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腹腔镜 HIPEC 治疗胃癌的 II 期临床试验的经验教训。

Lessons learned from a phase II clinical trial of laparoscopic HIPEC for gastric cancer.

机构信息

Departments of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Department of Surgical Oncology, Unit 1484 MD Anderson Cancer Center, 1400 Pressler St., Houston, TX, 77030, USA.

出版信息

Surg Endosc. 2018 Jan;32(1):512. doi: 10.1007/s00464-017-5668-9. Epub 2017 Jun 22.

DOI:10.1007/s00464-017-5668-9
PMID:28643069
Abstract

BACKGROUND

Over the last two decades, intraperitoneal chemotherapy has been found to have activity for select subgroups of patients with carcinomatosis from colon, ovarian, appendiceal, and recently, gastric origins. However, there is little data to support an aggressive surgical approach of cytoreduction (debulking) and hyperthermic intraperitoneal perfusion with chemotherapy (HIPEC) for patients with gastric cancer and positive cytology or carcinomatosis. The morbidity and mortality rates of cytoreduction and HIPEC, in combination with gastrectomy, are significant and the survival rates of this approach may not extend beyond that of treatment with systemic chemotherapy. The objective of this clinical trial, therefore, was to perform HIPEC in a neoadjuvant fashion via a minimally invasive approach without cytoreduction for patients with gastric cancer and positive cytology or low volume carcinomatosis. Patients found to have resolution of all extra-gastric disease are then candidates for gastrectomy.

METHODS

Patients with gastric and gastroesophageal adenocarcinoma and positive peritoneal cytology or radiologically-occult carcinomatosis that have completed treatment with systemic chemotherapy were offered participation in the study.

RESULTS

We have performed 38 laparoscopic HIPEC procedures in 19 patients. Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg in 3-7 L of infusate circulated using an extracorporeal circulation device at a flow rate of 700-1500 mL/minute for 60 min. The Laparoscopic HIPEC procedure may be performed up to five times. In this video, we sought to present the surgical technique refined during our development and completion of this Phase II clinical trial (NCT02092298).

CONCLUSION

The purpose of this presentation is to (1) demonstrate the technique of laparoscopic HIPEC and (2) review the surgical lessons learned from performing multiple HIPEC procedures prior to attempted gastrectomy.

摘要

背景

在过去的二十年中,已经发现腹腔内化疗对来自结肠、卵巢、阑尾和最近的胃癌的癌性腹水的某些亚组患者具有活性。然而,几乎没有数据支持对胃癌患者进行积极的手术治疗方法,即减瘤(去块)和腹腔内高温灌注化疗(HIPEC)。减瘤和 HIPEC 联合胃切除术的发病率和死亡率很高,而且这种方法的生存率可能不会超过全身化疗的治疗效果。因此,本临床试验的目的是通过微创途径在新辅助治疗中进行 HIPEC,而不对患有阳性细胞学或低量癌性腹水的胃癌患者进行减瘤。对于所有胃外疾病均得到缓解的患者,然后可考虑进行胃切除术。

方法

已完成全身化疗的胃和胃食管腺癌患者,且有阳性腹膜细胞学或影像学隐匿性癌性腹水者,可参与本研究。

结果

我们在 19 名患者中进行了 38 例腹腔镜 HIPEC 手术。腹腔镜 HIPEC 包括丝裂霉素 C 30mg 和顺铂 200mg,在 3-7L 输液中循环,使用体外循环装置以 700-1500mL/分钟的流速循环 60 分钟。腹腔镜 HIPEC 手术可进行多达 5 次。在本视频中,我们试图展示在开展和完成这项 II 期临床试验(NCT02092298)过程中所完善的手术技术。

结论

本演示的目的是:(1)展示腹腔镜 HIPEC 的技术;(2)回顾在尝试胃切除术前进行多次 HIPEC 操作中所获得的手术经验教训。

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