Clinical trial NCT03829085: Study of the Diet in Patients With the Diagnostic of Acute Pancreatitis
Official title: Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Starting Early Oral Diet Versus Nil Per Oral in Patients With Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatitis, Acute
Keywords: Acute Pancreatitis
Oral refeeding
Nutrition
Length hospitalization
Lead sponsor: Consorci Sanitari del Garraf
Sponsor class: OTHER
Collaborators: name: Hospital Universitari Joan XXIII de Tarragona.
name: Hospital Clinic of Barcelona
First posted: 2019-02-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of hospitalization
timeFrame: measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days.
Secondary outcomes:
measure: Relapse of abdominal pain
timeFrame: 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)
measure: Duration of fasting
timeFrame: 2-3 days approximately since the first day of hospital admission
measure: Tolerance to food
timeFrame: 2-7 days approximately during hospital admission and during the follow up
measure: Elevation of serum amylase or lipase
timeFrame: 2-4 days approximately during hospital admission after oral refeeding, until hospital discharge
measure: Intra-abdominal infection
timeFrame: 1 month
measure: Death
timeFrame: During hospital stay (up to 1 day)
measure: Operation rate
timeFrame: 2 month
Other outcomes:
Locations:
city: Sant Pere De Ribes
country: Spain
facility: Consorci Sanitari del Garraf
state: Barcelona
Study officials:
affiliation: Consorcio Sanitari del Garraf
name: Elena Ramírez-Maldonado, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenberg JA, Hsu J, Bawazeer M, Marshall J, Friedrich JO, Nathens A, Coburn N, May GR, Pearsall E, McLeod RS. Clinical practice guideline: management of acute pancreatitis. Can J Surg. 2016 Apr;59(2):128-40. doi: 10.1503/cjs.015015.
citation: Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
citation: Bevan MG, Asrani VM, Bharmal S, Wu LM, Windsor JA, Petrov MS. Incidence and predictors of oral feeding intolerance in acute pancreatitis: A systematic review, meta-analysis, and meta-regression. Clin Nutr. 2017 Jun;36(3):722-729. doi: 10.1016/j.clnu.2016.06.006. Epub 2016 Jun 16.
citation: Lodewijkx PJ, Besselink MG, Witteman BJ, Schepers NJ, Gooszen HG, van Santvoort HC, Bakker OJ; Dutch Pancreatitis Study Group. Nutrition in acute pancreatitis: a critical review. Expert Rev Gastroenterol Hepatol. 2016;10(5):571-80. doi: 10.1586/17474124.2016.1141048. Epub 2016 Mar 15.
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citation: Petrov MS, Pylypchuk RD, Uchugina AF. A systematic review on the timing of artificial nutrition in acute pancreatitis. Br J Nutr. 2009 Mar;101(6):787-93. doi: 10.1017/S0007114508123443. Epub 2008 Nov 19.
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