Indocyanine Green Guided Fluorescence In The Pancreatic Stump In Predicting Postoperative Pancreatic Fistula In Patients Undergoing Pancreaticoduodenectomy A prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Among patients more than 18 years of age undergoing pancreaticoduodenectomy, the perfusion status of post resection pancreatic stump using ICG fluorescence, and its association with the occurrence of POPF will be studied.
研究概览
简要总结
The treatment of choice for periampullary tumors pancreaticoduodenectomy (PD).Post operative pancreatic fistulae (POPF) stands among the most common as well as challenging complications of PD, with a considerably high rate of morbidity as well as mortality. High incidence of
POPF is highly likely to occur if the main pancreatic duct is left undilated, if the texture of pancreas is soft, and if blood loss> 1000ml. Reduced perfusion of the pancreatic remnant is one of the proposed reasons for POPF.Realtime perfusion of organs can be evaluated by indocyanine green (ICG) and is being used in various GI surgical procedures to reduce anastomotic leak.Data is limited with respect to intra-operative ICG based vascularity of the pancreatic stump to decrease POPF after PD.Hence this study is being done to study intra-operative use of indocyanine green (ICG) for perfusion of pancreatic stump in
predicting post operative pancreatic fistula in patients undergoing pancreaticoduodenectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients above 18years of age undergoing pancreatodupdenectomy.
排除标准
- •Pregnancy, lactation, allergy to ICG, intra-operative distant metastasis, R2 resection, pancreatitis.
结局指标
主要结局
Among patients more than 18 years of age undergoing pancreaticoduodenectomy, the perfusion status of post resection pancreatic stump using ICG fluorescence, and its association with the occurrence of POPF will be studied.
时间窗: At baseline, Post operative day 0 and 3
次要结局
- 1.Incidence of post-pancreatectomy hemorrhage (PPH)(2.Biliary fistula)