Comparison Between Blumgart Anastomosis and Cattell Warren Anastomosis in Reduction of Post-Operative Complications After Pancreaticoduodenectomy Procedure
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Post-Operative Pancreatic Fistula
研究概览
简要总结
The aim of this study is to make a step for evaluation and presentation of a safe technique for pancreatico-jejunostomy that help in minimizing post-operative morbidity and mortality in pancreatic cancer patient by comparing Blumgart anastomosis with Cattell warren technique of anastomosis.
详细描述
Study Design This study is a randomized prospective clinical trial. Methods of randomization: Randomized block design
The objective of the study was to evaluate the effect of Blumgart anastomosis versus Cattell Warren techniques for pancreatico-jejunostomy regarding
- Surgical technique
- Peri-operative outcome including
- Length of hospital stay
- Post-operative pancreatic fistula
- ICU admission and stay
- Operative time
- Other morbidity and mortality
Data collection:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known Pancreatic head cancer diagnosed radiologically.
- •Operable and borderline pancreatic cancer.
- •Patients who will undergo upfront surgery and those who received neoadjuvant chemotherapy are included.
排除标准
- •Metastatic patients.
- •Locally advanced cases.
- •Patients with comorbidities who are unfit for major surgical procedures.
- •Patients with very small pancreatic duct where the pancreatic duct can't be identified.
结局指标
主要结局
Post-Operative Pancreatic Fistula
时间窗: Up to 10 days after the operation
We used the International Study Group of Pancreatic Fistula (ISGPF) definition which is any measurable pancreatic fluid output after postoperative day 3 (containing more than three times the normal serum amylase level; more than 300 IU/L) with clinical signs of an infection and/or necessitating a change in clinical management.
次要结局
- Post-Operative bleeding(1-3 weeks)
- Operative Time(During the operation)
- Hospital Stay(Immediate after surgery and until the discharge of the patient ,including the readmission within the first 30 days after the operation)
- primary or reactionary hemorrhage(During the operation and within the first 24 hours after the operation)
- Biliary leakage(Up to 10 days after the operation)
研究者
Ehab Abdulkarim Abdulmaksoud
Assistant Lecturer of Surgical Oncology
Cairo University