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

Noor J Sissingh, Anne Nagelhout, Marc G Besselink, Marja A Boermeester, Stefan A W Bouwense, Marco J Bruno, Paul Fockens, Anneke E Goudriaan, Mar D M Rodríquez-Girondo, Hjalmar C van Santvoort, Martijn Sijbom, Henk C P M van Weert, Jeanin E van Hooft, Devica S Umans, Robert C Verdonk

Journal: Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.] 2023;23(8):942-948

PMID: 37866999

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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.

Address: 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: [email protected].; Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands; Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.; Amsterdam UMC, Location University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; Amsterdam Gastroenterology Endocrinology Metabolism, 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.; Department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, the Netherlands.; Amsterdam Gastroenterology Endocrinology Metabolism, the Netherlands; Amsterdam UMC, Location University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam, the Netherlands.; Department of Psychiatry, Amsterdam University Medical Centres, Amsterdam, the Netherlands.; Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, the Netherlands.; Department of Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands; Department of Surgery, University Medical Centre Utrecht, Utrecht, the Netherlands.; Department of General Practice, Leiden University Medical Centre, Leiden, the Netherlands.; Department of General Practice, Amsterdam University Medical Centres, Amsterdam, the Netherlands.; Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, the Netherlands.; 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.; Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands. Electronic address: [email protected].

DOI: 10.1016/j.pan.2023.10.015

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MeSH Terms: Male, Humans, Female, Pancreatitis, Alcoholic, Quality of Life, Acute Disease, Risk Factors, Randomized Controlled Trials as Topic, Multicenter Studies as Topic