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.
N1 - 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 - 10.1016/j.pan.2023.10.015
DO - 10.1016/j.pan.2023.10.015
M3 - Article
C2 - 37866999
AN - SCOPUS:85174467297
SN - 1424-3903
VL - 23
SP - 942
EP - 948
JO - Pancreatology
JF - Pancreatology
IS - 8
ER -