A Prospective Cohort Study on Ligation of Pancreatic Stump With Quantified Force During Distal Pancreatectomy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pancreatic fistula
研究概览
简要总结
The goal of this clinical trial is to learn if igation of pancreatic stump with quantified force works in decrease postoperative pancreatic fistula following distal pancreatectomy. The main outcome measures are:
Postoperative pancreatic fistula; Postoperative hospital stay.
Researchers will compare ligation to other pancreatic stump closure techniques to see if it decrease postoperative pancreatic fistula and postoperative hospital stay following distal pancreatectomy.
详细描述
Introduction The closure of pancreatic stump after distal pancreatectomy remains controversial. Currently, the main methods of pancreatic stump closure include manual suturing and stapler closure. However, both methods carry a high risk of pancreatic fistula, which may be associated with the difficulty of balancing the provision of sufficient pancreatic duct burst pressure and ensuring blood supply to the stump. Through in vitro experiments, we demonstrated that applying quantified ligation forces to pancreatic stumps can provide a pancreatic duct burst pressure of approximately 50-70 mmHg. This burst pressure is higher than the upper limit of normal pancreatic duct pressure and lower than the normal mean arterial pressure, theoretically balancing the pancreatic duct burst pressure and stump blood supply. Therefore, we designed this prospective cohort study to verify the above hypothesis.
Methods and analysis This is a prospective cohort study at single centre in China. The major eligibility criterion is the presence of lesions planned for distal pancreatectomy. The texture of the pancreas was determined by the surgeon and the first assistant during the operation as soft, medium, or hard. After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force. Postoperative regular follow-up will be performed. The primary outcomes included pancreatic fistula and postoperative hospital stay, and the secondary outcomes included intra-abdominal infection, incision infection, and postoperative treatment costs. The primary outcomes and secondary outcomes of patients in this cohort will be statistically compared with historical data using appropriate tests.
Ethics and dissemination The study has been approved by the Ethics Committee of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology(2024-0833-02). The results of the study will be published in an international peer-reviewed journal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients fully understand this study, voluntarily participate, and sign the Informed Consent Form (ICF);
- •Age between 18 and 75 years old;
- •Planned for distal pancreatectomy (including body and tail of the pancreas);
- •The intended pancreatic transection line is located on the left side of the portal vein.
排除标准
- •History of previous pancreatic surgery;
- •Additional surgical procedures required for the residual pancreas;
- •Proximal pancreatic duct obstruction, with planned anastomosis between the residual pancreas and the digestive tract;
- •Use of long-acting somatostatin analogues during the perioperative period;
- •Patients who are judged by the investigator to be unsuitable for participation in this study.
研究组 & 干预措施
Experimental group
After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force.
干预措施: ligation of pancreatic stump with a quantified force (Other)
Control group
Handle the pancreatic stump according to conventional methods (manual suturing or stapling closure).
干预措施: Manual suturing or stapling closure. (Other)
结局指标
主要结局
Pancreatic fistula
时间窗: Up to half a year from enrollment
Postoperative pancreatic fistula adopts the definition proposed by the International Study Group of Pancreatic Surgery.
Postoperative hospital stay
时间窗: Up to half a year from enrollment
Stay from operation to discharge.
次要结局
- Postoperative treatment costs(Up to half a year from enrollment)
- Intra-abdominal infection(Up to half a year from enrollment)
- Incision infection(Up to half a year from enrollment)