Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany; Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany.
Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
Lancet. 2017 Sep 9;390(10099):1027-1037. doi: 10.1016/S0140-6736(17)31960-8.
There is substantial uncertainty regarding the optimal surgical treatment for chronic pancreatitis. Short-term outcomes have been found to be better after duodenum-preserving pancreatic head resection (DPPHR) than after partial pancreatoduodenectomy. Therefore, we designed the multicentre ChroPac trial to investigate the long-term outcomes of patients with chronic pancreatitis within 24 months after surgery.
This randomised, controlled, double-blind, parallel-group, superiority trial was done in 18 hospitals across Europe. Patients with chronic pancreatitis who were planned for elective surgical treatment were randomly assigned to DPPHR or partial pancreatoduodenectomy with a central web-based randomisation tool. The primary endpoint was mean quality of life within 24 months after surgery, measured with the physical functioning scale of the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Primary analysis included all patients who underwent one of the assigned procedures; safety analysis included all patients who underwent surgical intervention (categorised into groups as treated). Patients and outcome assessors were masked to group assignment. The trial was registered, ISRCTN38973832. Recruitment was completed on Sept 3, 2013.
Between Sept 10, 2009, and Sept 3, 2013, 250 patients were randomly assigned to DPPHR (n=125) or partial pancreatoduodenectomy (n=125), of whom 226 patients (115 in the DPPHR group and 111 in the partial pancreatoduodenectomy group) were analysed. No difference in quality of life was seen between the groups within 24 months after surgery (75·3 [SD 16·4] for partial pancreatoduodenectomy vs 73·0 [16·4] for DPPHR; mean difference -2·3, 95% CI -6·6 to 2·0; p=0·284). The incidence and severity of serious adverse events did not differ between the groups. 70 (64%) of 109 patients in the DPPHR group and 61 (52%) of 117 patients in the partial pancreatoduodenectomy group had at least one serious adverse event, with the most common being reoperations (for reasons other than chronic pancreatitis), gastrointestinal problems, and other surgical morbidity.
No differences in quality of life after surgery for chronic pancreatitis were seen between the interventions. Results from single-centre trials showing superiority for DPPHR were not confirmed in the multicentre setting.
German Research Foundation (DFG).
慢性胰腺炎的最佳手术治疗方法仍存在较大不确定性。研究发现，保留十二指肠的胰头切除术（DPPHR）术后短期效果优于胰十二指肠切除术。因此，我们设计了多中心 ChroPac 试验，旨在调查慢性胰腺炎患者术后 24 个月内的长期结果。
这是一项在欧洲 18 家医院进行的随机、对照、双盲、平行分组的优效性试验。计划接受择期手术治疗的慢性胰腺炎患者，通过中央网络随机分组工具被随机分配至 DPPHR 或胰十二指肠切除术组。主要终点是术后 24 个月内的生活质量平均评分，采用欧洲癌症研究与治疗组织 EORTC QLQ-C30 问卷的躯体功能量表进行评估。主要分析纳入了所有接受指定手术的患者；安全性分析纳入了所有接受手术干预的患者（分为治疗组）。患者和结局评估者对分组情况设盲。该试验在 ISRCTN 注册，注册号为 ISRCTN38973832。招募工作于 2013 年 9 月 3 日完成。
2009 年 9 月 10 日至 2013 年 9 月 3 日期间，250 例患者被随机分配至 DPPHR 组（n=125）或胰十二指肠切除术组（n=125），其中 226 例患者（DPPHR 组 115 例，胰十二指肠切除术组 111 例）纳入分析。术后 24 个月时，两组间的生活质量评分无差异（胰十二指肠切除术组为 75.3[16.4]，DPPHR 组为 73.0[16.4]；平均差值 -2.3，95%CI -6.6 至 2.0；p=0.284）。两组间严重不良事件的发生率和严重程度无差异。DPPHR 组 109 例患者中，70 例（64%）至少发生了 1 次严重不良事件，胰十二指肠切除术组 117 例患者中，61 例（52%）至少发生了 1 次严重不良事件，最常见的是再手术（慢性胰腺炎以外的原因）、胃肠道问题和其他手术相关并发症。
两种干预方法治疗慢性胰腺炎术后的生活质量无差异。单中心试验显示 DPPHR 具有优势，但在多中心研究中并未得到证实。
德国研究基金会（DFG）。
