Preventing the Recurrence of Acute Pancreatitis by Alcohol and Smoking Cessation

Официальное название

Recurrent Acute Pancreatitis Prevention by the Elimination of Alcohol and Cigarette Smoking (REAPPEAR): Protocol of a Randomized Controlled Trial and a Cohort Study

Обзор

Recurrence of acute pancreatitis (AP) is often facilitated by regular alcohol consumption and smoking. An applied lifestyle intervention focusing on the cessation of alcohol consumption and smoking might prevent the recurrence of AP. REAPPEAR Study is a randomized controlled trial and a cohort study focusing on the efficacy of the lifestyle intervention and the effect of quitting alcohol and smoking respectively.

Подробное описание

Alcohol and smoking caused recurrent acute pancretitis might be prevented. The condition is known for it's causative effect of chronic pancreatitis and nonbeneficial effect on quality of life. Clinical equipoise regarding the impact of alcohol and smoking cessation still exists, due to the non existence of well designed clinical trials. The aim of the REAPPEAR study is to investigate the effect of cessation program of alcohol and tobacco use on the recurrence of acute pancreatitis.

The REAPPEAR Study is a combined clinical trial involving a randomized multicenter clinical trial (REAPPEAR-T), which assesses the effect of the cessation program on the recurrence of the acute pancreatitis, and a cohort analysis, which investigates the effect of smoking and alcohol cessation on the recurrance of acute pancreatitis. Daily smokers, hospitalized with alcohol-induced pancreatitis will be included in the trial. Standard cessational intervention will be provided for all patients before enrollment. Laboratory testing, measurement of blood pressure and BMI will be performed, while also hair, urine samples and blood will be retrieved for later biomarker measurement. The evaluation of motivation to change, addiction, quality of life and socioeconomic status will be recorded at every visit, which will take place every 3 months or yearly according to the random allocation. For patients, who present at visit of every 3 months a brief intervention will be provided, together with a laboratory testing to provide feedback. The primary composite endpoint of this study will be the recurrence rate of acute pancreatitis irrespective of etiology and all-cause mortality in a 2 year timeframe. The cost-effectiveness will be also evaluated.

Вмешательства

• Поведенческое Standard intervention only
  Standard intervention (SI) will be a part of standard care in all participating centers, and will be provided for all acute pancreatitis patients, who are hospitalized and their condition is alcohol induced. A specially trained study nurse will deliver the intervention, since they were found to be the most effective regarding the decrease in alcohol consumption and smoking. The cost- effectiveness of the intervention and the feasibility were also taken into account. The Assist-linked brief inter
• Поведенческое Standard intervention plus repeated intervention
  Standard intervention (SI) will be performed as described above. The repeated intervention will be delivered by the former mentioned same nurse and will be structured similarly to the standard intervention. Every visit and intervention will be individually altered according to the motivation of the patient, but they will follow the same structure. The sessions can be divided into three main parts: first, highlighting the harmful effects of smoking and alcohol on the pancreatic functions. Secondl

Первичные конечные точки

• Composite endpoint of recurrence rate of AP and all cause mortality [Срок оценки: 24 months]

Вторичные конечные точки (11)

• Recurrence of acute pancreatitis irrespective of etiology [Срок оценки: 6, 18,24 months]
• Recurrence of alcohol-induced AP [Срок оценки: 24 months]
• Likely pancreatitis [Срок оценки: 3, 6, 9, 12, 15, 18, 21, 24 months]
• Length of hospital stay [Срок оценки: 3, 6, 9, 12, 15, 18, 21, 24 months]
• Presentation to the emergency unit, hospital re-admission [Срок оценки: 3, 6, 9, 12, 15, 18, 21, 24 months]
• Development of chronic pancreatitis [Срок оценки: 3, 6, 9, 12, 15, 18, 21, 24 months]
• Healthcare cost [Срок оценки: 3, 6, 9, 12, 15, 18, 21, 24 months]
• Quality adjusted life years [Срок оценки: 3, 6, 9, 12, 15, 18, 21, 24 months]
• Change of alcohol consumption given in gram per week [Срок оценки: 3, 6, 9, 12, 15, 18, 21, 24 months]
• Change of tobacco use given in pieces per day [Срок оценки: 3, 6, 9, 12, 15, 18, 21, 24 months]
• Change of alcohol consumption [Срок оценки: 3, 6, 9, 12, 15, 18, 21, 24 months]

Критерии участия

Критерии включения

• Patient hospitalized with alcohol-induced AP (defined by the revised Atlanta criteria 38)
• Every day smoker (defined as an adult patient who smoked at least 100 cigarettes in his or her lifetime, and now smokes on a daily basis; as per the CDC definition), with at least 1-year history of smoking
• Aged 18-80 years
• Provided written informed consent
• Willing to participate in the intervention in every three months

Критерии исключения

• Possible etiologies for AP other than alcohol (eg. gallstone-related, hypertriglyceridemia above 11.5 mM 40-42, hypercalcemia, viral infection) if the etiological cannot be terminated during the index admission (lack of same admission cholecystectomy, familiar hypertrygliceridemia) and cases with combined etiological factors will be excluded
• Untreated, decompensated or severe mMajor psychiatric illnesses (e.g. schizophrenia, bipolar disorder, dementia)
• Currently taking part in a smoking cessation program
• Undergoing active or palliative treatment for malignancy
• Pregnancy, breastfeeding
• Life expectancy is less than two years
• Didn't agreed to participate
• Other

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Венгрия · 1 центр

• Institute for Translational Medicine, University of Pécs — Pécs

Публикации

• Wadhwa V, Patwardhan S, Garg SK, Jobanputra Y, Lopez R, Sanaka MR. Health Care Utilization and Costs Associated With Acute Pancreatitis. Pancreas. 2017 Mar;46(3):410-415. doi: 10.1097/MPA.0000000000000755. PMID 28099261
• Szentesi A, Toth E, Balint E, Fanczal J, Madacsy T, Laczko D, Ignath I, Balazs A, Pallagi P, Maleth J, Rakonczay Z Jr, Kui B, Illes D, Marta K, Blasko A, Demcsak A, Parniczky A, Par G, Godi S, Mosztbacher D, Szucs A, Halasz A, Izbeki F, Farkas N, Hegyi P; Hungarian Pancreatic Study Group. Analysis of Research Activity in Gastroenterology: Pancreatitis Is in Real Danger. PLoS One. 2016 Oct 24;11(10 PMID 27776171
• Machicado JD, Yadav D. Epidemiology of Recurrent Acute and Chronic Pancreatitis: Similarities and Differences. Dig Dis Sci. 2017 Jul;62(7):1683-1691. doi: 10.1007/s10620-017-4510-5. Epub 2017 Mar 9. PMID 28281168
• Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30. PMID 23896955
• Guda NM, Muddana V, Whitcomb DC, Levy P, Garg P, Cote G, Uc A, Varadarajulu S, Vege SS, Chari ST, Forsmark CE, Yadav D, Reddy DN, Tenner S, Johnson CD, Akisik F, Saluja AK, Lerch MM, Mallery JS, Freeman ML. Recurrent Acute Pancreatitis: International State-of-the-Science Conference With Recommendations. Pancreas. 2018 Jul;47(6):653-666. doi: 10.1097/MPA.0000000000001053. PMID 29894415
• Yadav D, O'Connell M, Papachristou GI. Natural history following the first attack of acute pancreatitis. Am J Gastroenterol. 2012 Jul;107(7):1096-103. doi: 10.1038/ajg.2012.126. Epub 2012 May 22. PMID 22613906
• Cote GA, Yadav D, Abberbock JA, Whitcomb DC, Sherman S, Sandhu BS, Anderson MA, Lewis MD, Alkaade S, Singh VK, Baillie J, Banks PA, Conwell D, Guda NM, Muniraj T, Tang G, Brand R, Gelrud A, Amann ST, Forsmark CE, Wilcox MC, Slivka A, Gardner TB. Recurrent Acute Pancreatitis Significantly Reduces Quality of Life Even in the Absence of Overt Chronic Pancreatitis. Am J Gastroenterol. 2018 Jun;113(6): PMID 29867178
• Mandalia A, Wamsteker EJ, DiMagno MJ. Recent advances in understanding and managing acute pancreatitis. F1000Res. 2018 Jun 28;7:F1000 Faculty Rev-959. doi: 10.12688/f1000research.14244.2. eCollection 2018. PMID 30026919

Идентификаторы

NCT: NCT04647097 · 40394-10/2020/EÜIG

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗