A Prospective Randomized Trial of Efficacy of Stump Closure for Distal Pancreatectomy
研究概览
详细说明
Pancreatic surgery has been called formidable operation not only the technical challenge to surgeons but also demanding for patients. It evolved into a safe procedure with mortality rates of <5% recently, cutting down gradually from 25% in the 1960s. However, overall morbidity rate remained high ranging from 30% to 60%.
Distal pancreatectomy (DP) has been believed a safer and minor procedure compared with pancreatic head resection including standard pancreaticoduodenectomy (PD), pylorus-preserving pancreaticoduodenectomy (PPPD), or duodenum-preserving pancreatic head resection (DPPHR). Whilst postoperative pancreatic fistula (POPF) remains serious and also is one of the most common complications after DP. Büchler et al observed that the POPF rate was in fact significantly higher after DP when compared to pancreatic head resections. The variable documented incidence of POPF following DP ranges from 12% to 40%. POPF after DP is also associated with major complications such as bleeding or septic shock and remains an equivocal problem.
Although the majority of complications are not life-threatening, POPF could prolong hospitalization, expend expenditure for healthcare, abrade the quality of life; moreover, delay in further management for a fraction of patients with malignancy. Over the past two decades, various risk factors and multitudinous operative procedures have been held for reduction POPD following DP. These include underlying disease process, method of stump closure, and concomitant splenectomy However, all these reports were retrospective review, non-randomized study, or individual experience. As always, this issue remains in obscurity and seek for a more concrete evidence to solve.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Taipei city、台湾、10002
- 招聘中
- National Taiwan University Hospital
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接触：
- Ting-Chun Kuo, MD
- 电话号码：63746 +886-2-23123456
- 邮箱：tina@ntuh.gov.tw
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接触：
- Yu-Wen Tien, PhD
- 电话号码：65083 +886-2-23123456
- 邮箱：ywtien5106@ntu.edu.tw
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- age>= 20 years
- scheduled distal pancreatectomy at NTUH
- unable to realize this trial and willing to sign the informed consent form
Exclusion Criteria:
- age< 20 years, pregnent women, breast-feeding women, or mentally illed
- active malignancy within 2 years
- received other upper abdomen major surgery
- scheduled spleen preservation or associated major organ resection
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Conventional
Stump closure as our institute routine, using interrupted silk mattress suture and continuous prolene sutures.
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We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.
其他名称：
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实验性的：Surgicel
Stump closure modified from our institute routine, using interrupted silk mattress suture and continuous prolene sutures with NU-KNIT SURGICEL overlying for reinforcement.
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We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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POPF rate
大体时间：through study completion, an average of 16 days
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The percentage of overall (grade A, B, C) POPF.
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through study completion, an average of 16 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Duration of drainage replacement
大体时间：through study completion, an average of 16 days
|
Duration of drainage replacement after DP
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through study completion, an average of 16 days
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Hospitalization
大体时间：through study completion, an average of 16 days
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Duration of hospital stay after DP
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through study completion, an average of 16 days
|
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Hospitalization cost
大体时间：through study completion, an average of 16 days
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Total hospital cost of for DP
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through study completion, an average of 16 days
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Mortality
大体时间：90 days
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Procedure-related mortality after DP
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90 days
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.