Phase 3 Prospective, Multicentric Randomized Study of Endoscopic Versus Surgical Treatment of Bile Duct Stricture in Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 7
- 主要终点
- normalization of serum alkaline phosphatase (considered as < 130 UI/L)
研究概览
简要总结
Biliary obstruction complicates the course of chronic pancreatitis in 3%-23% of patients and in these cases, endoscopy and surgery are the treatment modalities of choice. Morbid-mortality of these procedures is similar and physicians face the decision between endoscopy and surgery for this group of patients, with no randomized controlled trial available comparing these procedures.
The PASTEC trial is a multicenter, phase III, randomized, comparing the effectiveness of surgical and endoscopic interventions in the management of bile duct stricture for chronic pancreatitis.
The primary end point is 18-months normalization of serum alkaline phosphatase. Secondary end points are morbid-mortality rate, quality of life, numbers of endoscopic or surgical procedures, length of stay. Eighty-six patients need to be included.
详细描述
This study is planned to last for 4 years, with a 2-year inclusion period and a 2-year follow-up period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical symptomatic chronic pancreatitis-related biliary duct stricture (pain or jaundice or pale stool / dark urine)
- •Biological symptomatic chronic pancreatitis-related biliary duct stricture (elevation of serum alkaline phosphatase (>2 or 3 times the upper limit of normal values) and/or of serum bilirubin for longer than 1 month)
- •Isolated biliary stricture or biliary stricture associated to main pancreatic duct stricture
- •Secondary biliary cirrhosis
- •Progression of biliary stricture
排除标准
- •Pancreatic malignancy
- •Cirrhosis
- •Portal vein thrombosis, portal cavernoma
- •Primary sclerosing cholangitis
- •Recent acute pancreatitis (i.e., in the previous 3 weeks)
- •Acute hepatitis
- •Post-surgical biliary stricture
- •Biliary stones or pseudocyst-related biliary duct stricture
- •Previous pancreatic surgery or endoscopic sphincterotomy
- •Score IV or V on the American Society of Anesthesiologists scale
- •Pregnancy or breastfeeding
- •Patient aged under 18 yrs
- •Emergency clinical situations (i.e., angiocholitis with septicemia)
- •Non-compliant patients or suffering from legal incapacity
- •Contra-indication for endoscopic or surgical treatment
研究组 & 干预措施
Endoscopic Biliary Stenting
Temporary self-expandable metallic covered stent
干预措施: Endoscopic Biliary Stenting (Device)
Surgical treatment
Bilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation
干预措施: Surgical treatment Bilio-enteric anastomosis (Procedure)
结局指标
主要结局
normalization of serum alkaline phosphatase (considered as < 130 UI/L)
时间窗: 18 months
A normal value of serum alkaline phosphatase will be considered as \< 130 UI/L
次要结局
- Quality of Life (EORTC health surveys)(At 18 months)
- abdominal pain (Clinical symptoms assessed by Izbicki's score)(at 1, 3, 6, 12,18 months after the procedure)
- jaundice, (Clinical symptoms assessed)(at 1, 3, 6, 12,18 months after the procedure)
- Liver failure(At 1, 3, 6, 12, 18 months after the procedure)
- presence of surgical complications ( dindo and Clavien )(At 1, 3, 6, 12, 18 months)
- Hospital length of stay(At 1, 3, 6, 12, 18 months)
- number of re - hospitalization(At 1, 3, 6, 12, 18 months)
- CT-Scan (Morphological assessment)(At 6 and 18 months after the procedure)
- Bili-MRI(At 6 and 18 months after the procedure)
- pale stool, (Clinical symptoms assessed)(at 1, 3, 6, 12,18 months after the procedure)
- Cholestasis(At 1, 3, 6, 12, 18 months after the procedure)
- pruritus, (Clinical symptoms assessed)(at 1, 3, 6, 12,18 months after the procedure)
- dark urine. (Clinical symptoms assessed)(at 1, 3, 6, 12,18 months after the procedure)
- Cytolysis(At 1, 3, 6, 12, 18 months after the procedure)