Open Versus Laparoscopic Pancreaticoduodenectomy: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Minia University
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Overall Morbidity (Clavien-Dindo Classification)
概览
简要总结
This is a monocentric, prospective, randomized controlled trial comparing the safety and efficacy of laparoscopic pancreaticoduodenectomy (LPD) versus open pancreaticoduodenectomy (OPD). The study aims to determine the morbimortality of the laparoscopic approach compared to the gold standard open approach in adult patients with pancreatic or periampullary lesions.
详细描述
This is a monocentric, prospective, randomized controlled trial comparing the safety and efficacy of laparoscopic pancreaticoduodenectomy (LPD) versus open pancreaticoduodenectomy (OPD). The study aims to determine the morbimortality of the laparoscopic approach compared to the gold standard open approach in adult patients with pancreatic or periampullary lesions.
This study will randomize 90 eligible patients to receive either LPD or OPD. The primary objective is to compare overall morbidity using the Clavien-Dindo Classification at 90 days postoperative. Secondary objectives include assessment of oncologic outcomes (lymph node harvest, margin status), perioperative metrics (operative time, blood loss), and postoperative recovery (length of stay, readmissions). The study utilizes a prospectively maintained database and adheres to CONSORT guidelines.
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
- 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
- •Age ≥18 years.
- •Histologically confirmed or clinically suspected lesions of: Pancreatic head adenocarcinoma, Ampullary carcinoma, Distal cholangiocarcinoma, Duodenal adenocarcinoma, Pancreatic neuroendocrine tumors, or Intraductal Papillary Mucinous Neoplasm(IPMN) .
- •Resectable disease based on preoperative imaging.
- •Eastern Cooperative Oncology Group(ECOG) performance status 0-
- •American Society of Anesthesiologists(ASA )classification I-III.
- •Patients able to provide informed consent.
排除标准
- •Emergency surgery.
- •Previous pancreatic surgery.
- •Concurrent major abdominal procedures .
- •ASA classification IV or higher.
- •Metastatic disease identified preoperatively.
- •Locally advanced unresectable disease.
- •Active infection or sepsis at time of surgery.
- •Severe cardiopulmonary comorbidities precluding major surgery.
- •Pregnancy.
- •Procedures requiring Total Pancreatectomy, Distal Pancreatectomy, or Enucleation .
研究组 & 干预措施
Open Pancreaticoduodenectomy (OPD)
Patients randomized to receive standard open pancreaticoduodenectomy through a bilateral subcostal incision.
干预措施: Open Pancreaticoduodenectomy (Procedure)
Laparoscopic Pancreaticoduodenectomy (LPD)
Patients randomized to receive total laparoscopic pancreaticoduodenectomy using a standardized six-port technique.
干预措施: Laparoscopic Pancreaticoduodenectomy (Procedure)
结局指标
主要结局
Overall Morbidity (Clavien-Dindo Classification)
时间窗: 90 days postoperative.
Assessment of all surgical complications graded by severity using the Clavien-Dindo Classification (Grades I-V). Major complications are defined as Grade III or higher.
次要结局
- Length of Hospital Stay(Up to 90 days.)
- Number of Lymph Nodes Retrieved(14 days postoperative.)
- Resection Margin Status (R0/R1/R2)(14 days postoperative.)
- Operative Time(Intraoperative)
- Estimated Blood Loss(Intraoperative)
研究者
Saleh Khairy Saleh MD
Lecturer
Minia University