A Prospective RCT Study of Distal Pancreatectomy Combined With Left Celiac Plexus Resection for Pancreatic Cancer at the Body and Tail
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This is a prospective study of left celiac plexus resection for pancreatic cancer at the body and tail during standard distal pancreatectomy.
详细描述
Pancreatic cancer has a property of nerve invasion. Pancreatic cancer cells first invade the nerves within the pancreas, then reach to the retroperitoneal celiax plexus and ganglion. Previous studies have showed nerve invasion was a negative prognostic factor for pancreatic cancer. Celiac plexus was thought as one the sources of tumor recurrence, which also led to severe abdominal and back pain in pancreatic cancer patients. This study is performed to confirm whether left celiac plexus resection could improve survival and relieve pain of pancreatic cancer patients.
Subjects undergoing surgery will be randomized to standard distal pancreatectomy plus left celiac plexus resection versus standard distal pancreatectom. Subjects will be followed every two months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of overall survival and the secondary endpoint of disease-specific free survival will be determined at two year post surgery.The other pre-specified outcome of pain control will be determined at one year post surgery.
Block randomization will be done using a computer generated sheet. All surgeries will be performed under general anesthesia with epidural analgesia. The surgery will be either performed by or under the direct supervision of pancreatic surgeons with experience in pancreas surgery. Operative time, blood loss, blood product replacement and all intraoperative details will be recorded in the proforma. Patients will be shifted postoperatively to the anesthesia care unit (PACU) for observation and subsequently to the recovery or high dependency ward once stabilized. Postoperative details including period of postoperative pancreatic fistula,postoperative haemorrhage,postoperative pancreatitis , hospital stay and other complications will be recorded. Postoperative mortality will be defined as 30-day mortality plus death before discharge after surgery.All collected data will be entered into a statistical software package for subsequent analysis
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
- Single (Participant)
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
- •Signed informed content obtained prior to treatment
- •Age ≥ 18 years and ≤ 80 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •The pathological staging does not exceed the stage IIB
- •The expected survival after surgery ≥ 3 months
- •Tumor locates at the body and tail of the pancreas without distant metastasis
- •No celiac trunk and superior mesenteric artery invasion by Loyer grading
- •No operation contraindication
排除标准
- •The pathological staging exceed the stage IIB
- •Pancreatic cancer at the head of the pancreas
- •Benign tumor at the body and tail of the pancreas
- •Distant metastasis
- •Severe important organ function impairment
- •Active second primary malignancy or history of second primary malignancy within the last 3 years
- •Pregnant or nursing women
- •Human immunodeficiency virus (HIV)-positive patients
- •Patients who are unwilling or unable to comply with study procedures
结局指标
主要结局
Overall survival
时间窗: 2 years
次要结局
- Disease-specific, recurrence-free survival(2 years)
研究者
Xian-Jun Yu
Professor and Chair,Department of Pancreatic & Hepatobiliary Surgery
Fudan University