Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
The purpose of this study is to investigate the feasibility, safety, and long-term prognosis of pancreas-sparing duodenectomy with regional lymphadenectomy in the treatment of early-stage (pTis/pT1/pT2) periampullary carcinoma with or without lymph node metastasis
详细描述
Pancreaticoduodenectomy (PD) is commonly used for periampullary carcinoma (PC). In recent years, morbidity and mortality rates following PD have decreased, but the operative stress induced by pancreatectomy is considerable. Less-invasive surgery should thus be elected for PC without pancreatic and diffuse lymph node involvement. From the perspective of organ-preserving resection, pancreas-sparing duodenectomy (PSD) represents an attractive option for selected periampullary tumors, and offers an alternative to PD.
Previous reports have described PSD for benign, premalignant and some selected malignant conditions of duodenum, and have emphasized this procedure as a safe and effective treatment associated with good quality of life. However, use of PSD for PC is still controversial.Available data about PSD for PC and published data from the follow-up evaluation in the literature are still limited.
Given the fact that 20%-60% pT1/pT2 patients have regional lymph node metastasis, regional lymph node dissection should be essential for PC. However, lymphadenectomy has never been promoted as a regular procedure of PSD.The aim of the present study was to investigate the feasibility, safety, and long-term results of PSD with regional lymphadenectomy for early-stage (pTis/pT1/pT2) periampullary cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven periampullary carcinoma (including cancers of distal common bile duct, ampulla or papilla of Vater)
- •Pre- and intra-operative stage(CT, EU stage):pTis or pT1 or pT2, N0 or N1, M0
- •ASA score: < 3
- •Liver function:Child-Pugh A
- •No history of other cancers
- •No history of preoperative chemotherapy or radiotherapy
- •Written informed consent
排除标准
- •There are concurrent cancers or the patients have been treated due to other type of cancers before diagnosed as periampullary carcinoma
- •Pre- and intra-operative stage: more advanced than T2,or with remote metastasis
- •The Patients received other non-surgical therapy, such as chemotherapy, immunotherapy, radiotherapy or endoscopic therapy
- •The Patients received upper abdominal surgery
- •ASA score: ≥ 3
- •Liver function:Child-Pugh B or C
- •Pregnancy patients
结局指标
主要结局
Disease free survival
时间窗: 5 years
It is an average time peroid.
次要结局
- Number of Patients with early postoperative complications as a Measure of Safety and Tolerability(up to 2 weeks)