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

Pancreatitis, Acute Clinical Trial

— PADI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03829085
• Other study ID #: PADI_01
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Consorci Sanitari del Garraf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute

Intervention

Other:
• EARLY ORAL REFEEDING
the oral refeeding will be started after admission. Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day

Locations

Country	Name	City	State
Spain	Consorci Sanitari del Garraf	Sant Pere De Ribes	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Consorci Sanitari del Garraf	Hospital Clinic of Barcelona, Hospital Universitari Joan XXIII de Tarragona.

Country where clinical trial is conducted

Spain, 

References & Publications (13)

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. Review. — View Citation

Eckerwall GE, Tingstedt BB, Bergenzaun PE, Andersson RG. Immediate oral feeding in patients with mild acute pancreatitis is safe and may accelerate recovery--a randomized clinical study. Clin Nutr. 2007 Dec;26(6):758-63. Epub 2007 Aug 24. — View 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. Review. — View Citation

Jacobson BC, Vander Vliet MB, Hughes MD, Maurer R, McManus K, Banks PA. A prospective, randomized trial of clear liquids versus low-fat solid diet as the initial meal in mild acute pancreatitis. Clin Gastroenterol Hepatol. 2007 Aug;5(8):946-51; quiz 886. — View Citation

Lariño-Noia J, Lindkvist B, Iglesias-García J, Seijo-Ríos S, Iglesias-Canle J, Domínguez-Muñoz JE. Early and/or immediately full caloric diet versus standard refeeding in mild acute pancreatitis: a randomized open-label trial. Pancreatology. 2014 May-Jun; — View Citation

Li J, Xue GJ, Liu YL, Javed MA, Zhao XL, Wan MH, Chen GY, Altaf K, Huang W, Tang WF. Early oral refeeding wisdom in patients with mild acute pancreatitis. Pancreas. 2013 Jan;42(1):88-91. doi: 10.1097/MPA.0b013e3182575fb5. — View Citation

Li X, Ma F, Jia K. Early enteral nutrition within 24 hours or between 24 and 72 hours for acute pancreatitis: evidence based on 12 RCTs. Med Sci Monit. 2014 Nov 17;20:2327-35. doi: 10.12659/MSM.892770. — View 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: 10.1586/17474124.2 — View Citation

Oláh A, Romics L Jr. Enteral nutrition in acute pancreatitis: a review of the current evidence. World J Gastroenterol. 2014 Nov 21;20(43):16123-31. doi: 10.3748/wjg.v20.i43.16123. Review. — View 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. Review. — View Citation

Petrov MS, van Santvoort HC, Besselink MG, Cirkel GA, Brink MA, Gooszen HG. Oral refeeding after onset of acute pancreatitis: a review of literature. Am J Gastroenterol. 2007 Sep;102(9):2079-84; quiz 2085. Epub 2007 Jun 16. Review. — View 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. Erratum in: Am J Gastroenterol. 2014 Feb;109(2):302. — View Citation

Zhao XL, Zhu SF, Xue GJ, Li J, Liu YL, Wan MH, Huang W, Xia Q, Tang WF. Early oral refeeding based on hunger in moderate and severe acute pancreatitis: a prospective controlled, randomized clinical trial. Nutrition. 2015 Jan;31(1):171-5. doi: 10.1016/j.nu — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospitalization	Days	measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days.
Secondary	Relapse of abdominal pain	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	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)
Secondary	Duration of fasting	Days	2-3 days approximately since the first day of hospital admission
Secondary	Tolerance to food	The patient's symptoms are controlled with the established treatment and the patient can eat at least 50% of the meals	2-7 days approximately during hospital admission and during the follow up
Secondary	Elevation of serum amylase or lipase	Elevation amylase or lipase level after oral refeeding	2-4 days approximately during hospital admission after oral refeeding, until hospital discharge
Secondary	Intra-abdominal infection	Fever: temperature greater than 38 or positive cultures of blood or pancreatic necrosis	1 month
Secondary	Death	Mortality	During hospital stay (up to 1 day)
Secondary	Operation rate	The rate of patients received operation for pancreatitis debridement	2 month