Recurrent acute pancreatitis prevention by the elimination of alcohol and cigarette smoking (REAPPEAR): protocol of a randomised controlled trial and a cohort study
Por:
Ocskay, K, Juhasz, M, Farkas, N, Zadori, N, Szako, L, Szakacs, Z, Szentesi, A, Eross, B, Miklos, E, Zemplenyi, A, Birkas, B, Csatho, A, Hartung, I, Nagy, T, Czopf, L, Izbeki, F, Gajdan, L, Papp, M, Czako, L, Illes, D, Marino, M, Mirabella, A, Malecka-Panas, E, Zatorski, H, Susak, Y, Opalchuk, K, Capurso, G, Apadula, L, Gheorghe, C, Saizu, I, Petersen, O, De-Madaria, E, Rosendahl, J, Parniczky, A, Hegyi, P and Hungarian Pancreatic Study Grp
Publicada:
1 ene 2022
Ahead of Print:
4 ene 2022
Resumen:
Background/objectives Acute recurrent pancreatitis (ARP) due to alcohol and/or tobacco abuse is a preventable disease which lowers quality of life and can lead to chronic pancreatitis. The REAPPEAR study aims to investigate whether a combined patient education and cessation programme for smoking and alcohol prevents ARP.
Methods and analysis The REAPPEAR study consists of an international multicentre randomised controlled trial (REAPPEAR-T) testing the efficacy of a cessation programme on alcohol and smoking and a prospective cohort study (REAPPEAR-C) assessing the effects of change in alcohol consumption and smoking (irrespective of intervention). Daily smoker patients hospitalised with alcohol-induced acute pancreatitis (AP) will be enrolled. All patients will receive a standard intervention priorly to encourage alcohol and smoking cessation. Participants will be subjected to laboratory testing, measurement of blood pressure and body mass index and will provide blood, hair and urine samples for later biomarker analysis. Addiction, motivation to change, socioeconomic status and quality of life will be evaluated with questionnaires. In the trial, patients will be randomised either to the cessation programme with 3-monthly visits or to the control group with annual visits. Participants of the cessation programme will receive a brief intervention at every visit with direct feedback on their alcohol consumption based on laboratory results. The primary endpoint will be the composite of 2-year all-cause recurrence rate of AP and/or 2-year all-cause mortality. The cost-effectiveness of the cessation programme will be evaluated. An estimated 182 participants will be enrolled per group to the REAPPEAR-T with further enrolment to the cohort.
Ethics and dissemination The study was approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (40394-10/2020/EuIG), all local ethical approvals are in place. Results will be disseminated at conferences and in peer-reviewed journals.
Filiaciones:
Ocskay, K:
Univ Pecs, Szentagothai Res Ctr, Med Sch, Inst Translat Med, Pecs, Hungary
Semmelweis Univ, Ctr Translat Med, Budapest, Hungary
Juhasz, M:
Univ Pecs, Med Sch, Inst Translat Med, Pecs, Hungary
Farkas, N:
Univ Pecs, Med Sch, Inst Translat Med, Pecs, Hungary
Univ Pecs, Med Sch, Inst Bioanal, Pecs, Hungary
Zadori, N:
Univ Pecs, Med Sch, Inst Translat Med, Pecs, Hungary
Szako, L:
Univ Pecs, Med Sch, Inst Translat Med, Pecs, Hungary
Szakacs, Z:
Univ Pecs, Szentagothai Res Ctr, Med Sch, Inst Translat Med, Pecs, Hungary
Szentesi, A:
Univ Pecs, Szentagothai Res Ctr, Med Sch, Inst Translat Med, Pecs, Hungary
Eross, B:
Univ Pecs, Szentagothai Res Ctr, Med Sch, Inst Translat Med, Pecs, Hungary
Semmelweis Univ, Ctr Translat Med, Budapest, Hungary
Miklos, E:
Univ Pecs, Med Sch, Inst Translat Med, Pecs, Hungary
Zemplenyi, A:
Univ Pecs, Fac Pharm, Div Pharmacoecon, Pecs, Hungary
Univ Pecs, Ctr Hlth Technol Assessment, Pecs, Hungary
Birkas, B:
Univ Pecs, Med Sch, Inst Behav Sci, Pecs, Hungary
Csatho, A:
Univ Pecs, Med Sch, Inst Behav Sci, Pecs, Hungary
Hartung, I:
Univ Pecs, Med Sch, Inst Behav Sci, Pecs, Hungary
Nagy, T:
Univ Pecs, Med Sch, Dept Lab Med, Pecs, Hungary
Czopf, L:
Univ Pecs, Med Sch, Dept Med 1, Div Cardiol & Angiol, Pecs, Hungary
Izbeki, F:
Szent Gyorgy Univ Teaching Hosp Fejer Cty, Dept Internal Med 1, Szekesfehervar, Hungary
Gajdan, L:
Szent Gyorgy Univ Teaching Hosp Fejer Cty, Dept Internal Med 1, Szekesfehervar, Hungary
Papp, M:
Univ Debrecen, Dept Internal Med, Div Gastroenterol, Debrecen, Hungary
Czako, L:
Univ Szeged, Fac Med, Dept Med 1, Szeged, Hungary
Illes, D:
Univ Szeged, Fac Med, Dept Med 1, Szeged, Hungary
Marino, M:
Azienda Osped Osped Riuniti Villa Sofia Cervello, Gen & Emergency Surg Dept, Palermo, Italy
Mirabella, A:
Azienda Osped Osped Riuniti Villa Sofia Cervello, Gen & Emergency Surg Dept, Palermo, Italy
Malecka-Panas, E:
Med Univ Lodz, Dept Digest Tract Dis, Lodz, Poland
Zatorski, H:
Med Univ Lodz, Dept Digest Tract Dis, Lodz, Poland
Susak, Y:
Bogomolets Natl Med Univ, Dept Surg, Kiev, Ukraine
Opalchuk, K:
Bogomolets Natl Med Univ, Dept Surg, Kiev, Ukraine
Capurso, G:
Univ Vita Salute San Raffaele, San Raffaele Sci Inst, Pancreas Translat & Clin Res Ctr, Milan, Italy
Apadula, L:
Univ Vita Salute San Raffaele, San Raffaele Sci Inst, Pancreas Translat & Clin Res Ctr, Milan, Italy
Gheorghe, C:
Clin Inst Fundeni, Bucharest, Romania
Carol Davila Univ Med & Pharm, Bucharest, Romania
Saizu, I:
Clin Inst Fundeni, Bucharest, Romania
Carol Davila Univ Med & Pharm, Bucharest, Romania
Petersen, O:
Cardiff Univ, Cardiff, Wales
:
Alicante Univ Gen Hosp, Alicante Inst Hlth & Biomed Res ISABIAL, Gastroenterol Dept, Alicante, Spain
Rosendahl, J:
Martin Luther Univ Halle Wittenberg, Dept Internal Med 1, Halle, Germany
Parniczky, A:
Univ Pecs, Med Sch, Inst Translat Med, Pecs, Hungary
Heim Pal Natl Pediat Inst, Budapest, Hungary
Hegyi, P:
Univ Pecs, Szentagothai Res Ctr, Med Sch, Inst Translat Med, Pecs, Hungary
Semmelweis Univ, Ctr Translat Med, Budapest, Hungary
gold, Green Accepted
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