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腹腔镜 D2 胃切除术联合加压腹腔内气溶胶化疗(PIPAC)治疗高复发风险胃癌患者的可行性和安全性:PIPAC-OPC4 研究。

Feasibility and Safety of Laparoscopic D2 Gastrectomy in Combination with Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients with Gastric Cancer at High Risk of Recurrence-The PIPAC-OPC4 Study.

机构信息

Odense PIPAC Center, Odense University Hospital, Odense, Denmark.

Department of Surgery, Odense University Hospital, Odense, Denmark.

出版信息

Ann Surg Oncol. 2023 Jul;30(7):4433-4441. doi: 10.1245/s10434-023-13278-w. Epub 2023 Mar 3.

DOI:10.1245/s10434-023-13278-w
PMID:36867174
Abstract

BACKGROUND

Patients with gastric adenocarcinoma (GAC) are at high risk of peritoneal recurrence despite perioperative chemotherapy and radical resection. This study evaluated feasibility and safety of laparoscopic D2 gastrectomy in combination with pressurized intraperitoneal aerosol chemotherapy (PIPAC).

METHODS

This was a prospective, controlled bi-institutional study in patients with GAC at high risk of recurrence treated with PIPAC with cisplatin and doxorubicin (PIPAC C/D) after laparoscopic D2 gastrectomy. High risk was defined as a poorly cohesive subtype with predominance of signet-ring cells, clinical stage ≥ T3 and/or ≥ N2, or positive peritoneal cytology. Peritoneal lavage fluid was collected before and after resection. Cisplatin (10.5 mg/m) and doxorubicin (2.1 mg/m) were aerosolized after anastomosis (flow 0.5-0.8 ml/s, maximum pressure 300 PSI). Treatment was feasible and safe if ≤ 20% had Dindo-Clavien ≥ 3b surgical complications or CTCAE ≥ 4 medical adverse events within 30 days. Secondary outcomes were length of stay (LOS), peritoneal lavage cytology, and completion of postoperative systemic chemotherapy.

RESULTS

Twenty-one patients were treated with a D2 gastrectomy and PIPAC C/D. The median age was 61 years (range 24-76), there were eleven female patients, and 20 patients had preoperative chemotherapy. There was no mortality. Two patients had grade 3b complications that were potentially related to PIPAC C/D (one anastomotic leakage, and one late duodenal blow-out). One patient had severe neutropenia, and nine patients had moderate pain. The LOS was 6 days (4-26). One patient had positive peritoneal lavage cytology before resection, and none were positive after. Fifteen patients had postoperative chemotherapy.

CONCLUSIONS

Laparoscopic D2 gastrectomy in combination with PIPAC C/D is feasible and safe.

摘要

背景

尽管进行了围手术期化疗和根治性切除术,胃腺癌(GAC)患者仍有很高的腹膜复发风险。本研究评估了腹腔镜 D2 胃切除术联合加压腹腔内气溶胶化疗(PIPAC)治疗高复发风险 GAC 患者的可行性和安全性。

方法

这是一项前瞻性、对照的双联机构研究,在腹腔镜 D2 胃切除术后,采用顺铂和多柔比星(PIPAC C/D)对高复发风险的 GAC 患者进行 PIPAC 治疗。高危定义为具有明显印戒细胞、临床分期≥T3 和/或≥N2、或阳性腹膜细胞学的非黏附型。在切除前后收集腹腔灌洗液。吻合后雾化顺铂(10.5mg/m)和多柔比星(2.1mg/m)(流速 0.5-0.8ml/s,最大压力 300PSI)。如果在 30 天内≤20%的患者出现 Dindo-Clavien≥3b 级手术并发症或 CTCAE≥4 级的医疗不良事件,则治疗是可行和安全的。次要结局包括住院时间(LOS)、腹腔灌洗细胞学和术后全身化疗的完成情况。

结果

21 例患者接受了 D2 胃切除术和 PIPAC C/D 治疗。中位年龄为 61 岁(范围 24-76 岁),女性 11 例,20 例患者术前接受了化疗。无死亡病例。2 例患者出现 3b 级并发症,可能与 PIPAC C/D 有关(1 例吻合口漏,1 例迟发性十二指肠破裂)。1 例患者发生严重中性粒细胞减少,9 例患者出现中度疼痛。LOS 为 6 天(4-26 天)。1 例患者在切除前腹腔灌洗液细胞学阳性,切除后均为阴性。15 例患者接受了术后化疗。

结论

腹腔镜 D2 胃切除术联合 PIPAC C/D 是可行和安全的。

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