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.
| Original language | English |
|---|---|
| Pages (from-to) | 942-948 |
| Number of pages | 7 |
| Journal | Pancreatology |
| Volume | 23 |
| Issue number | 8 |
| Early online date | 2023 |
| DOIs | |
| Publication status | Published - Dec 2023 |
Keywords
- Acute alcoholic pancreatitis
- Alcohol cessation
- Cluster randomised controlled trial
- Recurrence
- Support program
Access to Document
Other files and links
Cite this
- APA
- Author
- BIBTEX
- Harvard
- Standard
- RIS
- Vancouver
}
In: Pancreatology, Vol. 23, No. 8, 12.2023, p. 942-948.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Structured alcohol cessation support program versus current practice in acute alcoholic pancreatitis (PANDA)
T2 - Study protocol for a multicentre cluster randomised controlled trial
AU - Sissingh, Noor J.
AU - Nagelhout, Anne
AU - Besselink, Marc G.
AU - Boermeester, Marja A.
AU - Bouwense, Stefan A. W.
AU - Bruno, Marco J.
AU - Fockens, Paul
AU - Goudriaan, Anneke E.
AU - Rodríquez-Girondo, Mar D. M.
AU - van Santvoort, Hjalmar C.
AU - Sijbom, Martijn
AU - van Weert, Henk C. P. M.
AU - van Hooft, Jeanin E.
AU - Umans, Devica S.
AU - The Dutch Pancreatitis Study Group
AU - Verdonk, Robert C.
N1 - Funding Information: The authors thank the PANDA study group: Sunje Abraham (Department of Gastroenterology and Hepatology, Alrijne Hospital, Leiderdorp, The Netherlands), Marie-Paule G.F. Anten (Department of Gastroenterology and Hepatology, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands), Lambertus C. Baak (Department of Gastroenterology and Hepatology, OLVG, Amsterdam, The Netherlands), Abha Bhalla (Department of Gastroenterology and Hepatology, Haga Hospital, The Hague, The Netherlands), Menno A. Brink (Department of Gastroenterology and Hepatology, Meander MC, Amersfoort, The Netherlands), Lieke Brouwer-Hol (Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, The Netherlands), Wouter L. Curvers (Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands), Patty A.T. Dekker (Department of Gastroenterology and Hepatology, Flevo Hospital, Almere, The Netherlands), Vincent K. Dik (Department of Gastroenterology and Hepatology, Medical Centre Leeuwarden, Leeuwarden, The Netherlands), Peter van Duijvendijk (Department of Surgery, Gelre Hospitals, Apeldoorn, The Netherlands), Polat Dura (Department of Gastroenterology and Hepatology, Ziekenhuisgroep Twente, Hengelo, The Netherlands), Brechje C. van Eijck (Department of Gastroenterology and Hepatology, Spaarne Gasthuis, Hoofddorp, The Netherlands), G. Willemien Erkelens (Department of Gastroenterology and Hepatology, Gelre Hospitals, Apeldoorn, The Netherlands), Erwin J.M. van Geenen (Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands), Mike van der Have (Department of Gastroenterology and Hepatology, Admiraal de Ruyter Hospital, Goes, The Netherlands), G.J. Maarten Hemmink (Department of Gastroenterology and Hepatology, Isala, Zwolle, The Netherlands), Chantal V. Hoge (Department of Gastroenterology and Hepatology, Maastricht UMC+, Maastricht, The Netherlands), Pieter-Jan F. de Jonge (Department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, The Netherlands), Liesbeth M. Kager (Department of Gastroenterology and Hepatology, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands), Yolande Keulemans (Department of Gastroenterology and Hepatology, Zuyderland MC, Sittard, The Netherlands), Parweez Koehestanie (Department of Gastroenterology and Hepatology, Bravis Hospital, Roosendaal, The Netherlands), Edith M. Koehler (Department of Gastroenterology and Hepatology, Ikazia Hospital, Rotterdam, The Netherlands), Michiel Ledeboer (Department of Gastroenterology and Hepatology, Deventer Hospital, Deventer, The Netherlands), Sarah Bos (Department of Gastroenterology and Hepatology, Treant Zorggroep, Emmen, The Netherlands), Marianne E. Smits (Department of Gastroenterology and Hepatology, TerGooi, Hilversum, The Netherlands), Rutger Quispel (Department of Gastroenterology and Hepatology, Reinier de Graaf Gasthuis, Delft, The Netherlands), Adriaan C.I.T.L. Tan (Department of Gastroenterology and Hepatology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands), Niels G. Venneman (Department of Gastroenterology and Hepatology, Medical Spectrum Twente, Enschede, The Netherlands), Frank P. Vleggaar (Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, The Netherlands), Marije S. Vlug (Department of Gastroenterology and Hepatology, Dijklander Hospital, Hoorn, The Netherlands), Rogier P. Voermans (Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre, Amsterdam, The Netherlands), Roy L.J. van Wanrooij (Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre, Amsterdam, The Netherlands) and Tessa Verlaan ((Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, Ede, The Netherlands). The PANDA trial is an investigator-initiated trial. Financial support is provided by the Dutch Digestive Disease Foundation (Maag Lever Darm Stichting, grant number WO 19-10). The authors reports no conflict of interest in this work. Funding Information: The PANDA trial is an investigator-initiated trial. Financial support is provided by the Dutch Digestive Disease Foundation (Maag Lever Darm Stichting, grant number WO 19-10 ). The authors reports no conflict of interest in this work. Publisher Copyright: © 2023 The Author(s)
PY - 2023/12
Y1 - 2023/12
N2 - 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.
AB - 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.
KW - Acute alcoholic pancreatitis
KW - Alcohol cessation
KW - Cluster randomised controlled trial
KW - Recurrence
KW - Support program
UR - http://www.scopus.com/inward/record.url?scp=85174467297&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.pan.2023.10.015
DO - https://doi.org/10.1016/j.pan.2023.10.015
M3 - Article
C2 - 37866999
SN - 1424-3903
VL - 23
SP - 942
EP - 948
JO - Pancreatology
JF - Pancreatology
IS - 8
ER -