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High versus low energy administration in the early phase of acute pancreatitis (GOULASH trial): protocol of a multicentre randomised double-blind clinical trial
  1. Katalin Márta1,
  2. Anikó N Szabó1,
  3. Dániel Pécsi1,
  4. Péter Varjú1,
  5. Judit Bajor1,2,
  6. Szilárd Gódi1,2,
  7. Patrícia Sarlós1,2,
  8. Alexandra Mikó1,2,
  9. Kata Szemes2,
  10. Mária Papp3,
  11. Tamás Tornai3,
  12. Áron Vincze2,
  13. Zsolt Márton2,
  14. Patrícia A Vincze4,
  15. Erzsébet Lankó4,
  16. Andrea Szentesi1,5,
  17. Tímea Molnár1,
  18. Roland Hágendorn2,
  19. Nándor Faluhelyi6,
  20. István Battyáni6,
  21. Dezső Kelemen7,
  22. Róbert Papp7,
  23. Attila Miseta8,
  24. Zsófia Verzár9,
  25. Markus M Lerch10,
  26. John P Neoptolemos11,
  27. Miklós Sahin-Tóth12,
  28. Ole H Petersen13,
  29. Péter Hegyi1,5
  30. on behalf of the Hungarian Pancreatic Study Group
  1. 1 Institute for Translational Medicine, University of Pécs, Pecs, Hungary
  2. 2 1st Department of Internal Medicine, University of Pécs, Pécs, Hungary
  3. 3 2nd Department of Internal Medicine, University of Debrecen, Debrecen, Hungary
  4. 4 Department of Pharmaceutics and Central Clinical Pharmacy, University of Pécs, Pécs, Hungary
  5. 5 MTA-SZTE Translational Gastroenterology Research Group, Szeged, Hungary
  6. 6 Department of Radiology, University of Pécs, Pécs, Hungary
  7. 7 Surgery Clinic, University of Pécs, Pécs, Hungary
  8. 8 Department of Laboratory Medicine, University of Pécs, Pécs, Hungary
  9. 9 Department of Emergency Medicine, University of Pécs, Pécs, Hungary
  10. 10 Department of Medicine A, University Medicine Greifswald, Greifswald, Germany
  11. 11 Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK
  12. 12 Center for Exocrine Disorders, Department of Molecular and Cell Biology, Boston University Henry M. Goldman School of Dental Medicine, Boston, Massachusetts, USA
  13. 13 Medical Research Council Group, Cardiff School of Biosciences, Cardiff University, Cardiff, UK
  1. Correspondence to Dr Péter Hegyi; p.hegyi{at}tm-pte.org

Abstract

Introduction Acute pancreatitis (AP) is an inflammatory disease with no specific treatment. Mitochondrial injury followed by ATP depletion in both acinar and ductal cells is a recently discovered early event in its pathogenesis. Importantly, preclinical research has shown that intracellular ATP delivery restores the physiological function of the cells and protects from cell injury, suggesting that restoration of energy levels in the pancreas is therapeutically beneficial. Despite several high quality experimental observations in this area, no randomised trials have been conducted to date to address the requirements for energy intake in the early phase of AP.

Methods/design This is a randomised controlled two-arm double-blind multicentre trial. Patients with AP will be randomly assigned to groups A (30 kcal/kg/day energy administration starting within 24 hours of hospital admission) or B (low energy administration during the first 72 hours of hospital admission). Energy will be delivered by nasoenteric tube feeding with additional intravenous glucose supplementation or total parenteral nutrition if necessary. A combination of multiorgan failure for more than 48 hours and mortality is defined as the primary endpoint, whereas several secondary endpoints such as length of hospitalisation or pain will be determined to elucidate more detailed differences between the groups. The general feasibility, safety and quality checks required for high quality evidence will be adhered to.

Ethics and dissemination The study has been approved by the relevant organisation, the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (55961-2/2016/EKU). This study will provide evidence as to whether early high energy nutritional support is beneficial in the clinical management of AP. The results of this trial will be published in an open access way and disseminated among medical doctors.

Trial registration The trial has been registered at the ISRCTN (ISRTCN 63827758).

  • acute pancreatitis
  • energy administration
  • enteral feeding
  • randomized clinical trial

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors All authors were involved in the study design, edited the manuscript, read and approved the final manuscript. During the study KM, ANS, DP and PV are going to randomise the patients and ensure the blinding. AM, KS, JB, SG, MP, PS, ZV and TT are going to manage the treatment of the patients. ÁV will be responsible for the organisation, quality and timing of the endoscopic treatments, ZM and RH for the intensive care, NF and IB for the imaging and interventional radiology, DK and RP for the surgical treatment if needed. PAV and EL will prepare the nutritional solutions. MML, JPN, MST and OHP are members of ITAB. TM and AS will be members of SC. PH and KM drafted the manuscript.

  • Funding Centre costs (IT, biostatistics, trial organization, etc) are covered by the University of Pécs, Momentum Grant of the Hungarian Academy of Sciences (LP2014-10/2014); and Economic Development and Innovation Operative Programme Grant and Highly Cited Publication Grant of the National Research, Development and Innovation Office (GINOP-2.3.2-15-2016-00015, KH-125678). Since no additional treatment is necessary for the study, the general healthcare costs are covered by the National Healthcare System.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval The Scientific and Research Ethics Committee of the Medical Research Council, 55961-2/2016/EKU.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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