Phase II Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Determine the percentage of patients who, at Day 28 after the first attempt stenting (T0 = date of the first act), has received or is able to receive FOLFIRINOX.
研究概览
简要总结
For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on the endoscopic biliary stent. This technique has been shown to be preferable to a surgical shunt.
Recently, adjuvant chemotherapy with FOLFIRINOX regimen (clinical trial) has revolutionized the treatment of metastatic pancreatic adenocarcinoma increasing overall survival in a major way. This design will also be developed in patients with neoadjuvant tumor called "borderline" (the limit of the resectability).
However, several conditions (protocol) are required to consider the implementation of this design : age ≤ 75 years, PS 0 or 1, good hematological parameters and bilirubin ≤ 1.5 times the ULN.
In addition, a randomized study showed that preoperative biliary stent treatment, despite a success rate of 94%, is associated with more complications than surgery fast (related gesture bladder).
It would be interesting to analyze, prospectively, the fate of a series of patients with cancer of the pancreatic head with compression of the lower part of the bile duct, PS 0 or 1 and for which the only limit to FOLFIRINOX design is jaundice or high risk of jaundice.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged > 18 ans and ≤ 75 ans
- •Suspicion of adenocarcinoma of the head of the pancreas leading to the placement of a biliary stent
- •Either metastatic or "borderline" (at the limit of resectability) or locally advanced
- •PS = 0 or 1
- •Hematological laboratory parameters (ANC ≥ 1.5 ** 10 9 / l (/ mm3), platelets ≥ 100 ** 10 9 / l (G / L)) and kidney (calculated creatinin clearance> 60 ml / min)
- •Jaundice (bilirubin> 20 mmol / L) by compressing the lower part of the bile duct (dilatation of the extrahepatic bile duct)
- •Written informed Consent
- •Affiliation to social security
排除标准
- •Pregnant or lactating woman or without contraception (for child bearing potential women)
- •Patient deprived of liberty or under supervision of a guardian
- •Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons
- •Contra-indication for study procedure
- •Predictable technical impossibility to position a stent endoscopically (prior upper GI surgery)
- •Life expectancy assumed less than 3 months
结局指标
主要结局
Determine the percentage of patients who, at Day 28 after the first attempt stenting (T0 = date of the first act), has received or is able to receive FOLFIRINOX.
时间窗: At day 28 after the laying of the biliary stent
次要结局
- Rate of biliary infection starting within 3 months after insertion of the prosthesis(From the laying of the biliary stent to 3 months follow up)
- Prosthetic dysfunction within 3 months (recurrence of jaundice with dilated bile ducts)(From the laying of the biliary stent to 3 months follow up)
- Complication (s) other (s) (bleeding, perforation, ...) possibly attached (s) endoscopic treatment within 3 months.(From the laying of the biliary stent to 3 months follow up)