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

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

Interventions

PROCEDURE

Early Definitive Treatment

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)

Sponsors & Collaborators

• Istituto Di Ricerche Farmacologiche Mario Negri

  collaborator OTHER

• Federico Coccolini - General, Emergency and Trauma Surgery, Pisa

  collaborator UNKNOWN

• Salomone di Saverio -Department of Surgery, Varese

  collaborator UNKNOWN

• Gianluca Pellino - Universitá degli Studi della Campania 'Luigi Vanvitelli', Naples

  collaborator UNKNOWN

• Francesco Pata - General Surgery Unit, Nicola Giannettasio Hospital, Corigliano-Rossano

  collaborator UNKNOWN

• Benedetto Ielpo - HPB Surgery Unit, Hospital del Mar, Barcelona

  collaborator UNKNOWN

• Francesco Virdis - Trauma and Acute Care Surgery Unit, Milan

  collaborator UNKNOWN

• Dimitrios Damaskos - Royal Infirmary of Edinburgh, Edinburgh

  collaborator UNKNOWN

• Stavros Gourgiotis - Addenbrooke's Hospital, Cambridge

  collaborator UNKNOWN

• Gaetano Poillucci - Department of Surgery "Paride Stefanini", Rome

  collaborator UNKNOWN

• Daniela Pacella - University of Naples Federico II, Naples

  collaborator UNKNOWN

• Kumar Jayant- University of Chicago, USA

  collaborator UNKNOWN

• Ferdinando Agresta- Vittorio Veneto Civil Hospital, Italy

  collaborator UNKNOWN

• Ari Leppaniemi - University of Helsinki, Finland

  collaborator UNKNOWN

• Fausto Catena - Maggiore Hospital, Parma

  collaborator UNKNOWN

• Yoram Kluger - Rambam Health care campus, Haifa

  collaborator UNKNOWN

• Adolfo Pisanu - University of Cagliari, Cagliari

  collaborator UNKNOWN

• University of Cagliari

  lead OTHER

Principal Investigators

• Mauro Podda, M.D. · University of Cagliari

• Adolfo Pisanu, Ph.D. · University of Cagliari - Department of Surgical Science

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2021-07-01

Completion

2021-09-01

Countries

• Italy
• Spain

Study Locations