Efficacy of oral steroid gel in preventing esophageal stricture after extensive endoscopic submucosal dissection: a randomized controlled trial.

Abstract

BACKGROUND AND AIMS:

Esophageal stricture is a distressing issue for patients with early esophageal cancer following extensive endoscopic submucosal dissection (ESD), and the current steroid-based approaches are unsatisfactory for stricture prophylaxis. We evaluated the efficacy of oral hydrocortisone sodium succinate and aluminum phosphate gel (OHA) for stricture prophylaxis after extensive ESD.

METHODS:

Patients undergoing > 3/4 circumferential ESD were randomized to either the endoscopic loco-regional triamcinolone acetonide injection (ETI) plus oral prednisone group or the OHA group. The primary endpoint was incidence of esophageal stricture, and the secondary endpoints included adverse events (AEs) and endoscopic balloon dilations (EBDs).

RESULTS:

The incidence of esophageal stricture in OHA group (per-protocol analysis, 9.4%, 3/32; intention-to-treat analysis, 12.1%, 4/33) was significantly less than that of control group (per-protocol analysis, 35.5%, 11/31, P = 0.013; intention-to-treat analysis, 39.4%, 13/33, P = 0.011). Two sessions of EBD were necessary to release all strictures in the OHA group, while the similar EBDs (median 2, range 1-4) for 11 of the control. Operation-related AEs included infection (control vs. OHA group = 9.7% vs. 31.3%, P = 0.034), operation-related hypokalemia (19.4% vs. 31.3%, P = 0.278), perforation (3.2% vs. 3.1%), post-ESD hemorrhage (6.5% vs. 0%), and cardiac arrhythmia (0% vs. 6.3%). Steroid-related AEs included steroid-related hypokalemia (16.1% vs. 25%) and bone fracture (3.2% vs. 0%). Multivariate logistic regression analysis demonstrated that OHA was an independent protective factor for stricture (OR 0.079; 95%CI 0.011, 0.544; P = 0.01) and mucosal defect > 11/12 circumference was an independent risk factor (OR 49.91; 95%CI 6.7, 371.83; P < 0.001).

CONCLUSIONS:

OHA showed significantly better efficacy in preventing esophageal stricture after > 3/4 circumferential ESD compared to ETI plus oral prednisone.

• Authors: Yiyang Zhang, Xiue Yan, Yonghui Huang, Dan Nie, Yingchun Wang, Hong Chang, Yaopeng Zhang, Wei Yao, Ke Li
• Journal: Surgical endoscopy (Surg Endosc) Vol. 36 Issue 1 Pg. 402-412 (01 2022) ISSN: 1432-2218 [Electronic] Germany
• PMID: 33492500 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC part of Springer Nature.

Chemical References

• Steroids
• Triamcinolone

Topics

• Endoscopic Mucosal Resection (adverse effects)
• Esophageal Neoplasms (complications)
• Esophageal Stenosis (etiology, prevention & control)
• Humans
• Steroids
• Triamcinolone