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.

BACKGROUND AND AIMS: 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.

METHODS: 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.

RESULTS: Forty-six males and 12 females with a mean age of 46.1 ± 9.4 years 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. 106.5 min, 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 - 1.6 g/L in the STER group and 14.7 g/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 < 20.0 mm were 100% in both groups while STER achieved only 71.4% en bloc resection rate for SMTs ≥ 20.0 mm.

CONCLUSION: 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 < 20.0 mm while VATE is recommended for SMTs with a transverse diameter > 35.0 mm. Clinical trail registration statement: This study is registered at https://www.chictr.org.cn/showproj.aspx?proj=4814 . The registration identification number is ChiCTR-TRC-14004759. The registration date is April 30, 2014.