Padilla-Valverde David, García-Santos Esther, Sanchez Susana, Manzanares Carmen, Rodriguez Marta, González Lucia, Ambrós Alfonso, Cano Juana M, Serrano Leticia, Bodoque Raquel, Vergara Teresa, Martin Jesus
Department of Surgery, University General Hospital, Ciudad Real, Faculty of Medicine, Ciudad Real, University of Castilla-La Mancha, Castilla La Mancha, Spain.
Department of Pharmacy, University General Hospital, Ciudad Real, Faculty of Medicine, Ciudad Real, University of Castilla-La Mancha, Castilla La Mancha, Spain.
J Gastrointest Oncol. 2021 Apr;12(Suppl 1):S80-S90. doi: 10.21037/jgo-20-238.
Hyperthermic intraperitoneal chemotherapy (HIPEC) with gemcitabine, after cytoreductive surgery, may reduce the tumor progression of pancreatic cancer through the reduction of the neoplastic volume and the subpopulation of residual pancreatic cancer stem cells, improving the survival of patients with pancreatic cancer and decreasing the recurrence of the disease.
A pilot study is performed with the first ten patients in the experimental group. A randomized study (phase II-III clinical trial) that requires a population of 42 patients, with 21 patients in each group. All patients have a diagnosis of ductal adenocarcinoma of the pancreas, which will be surgically resected with curative intention. (I) Group I: after an R0 resection, patients receive individualized adjuvant treatments. (II) Group II: after an R0 resection, HIPEC is performed with gemcitabine (120 mg/m for 30 min), and they also receive individualized adjuvant treatments. To analyze the safety of the procedure, the main variables measured were as follows: grades of complications by means of the Clavien-Dindo system: pancreas surgery complications (e.g., pancreatic fistula, perioperative hemorrhage, delayed gastric emptying, biliary fistula), operative mortality, and laboratory parameters to control system functions. Values were measured three times: preoperatively, twenty-four hours after surgery, and on the 7th postoperative day.
From 2018 to 2019, 31 patients were recruited for our clinical trial. Fifteen patients were excluded because of intraoperative unresectability or a different intraoperative histologic diagnosis. Ten patients were included in the experimental group (resection plus HIPEC gemcitabine). The mean age was 65±7 years, and six patients were female (60%). We confirmed the histologic diagnosis of ductal pancreatic adenocarcinoma in all patients prior to HIPEC. Total pancreatectomy was performed in five patients. The surgical median time was 360 min, and the hospital stay was 11 days. Four patients showed complications classified as Clavien-Dindo type II and one showing type I. Six patients were classified as having stage III tumors. To date, no hospital mortality, locoregional recurrence, or differences between the two groups in terms of perioperative complications, biochemical and gasometric values, or Clavien-Dindo complication grades were observed.
Our clinical pilot study demonstrated a similar perioperative outcome that allows the trial until main objectives are achieved.
在减瘤手术后，使用吉西他滨进行腹腔内热化疗（HIPEC）可能通过减小肿瘤体积和残余胰腺癌干细胞亚群来降低胰腺癌的肿瘤进展，提高胰腺癌患者的生存率并减少疾病复发。
对实验组的前10名患者进行了一项试点研究。一项随机研究（II-III期临床试验），需要42名患者，每组21名。所有患者均诊断为胰腺导管腺癌，将进行根治性手术切除。（I）第一组：在R0切除术后，患者接受个体化辅助治疗。（II）第二组：在R0切除术后，用吉西他滨（120mg/m²，持续30分钟）进行HIPEC，他们也接受个体化辅助治疗。为分析该手术的安全性，测量的主要变量如下：通过Clavien-Dindo系统评估的并发症等级：胰腺手术并发症（如胰瘘、围手术期出血、胃排空延迟、胆瘘）、手术死亡率以及用于控制系统功能的实验室参数。在术前、术后24小时和术后第7天进行三次测量。
2018年至2019年，31名患者被纳入我们的临床试验。15名患者因术中无法切除或术中组织学诊断不同而被排除。10名患者被纳入实验组（切除加吉西他滨HIPEC）。平均年龄为65±7岁，6名患者为女性（60%）。在进行HIPEC之前，我们在所有患者中均确诊了胰腺导管腺癌的组织学诊断。5名患者进行了全胰切除术。手术中位时间为360分钟，住院时间为11天。4名患者出现Clavien-Dindo II型并发症，1名患者出现I型并发症。6名患者被分类为III期肿瘤。迄今为止，未观察到医院死亡率、局部区域复发，两组在围手术期并发症、生化和气体测量值或Clavien-Dindo并发症等级方面也无差异。
我们的临床试点研究表明围手术期结果相似，这使得该试验能够继续进行直至实现主要目标。
