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内镜射频消融治疗食管早期鳞状细胞癌的前瞻性试验结果。

Outcomes from a prospective trial of endoscopic radiofrequency ablation of early squamous cell neoplasia of the esophagus.

机构信息

Department of Gastroenterology and Hepatology, Academic Medical Centre, Amsterdam, the Netherlands.

出版信息

Gastrointest Endosc. 2011 Dec;74(6):1181-90. doi: 10.1016/j.gie.2011.05.024. Epub 2011 Aug 15.

Abstract

BACKGROUND

Radiofrequency ablation (RFA) is safe and effective for eradicating neoplasia in Barrett's esophagus.

OBJECTIVE

To evaluate RFA for eradicating early esophageal squamous cell neoplasia (ESCN) defined as moderate-grade squamous intraepithelial neoplasia (MGIN) and high-grade squamous intraepithelial neoplasia (HGIN) and early flat-type esophageal squamous cell carcinoma (ESCC).

DESIGN

Prospective cohort study.

SETTING

Tertiary referral center.

PATIENTS

Esophageal unstained lesions (USLs) were identified using Lugol's chromoendoscopy. Inclusion criteria were at least 1 flat (type 0-IIb) USL 3 cm or larger, USL-bearing esophagus 12 cm or less, and a consensus diagnosis of MGIN, HGIN, or ESCC by 2 expert GI pathologists. Exclusion criteria were previous endoscopic resection or ablation, stricture, or any nonflat mucosa.

INTERVENTIONS

Circumferential RFA creating a continuous treatment area (TA) including all USLs. At 3-month intervals thereafter, chromoendoscopy with biopsies followed by focal RFA of USLs, if present.

MAIN OUTCOME MEASUREMENTS

Complete response (CR) at 12 months defined as absence of MGIN, HGIN, or ESCC in the TA, CR after 1 RFA session, neoplastic progression from baseline, and adverse events.

RESULTS

Twenty-nine patients (14 male, mean age 60.3 years) with MGIN (n = 18), HGIN (n = 10), or ESCC (n = 1) participated. Mean USL length was 6.2 cm (TA 8.2 cm). At 3 months after 1 RFA session, 86% of patients (25/29) had a CR. At 12 months, 97% of patients (28/29) had a CR. There was no neoplastic progression. There were 4 strictures, all dilated to resolution.

LIMITATIONS

Single-center study with limited number of patients.

CONCLUSIONS

In patients with early ESCN (MGIN, HGIN, flat-type ESCC), RFA was associated with a high rate of histological complete response (97% of patients), no neoplastic progression, and an acceptable adverse event profile.

摘要

背景

射频消融 (RFA) 是一种安全有效的方法,可用于消除巴雷特食管中的肿瘤。

目的

评估 RFA 治疗早期食管鳞状细胞癌前病变(ESCN)的效果,这些病变定义为中度鳞状上皮内瘤变(MGIN)和高级别鳞状上皮内瘤变(HGIN)以及早期平坦型食管鳞状细胞癌(ESCC)。

设计

前瞻性队列研究。

设置

三级转诊中心。

患者

使用卢戈氏染色内镜发现食管未染色病变(USL)。纳入标准为至少 1 个平坦(0-IIb 型)USL 大于等于 3cm,USL 所在食管长度不超过 12cm,且 2 位专家胃肠病理学家一致诊断为 MGIN、HGIN 或 ESCC。排除标准为既往内镜下切除或消融、狭窄或任何非平坦黏膜。

干预

环形 RFA 形成一个连续的治疗区域(TA),包含所有 USL。此后每隔 3 个月,进行染色内镜检查和活检,如有 USL 存在则进行焦点 RFA。

主要观察指标

12 个月时的完全缓解(CR)定义为 TA 中无 MGIN、HGIN 或 ESCC,1 次 RFA 治疗后的 CR、基线时的肿瘤进展和不良事件。

结果

29 例患者(14 例男性,平均年龄 60.3 岁)入组,其中 MGIN(n=18)、HGIN(n=10)和 ESCC(n=1)各 1 例。平均 USL 长度为 6.2cm(TA 为 8.2cm)。1 次 RFA 治疗后 3 个月时,86%的患者(25/29)获得了 CR。12 个月时,97%的患者(28/29)获得了 CR。无肿瘤进展。发生 4 例狭窄,均经扩张后缓解。

局限性

单中心研究,患者数量有限。

结论

在患有早期 ESCN(MGIN、HGIN、平坦型 ESCC)的患者中,RFA 与较高的组织学完全缓解率(97%的患者)、无肿瘤进展和可接受的不良事件谱相关。

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