Ursodeoxycolic acid for the prevention of relapsing complications after gallstone acute pancreatitis, a double-blind multicenter randomized-controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 332
- 试验地点
- 21
- 主要终点
- Death and / or complication associated with gallstones (new episode of PAB, cholangitis, cholecystitis, choledocholithiasis or biliary colic, variable based on the primary endpoint of the PONCHO clinical trial (1)), until cholecystectomy is performed or until 1 year.
研究概览
简要总结
To assess the incidence during follow-up of patients who have had a first episode of PAB, of the main variable of the study: death or complication associated with gallstones (acute pancreatitis, biliary colic, cholecystitis, cholangitis or choledocholithiasis), until have cholecystectomy performed or up to one year after the initial PAB.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adulthood (18 years or older)
- •Income from PAB (will meet conditions 1 and 2):
- •Diagnosis of acute pancreatitis, at least 2 of the following 3 criteria (2) i) Acute abdominal pain in upper hemiabdomen or mesogastrium ii) Amylasemia or lipasemia greater than 3 times the upper limit of normal iii) Imaging test compatible with acute pancreatitis
- •Diagnosis of biliary etiology: cholelithiasis, microlithiasis or gallbladder sludge diagnosed by ultrasound, CT, MRI or endoscopic ultrasound.
- •Signature of the informed consent.
排除标准
- •Endoscopic cholecystectomy and / or sphincterotomy prior to recruitment
- •Hypertriglyceridemia greater than 400 mg / dL during admission or a history of poorly controlled severe hypertriglyceridemia.
- •Chronic pancreatitis (pancreatic calcifications and / or Wirsung duct of 4 or more mm)
- •Pancreatic cystic lesions not attributed to the PAB itself
- •Wirsung duct stenosis.
- •Primary hyperparathyroidism
- •Recurrent acute pancreatitis (1 or more previous episodes of pancreatitis of any origin)
- •Current waiting list at your center for cholecystectomy for PAB less than 30 days
- •Randomization more than 3 days after discharge from hospital for PAB
- •UDCA consumption in the last 5 years
- •Allergy, intolerance or presence of contraindications to UDCA (contraindicated in patients with gastric or duodenal ulcer, liver or intestinal disorders that interfere with the enterohepatic circulation of bile salts and lactation).
- •Presence of choledocholithiasis diagnosed by imaging tests prior to randomization.
- •Active alcoholism greater than or equal to 5 alcoholic drinks per day or high clinical suspicion of clinically significant alcoholism
- •Recent history of significant therapeutic non-compliance or social problem that makes follow-up difficult
结局指标
主要结局
Death and / or complication associated with gallstones (new episode of PAB, cholangitis, cholecystitis, choledocholithiasis or biliary colic, variable based on the primary endpoint of the PONCHO clinical trial (1)), until cholecystectomy is performed or until 1 year.
Death and / or complication associated with gallstones (new episode of PAB, cholangitis, cholecystitis, choledocholithiasis or biliary colic, variable based on the primary endpoint of the PONCHO clinical trial (1)), until cholecystectomy is performed or until 1 year.
次要结局
未报告次要终点
研究者
Alicia Vaillo
Scientific
Hospital General Universitario Dr. Balmis