Early Oral Refeeding in Mild Acute Pancreatitis

NCT04168801 | Completed DMC

• 2 other identifiers: HraebEORvsUOR project
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Background The aim of the study is to compare the onset of oral feeding in the first 24 hours after hospital admission and determine if this influences the recurrence of pain or alters the blood levels of pancreatic enzymes, compared to usual oral refeeding in patients with mild acute pancreatitis Methods This Non-Inferiority Randomized controlled trial was carried out between September 2018 and June 2019, prior authorization from the ethics committee in health research. Patients with diagnosis of mild acute biliary pancreatitis, were divided into: Group A (early oral refeeding) and Group B (usual oral refeeding). Outcome measures were lipase pancreatic, systemic inflammatory response (concentrations of leukocytes) were used as marker for it, feasibility evaluated by abdominal pain recurrence, presence and recurrence of gastrointestinal symptoms and length of hospital stay. The aim of the present study is to compare the onset of oral feeding in the first 24 hours after hospital admission and determine if this influences the recurrence of pain or alters the blood levels of pancreatic enzymes, compared to usual oral refeeding in patients with mild acute pancreatitis.

Conditions

Pancreatitis

Keywords

Mild acute pancreatitis; Oral refeeding; Non inferiority clinical trial

Outcome Measures

Primary Outcomes (1)

• abdominal pain recurrence

  Presence of abdominal pain after to oral refeeding

  72 hours

Secondary Outcomes (1)

• systemic inflammatory response

  72 hours

Study Arms (2)

Early oral refeeding

EXPERIMENTAL

Once the patient had a score of 1-3 of the analogue numerical scale (ENA), he was interrogated about symptoms such as nausea or vomiting, if he did not have them, then receives diet indicated between 16 and 24 hours after admission.

Dietary Supplement: early oral refeeding

Usual oral refeeding

ACTIVE COMPARATOR

usual oral refeeding (UOR) Once the attending physician decided according to his clinical judgment to restart the oral feeding

Dietary Supplement: early oral refeeding

Interventions

early oral refeeding DIETARY_SUPPLEMENT

Once the patient had a score of 1-3 of the analogue numerical scale (ENA), he was interrogated about symptoms such as nausea or vomiting, receives diet indicated between 16 and 24 hours after admission.

Also known as: Early Vs Usual oral refeeding

Early oral refeeding; Usual oral refeeding

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted to the surgery services with diagnosis of acute biliary pancreatitis
• Whit mild episode criteria and symptom onset time less than 24 hours

You may not qualify if:

• Patients with pancreatitis from another cause other than biliary
• Pregnant
• History of chronic pancreatitis
• Under 18 or over 75 years
• With moderately severe or severe acute biliary pancreatitis

Sponsors & Collaborators

• Hospital Regional de Alta Especialidad del Bajio: lead

Study Sites (1)

Hospital Regional de Alta Especilidad del bajio

León, Guanajuato, 37660, Mexico

Location

Related Publications (21)

• Li JY, Yu T, Chen GC, Yuan YH, Zhong W, Zhao LN, Chen QK. Enteral nutrition within 48 hours of admission improves clinical outcomes of acute pancreatitis by reducing complications: a meta-analysis. PLoS One. 2013 Jun 6;8(6):e64926. doi: 10.1371/journal.pone.0064926. Print 2013.

  PMID: 23762266 BACKGROUND

• Samanta J, Rana A, Dhaka N, Agarwala R, Gupta P, Sinha SK, Gupta V, Yadav TD, Kochhar R. Ascites in acute pancreatitis: not a silent bystander. Pancreatology. 2019 Jul;19(5):646-652. doi: 10.1016/j.pan.2019.06.004. Epub 2019 Jun 9.

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• van Dijk SM, Hallensleben NDL, van Santvoort HC, Fockens P, van Goor H, Bruno MJ, Besselink MG; Dutch Pancreatitis Study Group. Acute pancreatitis: recent advances through randomised trials. Gut. 2017 Nov;66(11):2024-2032. doi: 10.1136/gutjnl-2016-313595. Epub 2017 Aug 24.

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• Chebli JM, Gaburri PD, Chebli LA. Oral refeeding in mild acute pancreatitis: an old challenge. World J Gastrointest Pathophysiol. 2011 Dec 15;2(6):100-2. doi: 10.4291/wjgp.v2.i6.100.

  PMID: 22180843 BACKGROUND

• Ammori BJ, Leeder PC, King RF, Barclay GR, Martin IG, Larvin M, McMahon MJ. Early increase in intestinal permeability in patients with severe acute pancreatitis: correlation with endotoxemia, organ failure, and mortality. J Gastrointest Surg. 1999 May-Jun;3(3):252-62. doi: 10.1016/s1091-255x(99)80067-5.

  PMID: 10481118 BACKGROUND

• Fritz S, Hackert T, Hartwig W, Rossmanith F, Strobel O, Schneider L, Will-Schweiger K, Kommerell M, Buchler MW, Werner J. Bacterial translocation and infected pancreatic necrosis in acute necrotizing pancreatitis derives from small bowel rather than from colon. Am J Surg. 2010 Jul;200(1):111-7. doi: 10.1016/j.amjsurg.2009.08.019.

  PMID: 20637344 BACKGROUND

• Marik PE. What is the best way to feed patients with pancreatitis? Curr Opin Crit Care. 2009 Apr;15(2):131-8. doi: 10.1097/MCC.0b013e328319910a.

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• McClave SA, Heyland DK. The physiologic response and associated clinical benefits from provision of early enteral nutrition. Nutr Clin Pract. 2009 Jun-Jul;24(3):305-15. doi: 10.1177/0884533609335176.

  PMID: 19483060 BACKGROUND

• Yi F, Ge L, Zhao J, Lei Y, Zhou F, Chen Z, Zhu Y, Xia B. Meta-analysis: total parenteral nutrition versus total enteral nutrition in predicted severe acute pancreatitis. Intern Med. 2012;51(6):523-30. doi: 10.2169/internalmedicine.51.6685. Epub 2012 Mar 15.

  PMID: 22449657 BACKGROUND

• Leppaniemi A, Tolonen M, Tarasconi A, Segovia-Lohse H, Gamberini E, Kirkpatrick AW, Ball CG, Parry N, Sartelli M, Wolbrink D, van Goor H, Baiocchi G, Ansaloni L, Biffl W, Coccolini F, Di Saverio S, Kluger Y, Moore E, Catena F. 2019 WSES guidelines for the management of severe acute pancreatitis. World J Emerg Surg. 2019 Jun 13;14:27. doi: 10.1186/s13017-019-0247-0. eCollection 2019.

  PMID: 31210778 BACKGROUND

• 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. doi: 10.1016/j.clnu.2007.04.007. Epub 2007 Aug 24.

  PMID: 17719703 BACKGROUND

• Moraes JM, Felga GE, Chebli LA, Franco MB, Gomes CA, Gaburri PD, Zanini A, Chebli JM. A full solid diet as the initial meal in mild acute pancreatitis is safe and result in a shorter length of hospitalization: results from a prospective, randomized, controlled, double-blind clinical trial. J Clin Gastroenterol. 2010 Aug;44(7):517-22. doi: 10.1097/MCG.0b013e3181c986b3.

  PMID: 20054282 BACKGROUND

• Teich N, Aghdassi A, Fischer J, Walz B, Caca K, Wallochny T, von Aretin A, von Boyen G, Gopel S, Ockenga J, Leodolter A, Ruddel J, Weber E, Mayerle J, Lerch MM, Mossner J, Schiefke I. Optimal timing of oral refeeding in mild acute pancreatitis: results of an open randomized multicenter trial. Pancreas. 2010 Oct;39(7):1088-92. doi: 10.1097/MPA.0b013e3181d3ce05.

  PMID: 20357692 BACKGROUND

• Bouman AC, ten Cate-Hoek AJ, Ramaekers BL, Joore MA. Sample Size Estimation for Non-Inferiority Trials: Frequentist Approach versus Decision Theory Approach. PLoS One. 2015 Jun 15;10(6):e0130531. doi: 10.1371/journal.pone.0130531. eCollection 2015.

  PMID: 26076354 BACKGROUND

• Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

  PMID: 23100216 BACKGROUND

• Marshall JC, Cook DJ, Christou NV, Bernard GR, Sprung CL, Sibbald WJ. Multiple organ dysfunction score: a reliable descriptor of a complex clinical outcome. Crit Care Med. 1995 Oct;23(10):1638-52. doi: 10.1097/00003246-199510000-00007.

  PMID: 7587228 BACKGROUND

• Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.

  PMID: 24054878 BACKGROUND

• Larino-Noia J, Lindkvist B, Iglesias-Garcia J, Seijo-Rios S, Iglesias-Canle J, Dominguez-Munoz JE. Early and/or immediately full caloric diet versus standard refeeding in mild acute pancreatitis: a randomized open-label trial. Pancreatology. 2014 May-Jun;14(3):167-73. doi: 10.1016/j.pan.2014.02.008. Epub 2014 Mar 14.

  PMID: 24854611 BACKGROUND

• Meng WB, Li X, Li YM, Zhou WC, Zhu XL. Three initial diets for management of mild acute pancreatitis: a meta-analysis. World J Gastroenterol. 2011 Oct 7;17(37):4235-41. doi: 10.3748/wjg.v17.i37.4235.

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• Horibe M, Nishizawa T, Suzuki H, Minami K, Yahagi N, Iwasaki E, Kanai T. Timing of oral refeeding in acute pancreatitis: A systematic review and meta-analysis. United European Gastroenterol J. 2016 Dec;4(6):725-732. doi: 10.1177/2050640615612368. Epub 2015 Oct 13.

  PMID: 28408989 BACKGROUND

• Lozada-Hernandez EE, Barron-Gonzalez O, Vazquez-Romero S, Cano-Rosas M, Apolinar-Jimenez E. Non-inferiority comparative clinical trial between early oral REFEEDING and usual oral REFEEDING in predicted mild acute biliary pancreatitis. BMC Gastroenterol. 2020 Jul 16;20(1):228. doi: 10.1186/s12876-020-01363-3.

  PMID: 32677891 DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Edgard Lozada, Dr

  Hospital Regional de Alta Especialidad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the person who performed the statistical analysis did not know to which group each patient belonged
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prior authorization from the ethics committee in health research. Patients with diagnosis of mild acute biliary pancreatitis, were divided into: Group A (early oral refeeding) and Group B (usual oral refeeding). Outcome measures were lipase pancreatic, systemic inflammatory response (concentrations of leukocytes) were used as marker for it, feasibility evaluated by abdominal pain recurrence, presence and recurrence of gastrointestinal symptoms and length of hospital stay.

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 19, 2019
• Study Start: September 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 20, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1 year
• Access Criteria: will be sent via e-mail as soon as requested

Locations

ME (1)