State Key Laboratory of Cancer Biology, Xijing Hospital of Digestive Diseases, Air Force Medical University (Fourth Military Medical University), Xi'an, China; Xijing Hospital of Digestive Diseases, Air Force Medical University (Fourth Military Medical University), Xi'an, China.
Department of Endoscopy Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, China.
Gastrointest Endosc. 2022 Sep;96(3):436-444. doi: 10.1016/j.gie.2022.04.016. Epub 2022 Apr 22.
Endoscopic submucosal dissection (ESD) is widely accepted as a primary treatment modality for dysplastic and early cancerous lesions of the GI tract. However, prolonged procedure time and life-threatening adverse events remain obstacles to the successful treatment of esophageal cancer. This study aimed to compare the efficacy and safety of tunnel ESD (T-ESD) with conventional ESD (C-ESD) for superficial esophageal squamous neoplasms.
A prospective, multicenter trial was conducted at 5 hospitals in China. Patients with esophageal squamous neoplasms were enrolled and randomly assigned to undergo C-ESD or T-ESD. Randomization was stratified by tumor location and circumference extent (<1/2 or ≥1/2). The primary endpoint was procedure time.
Between January and July 2018, 160 patients were enrolled. One hundred fifty-two patients (76 in the C-ESD group and 76 in the T-ESD group) were included in the final analysis. The median procedure time was 47.3 minutes (interquartile range, 31.7-81.3) for C-ESD and 40.0 minutes (interquartile range, 30.0-60.0) for T-ESD (P = .095). However, T-ESD specifically reduced the median procedure time 34.5% (29.5 minutes) compared with C-ESD for lesions ≥1/2 circumference (P < .001). Among the multiple secondary outcomes, muscular injury was less frequent in the T-ESD group compared with the C-ESD group (18.4% vs 38.2%, P = .007), but complete healing of artificial mucosal defect in 1-month follow-up was more common in the T-ESD group than the C-ESD group (95.9% vs 84.7%, P =.026).
Our study suggests that T-ESD results in shorter procedure time, specifically for lesions ≥1/2 circumference of the esophagus. In addition, T-ESD has a better safety profile indicated by less frequent muscular injury and improved healing of artificial mucosal defects caused by ESD procedures. (Clinical trial registration number: NCT03404921.).
内镜黏膜下剥离术（ESD）已被广泛接受，作为治疗胃肠道黏膜下肿瘤和早期癌的主要治疗方法。然而，较长的手术时间和危及生命的不良事件仍然是成功治疗食管癌的障碍。本研究旨在比较隧道内镜黏膜下剥离术（T-ESD）与传统内镜黏膜下剥离术（C-ESD）治疗食管浅表鳞状肿瘤的疗效和安全性。
这是一项在中国 5 家医院进行的前瞻性、多中心临床试验。纳入食管鳞状上皮肿瘤患者，并随机分为 C-ESD 组或 T-ESD 组。按肿瘤位置和周径范围（<1/2 或≥1/2）进行分层随机化。主要终点为手术时间。
2018 年 1 月至 7 月，共纳入 160 例患者。最终有 152 例患者（C-ESD 组 76 例，T-ESD 组 76 例）纳入最终分析。C-ESD 组的中位手术时间为 47.3 分钟（四分位间距 31.7-81.3），T-ESD 组为 40.0 分钟（四分位间距 30.0-60.0）（P=0.095）。然而，对于周径≥1/2 的病变，T-ESD 组的中位手术时间比 C-ESD 组缩短 34.5%（29.5 分钟）（P<0.001）。在多个次要结局中，T-ESD 组的肌层损伤发生率低于 C-ESD 组（18.4%比 38.2%，P=0.007），而 T-ESD 组在 1 个月随访时人工黏膜缺损完全愈合的比例高于 C-ESD 组（95.9%比 84.7%，P=0.026）。
本研究表明，T-ESD 可缩短手术时间，特别是对于食管周径≥1/2 的病变。此外，T-ESD 具有更好的安全性，肌层损伤发生率较低，ESD 术后人工黏膜缺损愈合更好。（临床试验注册号：NCT03404921.）。
