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临床试验/NCT00689715
NCT00689715Unknown2 期

Long Term Outcomes After EUS-guided Ablation for Cystic Tumors of the Pancreas

Asan Medical Center2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2006年6月最近更新:
适应症

试验速览

阶段
2 期
入组人数
50
试验地点
2
主要终点
Incidence of adverse events Treatment response by change of calculated cyst volume

研究概览

简要总结

Cystic lesions of the pancreas are defined as round, fluid-filled structures within the pancreas detected by radiologic imaging. With widespread use of cross-sectional imaging modalities for various indications, such lesions are now detected in nearly 20% of abdominal imagings, with the majority discovered incidentally. These lesions encompass a wide spectrum of histopathologic entities and biologic behavior, ranging from benign to malignant. Substantial morphologic overlap restricts the accuracy in diagnosing specific type of cystic lesion in spite of recent advances in diagnostic modalities. It is a challenging issue to differentiate each cystic lesion and make a management plan since cystic lesions that are relatively common and asymptomatic may possess malignant potential. Although inflammatory pseudocysts were thought to account for 80-90% of cystic lesions of the pancreas, with cystic tumors accounting for the remaining,10 the latter may occur much more frequently than traditionally estimated.

To date, surgical resection is generally recommended for malignant and potentially malignant lesions. However, surgical resection of the pancreas still carries substantial morbidity and sometimes mortality, especially for the cystic lesion located in the head portion. Therefore, management should be individualized by risk-benefit analysis for each patient.

Recently, a pilot study of EUS-guided ethanol lavage for cystic tumors of the pancreas reported that complete resolution was achieved in only one-third of patients even though epithelial lining ablation was demonstrated in all resected specimens. Therefore, more effective treatment modalities or ablation agents are required to improve treatment responses. Intratumoral or intraperitoneal injection of chemotherapeutic agent has been used for endobronchial lesions of lung cancer, brain tumors and advanced ovarian cancer.13-16 EUS-guided injection of antitumor material has been reported in advanced pancreatic cancer. Although local injection of chemotherapeutic agents into pancreatic cystic tumors has not yet been reported, it is reasonable to suggest that such an approach may have an additive effect on ablation of the epithelial lining of cystic tumor when combined with ethanol lavage.

Paclitaxel, a widely used chemotherapeutic agent, inhibits cell processes that are dependent on microtubule turnover. Due to its highly hydrophobic nature,19 paclitaxel is expected to exert its effect longer when instilled within a closed cavity such as a cyst. The hydrophobic and viscous nature of paclitaxel may reduce the possibility of it leaking through a puncture site and causing complications.

The present study evaluated safety, feasibility and response following EUS-guided ethanol lavage with paclitaxel injection (EUS-EP) for treating cystic tumors of the pancreas.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • uni- or oligo-locular cystic tumors
  • indeterminate cystic tumors for which EUS-guided fine needle aspiration (FNA) was required to obtain additional information
  • cystic tumors that increased in size during the observation period

排除标准

  • cystic tumors which had the typical morphology of serous cystadenomas (i.e., honeycomb appearance) and pseudocysts (i.e., parenchymal changes)
  • evidence of communication between the cystic lesion and the main pancreatic duct according to endoscopic retrograde pancreatograms
  • overt carcinomas with peripancreatic invasion
  • patients with a bleeding tendency (prothrombin time > 1.5 international normalized ratio [INR] or platelet count < 50,000/μL).

结局指标

主要结局

Incidence of adverse events Treatment response by change of calculated cyst volume

时间窗: early (< 7 days) and late (> 7days) adverse events

recurrence during follow up

时间窗: any recurrence of cyst after complete resolution during at least 3 years follow up

次要结局

  • predictive factors for complete resolution(1 year)
  • treatment response(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong Wan Seo

Professor

Asan Medical Center

研究点 (2)

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