Study of the Diet in Patients With the Diagnostic of Acute Pancreatitis

Not Applicable

Completed

• Conditions: Pancreatitis, Acute
• Interventions: Other: EARLY ORAL REFEEDING

• Registration Number: NCT03829085
• Lead Sponsor: Consorci Sanitari del Garraf

Brief Summary

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.

Detailed Description

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:

1. Length of hospital admission (the primary endpoint)

2. 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.

3. Weight, at hospital admission and discharge, and at day 30 post-discharge clinic follow-up.

4. Systemic complications including hemodynamic instability, renal failure, intensive care admission, surgery, radiological and endoscopic procedures.

5. Pain and Analgesic requirement.

6. Local complications including pancreatic necrosis, abscess, pseudocyst.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Study First Submitted: 2019-01-27
• Study First Submitted QC: 2019-01-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Study First Posted: 2019-02-04
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 1. 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)
• 2. age > 18 years, sign consent form.

Exclusion Criteria

• 1. pregnant o breastfeeding women;
• 2. abdominal pain lasting >96 horas before admission;
• 3. the possibility of poor oral intake for reasons other than AP;
• 4. Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology;
• 5. Chronic pancreatitis;
• 6. Randomization greater the 12 hours after admission

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early oral refeeding	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

Primary Outcome Measures

Name	Time	Method
Length of hospitalization	measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days.	Days

Secondary Outcome Measures

Name	Time	Method
Elevation of serum amylase or lipase	2-4 days approximately during hospital admission after oral refeeding, until hospital discharge	Elevation amylase or lipase level after oral refeeding
Operation rate	2 month	The rate of patients received operation for pancreatitis debridement
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)	Pain Scale: 0=No pain, 1=Very mild, 2=Discomforting, 3=Tolerable, 4=Distressing, 5=Distressing, 6=Intense pain, 7=Very intense pain, 8=Horrible pain, 9=Excruciating, 10=Unimaginable pain
Duration of fasting	2-3 days approximately since the first day of hospital admission	Days
Death	During hospital stay (up to 1 day)	Mortality
Tolerance to food	2-7 days approximately during hospital admission and during the follow up	The patient's symptoms are controlled with the established treatment and the patient can eat at least 50% of the meals
Intra-abdominal infection	1 month	Fever: temperature greater than 38 or positive cultures of blood or pancreatic necrosis

Trial Locations

Locations (1)

Consorci Sanitari del Garraf; 🇪🇸 Sant Pere De Ribes, Barcelona, Spain