Partial pancreatoduodenectomy versus duodenum-preserving pancreatic head resection in chronic pancreatitis: the multicentre, randomised, controlled, double-blind ChroPac trial
Partial pancreatoduodenectomy versus duodenum-preserving pancreatic head resection in chronic pancreatitis: the multicentre, randomised, controlled, double-blind ChroPac trial
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DOI：
10.1016/s0140-6736(17)31960-8
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发表时间：
2017-09-09
期刊：
影响因子：
168.9
通讯作者：
Buechler, Markus W.
中科院分区：
文献类型：
--
作者：
Diener, Markus K.;Huettner, Felix J.;Buechler, Markus W.
慢性胰腺炎的最佳手术治疗方法存在很大的不确定性。已经发现保留胰头的胰头切除术（DPPHR）的短期结果优于部分胰头切除术。因此，我们设计的多中心ChroPac试验，以调查慢性胰腺炎患者的长期预后在24个月内surgery.Methods这种随机，对照，双盲，平行组，优越性试验在欧洲18家医院完成。计划进行择期手术治疗的慢性胰腺炎患者通过基于网络的中心随机化工具随机分配至DPPHR或部分胰腺切除术组。主要终点是术后24个月内的平均生活质量，采用欧洲癌症研究和治疗组织QLQ-C30问卷的身体功能量表进行测量。主要分析包括接受指定手术之一的所有患者;安全性分析包括接受手术干预的所有患者（按治疗分组）。患者和结局评估者对分组设盲。该试验已注册，ISRCTN 38973832。结果2009年9月10日至2013年9月3日，250例患者被随机分配到DPPHR组（n=125）或部分胰腺切除术组（n=125），其中226例患者（DPPHR组115例，部分胰腺切除术组111例）进行了分析。术后24个月内，两组的生活质量无差异（部分胰腺切除术组为75.3 [SD 16.4]，DPPHR组为73.0 [16.4];平均差异为-2.3，95% CI为-6.6至2.0; p=0.284）。两组之间严重不良事件的发生率和严重程度没有差异。DPPHR组109例患者中有70例（64%）和部分胰腺切除术组117例患者中有61例（52%）至少发生了一起严重不良事件，最常见的是再次手术（慢性胰腺炎以外的原因），胃肠道问题，解释慢性胰腺炎手术后的生活质量在两种干预措施之间没有差异。显示DPPHR优效性的单中心试验结果未在多中心环境中得到证实。
Background 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.Methods 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.Findings 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.Interpretation 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.