PrEveNtion of Biliary Events After Acute Pancreatitis in NonSUrgicaL PAtients. Sphincterotomy Vs Conservative Treatment. Multicenter Randomized Clinical Trial: PENINSULA Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 126
- 试验地点
- 6
- 主要终点
- Biliopancreatic events (BPE)
研究概览
简要总结
Acute pancreatitis (AP) is a common condition and its main etiology is biliary. Cholecystectomy is the standard preventive treatment for recurrence of AP after admission. However, due to an increasingly older population and increased patient comorbidity, it is not always a possible option these days. If cholecystectomy is not performed, there is a significant risk for a recurrence of a biliopancreatic event (pancreatitis, biliary colic, choledocholithiasis, cholecystitis or cholangitis) of around 50% in the first year. This can lead to further episodes of pain, patient readmissions, and a reduced quality of life. Additionally, frequent readmissions can create a high cost burden on the health system. Currently, certain clinical guidelines propose biliary sphincterotomy as an alternative for patients in whom surgery is not feasible. However, this recommendation is based on retrospective studies with small sample size and the adherence to this recommendation is very low (12-23%).
The goal of this clinical trial is to evaluate the recurrence of biliopancreatic events in the first year after admission for an acute biliary pancreatitis episode in patients that are not suitable for surgery. The main question it aims to answer is:
Does biliary sphincterotomy prevent biliopancreatic event recurrence in non surgical patients after an episode of biliary acute pancreatitis?
Researchers will compare biliary sphincterotomy vs conservative treatment to see if there is a reduction in biliopancreatic events during the first year after admission for acute pancreatitis in non surgical patients.
Participants will be randomized to conservative treatment or biliary sphincterotomy and will be followed up for one year at 1 month, 6 months and 12 months to evaluate recurrence of BPE, readmissions, quality of life and mortality. Security of the technique will also be assessed in this specific population.
详细描述
Our working hypothesis is that endoscopic treatment with biliary sphincterotomy will reduce the number of biliopancreatic events compared to conservative treatment in patients with non-operable biliary acute pancreatitis (AP) due to a high surgical risk or in those patients who refuse surgery.
The primary aim is to assess the recurrence of the combined variable of biliopancreatic events (BPE) (biliary colic, cholangitis, choledocholithiasis, acute cholecystitis or AP) of the endoscopic sphincterotomy strategy during the follow-up time after diagnosis of AP of biliary origin in inoperable patients with respect to conservative treatment.
This is a randomized, multicenter, open-label, nationwide, intention-to-treat clinical trial. Patients will be randomized 1:1 to the two treatment groups stratified by center and AP severity.
Centers considered to participate as collaborators centers will need to have an endoscopy unit with ERCP availability that perform more than 150 ERCPs/year, and endoscopists trained in this technique. Patient inclusion and exclusion criteria is specified in a specific section of the protocol.
For the inclusion of patients, after diagnosis of biliary AP (BAP), and having ruled cholecystectomy as a possibility for the patient because of high surgical risk (after evaluation by surgery or anesthesia) or patient's refusal to undergo cholecystectomy, the absence of choledocholithiasis will be confirmed by MRCP or EUS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient older than 18 years old.
- •Definitive diagnosis of acute pancreatitis according to the presence of two out of three criteria from the Revised Atlanta Classification. At least 2 criteria: A) Typical pain, B) Amylase or lipase ≥x3 normal limit, C) Imaging evidence compatible with acute pancreatitis).
- •Biliary etiology: (any imaging test that describes gallbladder lithiasis/microlithiasis or biliary sludge).
- •Magnetic resonance cholangiography (MRCP) or endoscopic ultrasound (EUS) is required without evidence of choledocholithiasis.
- •Surgical decision of inoperable patient (if meets one or more of the following criteria: age ≥ 80 years, American Society of Anesthesiology (ASA) III or more, Charlson Comorbidity Index > 5 and/or Karnofsky < 50 or patient's decision not to undergo surgery. Patient must have been evaluated by general surgery or anesthesia.
- •Signature of the informed consent for the study
排除标准
- •Patient refusal to participate in the study.
- •Active ethylism greater than or equal to 5 drinking units per day in men and 3 in women or strong clinical suspicion of clinically significant ethylism that could be a cause of their AP.
- •Hypertriglyceridemia greater than 400 mg/dl at admission or history of poorly controlled hypertriglyceridemia.
- •Chronic pancreatitis: pancreatic calcifications in body or Wirsung on imaging or Wirsung ≥ 4 mm
- •Biliary condition requiring sphincterotomy during index admission (cholangitis or symptomatic choledocholithiasis) or previous biliary sphincterotomy.
- •Previous cholecystectomy
- •Actual use of ursodeoxycholic acid
- •Gastrointestinal tract anatomy altered by previous hepatobiliary or upper gastrointestinal surgery.
- •Inability to tolerate endoscopy sedation, perforation of the digestive tract or other contraindication to endoscopy.
- •Coagulopathy with uncorrectable International Normalized Ratio > 1.5 or uncorrectable thrombocytopenia < 50000/mm
- •Other concomitant diagnoses on admission (liver abscesses, biliopancreatic neoplasia, acute cholecystitis).
- •Hemodynamic instability.
- •Baseline ECOG ≥4
结局指标
主要结局
Biliopancreatic events (BPE)
时间窗: From enrollment until 12 months after
The primary aim is to assess the recurrence of the combined variable of biliopancreatic events (biliary colic, cholangitis, choledocholithiasis, acute cholecystitis or AP) of the endoscopic sphincterotomy strategy during the follow-up time after diagnosis of AP of biliary origin in inoperable patients with respect to conservative treatment.
次要结局
- Sphincterotomy related adverse events(From enrollment until one month after)
- Emergency room visits (not BPE related)(From enrollment until 12 months after)
- Mortality at 30 days(From enrollment until one month after)
- Time to recurrence of BPE(From enrollment until 12 months after)
- Recurrence of each of the variables that make up the combined variable BPE separately(From enrollment until 12 months after)
- Technical success of biliary sphincterotomy(From enrollment until one month after)
- Admission rate (not BPE related)(From enrollment until 12 months after)
- Emergency room visits (BPE related)(From enrollment until 12 months after)
- Admission rate (BPE related)(From enrollment until 12 months after)
- Quality of life during follow-up(From enrollment until 12 months after)
- Hospital readmission at 30 days(From enrollment until one month after)
- Mortality at one year(From enrollment until 12 months after)
- Index admission duration(From enrollment until one month after)
研究者
Jose Ramon Aparicio Tormo
Medical Doctor, Chief of Endoscopy Unit
Hospital General Universitario de Alicante