coMpliAnce With evideNce-based cliniCal Guidelines in the managemenT of Acute biliaRy pancreAtitis

NCT04747990 | Completed DMC

• 1 other identifier: Biliary Pancreatitis
• Study Type: observational
• Target: 600
• Locations: 2 countries
• Sites: 3

Brief Summary

Acute pancreatitis (AP) is an inflammatory disease of the pancreas, most commonly caused by gallstones, or excessive use of alcohol. It represents a management challenge and a significant healthcare burden. The incidence of AP ranges globally from 5 to 30 cases per 100.000 inhabitants/year, and there is evidence that the incidence has been rising in recent years. The overall case-fatality rate for AP is roughly 5%, and it is expectedly higher for more severe stages of the disease. In most cases (80%), the outcome of AP is rapidly favorable. However, acute necrotizing pancreatitis (ANP) may develop in up to 20% of cases, and is associated with significant rates of early organ failure (38%), needing some type of surgical/endoscopic intervention (38%) and death (15%). In the United States, AP is a leading cause of inpatient care among gastrointestinal conditions: more than 270.000 patients are hospitalized for AP annually, at an aggregate cost of over 2.5 billion dollars per year. In Europe, the UK incidence of AP is estimated as 15-42 cases per 100.000/year and is rising by 2.7% each year. Despite existing evidence-based practice guidelines for the management of biliary AP, clinical compliance with recommendations is poor, with studies on this field identifying major discrepancies between evidence-based recommendations and daily clinical practice. Audits about biliary AP have been performed in Italy, Germany, France, and England, with quite disappointing results. Indeed, in these audits, the treatment of biliary AP differed substantially from the recommendations. For example, less than 15% of the responders stated that they strictly followed all recommendations included in the guidelines in Germany and 25.8% of patients did not receive definitive treatment for biliary AP within 1 year in the UK. These findings support the view that publication alone of nationally or internationally developed and approved guidelines is insufficient to modify the practice of non-specialists and raises the question of how best to spread guideline recommendations. In 2020, the spread of the virus Covid-19 has represented a pandemic that also had a profound impact on the surgical community. There are many ways through which the outbreak of the Covid-19 pandemic could have influenced daily clinical practice for patients with biliary AP also leading to a failure to adhere to the recommendations coming from the guidelines, especially those regarding the early and definitive treatment with cholecystectomy or ERCP and sphincterotomy. First of all, the recommendation to postpone all non-urgent endoscopic procedures during the peak of the pandemic. Second, the recommendation to conservatively treat inflammatory conditions such as acute cholecystitis and acute appendicitis wherever possible. Since the clinical compliance with recommendations about AP is poor and the impact of implementing guideline recommendations in biliary AP has not been well studied on a global basis, we launched the MANCTRA-1 study with the aim to demonstrate areas where there is currently a sub-optimal implementation of contemporary guidelines on biliary AP. Moreover, we argue that during the Covid-19 pandemic the tendency to disregard the guidelines recommendations has been more marked than usual and we will try to find out if AP patients' care during the Covid-19 pandemic resulted in a higher rate of adverse outcomes compared to non-pandemic times due to the lack in the compliance of the guidelines. The MANCTRA-1 can identify a number of areas for quality improvement that will require new implementation strategies. Our aim is to summarize the main areas of sub-optimal care to provide the basis for introducing a number of bundles in the management of AP patients to be implemented during the next years. The primary objective of the study is to evaluate which items of the current AP guidelines if disregarded, correlate with negative clinical outcomes according to the different clinical presentations of the disease. Secondary objectives are to assess the compliance of surgeons worldwide to the most up-to-date international guidelines on biliary AP, to evaluate the medical and surgical practice in the management of biliary AP during the non-pandemic (2019) and pandemic Covid-19 periods (2020), and to investigate outcomes of patients with biliary AP treatment during the two study periods.

Conditions

Acute Pancreatitis; Acute Pancreatic Necrosis; Acute Pancreatitis Due to Gallstones; Acute Pancreatic Fluid Collection; Acute Pancreatitis With Infected Necrosis; Acute Pancreatitis Without Necrosis or Infection; Acute Pancreatitis Due to Common Bile Duct Calculus; Acute Pancreatitis Recurrent; Acute Pancreatitis Without Necrosis or Infection (Diagnosis); Covid19

Keywords

Acute Pancreatitis; Biliary Pancreatitis; Gallstones Pancreatitis; COVID-19; Pancreatic Necrosis; Optimal Care; Guidelines

Outcome Measures

Primary Outcomes (1)

• Mortality

  30-day mortality: assessed by the number of AP patients with biliary etiology deceased during the non-pandemic period (2019) and the Covid-19 pandemic period (2020)

  30-day

Secondary Outcomes (4)

• Early Cholecystectomy or ERCP and Sphincterotomy

  2 weeks

• Hospital re-admission

  30-days

• Morbidity

  30-day

• Hospital readmission

  30-day

Study Arms (2)

Baseline (Pre-Covid19) group

All patients admitted to the participating surgical departments with a clinical and radiological diagnosis of biliary acute pancreatitis in 2019

Procedure: Early Definitive Treatment

Pandemic (During Covid-19) group

All patients admitted to the participating surgical departments with a clinical and radiological diagnosis of biliary acute pancreatitis in 2020

Procedure: Early Definitive Treatment

Interventions

Early Definitive Treatment PROCEDURE

defined as treatment in accordance with the current guidelines (cholecystectomy or ERCP with endoscopic sphincterotomy during the same hospital admission or within 2 weeks of discharge)

Baseline (Pre-Covid19) group; Pandemic (During Covid-19) group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted to the participating surgical departments with a clinical and radiological diagnosis of biliary AP (with and without concomitant cholecystitis). In the United States, AP is a leading cause of inpatient care among gastrointestinal conditions: more than 270.000 patients are hospitalized for AP annually, at an aggregate cost of over 2.5 billion dollars per year \[5\]. In Europe, the UK incidence of AP is estimated as 15-42 cases per 100.000/year and is rising by 2.7% each year \[6\].

You may qualify if:

• Patients of both sexes, ≥ 16 years old, admitted to any of the participating surgical departments for biliary AP.

You may not qualify if:

• Patients with AP of etiology other than gallstones; Pregnant patients.

Sponsors & Collaborators

• University of Cagliari: lead
• Istituto Di Ricerche Farmacologiche Mario Negri: collaborator
• Federico Coccolini - General, Emergency and Trauma Surgery, Pisa: collaborator
• Salomone di Saverio -Department of Surgery, Varese: collaborator
• Gianluca Pellino - Universitá degli Studi della Campania 'Luigi Vanvitelli', Naples: collaborator
• Francesco Pata - General Surgery Unit, Nicola Giannettasio Hospital, Corigliano-Rossano: collaborator
• Benedetto Ielpo - HPB Surgery Unit, Hospital del Mar, Barcelona: collaborator
• Francesco Virdis - Trauma and Acute Care Surgery Unit, Milan: collaborator
• Dimitrios Damaskos - Royal Infirmary of Edinburgh, Edinburgh: collaborator
• Stavros Gourgiotis - Addenbrooke's Hospital, Cambridge: collaborator
• Gaetano Poillucci - Department of Surgery "Paride Stefanini", Rome: collaborator
• Daniela Pacella - University of Naples Federico II, Naples: collaborator
• Kumar Jayant- University of Chicago, USA: collaborator
• Ferdinando Agresta- Vittorio Veneto Civil Hospital, Italy: collaborator
• Ari Leppaniemi - University of Helsinki, Finland: collaborator
• Fausto Catena - Maggiore Hospital, Parma: collaborator
• Yoram Kluger - Rambam Health care campus, Haifa: collaborator
• Adolfo Pisanu - University of Cagliari, Cagliari: collaborator

Study Sites (3)

Cagliari University Hospital

Cagliari, Italy

Location

Niguarda Hospital Trauma Center - Acute Care Surgery

Milan, Italy

Location

Hospital Del Mar Barcelona

Barcelona, Spain

Location

Related Publications (26)

• Krishna SG, Kamboj AK, Hart PA, Hinton A, Conwell DL. The Changing Epidemiology of Acute Pancreatitis Hospitalizations: A Decade of Trends and the Impact of Chronic Pancreatitis. Pancreas. 2017 Apr;46(4):482-488. doi: 10.1097/MPA.0000000000000783.

  PMID: 28196021 BACKGROUND

• Koutroumpakis E, Slivka A, Furlan A, Dasyam AK, Dudekula A, Greer JB, Whitcomb DC, Yadav D, Papachristou GI. Management and outcomes of acute pancreatitis patients over the last decade: A US tertiary-center experience. Pancreatology. 2017 Jan-Feb;17(1):32-40. doi: 10.1016/j.pan.2016.10.011. Epub 2016 Oct 24.

  PMID: 28341116 BACKGROUND

• Singh VK, Bollen TL, Wu BU, Repas K, Maurer R, Yu S, Mortele KJ, Conwell DL, Banks PA. An assessment of the severity of interstitial pancreatitis. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1098-103. doi: 10.1016/j.cgh.2011.08.026. Epub 2011 Sep 3.

  PMID: 21893128 BACKGROUND

• van Santvoort HC, Bakker OJ, Bollen TL, Besselink MG, Ahmed Ali U, Schrijver AM, Boermeester MA, van Goor H, Dejong CH, van Eijck CH, van Ramshorst B, Schaapherder AF, van der Harst E, Hofker S, Nieuwenhuijs VB, Brink MA, Kruyt PM, Manusama ER, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, Cuesta MA, Wahab PJ, Gooszen HG; Dutch Pancreatitis Study Group. A conservative and minimally invasive approach to necrotizing pancreatitis improves outcome. Gastroenterology. 2011 Oct;141(4):1254-63. doi: 10.1053/j.gastro.2011.06.073. Epub 2011 Jul 8.

  PMID: 21741922 BACKGROUND

• Peery AF, Crockett SD, Barritt AS, Dellon ES, Eluri S, Gangarosa LM, Jensen ET, Lund JL, Pasricha S, Runge T, Schmidt M, Shaheen NJ, Sandler RS. Burden of Gastrointestinal, Liver, and Pancreatic Diseases in the United States. Gastroenterology. 2015 Dec;149(7):1731-1741.e3. doi: 10.1053/j.gastro.2015.08.045. Epub 2015 Aug 29.

  PMID: 26327134 BACKGROUND

• Goodchild G, Chouhan M, Johnson GJ. Practical guide to the management of acute pancreatitis. Frontline Gastroenterol. 2019 Jul;10(3):292-299. doi: 10.1136/flgastro-2018-101102. Epub 2019 Mar 2.

  PMID: 31288253 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

• Toh SK, Phillips S, Johnson CD. A prospective audit against national standards of the presentation and management of acute pancreatitis in the South of England. Gut. 2000 Feb;46(2):239-43. doi: 10.1136/gut.46.2.239.

  PMID: 10644319 BACKGROUND

• Gurusamy KS, Farouk M, Tweedie JH. UK guidelines for management of acute pancreatitis: is it time to change? Gut. 2005 Sep;54(9):1344-5. doi: 10.1136/gut.2005.071076. No abstract available.

  PMID: 16099804 BACKGROUND

• Lankisch PG, Weber-Dany B, Lerch MM. Clinical perspectives in pancreatology: compliance with acute pancreatitis guidelines in Germany. Pancreatology. 2005;5(6):591-3. doi: 10.1159/000087501. Epub 2005 Aug 16. No abstract available.

  PMID: 16110257 BACKGROUND

• Cavallini G, Frulloni L, Bassi C, Gabbrielli A, Castoldi L, Costamagna G, De Rai P, Di Carlo V, Falconi M, Pezzilli R, Uomo G; ProInf-AISP Study Group. Prospective multicentre survey on acute pancreatitis in Italy (ProInf-AISP): results on 1005 patients. Dig Liver Dis. 2004 Mar;36(3):205-11. doi: 10.1016/j.dld.2003.11.027.

  PMID: 15046191 BACKGROUND

• Green R, Charman SC, Palser T. Early definitive treatment rate as a quality indicator of care in acute gallstone pancreatitis. Br J Surg. 2017 Nov;104(12):1686-1694. doi: 10.1002/bjs.10578. Epub 2017 Aug 9.

  PMID: 28792589 BACKGROUND

• Tan JW, Gao Y, Kow AWC, Bonney G, Madhavan K, Windsor JA, Iyer SG. Clinical management and outcomes of acute pancreatitis: Identifying areas for quality improvement in a tertiary Asian setting. Pancreatology. 2019 Jun;19(4):507-518. doi: 10.1016/j.pan.2019.04.011. Epub 2019 Apr 30.

  PMID: 31088718 BACKGROUND

• Greenberg JA, Hsu J, Bawazeer M, Marshall J, Friedrich JO, Nathens A, Coburn N, Huang H, McLeod RS. Compliance with Evidence-Based Guidelines in Acute Pancreatitis: an Audit of Practices in University of Toronto Hospitals. J Gastrointest Surg. 2016 Feb;20(2):392-400. doi: 10.1007/s11605-015-3023-9. Epub 2015 Nov 30.

  PMID: 26621675 BACKGROUND

• Jakobsen HL, Rosenberg J, Schulze S, Kristiansen VB. [Treatment of gallstone pancreatitis in Denmark]. Ugeskr Laeger. 2005 Jun 13;167(24):2651-3. Danish.

  PMID: 16014225 BACKGROUND

• Pezzilli R, Uomo G, Gabbrielli A, Zerbi A, Frulloni L, De Rai P, Castoldi L, Cavallini G, Di Carlo V; ProInf-AISP Study Group. A prospective multicentre survey on the treatment of acute pancreatitis in Italy. Dig Liver Dis. 2007 Sep;39(9):838-46. doi: 10.1016/j.dld.2007.05.014. Epub 2007 Jun 29.

  PMID: 17602904 BACKGROUND

• Ragnarsson T, Andersson R, Ansari D, Persson U, Andersson B. Acute biliary pancreatitis: focus on recurrence rate and costs when current guidelines are not complied. Scand J Gastroenterol. 2017 Mar;52(3):264-269. doi: 10.1080/00365521.2016.1243258. Epub 2016 Dec 9.

  PMID: 27700180 BACKGROUND

• Aly EA, Milne R, Johnson CD. Non-compliance with national guidelines in the management of acute pancreatitis in the United kingdom. Dig Surg. 2002;19(3):192-8. doi: 10.1159/000064212.

  PMID: 12119521 BACKGROUND

• Baron TH, DiMaio CJ, Wang AY, Morgan KA. American Gastroenterological Association Clinical Practice Update: Management of Pancreatic Necrosis. Gastroenterology. 2020 Jan;158(1):67-75.e1. doi: 10.1053/j.gastro.2019.07.064. Epub 2019 Aug 31.

  PMID: 31479658 BACKGROUND

• Trikudanathan G, Wolbrink DRJ, van Santvoort HC, Mallery S, Freeman M, Besselink MG. Current Concepts in Severe Acute and Necrotizing Pancreatitis: An Evidence-Based Approach. Gastroenterology. 2019 May;156(7):1994-2007.e3. doi: 10.1053/j.gastro.2019.01.269. Epub 2019 Feb 15.

  PMID: 30776347 BACKGROUND

• Lim CL, Lee W, Liew YX, Tang SS, Chlebicki MP, Kwa AL. Role of antibiotic prophylaxis in necrotizing pancreatitis: a meta-analysis. J Gastrointest Surg. 2015 Mar;19(3):480-91. doi: 10.1007/s11605-014-2662-6. Epub 2015 Jan 22.

  PMID: 25608671 BACKGROUND

• Baltatzis M, Jegatheeswaran S, O'Reilly DA, Siriwardena AK. Antibiotic use in acute pancreatitis: Global overview of compliance with international guidelines. Pancreatology. 2016 Mar-Apr;16(2):189-93. doi: 10.1016/j.pan.2015.12.179. Epub 2016 Jan 12.

  PMID: 26804006 BACKGROUND

• Rebours V, Levy P, Bretagne JF, Bommelaer G, Hammel P, Ruszniewski P. Do guidelines influence medical practice? Changes in management of acute pancreatitis 7 years after the publication of the French guidelines. Eur J Gastroenterol Hepatol. 2012 Feb;24(2):143-8. doi: 10.1097/MEG.0b013e32834d864f.

  PMID: 22123707 BACKGROUND

• Podda M, Pellino G, Di Saverio S, Coccolini F, Pacella D, Cioffi SPB, Virdis F, Balla A, Ielpo B, Pata F, Poillucci G, Ortenzi M, Damaskos D, De Simone B, Sartelli M, Leppaniemi A, Jayant K, Catena F, Giuliani A, Di Martino M, Pisanu A; MANCTRA-1 Collaborative Group. Infected pancreatic necrosis: outcomes and clinical predictors of mortality. A post hoc analysis of the MANCTRA-1 international study. Updates Surg. 2023 Apr;75(3):493-522. doi: 10.1007/s13304-023-01488-6. Epub 2023 Mar 11.

  PMID: 36899292 DERIVED

• Podda M, Pacella D, Pellino G, Coccolini F, Giordano A, Di Saverio S, Pata F, Ielpo B, Virdis F, Damaskos D, De Simone B, Agresta F, Sartelli M, Leppaniemi A, Riboni C, Agnoletti V, Mole D, Kluger Y, Catena F, Pisanu A; MANCTRA-1 Collaborative Group; Principal Investigator; Steering Committee; MANCTRA-1 Coordinating Group; Local Collaborators; Argentina; Australia; Bahrain; Brazil; Bulgaria; China; Colombia; Czech Republic; Egypt; France; Georgia; Greece; Guatemala; India; Italy; Jordan; Malaysia; Mexico; Nigeria; Pakistan; Paraguay; Peru; Philippines; Poland; Portugal; Qatar; Romania; Russia; Serbia; Slovak Republic; South Africa; Spain; Sudan; Switzerland; Syria; Tunisia; Turkey; United Kingdom; Uruguay; Yemen. coMpliAnce with evideNce-based cliniCal guidelines in the managemenT of acute biliaRy pancreAtitis): The MANCTRA-1 international audit. Pancreatology. 2022 Nov;22(7):902-916. doi: 10.1016/j.pan.2022.07.007. Epub 2022 Jul 16.

  PMID: 35963665 DERIVED

• Podda M, Pellino G, Coccolini F, Gerardi C, Di Saverio S, Pata F, Ielpo B, Virdis F, Damaskos D, Gourgiotis S, Poillucci G, Pacella D, Jayant K, Agresta F, Sartelli M, Leppaniemi A, Kluger Y, Catena F, Pisanu A. Compliance with evidence-based clinical guidelines in the management of acute biliary pancreatitis: the MANCTRA-1 study protocol. Updates Surg. 2021 Oct;73(5):1757-1765. doi: 10.1007/s13304-021-01118-z. Epub 2021 Jun 17.

  PMID: 34142315 DERIVED

MeSH Terms

Conditions

Pancreatitis; Infections; Disease; COVID-19; Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mauro Podda, M.D.

  University of Cagliari

  STUDY CHAIR

• Adolfo Pisanu, Ph.D.

  University of Cagliari - Department of Surgical Science

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Consultant Surgeon

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: April 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); ES (1)