Structured alcohol cessation support program versus current practice in acute alcoholic pancreatitis (PANDA): Study protocol for a multicentre cluster randomised controlled trial

Pancreatology, vol. 23, pp. 942–948

Abstract

BACKGROUND/OBJECTIVES: The most important risk factor for recurrent pancreatitis after an episode of acute alcoholic pancreatitis is continuation of alcohol use. Current guidelines do not recommend any specific treatment strategy regarding alcohol cessation. The PANDA trial investigates whether implementation of a structured alcohol cessation support program prevents pancreatitis recurrence after a first episode of acute alcoholic pancreatitis. METHODS: PANDA is a nationwide cluster randomised superiority trial. Participating hospitals are randomised for the investigational management, consisting of a structured alcohol cessation support program, or current practice. Patients with a first episode of acute pancreatitis caused by harmful drinking (AUDIT score >7 and < 16 for men and >6 and < 14 for women) will be included. The primary endpoint is recurrence of acute pancreatitis. Secondary endpoints include cessation or reduction of alcohol use, other alcohol-related diseases, mortality, quality of life, quality-adjusted life years (QALYs) and costs. The follow-up period comprises one year after inclusion. DISCUSSION: This is the first multicentre trial with a cluster randomised trial design to investigate whether a structured alcohol cessation support program reduces recurrent acute pancreatitis in patients after a first episode of acute alcoholic pancreatitis, as compared with current practice. TRIAL REGISTRATION: Netherlands Trial Registry (NL8852). Prospectively registered.

Authors 14

1. Noor J. Sissingh corresponding Aachen Department of Gastroenterology and Hepatology

   Leiden University · Leiden University Medical Center · St. Antonius Ziekenhuis

   Affiliation as printed

   Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, the Netherlands; Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands. Electronic address: n.j.sissingh@lumc.nl

   Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, the Netherlands

   Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands

2. Anne Nagelhout

   Radboud University Nijmegen · Radboud University Medical Center · St. Antonius Ziekenhuis

   Affiliation as printed

   Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands; Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands

   Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands

   Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands

3. Marc G. Besselink

   Amsterdam UMC Location University of Amsterdam · Amsterdam Gastroenterology Endocrinology Metabolism

   Affiliation as printed

   Amsterdam UMC, Location University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; Amsterdam Gastroenterology Endocrinology Metabolism, the Netherlands

   Amsterdam Gastroenterology Endocrinology Metabolism, the Netherlands

   Amsterdam UMC, Location University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands

4. Marja A. Boermeester

   Amsterdam UMC Location University of Amsterdam · Amsterdam Gastroenterology Endocrinology Metabolism

   Affiliation as printed

   Amsterdam UMC, Location University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; Amsterdam Gastroenterology Endocrinology Metabolism, the Netherlands

   Amsterdam Gastroenterology Endocrinology Metabolism, the Netherlands

   Amsterdam UMC, Location University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands

5. Stefan A.W. Bouwense

   Maastricht University Medical Centre · Maastricht University

   Affiliation as printed

   Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands; NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands

   Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands

   NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands

6. Marco J. Bruno

   Erasmus MC

   Affiliation as printed

   Department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, the Netherlands

7. Paul Fockens

   Amsterdam UMC Location University of Amsterdam · Amsterdam Gastroenterology Endocrinology Metabolism

   Affiliation as printed

   Amsterdam Gastroenterology Endocrinology Metabolism, the Netherlands; Amsterdam UMC, Location University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam, the Netherlands

   Amsterdam Gastroenterology Endocrinology Metabolism, the Netherlands

   Amsterdam UMC, Location University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam, the Netherlands

8. Mar D.M. Rodríquez-Girondo Aachen Department of Biomedical Data Sciences

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, the Netherlands

9. Hjalmar C. van Santvoort

   University Medical Center Utrecht · St. Antonius Ziekenhuis

   Affiliation as printed

   Department of Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands; Department of Surgery, University Medical Centre Utrecht, Utrecht, the Netherlands

   Department of Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands

   Department of Surgery, University Medical Centre Utrecht, Utrecht, the Netherlands

10. Martijn Sijbom Aachen Department of General Practice

    Leiden University · Leiden University Medical Center

    Affiliation as printed

    Department of General Practice, Leiden University Medical Centre, Leiden, the Netherlands

11. Henk C P M van Weert

    Amsterdam University Medical Centers

    Affiliation as printed

    Department of General Practice, Amsterdam University Medical Centres, Amsterdam, the Netherlands

12. Jeanin Elise van Hooft Aachen Department of Gastroenterology and Hepatology

    Leiden University · Leiden University Medical Center

    Affiliation as printed

    Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, the Netherlands

13. Devica S. Umans

    Amsterdam UMC Location University of Amsterdam · St. Antonius Ziekenhuis

    Affiliation as printed

    Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands; Amsterdam UMC, Location University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam, the Netherlands

    Amsterdam UMC, Location University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam, the Netherlands

    Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands

14. Robert C. Verdonk corresponding

    St. Antonius Ziekenhuis

    Affiliation as printed

    Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands. Electronic address: r.verdonk@antoniusziekenhuis.nl

    Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands