학술논문
Structured alcohol cessation support program versus current practice in acute alcoholic pancreatitis (PANDA): Study protocol for a multicentre cluster randomised controlled trial.
Document Type
Academic Journal
Author
Sissingh NJ; 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.; Nagelhout A; Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands; Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.; Besselink MG; Amsterdam UMC, Location University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; Amsterdam Gastroenterology Endocrinology Metabolism, the Netherlands.; Boermeester MA; Amsterdam UMC, Location University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; Amsterdam Gastroenterology Endocrinology Metabolism, the Netherlands.; Bouwense SAW; Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands; NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands.; Bruno MJ; Department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, the Netherlands.; Fockens P; Amsterdam Gastroenterology Endocrinology Metabolism, the Netherlands; Amsterdam UMC, Location University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam, the Netherlands.; Goudriaan AE; Department of Psychiatry, Amsterdam University Medical Centres, Amsterdam, the Netherlands.; Rodríquez-Girondo MDM; Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, the Netherlands.; van Santvoort HC; Department of Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands; Department of Surgery, University Medical Centre Utrecht, Utrecht, the Netherlands.; Sijbom M; Department of General Practice, Leiden University Medical Centre, Leiden, the Netherlands.; van Weert HCPM; Department of General Practice, Amsterdam University Medical Centres, Amsterdam, the Netherlands.; van Hooft JE; Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, the Netherlands.; Umans DS; 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.; Verdonk RC; Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands. Electronic address: r.verdonk@antoniusziekenhuis.nl.
Source
Publisher: Country of Publication: Switzerland NLM ID: 100966936 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1424-3911 (Electronic) Linking ISSN: 14243903 NLM ISO Abbreviation: Pancreatology Subsets: MEDLINE
Subject
Language
English
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.
(Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)
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.
(Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)