A Novel Self-help Inflatable Balloon To Prevent And Treat Esophageal Stricture After Endoscopic Submucosal Dissection

Aim:Although endoscopic submucosal dissection(ESD)is gradually becoming a first-line treatment for early esophageal cancer,esophageal stricture is a major problem after ESD.The incidence of stricture is as high as 100%after resection of entire circumferential lesions.A standard method has not been established.Thus,we propose a novel self-help inflatable balloon to prevent and treat esophageal stricture.Method:The study was divided into two parts.Part 1.Patients whose mucosal defect was≥5/6 of the circumference and ≤100 mm in length after esophageal ESD were prospective enrolled.The incidence of stricture after renoval of the self-help balloon.the time from ESD to first observation of stricture,and other adverse events,such as delayed bleeding,perforation,pneumonia,and pleural effusion were all recorded.The safety and effectiveness of the new balloon for preventing esophageal stricture was evaluated.Part 2.Patients with benign esophageal stricture caused by endoscopic resection,and treated with self-help inflatable balloon were prospective enrolled.The incidence of recurrent stricture after removing the self-help balloon,and other adverse events were all recorded.The safety and effectiveness of the new balloon for treating esophageal stricture was evaluated.Results:Part 1.From January 2018 to December 2018,13 patients were enrolled.There were 3 females and 10 males,twelve patients underwent entire circumferential ESD.The median size of the circumferential mucosal defects was 72.5 mm(range:40 to 100 mm).The median time point for removing the self-help inflatable balloon was 88.1 days(range,61-119 days).Only 2(15.3%)patients experienced stricture after balloon removal.No patient experienced perforation or delayed bleeding.The most common adverse events were sore throat and sore nose,which occurred in 84.6%and 76.9%of all patients,respectively.Part 2.From November 2017 to October 2018.12 patients were enrolled.There were 2 females and 10 males,four patients were diagnosed with refractory benign strictures,four patients were diagnosed with cardia strictures.The median length and diameter of the stricture were 15.0 mm(range:10 to 30 mm)and 4.8 mm(range:2 to 6 mm).The median time point for removing the self-help inflatable balloon was 71.8 days(range,40-123 days).Only 3(25.0%)patients experienced recurrent stricture after balloon removal.The dysphagia score of pre-and post-operation had significant difference(3.0 vs 0.5,p=0.000).The most common adverse events were sore throat and sore nose,which occurred in 91.7%and 70.5%of all patients,respectively.Conclusions:The efficiency of the novel self-help inflatable balloon to prevent and treat esophageal stricture were 84.6%and 75.0%,respectively.No patient experienced perforation or delayed bleeding.The most common adverse events were sore throat and sore nose,and all were relieved gradually without intervention.The method is simple,economic,and feasible,and may have high safety and effectiveness.