Kantsevoy Sergey V, Palmer Angela, Hockett Deborah, Vilches April
Institute for Digestive Health and Liver Diseases, Mercy Medical Center, Baltimore, Maryland, USA.
Gastrointest Endosc. 2025 Jan;101(1):149-157. doi: 10.1016/j.gie.2024.07.001. Epub 2024 Jul 5.
Endoscopic submucosal dissection (ESD) can be challenging and time-consuming. A double-balloon interventional platform (DBIP) was designed to assist with navigation, stabilization, traction, and device delivery during complex colorectal polypectomy. We compared traditional ESD (T-ESD) with DBIP-assisted ESD (DBIP-ESD) in a prospective, randomized trial.
Patients with colorectal polyps ≥2 cm were randomly assigned (1:1) to DBIP-ESD or T-ESD. The primary study endpoint was the mean total procedure time difference between groups. Secondary endpoints were intraprocedural time points, en bloc resection rate, procedure cost, adverse events, and 3-month assessment. A sample size of 200 subjects for ≥80% power was calculated. Interim analysis for early study termination was planned at 70% enrollment if the primary endpoint was met (P ≤ .05).
One hundred forty-seven patients were enrolled between February 2019 and February 2020. Seven patients dropped out, and the interim analysis was performed on 140 patients (71 DBIP-ESD, 69 T-ESD). Demographics, comorbidities, and lesion size, location, and classification were similar between groups. The mean procedure time decreased with DBIP-ESD (88.6 ± 42.7 minutes) versus T-ESD (139.5 ± 83.2 minutes; difference of ∼51 minutes [36.5%]; P < .001], with procedural savings of $610.16 (11.4%) per patient after DBIP cost. The DBIP increased dissection speed by 49.0% (15.1 ± 8.0 vs 7.7 ± 6.6 cm/h, P < .001). En bloc resection was superior with the addition of DBIP (97.2% vs 87.0%, P = .030). The mean navigation time with DBIP-ESD for sutured defect closure decreased by 7.7 minutes (P < .001). There were no adverse events in the DBIP-ESD group.
DBIP-ESD decreased the total procedure time, improved the en bloc resection rate, and facilitated sutured defect closure, making DBIP a promising and cost-effective tool to improve colorectal ESD adoption. (Clinical trial registration number: NCT03846609.).
内镜黏膜下剥离术（ESD）具有挑战性且耗时。设计了一种双气囊介入平台（DBIP），以辅助复杂结直肠息肉切除术中的导航、稳定、牵引和器械递送。我们在一项前瞻性随机试验中比较了传统ESD（T-ESD）与DBIP辅助ESD（DBIP-ESD）。
将结直肠息肉≥2 cm的患者随机（1:1）分配至DBIP-ESD组或T-ESD组。主要研究终点是两组之间的平均总手术时间差异。次要终点是术中时间点、整块切除率、手术成本、不良事件和3个月评估。计算出样本量为200名受试者，检验效能≥80%。如果达到主要终点（P≤0.05），计划在入组70%时进行早期研究终止的中期分析。
2019年2月至2020年2月共纳入147例患者。7例患者退出，对140例患者（71例DBIP-ESD，69例T-ESD）进行了中期分析。两组间的人口统计学、合并症以及病变大小、位置和分类相似。与T-ESD（139.5±83.2分钟）相比，DBIP-ESD的平均手术时间缩短（88.6±42.7分钟；差异约51分钟[36.5%]；P<0.001），扣除DBIP成本后每位患者节省手术费用610.16美元（11.4%）。DBIP使剥离速度提高了49.0%（15.1±8.0 vs 7.7±6.6 cm/h，P<0.001）。增加DBIP后整块切除效果更好（97.2%对87.0%，P=0.030）。DBIP-ESD用于缝合缺损闭合的平均导航时间减少了7.7分钟（P<0.001）。DBIP-ESD组无不良事件发生。
DBIP-ESD缩短了总手术时间，提高了整块切除率，并便于缝合缺损闭合，使DBIP成为一种有前景且具成本效益的工具，有助于提高结直肠ESD的应用。（临床试验注册号：NCT03846609。）
