Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head - A randomized controlled multicentre trial. ChroPac

由于胰头慢性炎症引起顽固性疼痛的患者通常会出现局部并发症（十二指肠、胆总管、胰管狭窄），需要手术治疗。由于我们的系统性综述和荟萃分析的数据发现，与维普莱手术相比，保留胰头的胰头切除技术的生活质量（QoL）更好，而发病率或死亡率没有增加，因此设计了ChroPac试验（随机对照观察者和患者设盲），以研究两年内通过EORTC-QLQ-C30身体评分6、12测量的QoL差异，术后18和24个月。样本量计算基于10%的平均差和20%的估计标准差。显著性水平为5%，把握度为90%，每个治疗组需要86例患者。假设脱落，总共需要对200例患者进行随机化。基于意向治疗人群，将使用根据年龄、性别、中心和术前QoL调整的固定效应线性模型进行分析。该试验使用德国外科学会研究中心的既定基础设施进行，并计划在功能性远端胰腺切除术（DISPACT）试验组内招募。首例患者（FPI）于2009年6月10日随机分组。然而，由于以下原因，一年后的招募落后于计划：接受胃肠病学治疗（如支架植入）的患者比例较大，因恶性肿瘤或二次介入而被排除，患者不适合两种介入治疗。通过实施一系列措施，如专门的研究者会议、启动额外的试验中心、向科学界以及患者和非专业人士提供信息，我们能够改善招募情况。到2011年第一季度，招募率可能会提高到最初计划的数量，有19个活跃的中心（计划为11个中心）。迄今为止，200例患者中有163例已接受随机化，因此，在2012年第一季度末之前完成招募是可行的。到目前为止，在试验的进行或安全方面没有出现任何问题。根据试验方案，已编制了2009/2010年安全性报告并发送至DSMB。关于报告的SAE，未观察到风险-获益评估的变化。在过去的12个月里，文件的完整性接近或超过90%，显示了试验组的出色表现。

Patients with intractable pain due to chronic inflammation of the pancreatic head often suffer from local complications (stenosis of the duodenum, common bile duct, pancreatic duct) which necessitate surgical treatment. Since data from our systematic review and a meta-analysis detected a better Quality of Life (QoL) for the duodenumpreserving pancreatic head resection techniques compared to the Whipple procedure without an increased morbidity or mortality, ChroPac trial was designed (randomized controlled observer and patient blinded) to investigate differences in QoL within two years measured by the EORTC-QLQ-C30 physical score 6, 12, 18 and 24 months after surgery. Sample size calculation is based on a mean difference of 10% with an estimated standard deviation of 20%. With a level of significance of 5 % and a power of 90 % 86 patients are needed per treatment group. Assuming drop outs a total of 200 patients need to be randomized. Based on the intention-to-treat population a fixed effects linear model adjusting for age, gender, center and QoL before surgery will be used for analysis. The trial is conducted using the established infrastructures of the Study Centre of the German Surgical Society and recruitment was planned within the functioning Distal Pancreatectomy (DISPACT) Trial Group. First patient (FPI) was randomized on June 10th, 2009. However, recruitment after one year was behind schedule due to the following reasons: larger fraction of patients treated by gastroenterological therapy like stent implantation, exclusion because of malignant tumor or secondary intervention, patient not suited for both interventions. With implementation of a number of measures like a specific investigator meeting, initiation of additional trial centers, information to scientific community as well as patients and lay people, we were able to improve recruitment. By the first quarter of 2011 recruitment rates could be enhanced to the originally scheduled numbers with 19 active centers (compared to 11 centers planned). To date 163 of 200 patients have been randomized and thus, completion of recruitment is feasible until the end of the first quarter 2012. So far, no problems emerged concerning the conduct or safety aspects of the trial. According to trial protocol the safety report 2009/2010 has been compiled and sent to the DSMB. Regarding the reported SAEs no change in the risk-benefit assessment was seen. Documentation is excellent with near to or above 90% completeness during the last twelve months, showing an outstanding performance of the trial group.