Prognostic Outcomes of Total Mesopancreas Excision During Pancreaticoduodenectomy for Pancreatic Head Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Disease-Free Survival (DFS)
研究概览
简要总结
Pancreatic ductal adenocarcinoma (PDAC) has poor prognosis due to high recurrence rates after standard pancreaticoduodenectomy (PD). The concept of Total Mesopancreas Excision (TMpE), analogous to total mesorectal excision, aims to improve oncological outcomes by achieving higher R0 resection rates through the comprehensive removal of retroperitoneal connective tissue surrounding major peripancreatic vessels. This single arm prospective study will evaluate the prognostic outcomes, primarily Disease- Free Survival (DFS) at 24 months, of a standardized TMpE technique performed during pancreaticoduodenectomy for resectable pancreatic head cancer. Secondary objectives include assessing Overall Survival (OS), R0 resection rates, recurrence patterns, and perioperative outcomes in 90 consecutive patients.
详细描述
Pancreatic duct adenocarcinoma (PDAC) is one of the most aggressive malignancies, with a 5-year overall survival rate of approximately 20-25% even after curative resection. Standard pancreaticoduodenectomy (PD, or Whipple procedure) often results in high rates of local recurrence (up to 40-50%) due to incomplete clearance of peripancreatic tissues, leading to R1 resections in 15-35% of cases. The concept of the "mesopancreas" was introduced by Gockel et al. in 2007 as an anatomical entity analogous to the mesorectum in rectal cancer surgery. Excision of the mesopancreas aims to achieve total en bloc removal of retroperitoneal tissues harboring lymphatic, neural, and vascular pathways for tumor spread, potentially improving R0 resection rates (to 80-90%), reducing local recurrence (to 15-20%), and enhancing survival. Existing retrospective and meta-analyses suggest that total mesopancreatic excision (TMpE) increases R0 rates and reduces locoregional recurrence while maintaining acceptable safety. However, prospective data are limited, and no large randomized trials exist. This study prospectively evaluates TMpE in resectable PDAC to assess its impact on local control and survival . Objectives
Primary Objectives:
• To determine disease-free survival (DFS).
Secondary Objectives:
- To assess the impact of TMpE on overall survival (OS).
- To evaluate R0 resection rates and surgical morbidity.
- To identify predictors of recurrence and survival through preoperative,intraoperative, and postoperative data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Patients scheduled to undergo pancreaticoduodenectomy with planned mesopancreatic excision.
- •Histologically confirmed PDAC of the pancreatic head (via endoscopic ultrasound-guided biopsy).
- •Resectable disease per National Comprehensive Cancer Network(NCCN) guidelines (no distant metastases, no arterial involvement >180°, venous involvement reconstructable).
- •Eastern Cooperative Oncology Group(ECOG) performance status 0-
- •Adequate organ function (e.g., bilirubin <1.5x upper limit of normal(ULN), creatinine clearance >50 mL/min).
- •Informed consent.
排除标准
- •Irresectable PDAC.
- •Distant metastases.
- •Periampullary tumors other than pancreatic adenocarcinoma
- •Prior neoadjuvant chemotherapy or radiotherapy (to isolate TMpE effect;may be amended for subgroups).
- •Active second malignancy.
- •Severe comorbidities precluding surgery (e.g., uncontrolled cardiac disease).
- •Pregnancy or lactation.
- •Patients who have received prior radiotherapy to the abdomen.
- •Patients unwilling or unable to provide informed consent.
研究组 & 干预措施
Total Mesopancreas Excision (TMpE)
Patients with resectable or borderline resectable pancreatic head cancer undergoing pancreaticoduodenectomy with curative intent.
干预措施: Total Mesopancreas Excision (TMpE) (Procedure)
结局指标
主要结局
Disease-Free Survival (DFS)
时间窗: 24 months post-surgery
Time from surgery to first evidence of local recurrence, distant metastases, or death from any cause, whichever occurs first.
次要结局
- R0 Resection Rate(Within 30 days post-surgery (Pathology report))
- Lymph Node Yield and Ratio(Within 30 days post-surgery (Pathology report))
- Completeness of Mesopancreas Excision(Within 30 days post-surgery (Pathology report))
- Overall Survival (OS)(Up to 24 months post-surgery)
- Prognostic Factors(Up to 24 months post-surgery)
- Recurrence-Free Survival (RFS)(Up to 2 years post-surgery)
- Local Disease Control(Up to 2 years post-surgery (assessed at 3, 6, 12, 18 and 24 months).])
研究者
Saleh Khairy Saleh MD
Lecturer
Minia University