Predictors of Severity of Postoperative Pancreatic Fistula After Pancreatoduodenectomy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change in pancreatic parenchymal thickness at pancreaticojejunostomy site/spleno-portal confluence on postoperative day 5 predicts the severity of postoperative pancreatic fistula after pancreatoduodenectomy in early postoperative period
研究概览
简要总结
Pancreaticoduodenectomy is one of the commonly performed procedure for periampullary carcinoma/distal cholangio carcinoma/head of pancreas carcinoma. Postoperative pancreatic fistula remains the most important postoperative complication following pancreatic surgery. It's severity ranges from biochemical leak to grade C POPF which can lead to mortality. Radiological and biochemical parameters in early postoperative period predicts the severity of POPF after pancreatoduodenectomy. In this study, we will be evaluating the biochemical parameters and imaging findings as predictors of the severity of postoperative pancreatic fistula after pancreatoduodenectomy in early postoperative period.
详细描述
(a) Aim and Objective - The aim of this study is to evaluate the biochemical parameters and imaging findings as predictors of the severity of postoperative pancreatic fistula after pancreatoduodenectomy in early postoperative period
Methodology:
- Study population: All those operated for pancreatoduodenectomy during the period of December 2021 to May 2023 will be enrolled in this study, meeting the inclusion and exclusion criteria. On an average 3-4 cases are operated per month in ILBS.
- Study design: Prospective observational study.
- Study period: From the date of clearance by the Institutional Ethics Committee, till May 2023.
- Sample size with justification: All consecutive patients undergoing pancreatoduodenectomy for the above-mentioned study period (expected sample size 40)
- Intervention: none.
- Monitoring and assessment:
- Definitions: International study group on pancreatic fistula definition of Post-Operative Pancreatic Fistula POPF) will be used which are as follows: drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity
Variables to be assessed:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients undergoing Pancreatoduodenectomy at ILBS
- •Duct to mucosa pancreaticojejunostomy
排除标准
- •Refused for consent
- •Age < 18 yrs
- •Hepatopancreatoduodenectomy
- •Multi-visceral resection
- •Re-exploration before POD 5
- •Pancreaticogastrostomy
- •Dunking type of pancreaticojejunostomy
结局指标
主要结局
change in pancreatic parenchymal thickness at pancreaticojejunostomy site/spleno-portal confluence on postoperative day 5 predicts the severity of postoperative pancreatic fistula after pancreatoduodenectomy in early postoperative period
时间窗: Post operative day 5
次要结局
- Levels of serum procalcitonin among the different grades of postoperative pancreatic fistula.(Post operative day 5)
- Levels of serum albumin among the different grades of postoperative pancreatic fistula.(Post operative day 5)
- Location of intra-abdominal collection among the different grades of postoperative pancreatic fistula by NCCT abdomen.(Post operative day 5)
- Levels of C-reactive protein among the different grades of post operative pancreatic fistula(Post operative day 5)
- Intra-abdominal collection among the different grades of postoperative pancreatic fistula by NCCT abdomen.(Post operative day 5)