Abstract：
OBJECTIVE: 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.
CONCLUSIONS: 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.
BACKGROUND: Netherlands Trial Registry (NL8852). Prospectively registered.
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.
CONCLUSIONS: 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.
BACKGROUND: Netherlands Trial Registry (NL8852). Prospectively registered.
摘要：
目的：急性酒精性胰腺炎发作后复发胰腺炎的最重要危险因素是继续饮酒。目前的指南不建议任何关于戒酒的具体治疗策略。PANDA试验调查了在急性酒精性胰腺炎首次发作后实施结构化戒酒支持计划是否可以防止胰腺炎复发。
方法：PANDA是一项全国性的集群随机优势试验。参与的医院被随机分配用于调查管理，包括一个结构化的戒酒支持计划，或目前的做法。将包括由有害饮酒引起的首次急性胰腺炎发作的患者（男性AUDIT评分>7和<16，女性>6和<14）。主要终点是急性胰腺炎的复发。次要终点包括停止或减少酒精使用，其他与酒精有关的疾病，死亡率,生活质量,质量调整寿命年(QALYs)和成本。随访期为纳入后一年。
结论：这是第一项多中心试验，采用整群随机试验设计，旨在研究结构化戒酒支持计划是否能减少急性酒精性胰腺炎首次发作后患者的复发性急性胰腺炎，与目前的做法相比。
背景：荷兰试验登记处（NL8852）。前瞻性注册。
方法：PANDA是一项全国性的集群随机优势试验。参与的医院被随机分配用于调查管理，包括一个结构化的戒酒支持计划，或目前的做法。将包括由有害饮酒引起的首次急性胰腺炎发作的患者（男性AUDIT评分>7和<16，女性>6和<14）。主要终点是急性胰腺炎的复发。次要终点包括停止或减少酒精使用，其他与酒精有关的疾病，死亡率,生活质量,质量调整寿命年(QALYs)和成本。随访期为纳入后一年。
结论：这是第一项多中心试验，采用整群随机试验设计，旨在研究结构化戒酒支持计划是否能减少急性酒精性胰腺炎首次发作后患者的复发性急性胰腺炎，与目前的做法相比。
背景：荷兰试验登记处（NL8852）。前瞻性注册。
