Department of Visceral, Thoracic and Vascular Surgery, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstrasse 74, 01307, Dresden, Germany.
National Center for Tumor Diseases (NCT/UCC), Dresden, Germany: German Cancer Research Center (DKFZ), Heidelberg, Germany; Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany; Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Dresden, Germany.
Trials. 2023 Oct 5;24(1):641. doi: 10.1186/s13063-023-07636-y.
Colorectal cancer stands as a prevalent cause of cancer-related mortality, necessitating effective treatment strategies. Acute colonic obstruction occurs in approximately 20% of patients and represents a surgical emergency with substantial morbidity and mortality. The optimal approach for managing left-sided colon cancer with acute colonic obstruction remains debatable, with no consensus on whether emergency resection or bridge-to-surgery, involving initial decompressing stoma and subsequent elective resection after recovery, should be employed. Current studies show a decrease in morbidity and short-term mortality for the bridge-to-surgery approach, yet it remains unclear if the long-term oncological outcome is equivalent to emergency resection.
This prospective, randomized, multicenter trial aims to investigate the management of obstructive left-sided colon cancer in a comprehensive manner. The study will be conducted across 26 university hospitals and 40 academic hospitals in Germany. A total of 468 patients will be enrolled, providing a cohort of 420 evaluable patients, with an equal distribution of 210 patients in each treatment arm. Patients with left-sided colon cancer, defined as cancer between the left splenic flexure and > 12 cm ab ano and obstruction confirmed by X-ray or CT scan, are eligible. Randomization will be performed in a 1:1 ratio, assigning patients either to the oncological emergency resection group or the bridge-to-surgery group, wherein patients will undergo diverting stoma and subsequent elective oncological resection after recovery. The primary endpoint of this trial will be 120-day mortality, allowing for consideration of the time interval between diverting stoma and resection.
The findings derived from this trial possess the potential to reshape the current clinical approach of emergency resection for obstructive left-sided colon cancer by favoring the bridge-to-surgery practice, provided that a reduction in morbidity can be achieved without compromising the oncological long-term outcome.
German Clinical Trials Register (DRKS) under the identifier DRKS00031827. Registered on May 15, 2023.
28.04.2023, protocol version 2.0F.
结直肠癌是癌症相关死亡的主要原因之一，因此需要有效的治疗策略。约 20%的患者会发生急性结肠梗阻，这是一种具有较高发病率和死亡率的外科急症。对于伴有急性结肠梗阻的左侧结肠癌，最佳的治疗方法仍存在争议，目前尚无共识，即是否应采用紧急切除术或桥接手术（初始减压造口术，随后在恢复后进行选择性切除术）。目前的研究表明，桥接手术方法可降低发病率和短期死亡率，但尚不清楚其长期肿瘤学结果是否与紧急切除术相当。
本前瞻性、随机、多中心试验旨在全面研究梗阻性左侧结肠癌的治疗方法。该研究将在德国的 26 所大学医院和 40 所学术医院进行。共纳入 468 例患者，其中 420 例可评估患者为队列，每个治疗组各有 210 例患者。纳入标准为左侧结肠癌患者，定义为左脾曲以下和/或距肛门>12cm 处的癌症，且 X 射线或 CT 扫描证实存在梗阻。采用 1:1 比例随机分组，将患者分配至肿瘤紧急切除术组或桥接手术组，其中患者将接受转流造口术，然后在恢复后进行选择性肿瘤切除术。该试验的主要终点为 120 天死亡率，允许考虑转流造口术和切除术之间的时间间隔。
如果桥接手术能够在不影响肿瘤长期预后的情况下降低发病率，那么该试验的结果可能会改变目前对伴有急性结肠梗阻的左侧结肠癌采用紧急切除术的临床方法。
德国临床试验注册处（DRKS），DRKS00031827。注册于 2023 年 5 月 15 日。
2023 年 4 月 28 日，方案版本 2.0F。
