Endoscopic Background Mucosal Resurfacing to Prevent Metachronous Recurrence of Superficial Esophageal Squamous Cancer After Curative Endoscopic Submucosal Dissection: A Randomized Pilot Study With 5-Year Follow-Up (with video).

IF 6.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Gastrointestinal endoscopy Pub Date : 2024-11-07 DOI:10.1016/j.gie.2024.11.003
Wen-Lun Wang, Ying-Nan Tsai, Ming-Hung Hsu, Jaw-Town Lin, Hsiu-Po Wang, Ching-Tai Lee
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Abstract

Background and aims: Metachronous recurrence frequently develops in patients with superficial esophageal squamous cell carcinomas (ESCCs) after curative endoscopic submucosal dissection (ESD), especially in those with multiple (>10) small Lugol-voiding lesions (LVLs) over the esophageal background mucosa (i.e. speckled pattern). We conducted a randomized controlled trial to investigate whether endoscopic radiofrequency ablation (RFA) for esophageal background mucosal resurfacing (EBMR) can decrease the rate of metachronous neoplasia.

Methods: Patients who received curative ESD and whose Lugol staining showed a speckled pattern over the background mucosa were randomly assigned in a 1:1 ratio to either receive RFA (EBMR group) or endoscopic surveillance alone (control group). EBMR with RFA was performed with a balloon device for circumferential ablation of the total esophageal mucosa 2-3 months after ESD. The primary outcome was the metachronous recurrence of squamous neoplasia during a 5-year follow-up period. The secondary outcomes were major adverse events.

Results: Of 112 patients screened, 30 were randomized to receive EBMR (n = 15) or surveillance (n = 15). The mean procedure time of EBMR was 30.7 min (range: 25-40 min). One patient developed post-RFA stenosis, which resolved after 3 sessions of endoscopic dilation. EBMR reduced the risk of metachronous recurrence (0% in the EBMR group vs. 53% in the control group, p = 0.001), with the number needed to treat being 1.9. Reversal of the Lugol staining speckled pattern to only a few LVLs occurred in all patients and persisted for at least 5 years in the ablation group.

Conclusion: In this randomized trial of patients with multiple small LVLs over the esophageal background after curative ESD, EBMR with balloon-type RFA is a promising and safe procedure for preventing metachronous recurrence over 5 years of follow-up.

Clinical trial registration number: NCT03183115.

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内镜下粘膜下切除术后防止食管浅层鳞癌复发的内镜下粘膜背景重铺:随访 5 年的随机试点研究(附视频)。
背景和目的:浅表食管鳞状细胞癌(ESCC)患者在内镜下黏膜下剥离术(ESD)治愈后经常会出现间期复发,尤其是食管背景黏膜上有多个(>10个)小卢戈空洞病灶(LVL)(即斑点模式)的患者。我们进行了一项随机对照试验,研究内镜射频消融(RFA)用于食管背景粘膜重铺(EBMR)是否能降低远期肿瘤的发生率:方法:按1:1的比例随机分配接受根治性ESD治疗且Lugol染色显示背景粘膜有斑点的患者接受RFA治疗(EBMR组)或仅接受内镜监测(对照组)。EBMR 和 RFA 是在 ESD 2-3 个月后使用球囊装置对整个食管粘膜进行环形消融。主要结果是 5 年随访期间鳞状肿瘤的远期复发。次要结果为主要不良事件:在接受筛查的 112 名患者中,30 人被随机分配接受 EBMR(15 人)或监测(15 人)。EBMR 的平均手术时间为 30.7 分钟(25-40 分钟不等)。一名患者在射频消融术后出现血管狭窄,经过 3 次内镜扩张术后得以缓解。EBMR 降低了远期复发的风险(EBMR 组为 0%,对照组为 53%,P = 0.001),所需治疗人数为 1.9。所有患者的 Lugol 染色斑点模式均已逆转为仅有少数 LVL,消融组患者的 Lugol 染色斑点模式至少持续了 5 年:结论:在这项针对ESD根治性治疗后食管背景多发小LVL患者的随机试验中,EBMR与球囊型RFA是一种很有前景且安全的手术,可在5年的随访中预防远期复发:临床试验注册号:NCT03183115。
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来源期刊
Gastrointestinal endoscopy
Gastrointestinal endoscopy 医学-胃肠肝病学
CiteScore
10.30
自引率
7.80%
发文量
1441
审稿时长
38 days
期刊介绍: Gastrointestinal Endoscopy is a journal publishing original, peer-reviewed articles on endoscopic procedures for studying, diagnosing, and treating digestive diseases. It covers outcomes research, prospective studies, and controlled trials of new endoscopic instruments and treatment methods. The online features include full-text articles, video and audio clips, and MEDLINE links. The journal serves as an international forum for the latest developments in the specialty, offering challenging reports from authorities worldwide. It also publishes abstracts of significant articles from other clinical publications, accompanied by expert commentaries.
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