Structured alcohol cessation support program versus current practice in acute alcoholic pancreatitis (PANDA) : Study protocol for a multicentre cluster randomised controlled trial
Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:23 |
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| Enthalten in: |
Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al. - 23(2023), 8 vom: 15. Dez., Seite 942-948 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Sissingh, Noor J [VerfasserIn] |
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| Links: |
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| Themen: |
Acute alcoholic pancreatitis |
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| Anmerkungen: |
Date Completed 16.12.2023 Date Revised 16.12.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.pan.2023.10.015 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM363593233 |
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| 245 | 1 | 0 | |a Structured alcohol cessation support program versus current practice in acute alcoholic pancreatitis (PANDA) |b Study protocol for a multicentre cluster randomised controlled trial |
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| 520 | |a Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION: Netherlands Trial Registry (NL8852). Prospectively registered | ||
| 650 | 4 | |a Clinical Trial Protocol | |
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| 650 | 4 | |a Acute alcoholic pancreatitis | |
| 650 | 4 | |a Alcohol cessation | |
| 650 | 4 | |a Cluster randomised controlled trial | |
| 650 | 4 | |a Recurrence | |
| 650 | 4 | |a Support program | |
| 700 | 1 | |a Nagelhout, Anne |e verfasserin |4 aut | |
| 700 | 1 | |a Besselink, Marc G |e verfasserin |4 aut | |
| 700 | 1 | |a Boermeester, Marja A |e verfasserin |4 aut | |
| 700 | 1 | |a Bouwense, Stefan A W |e verfasserin |4 aut | |
| 700 | 1 | |a Bruno, Marco J |e verfasserin |4 aut | |
| 700 | 1 | |a Fockens, Paul |e verfasserin |4 aut | |
| 700 | 1 | |a Goudriaan, Anneke E |e verfasserin |4 aut | |
| 700 | 1 | |a Rodríquez-Girondo, Mar D M |e verfasserin |4 aut | |
| 700 | 1 | |a van Santvoort, Hjalmar C |e verfasserin |4 aut | |
| 700 | 1 | |a Sijbom, Martijn |e verfasserin |4 aut | |
| 700 | 1 | |a van Weert, Henk C P M |e verfasserin |4 aut | |
| 700 | 1 | |a van Hooft, Jeanin E |e verfasserin |4 aut | |
| 700 | 1 | |a Umans, Devica S |e verfasserin |4 aut | |
| 700 | 1 | |a Verdonk, Robert C |e verfasserin |4 aut | |
| 700 | 0 | |a Dutch Pancreatitis Study Group |e verfasserin |4 aut | |
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