A Multi-center Study to Evaluate the Efficacy and Safety of Pancreatic Duct Stents Placement Before the Enucleation of Insulinoma Located in the Head and Neck of the Pancreas Near the Main Pancreatic Duct
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Rate of POPF within 3 months after EN.
研究概览
简要总结
The purpose of this study is to compare the clinical efficacy and economic cost of enucleation after placement of pancreatic duct stents before surgery with that of direct enucleation alone, and to evaluate its safety and feasibility.
详细描述
The research contents of this study include: patients with insulinoma near the main pancreatic duct in the head and neck of the pancreas were randomly divided into two groups: the preoperative pancreatic duct stent enucleation group (stended EN), the direct en group (DEN), the Sen group asked a digestive endoscopist to place the pancreatic duct stent before surgery, and the next day or the next day after surgery, and the den group received enucleation directly. The safety of the two groups was compared, including the evaluation of surgical effect Postoperative complications and long-term prognosis based on follow-up data analysis; At the same time, the differences between the two groups were evaluated from the perspective of health economics.
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 (Outcomes Assessor)
盲法说明
Outcome assessors are kept blinded to participant group allocation. Objective clinical data are provided to independent assessors with blindness of allocation. With clear definition for each endpoints, assessors are able to make grading for complications in primary and secondary endpoints
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The clinical qualitative diagnosis of insulinoma was clear;
- •The localization diagnosis was clear, and it was determined that the tumor was single, located in the head and neck;
- •The distance between the tumor and the main pancreatic duct was determined to be ≤ 2mm by preoperative imaging (enhanced CT, MRI, etc.);
- •Truly informed and voluntarily participate in this study.
排除标准
- •Maximum diameter of the tumor >2cm proved pathologically
- •Severe cardiopulmonary complications before operation
- •Combined with other known tumor diseases
- •Insulinoma is invasive or has suspicious metastatic lesions
- •Previous upper abdominal surgery history
- •Refusal or inability to cooperate in the study
结局指标
主要结局
Rate of POPF within 3 months after EN.
时间窗: 3 days to 3 months after enucleation (or the extubation time),up to 6 month after inclusion
Postoperative clinically relevant pancreatic fistula in this study adopts the definition proposed by the international pancreatic surgery research group (ISGPS)
次要结局
- Rate of postoperative lung infection within 3 weeks after EN(1 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion)
- Rate of postoperative dyspepsia within 6 months after EN(2 weeks to 6 months after enucleation,,up to 6 month after inclusion)
- Operation time(Measure during operation,,up to 6 month after inclusion)
- Intraoperative blood loss(Measure during operation,,up to 6 month after inclusion)
- Rate of postoperative delayed gastric emptying within 3 weeks after EN(3 days to 3 weeks after enucleation (or the extubation time))
- Rate of postoperative hemorrhagepostpancreatectomy haemorrhage within 3 weeks after EN(1 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion)
- Rate of post-stent-placement acute pancreatitis in Stented EN group within in 3 weeks after EN(1 days to 3 days after stent placement,,up to 6 month after inclusion)
- Rate of postoperative abdominal infection within 3 weeks after EN(3 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion)
- Rate of postoperative hyperglycemia within 6 months after EN(2 weeks to 6 months after enucleation,,up to 6 month after inclusion)
- Total cost of hospitalization(Measure during the whole hospitalization procedure of each patient,,up to 6 month after inclusion)