Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Starting Early Oral Diet Versus Nil Per Oral in Patients With Acute Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Length of hospitalization
研究概览
简要总结
Acute pancreatitis (AP) is a common condition in emergency services worldwide. Approximately 85% of AP are mild and the patients usually recover within 1 to 2 weeks, not requeiring any critical care and organ support. The management of mild AP conventionally involves fasting, intravenous hydration and adequate analgesia until pain improves in order to prevent stimulation and allow the pancreas gland to rest.
The current guidelines recommend the oral food intake should be tried as soon as possible, and beneficial effects or early enteral nutrition with mild AP have been reported in literature.
Then, early oral refeeding (EORF) after mild and moderate AP is beneficial, but the optimal timing and starting criteria are unclear. Even now, refeeding after mild and moderate AP is typically started until clinical symptoms have resolved and pancreatic enzymes are decreasing, in a successively increasing manner. The aim of this study is to evaluate length of hospital stay, clinical findings and complications for EORF with immediately full caloric intake in patients with mild and moderate AP.
详细描述
This is prospective, randomized, controlled, multicentre trial. Patients with mild and moderate acute pancreatitis (AP) will be randomly in two groups: group A: with early oral refeeding (EOR) with low fat solid diet (LFSD), started from the first day of admission in the hospital, and group B: with Nil Per Oral (NPO), until the symptoms, signs, inflammatory parameters of AP have resolved.
The primary and several secondary endpoints will be obtained and EORF with LFSD will improve the following measures of outcome:
- Length of hospital admission (the primary endpoint)
- Serum amylase, lipase, electrolytes, calcium, urea, creatinine, liver function tests, C-reactive protein (biomarker of inflammation), nutritional parameters (albumin, prealbumin, cholesterol, triglycerides) and full blood count - routine blood tests performed daily until normalization of serum lipase or until discharge.
- Weight, at hospital admission and discharge, and at day 30 post-discharge clinic follow-up.
- Systemic complications including hemodynamic instability, renal failure, intensive care admission, surgery, radiological and endoscopic procedures.
- Pain and Analgesic requirement.
- Local complications including pancreatic necrosis, abscess, pseudocyst.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed of AP by at least two of these three criteria: compatible abdominal pain, amylase or lipase level superior in three-fold respective laboratory baseline levels, and suitable findings in imaging techniques (CT, ultrasound or MRI)
- •age > 18 years, sign consent form.
排除标准
- •pregnant o breastfeeding women;
- •abdominal pain lasting >96 horas before admission;
- •the possibility of poor oral intake for reasons other than AP;
- •Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology;
- •Chronic pancreatitis;
- •Randomization greater the 12 hours after admission
研究组 & 干预措施
Early oral refeeding
The patients will be started the oral refeeding from the first day of admission in the hospital.
Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day
干预措施: EARLY ORAL REFEEDING (Other)
FASTING
The oral diet will be reintroduced in a traditional stepwise manner until the symptoms, signs, inflammatory parameters of AP have resolved
结局指标
主要结局
Length of hospitalization
时间窗: measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days.
Days
次要结局
- Elevation of serum amylase or lipase(2-4 days approximately during hospital admission after oral refeeding, until hospital discharge)
- Operation rate(2 month)
- Relapse of abdominal pain(measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days, and during the follow up (1 month after discharge))
- Duration of fasting(2-3 days approximately since the first day of hospital admission)
- Death(During hospital stay (up to 1 day))
- Tolerance to food(2-7 days approximately during hospital admission and during the follow up)
- Intra-abdominal infection(1 month)
研究者
Elena Ramírez-Maldonado
Principal investigator
Consorci Sanitari del Garraf