"Impact of Preoperative Biliary Drainage on Surgical and Oncologic Outcomes After Pancreatico-Duodenectomy in Patients With Operable Malignant Periampulary Tumors. A Randomized Controlled Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Early postoperative mortality (within 3 months)
研究概览
简要总结
The impact of preoperative biliary drainage (PBD) on morbidity and mortality associated with Pancreaticoduodenectomy (PD) in patients with peri-ampulary tumors is still controversial. The objective of this study is to evaluate the impact of PBD on surgical and oncologic outcomes after PD in jaundiced patients with operable peri-ampulary tumors.
详细描述
150 consecutive jaundiced patients with suspected operable peri-ampullary tumors were randomized via concealed envelopes into 2 groups (each included 75 patients), group I managed by direct surgery while group II managed by PBD followed by surgery. Both groups were compared regarding perioperative mortality, morbidities, tumor recurrence and 2 years survival rates.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serum bilirubin level above 4 mg/dl
- •suspected peri-ampullary tumor at computed tomography (CT)
- •No evidence of distant metastasis or locally advanced tumor
排除标准
- •Patients with evidence of distant metastasis or locally advanced tumor
- •Prior neoadjuvant chemotherapy or Radiotherapy
- •Prior biliary surgery
- •Patients with contraindication for major surgery
结局指标
主要结局
Early postoperative mortality (within 3 months)
时间窗: within 90 days after surgery
Death within 90 days postoperatively
Early postoperative morbidities (within 3 months)
时间窗: within 90 days after surgery
Any complications related to surgery within 3 months including: postoperative bleeding, pancreatic fistula, Biliary leakage, Intra-abdominal infection, wound infection/ dehiscence
次要结局
- Overall survival (OS)(2 years follow up after surgery)
- Tumor recurrence(2 years follow up after surgery)
- Disease free survival (DFS)(2 years follow up after surgery)
研究者
Mohamed El Messiry
Ass. Professor
University of Alexandria