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临床试验/NCT06164769
NCT06164769招募中不适用

A Prospective Study of Enucleation of Pancreatic Tumor by Blocking Abdominal Trunk and Superior Mesenteric Artery

Zhejiang University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
blood loss

研究概览

简要总结

Pancreatic enucleation could preserve more healthy pancreatic tissues and functions with a low recurrence risk. However, conventional enucleation can cause significant intraoperative bleeding, especially in which tumors in the pancreatic head, neck, and uncinate process of pancreas, as these tissues are rich in blood supply, mainly including the abdominal trunk and the superior mesenteric artery. In this study, we developed a novel method to control the pancreatic blood flow in laparoscopic enucleation--blocking the abdominal trunk and superior mesenteric artery with vascular occlusion clips in the process of resection, and evaluated its effectiveness and safety.

详细描述

Between March 2023 and May 2026, patients who underwent laparoscopic pancreatic enucleation by blocking both the abdominal trunk and superior mesenteric artery in the Second Affiliated Hospital of Zhejiang University would be included in our prospective study. Inclusion criteria: 1) benign or borderline tumors diagnosed pathologically, such as pancreatic neuroendocrine tumors, solid pseudopapillary tumors, and cystadenomas, without vascular invasion or distant metastasis;.2) tumors sited in the pancreatic head, neck, and uncinate process of pancreas; 3) blockade of both the abdominal trunk and superior mesenteric artery in the laparoscopic enucleation. Exclusion criteria:1) highly malignant pancreatic tumors, or tumors with infiltration or metastasis; 2) tumors of the body and tail of the pancreas;3) transfer to LPD or laparotomy. Patient characteristic including clinical, biochemical and radiological data will be recorded and analyzed. All patients will provide written informed consent before inclusion.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Benign or borderline tumors diagnosed pathologically, such as pancreatic neuroendocrine tumors, solid pseudopapillary tumors, and cystadenomas, without vascular invasion or distant metastasis
  • Tumors sited in the pancreatic head, neck, and uncinate process of pancreas
  • Blockade of both the abdominal trunk and superior mesenteric artery in the laparoscopic enucleation

排除标准

  • Highly malignant pancreatic tumors, or tumors with infiltration or metastasis
  • Tumors of the body and tail of the pancreas
  • Transfer to LPD or laparotomy

结局指标

主要结局

blood loss

时间窗: in the procedure

blockade of both the abdominal trunk and superior mesenteric artery changes the blood loss

次要结局

未报告次要终点

研究者

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

Sheng Yan

Director, Head of Hepatology and Pancreatology, Principal Investigator, Clinical Professor.

Zhejiang University

研究点 (1)

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