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临床试验/NCT00550108
NCT00550108终止3 期

A Prospective Study of the Management of Incidentally Discovered Pancreatic Cysts

Massachusetts General Hospital2 个研究点 分布在 1 个国家开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
3 期
状态
终止
试验地点
2
主要终点
Patients not progressing to operation due to the development of symptoms, growth to a maximum diameter of >3cm, or development of a mural nodule.

研究概览

简要总结

The purpose of this study is to determine the natural history of pancreatic cysts and to determine if these cysts can be effectively treated with a less invasive therapy (ethanol injection vs periodic imaging) rather than surgical resection

详细描述

The appropriate management of patients with cystic lesions of the pancreas is controversial. The identification of small asymptomatic pancreatic cysts is increasing due to an improvement in the quality of radiologic imaging and the frequency that imaging is obtained. However, the natural history of these lesions is unknown1. The current consensus guidelines established at the International Consensus Conference in Sendai, Japan in 2005 suggest that branch chain IPMNs and mucinous cystic neoplasms that cause no symptoms, measure <3cm, and have no nodules can be observed with periodic imaging. However, the time course of these pre malignant mucinous lesions, intraductal papillary mucinous neoplasms (IPMN) or mucinous cystadenomas, from benign to malignant has not been determined. Due to the unknown natural history, and diagnostic uncertainty, some authors have recommended routine resection2, 3. Resection, despite improvements in surgical outcomes after pancreatectomy at high volume centers, carries a mortality and morbidity of 1-6% and 35-51%, respectively4-6. More recently studies are reporting a more selective approach to avoid the risk of operation in patients with benign lesions7. Improved radiographic and endoscopic studies have been able to identify some lesions with increased malignant potential8, 9. Thus, most patients will undergo pancreas specific radiologic imaging and endoscopic ultrasound with cyst aspiration. Since the natural history of cystic lesions is poorly understood no clear guidelines for surgical resection have been established. Some of the cysts will grow over time, with an increase in the cumulative risk of malignancy. Therefore, the therapeutic alternatives are to wait and watch for a change in the cyst morphology or to treat preemptively, which has been restricted to surgical resection. Based on the pilot study performed by Dr. William Brugge, at Massachusetts General Hospital, ethanol lavage of pancreatic cysts is safe and will result in a decrease in cyst diameter in 61% of patients. Additionally, if patients elect to not be treated preemptively it is unclear how to best follow these patients in terms of the type and the frequency of follow up studies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cyst between 1-3cm
  • No evidence of a mural nodule, solid component, or septations in the cyst
  • For patients with multiple cysts, the largest will be evaluated

排除标准

  • Any imaging or cytology concerning for malignancy
  • Pancreatic Pseudocyst
  • Gross Cyst >3cm as measured on MRCP
  • Clinically active pancreatitis or serum amylase or lipase >3x upper limit of normal
  • Coagulopathy (INR>1.5, PTT>100, Platelets<50K)
  • Inability to tolerate conscious sedation and endoscopy
  • Rated ASA IV or greater
  • Prior EUS and aspiration of the pancreatic cyst
  • Breast feeding
  • Pregnancy

结局指标

主要结局

Patients not progressing to operation due to the development of symptoms, growth to a maximum diameter of >3cm, or development of a mural nodule.

时间窗: 3 years

次要结局

  • A decrease in size by >1 cm on MRCP Relative decrease in size of cyst after 1 or 2 injections with ethanol Is reduction in size durable (over what length of time)?(3 years)

研究者

申办方类型
Other

研究点 (2)

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