跳至主要内容
临床试验/NCT03201653
NCT03201653Unknown不适用

A Prospective Randomized Trial of Efficacy of Stump Closure for Distal Pancreatectomy

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2017年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
84
试验地点
2
主要终点
POPF rate

研究概览

简要总结

Overall morbidity rate remained high after distal pancreatectomy (DP), ranging from 30% to 60%. Whilst postoperative pancreatic fistula (POPF) remains serious and also is one of the most common complications after DP (12% to 40%). POPF after DP is also associated with major complications such as bleeding or septic shock and remains an equivocal problem. However, all the previous reports were retrospective review, non-randomized study, or individual experience and showed no significant improvement of overall POPF. As always, this issue remains in obscurity and seek for a more concrete evidence to solve.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • age>= 20 years
  • scheduled distal pancreatectomy at NTUH
  • unable to realize this trial and willing to sign the informed consent form

排除标准

  • 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

结局指标

主要结局

POPF rate

时间窗: through study completion, an average of 16 days

The percentage of overall (grade A, B, C) POPF.

次要结局

  • Mortality(90 days)
  • Hospitalization cost(through study completion, an average of 16 days)
  • Duration of drainage replacement(through study completion, an average of 16 days)
  • Hospitalization(through study completion, an average of 16 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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