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临床试验/NCT06190535
NCT06190535尚未招募不适用

Doses Systematic Per Oral Administration of Etamsylate Can Reduce Postpancreatectomy Hemorrhage From Pancreatic Stump in Pancreatogastrostomy

University of Sfax1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Rate of postoperative early (24-48 hours) digestive hemorrhage

研究概览

简要总结

In several studies comparing the tow types of pancreato-digestive anastomosis: pancreatogastrostomy (PG) and pancreatojejunostomy (PJ), authors concluded that PG exposed to more postpancreatectomy hemorrhage (PPH) especially early, digestive and moderate hemorrhage classified as type A according to the classification of the ISGPS.

In this way we try to test the ability of the enteral administration through the nasogastric tube of Etamsylate for 48 hours after Whipple to reduce the rate of digestive PPH and mortality.

详细描述

Whipple procedure is usually performed for periampullary malignancies. If the mortality of this intervention has been markedly decreased, it persists a morbid one. Morbidity is mainly due to postoperative leak of the pancreato-digestive anastomosis or postoperative pancreatic fistula (POPF), but also to postpancreatectomy hemorrhage (PPH). In several studies comparing the tow types of pancreato-digestive anastomosis: pancreatogastrostomy (PG) and pancreatojejunostomy (PJ), authors concluded that PG exposed to more postpancreatectomy hemorrhage (PPH) especially early, digestive and moderate hemorrhage classified as type A according to the classification of the ISGPS. In this case of hemorrhage, blood generally comes from pancreatic stump which is anastomosed or telescoped in the stomac. Incomplete hemostasis , soft pancreatic tissue and vascular fragility can help PPH to occur.

Etamsylate is an antihemorrhagic agent which works by increasing the resistance in the endothelium of capillaries and stimulating platelet adhesion. It also inhibits synthesis and action of prostaglandins causing platelet disaggregation, vasodilation and increased capillary permeability.

In this way, the investigators try to test the ability of the enteral administration through the nasogastric tube of Etamsylate for 48 hours after Whipple to reduce the rate of digestive PPH and mortality.

研究设计

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

  • All patients undergoing Whipple procedure regardless the type of pathology and in which a PG is performed.

排除标准

  • Patients undergoing Whipple procedure regardless the type of pathology and in which a PJ is performed.

研究组 & 干预措施

Etamsylate +

Experimental

Arm in which etamsylate (Dicynone injectable 250mg/2ml) is administrated through the nasogastric tube (NT) 2 ampules twice (X2)/day for 48 hours.

干预措施: Etamsylate (Drug)

结局指标

主要结局

Rate of postoperative early (24-48 hours) digestive hemorrhage

时间窗: 24-48 hours, postoperative day Day 1, Day 2

Blood in NT, hematemesis in the postoperative course

次要结局

  • Operative mortality(30 day)

研究者

发起方
University of Sfax
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Kchaou

Ali Kchaou MD FACS

University of Sfax

研究点 (1)

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