Comparison between submucosal tunneling endoscopic resection and video-assisted thoracoscopic enucleation for esophageal submucosal tumors originating from the muscularis propria layer: a randomized controlled trial.

Abstract

Surgical resection is considered the first treatment option for submucosal tumors (SMTs) originating from the muscularis propria layer while submucosal tunneling endoscopic resection (STER) is proved to be a safe and effective method for treating SMTs. This study aimed to compare video-assisted thoracoscopic enucleation (VATE) with STER for treating esophageal SMTs. Sixty-six patients with small esophageal SMTs were prospectively randomized from July 2014 to December 2015. After exclusion of 8 patients, 58 subjects scheduled for STER or VATE were enrolled. Clinicopathological, endoscopic, and adverse events (AEs) data were collected and analyzed between STER and VATE. Forty-six males and 12 females with a mean age of 46.1 ± 9.4years were randomized to the STER (n = 30) and VATE (n = 28) groups, respectively. Demographics and lesion features were similar between the two groups. Median procedure time was shorter in the STER group than the VATE group (44.5 vs. 106.5min, P < 0.001); cost was lower in the STER group (4499.46 vs. 6137.32 USD, P = 0.010). Median decrease in hemoglobin levels post-procedure was - 1.6g/L in the STER group and 14.7g/L after VATE (P = 0.001). Lower postoperative pain scores were found in the STER group compared with the VATE group (2 vs. 4, P < 0.001). No recurrent or residual tumors were found in either group. En bloc resection rates, complete resection rates, hospital times, and post-procedure AEs were similar between two groups. The en bloc resection rates for SMTs < 20.0mm were 100% in both groups while STER achieved only 71.4% en bloc resection rate for SMTs≥ 20.0 mm. STER and VATE are comparably effective for esophageal SMTs; however, STER is superior to VATE with shorter operation time and decreased cost, and seems safer than VATE. STER is recommended for SMTs < 20.0mm while VATE is recommended for SMTs with a transverse diameter > 35.0mm. Clinical trail registration statement: This study is registered at http://www.chictr.org.cn/showproj.aspx?proj=4814 . The registration identification number is ChiCTR-TRC-14004759. The registration date is April 30, 2014.