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腹腔镜下细胞减灭术和腹腔内热化疗:一项前瞻性临床试验及对比分析。

Laparoscopic cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: a prospective clinical trial and comparative analysis.

机构信息

Department of Surgery, University of California, San Diego, 3855 Health Sciences Drive, Mail Code 0987, San Diego, La Jolla, CA, 92093, USA.

Department of Radiation Medicine, University of California, San Diego, La Jolla, USA.

出版信息

Surg Endosc. 2023 Jul;37(7):5644-5651. doi: 10.1007/s00464-022-09589-w. Epub 2022 Dec 7.

DOI:10.1007/s00464-022-09589-w
PMID:36477643
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10322763/
Abstract

BACKGROUND

Open cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is associated with high morbidity, which limits the degree to which patients may benefit from this therapy. This study aimed to determine the feasibility of laparoscopic CRS/HIPEC.

METHODS

This was a single institution prospective clinical trial and comparative study using historical controls. Patients with histologically confirmed peritoneal surface malignancy (PSM) of appendiceal, colorectal, ovarian, or primary peritoneal origin, peritoneal carcinomatosis index (PCI) [Formula: see text] 10 were eligible.

RESULTS

Clinical trial: 18 patients (median age 57 years, 39% female) with appendiceal (15) or colorectal (3) primary PSM underwent laparoscopic CRS/HIPEC. Median and range outcomes were: operative time 219 min (134-378), EBL 10 mL (0-100), time to return to bowel function 3 days (1-7), duration IV narcotic use 3 days (1-8), length of stay 6 days (3-11). All patients had a complete cytoreduction (CC-score 0). Three (17%) experienced minor morbidity, with no major morbidity or mortality. Median DFS and OS were not reached with median follow-up of 48 months. Comparative analysis: Laparoscopic approach associated with reduced time to return of bowel function (3 versus 4 days, p = 0.001), length of stay (8 versus 5 days, p < 0.001), and morbidity (16% versus 42%, p = 0.008). Independent predictors of DFS included prior chemotherapy (HR 5.07, 95% CI 1.85, 13.89; p = 0.002), and CC-score > 0 (HR 3.31, 95% CI 1.19, 9.41; p = 0.025), but not surgical approach. CC-score > 0 was the only independent predictor of OS (HR 10.12, 95% CI 2.16, 47.30, p = 0.003).

CONCLUSIONS AND RELEVANCE

Laparoscopic CRS/HIPEC should be considered for patients with PSM with low-volume disease, including those with adenocarcinoma histology.

TRIAL REGISTRATION

Clinicaltrials.gov; NCT02463877.

摘要

背景

开放性细胞减灭术(CRS)和腹腔内热灌注化疗(HIPEC)与高发病率相关,这限制了患者从这种治疗中获益的程度。本研究旨在确定腹腔镜 CRS/HIPEC 的可行性。

方法

这是一项单中心前瞻性临床试验和使用历史对照的比较研究。组织学证实的腹膜表面恶性肿瘤(PSM)的阑尾、结直肠、卵巢或原发性腹膜来源,腹膜肿瘤指数(PCI)[公式:见文本]10 的患者有资格参加。

结果

临床试验:18 名(中位年龄 57 岁,39%为女性)患有阑尾(15 例)或结直肠(3 例)原发性 PSM 的患者接受了腹腔镜 CRS/HIPEC。中位和范围结果为:手术时间 219 分钟(134-378),EBL 10 毫升(0-100),肠道功能恢复时间 3 天(1-7),静脉麻醉使用时间 3 天(1-8),住院时间 6 天(3-11)。所有患者均行完全减瘤术(CC 评分 0)。3 例(17%)发生轻微并发症,无严重并发症或死亡。中位无复发生存期和总生存期未达到,中位随访时间为 48 个月。

比较分析

腹腔镜方法与恢复肠道功能的时间缩短(3 天对 4 天,p=0.001)、住院时间(8 天对 5 天,p<0.001)和发病率(16%对 42%,p=0.008)相关。DFS 的独立预测因素包括先前的化疗(HR 5.07,95%CI 1.85,13.89;p=0.002)和 CC 评分>0(HR 3.31,95%CI 1.19,9.41;p=0.025),但与手术方法无关。CC 评分>0 是 OS 的唯一独立预测因素(HR 10.12,95%CI 2.16,47.30,p=0.003)。

结论和相关性

腹腔镜 CRS/HIPEC 应考虑用于低容量疾病的 PSM 患者,包括腺癌组织学患者。

试验注册

Clinicaltrials.gov;NCT02463877。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59c8/10322763/b420c53ffe9f/464_2022_9589_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59c8/10322763/e1309528b8cd/464_2022_9589_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59c8/10322763/a859ac98e40c/464_2022_9589_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59c8/10322763/b420c53ffe9f/464_2022_9589_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59c8/10322763/e1309528b8cd/464_2022_9589_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59c8/10322763/a859ac98e40c/464_2022_9589_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59c8/10322763/b420c53ffe9f/464_2022_9589_Fig3_HTML.jpg

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