A Prospective Study of Stent Covered With Triamcinolone-Soaked Polyglycolic Acid Sheet in Preventing Stricture Formation After Large Esophageal ESD

Abstract

Introduction: Stricture occurs almost 100% in circumferential lesions after endoscopic submucosal dissections (ESD), which leads to a low quality of life. As an intermediate-acting steroid, triamcinolone is easily absorbed into the submucosal layer and durable in inhibiting inflammation, while locoregional injections may cause delayed perforation and bleeding and oral prednisolone have systemic adverse effects. Polyglycolic acid(PGA) sheet outside of stent serves a scaffold for cell adhesion and proliferation, which can be gradually biodegradated in 30 days. We evaluate the safety and efficacy of a new method(stent covered with triamcinolone-soaked PGA sheet) for preventing stricture formation after large esophageal ESD. Methods: Form June 2016 to December 2016, 16 patients of large esophageal superficial cancer(≥3/4 of the esophageal circumference) were prospectively enrolled to perform ESD. Randomized to two groups(Group A: triamcinolone-soaked PGA sheet, n=8; Group B: PGA sheet, n=8). All stents were placed immediately after ESD and were removed 4 weeks post-ESD, The primary outcome was the incidence of stricture formation. The secondary outcome was the number of endoscopic balloon dilatation (EBD) sessions required. Results: No adverse events occurred in both groups. One patient required additional surgical resection in group A was excluded. Mean length of the resection in two groups have no statistical significance(9.00±3.37 cm vs 7.38±2.26 cm, P=0.287). Three patients(42.9%) in group A and 5(62.5%) in group B developed stricture(P=0.619). No stricture was found in post-operation with non-circumference resection in both groups. The stricture rate of circumferential lesions was 50%(3/6Symboland the medium diameter of stricture was 5mm(range 2-9mm) in group A, while 100%(5/5) and 3mm(range 2-4mm) in group B(stricture rate: P=0.182; diameter: P=0.216). All strictures were found in the middle of the defects in both groups(8/8). The medium numbres of EBD in group A was 3 (range 3-4) after a followed-up of 7.5 months(range 5-11months), and the number was 5 in group B(range 3-11) with followed-up of 8.0 months(range 5-11months)(P=0.122).SymbolConclusion: Triamcinolone-soaked PGA sheet is safe and radically decreases the incidence of esophageal stricture and the number of EBD sessions. Triamcinolone exposed to the surgical wound by saturating PGA sheet is a novel administration, which distinguishes from traditional oral prednisolone and locoregional steroid injections.Figure: Study flow chart.Table: Table. The incidence of stricture formation and the number of EBD dilatation