跳至主要内容
临床试验/NCT06914349
NCT06914349招募中不适用

Antecolic Versus Retrocolic Gastrojejunostomy Following Pancreaticoduodenectomy: a Prospective Randomised Study

University of Thessaly1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年3月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
76
试验地点
1
主要终点
Delayed Gastric Emptying

研究概览

简要总结

Aim: This randomized clinical study aims to compare occurrence of DGE in patients undergoing either antecolic or retrocolic gastrojejunostomy following pancreaticoduodenectomy.

Methods: Participants of this study will be patients undergoing pylorus preserving pancreaticoduodenectomy at the Surgical Department of the University Hospital of Larissa. Patients will be randomized to undergo either an antecolic or a retrocolic gastrojejunostomy and the occurrence of DGE will then be compared between the two groups. Individuals younger than 18 or older than 75 years old, as well as patients who do not consent to participate in this trial, will be excluded.

Expected results: Based on available literature, antecolic gastrojejunostomy may be related with a lower incidence of DGE, without a statistically significant difference between the two methods. We aim to show if one of the two methods of gastrointestinal reconstruction (antecolic versus retrocolic) affects DGE.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age over 18 years old
  • •Elective pancreaticoduodenectomy
  • •Signed consent form

排除标准

  • •Age under 18 years old
  • •Patients who are participants in other trials that may affect the results of this study
  • •Patients who do not consent to participate in the study

研究组 & 干预措施

Antecolic gastrojejunostomy

Active Comparator

干预措施: Antecolic gastrojejunostomy (Procedure)

Retrocolic gastrojejunostomy

Active Comparator

干预措施: Retrocolic gastrojejunostomy (Procedure)

结局指标

主要结局

Delayed Gastric Emptying

时间窗: 3 years

The occurence of delayed gastric emptying will be compared between two groups of patients: those who undergo an antecolic gastrojejunostomy and those who undergo a retrocolic approach.

次要结局

未报告次要终点

研究者

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

Chrysoula-Christina Kolla

MD, Msc

University of Thessaly

研究点 (1)

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