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临床试验/NCT05387538
NCT05387538Unknown不适用

One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy : Randomized Comparative Prospective Study .

Assiut University0 个研究点目标入组 50 人开始时间: 2022年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
主要终点
postoperative pancreatic fistula(POPF) rate

研究概览

简要总结

Postoperative pancreatic fistula (POPF) is one of the most frequent and ominous complications after PD, and its occurrence reportedly ranges from 2-40 %. Severe POPF prolongs hospital stay and requires the use of specific treatments, such as the use of antibiotics, nutritional support, endoscopy, interventional radiology, and/or reoperation, etc.. Several anastomotic surgical techniques have been developed to reduce the incidence of pancreatic fistula in recent decades, including the duct-to-mucosa method, pancreaticogastrostomy, Peng's binding method, and the "end-to-end" or "end-to-side" invaginated method. Among these techniques, the conventional duct-to-mucosa method remains the most popular anastomosis due to its advantages.

The size of the pancreatic remnant is not limited; moreover, the jejunal lumen and pancreatic remnant lead to easier anastomosis . Compared with two-layer duct-to-mucosa anastomosis, the novel one-layer duct-to-mucosa PJ anastomosis method has been reported to be efficient at reducing POPF occurrence. However, the two cited retrospective studies might lead to selection bias. Because this evidence is insufficient, we will conduct a randomized controlled trial to verify the superiority of one-layer duct-to-mucosa PJ anastomosis after PD over the two-layer technique.

详细描述

To date, pancreaticoduodenectomy (PD) has been regarded as the only potentially curative treatment for pancreatic head and periampullary tumors, including tumors in the ampullary region, distal biliary duct, and periampullary duodenum .

A retrospective study in which 1000 cases were recruited over the past three decades showed that PD has become an effective treatment to reduce hospital mortality. Mortality has been reduced to less than 5 %, but the morbidity remains at 30-50 % .

Postoperative pancreatic fistula (POPF) is one of the most frequent and ominous complications after PD, and its occurrence reportedly ranges from 2-40 %. Severe POPF prolongs hospital stay and requires the use of specific treatments, such as the use of antibiotics, nutritional support, endoscopy, interventional radiology, and/or reoperation, etc.

POPF risk is increased by many factors including pancreatic texture, main pancreatic duct diameter, and pancreaticojejunal (PJ) anastomotic technique .Among these factors, only anastomotic technique can be improved. According to the International Study Group of Pancreatic Surgery (ISGPS) definition, POPF exists if the drainage of any measurable volume of fluid containing amylase exceeds three times the normal serum value on or after postoperative day (POD) 3.

Several anastomotic surgical techniques have been developed to reduce the incidence of pancreatic fistula in recent decades, including the duct-to-mucosa method, pancreaticogastrostomy, Peng's binding method, and the "end-to-end" or "end-to-side" invaginated method. Among these techniques, the conventional duct-to-mucosa method remains the most popular anastomosis due to its advantages.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Both male and female, aged 18 to
  • •Patients scheduled to undergo pancreaticoduodenectomy.

排除标准

  • •; Patients who had a previous pancreatic operation; Patients with an immunodeficiency.

研究组 & 干预措施

One-layer Duct-to-mucosa Pancreaticojejunostomy

Experimental

pancreatic anastomosis to jejunum will be performed in one layer suturing the pancreatic duct to the mucosa of jejunum.

干预措施: One-layer Duct-to-mucosa Pancreaticojejunostomy (Procedure)

Two-layer Duct-to-mucosa Pancreaticojejunostomy

Experimental

pancreatic anastomosis to jejunum will be performed in two layer. The first layer will be suturing the pancreatic capsule to the seromuscular layer of jejunum and the 2nd layer will be suturing the pancreatic duct to the mucosa of jejunum.

干预措施: Two-layer Duct-to-mucosa Pancreaticojejunostomy (Procedure)

结局指标

主要结局

postoperative pancreatic fistula(POPF) rate

时间窗: 30 days

drainage of any measurable volume of fluid with an amylase content \>3 times the upper normal serum value on or after postoperative day 3.

次要结局

  • Duration of postoperative hospital stay(30 days)
  • anastomosis time(1 hour)

研究者

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

Dr. Hamada

assistant lecturer at general surgery department

Assiut University

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