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; Dutch Pancreatitis Study Group

doi:10.1016/j.pan.2023.10.015

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^*, Dutch Pancreatitis Study Group

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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	17 Oct 2023
DOIs	https://doi.org/10.1016/j.pan.2023.10.015
Publication status	Published - Dec 2023

Keywords

Acute alcoholic pancreatitis
Alcohol cessation
Cluster randomised controlled trial
Recurrence
Support program

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10.1016/j.pan.2023.10.015Licence: CC BY

Cite this

Sissingh, N. J., Nagelhout, A., Besselink, M. G., Boermeester, M. A., Bouwense, S. A. W., Bruno, M. J., Fockens, P., Goudriaan, A. E., Rodríquez-Girondo, M. D. M., van Santvoort, H. C., Sijbom, M., van Weert, H. C. P. M., van Hooft, J. E., Umans, D. S., Verdonk, R. C., & Dutch Pancreatitis Study Group (2023). Structured alcohol cessation support program versus current practice in acute alcoholic pancreatitis (PANDA): Study protocol for a multicentre cluster randomised controlled trial. Pancreatology, 23(8), 942-948. https://doi.org/10.1016/j.pan.2023.10.015

@article{fd459d8395414969823a2d6aeec4ff60,

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

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.",

keywords = "Acute alcoholic pancreatitis, Alcohol cessation, Cluster randomised controlled trial, Recurrence, Support program",

author = "Sissingh, {Noor J.} and Anne Nagelhout and Besselink, {Marc G.} and Boermeester, {Marja A.} and Bouwense, {Stefan A.W.} and Bruno, {Marco J.} and Paul Fockens and Goudriaan, {Anneke E.} and Rodr{\'i}quez-Girondo, {Mar D.M.} and {van Santvoort}, {Hjalmar C.} and Martijn Sijbom and {van Weert}, {Henk C.P.M.} and {van Hooft}, {Jeanin E.} and Umans, {Devica S.} and Verdonk, {Robert C.} and {Dutch Pancreatitis Study Group}",

note = "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: {\textcopyright} 2023 The Author(s)",

year = "2023",

month = dec,

doi = "10.1016/j.pan.2023.10.015",

language = "English",

volume = "23",

pages = "942--948",

journal = "Pancreatology",

issn = "1424-3903",

publisher = "Elsevier",

number = "8",

}

Sissingh, NJ, Nagelhout, A, Besselink, MG, Boermeester, MA, Bouwense, SAW, Bruno, MJ, Fockens, P, Goudriaan, AE, Rodríquez-Girondo, MDM, van Santvoort, HC, Sijbom, M, van Weert, HCPM, van Hooft, JE, Umans, DS, Verdonk, RC & Dutch Pancreatitis Study Group 2023, '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, no. 8, pp. 942-948. https://doi.org/10.1016/j.pan.2023.10.015

Structured alcohol cessation support program versus current practice in acute alcoholic pancreatitis (PANDA): Study protocol for a multicentre cluster randomised controlled trial. / Sissingh, Noor J.; Nagelhout, Anne; Besselink, Marc G. et al.
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 - Verdonk, Robert C.

AU - Dutch Pancreatitis Study Group

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

U2 - 10.1016/j.pan.2023.10.015

DO - 10.1016/j.pan.2023.10.015

M3 - Article

SN - 1424-3903

VL - 23

SP - 942

EP - 948

JO - Pancreatology

JF - Pancreatology

IS - 8

ER -