •Patients were excluded:
- •1) if the lesion had only a cystic component without a solid component suspected with pancreatic pseudocyst (pancreatic pseudocyst defined by 2012 Atlanta classification)
- •2) if the lesion had only a solid component without a cystic component
- •3) suspected pancreatic cystic tumors or pancreatic malignancies
- •4) if the coagulation parameters were abnormal (international normalized ratio >1.5 or platelet count <60,000 cells/cmm3)
- •5) postponing the antithrombotic therapy was impossible
- •6) if the patient had cardiopulmonary instability
- •7) pregnancy
- •8) if the patient had neuro-psychiatric disease such as dementia, seizure
- •9) Other situations impossible for EUS guided transmural drainage for walled-off necrosis with Niti-S HOT SPAXUSTM Stent or Compass BDS™ plastic stent
研究者
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