Modified Digestive Tract Reconstruction in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy: Inverted-Ω Anastomosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Operative time
研究概览
简要总结
The goal of this clinical trial is to learn if inverted-Ω anastomosis after pancreatic head resection or mid-pancreatectomy works in benign or low-grade malignant tumor. It will also learn about the safety and feasibility of inverted-Ω anastomosis. The main questions it aims to answer are:
- Does inverted-Ω anastomosis operate safely? (operative time, blood loss, transfusion and conversion rate)
- What is the incidence and severity of postoperative complications in inverted -Ω anastomosis? What advantages does it have over conventional anastomosis methods such as roux-en-y？
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years old, gender not limited;
- •Patients diagnosed with benign or low-grade malignant tumors in the head or middle section of the pancreas by CT or MRI;
- •ECOG score 0-1.
排除标准
- •Those with severe heart, liver or kidney insufficiency, or those who are assessed as intolerant to surgery or anesthesia, or those with ASA grade > 3;
- •Patients with a history of or concurrent other malignant tumors, or other serious infections or infectious diseases, or those who are unable to complete the anastomosis surgery;
- •Uncontrollable concomitant diseases, including but not limited to severe coronary artery disease, COPD or asthma, uncontrollable cerebrovascular diseases, symptomatic congestive failure, unstable angina pectoris, arrhythmia, or other diseases that the researchers consider ineligible for enrollment;
- •Patients who have undergone other upper abdominal surgeries and digestive tract reconstruction procedures in the past;
- •Patients requiring combined organ resection;
- •Preoperative assessment suggested that the patient might have factors such as active ulcers and bleeding in the digestive tract;
- •Pregnant and lactating women;
- •Any uncertain factors that have an impact on the patient's safety or compliance.
研究组 & 干预措施
Inverted-Ω Anastomosis
After meeting the inclusion and exclusion criteria, duodenum-preserving pancreatic head resection or mid-pancreatic resection will be performed, and inverted-Ω anastomosis will be carried out during the operation for the reconstruction of the digestive tract
干预措施: Inverted-Ω Anastomosis (Procedure)
结局指标
主要结局
Operative time
时间窗: During operation
Operative time
Safety and assessment of the surgical process
时间窗: During operation
The incidence of intraoperative adverse events such as conversion to open surgery rate
Intraoperative blood loss
时间窗: During operation
Intraoperative blood loss
Postoperative complications
时间窗: From the date of surgery (Day 0) up to 90 days postoperatively
The incidence and severity of postoperative complications, as defined by the International Study Group on Pancreatic Surgery (ISGPS)
次要结局
- Short-term survival(From the date of surgery (Day 0) up to 3 years postoperatively)
研究者
Xingchen Peng
professor
West China Hospital