Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 5-year overall survival
研究概览
简要总结
Background: Pancreatic cancer (PC) is one of the most aggressive malignant neoplasms with poor outcomes. Pancreatoduodenectomy (PD) is the only curative treatment for PC. Minimally invasive surgery has been progressively developed, first with the advent of hybrid-laparoscopy and recently with the total laparoscopy surgeries, but a number of issues are currently being debated, including the superiority between total laparoscopic pancreaticoduodenectomy (TLPD)and the open pancreaticoduodenectomy (OPD). Studies comparing these two surgery techniques are merging and randomized controlled trials (RCT) are lacking but clearly required.
Methods/design: TJDBPS07 is a multicenter prospective, randomized controlled, trial comparing TLPD and OPD in pancreatic cancers. A total of 200 patients with pancreatic cancer underwent PD will be randomly allocated to the TLPD group or OPD group with an enhanced recovery after surgery (ERAS) pattern. The trial's aim is to exploring the overall survival (OS), disease free survival (DFS) and quality of life. The duration of the entire trial is seven years including prearrangement, a presumably five-year follow-up and analyses.
Discussion: Despite the fact there are several RCTs comparing minimally invasive pancreaticoduodenectomy (MIPD) and Open approach or LPD versus OPD. This trial will be the first comparing TLPD and OPD in a large multicenter setting. TJDBPS01 trial is hypothesized to assess whether TLPD has superiority over OPD in recovery and other aspects.
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 (Outcomes Assessor)
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 between 18 years and 75 years.
- •Histologically confirmed PDAC or clinically diagnosed PDAC by an MDT without histopathologic evidence.
- •Patients feasible to undergo both LPD and OPD according to MDT evaluations.
- •Patients understanding and willing to comply with this trial.
- •Provision of written informed consent before patient registration.
- •Patients meeting the curative treatment intent in accordance with clinical guidelines.
排除标准
- •Patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
- •Patients requiring left, central or total pancreatectomy or other palliative surgery.
- •Preoperative American Society of Anaesthesiologists (ASA) score ≥
- •History of other malignant disease.
- •Pregnant or breast-feeding women.
- •Patients with serious mental disorders.
- •Patients treated with neoadjuvant therapy.
- •Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data.
- •Body mass index > 35 kg/m
- •Patients participating in any other clinical trials within 3 months.
结局指标
主要结局
5-year overall survival
时间窗: 5 year
5-year overall survival
次要结局
- overall survival(5 years)
- disease-free survival(5 years)
- 90-day mortality(90 days)
- complication rate(90 days)
- comprehensive complication index(90 days)
- length of stay(90 days)
- intraoperative indicators(90 days)