A Prospective, Randomized Trial of Sucralfate Versus Proton Pump Inhibitor On Prevention of Hemorrhage from the Artificial Ulcer After Endoscopic Submucosal Dissection

Abstract

Background: Endoscopic submucosal dissection (ESD) is a novel technique that enables complete en bloc resection of the early gastric cancer(EGC). ESD renders the endoscopists to dissect the submucosal layer with direct vision and remove larger lesions, hence complete histological diagnosis is possible while recurrence can be avoided. Recently, the indication of ESD is adjusted to encompass premalignant lesions and early gastric cancers as this procedure is widely performed. However, the risk of bleeding increases considerably as compared to conventional mucosal resection. To prevent post ESD bleeding, phamarcologic treatment using proton pump inhibitor (PPI) has been recommended. Theoretically, bleeding could be avoided by meticulous coagulation during ESD procedure and the use of PPI can inflict unnecessary cost elevation. The aim of this study was to elucidate the effect of the PPI versus sucralfate on the prevention of bleeding after ESD. Materials and Methods: A total of 128 patients with gastric premalignant or superficial carcinoma who underwent ESD were enrolled in a prospective randomized trial. After stratification by tumor size, shape, location, and other clinical variables, the patients were randomly assigned to two treatment groups. They received either pantoprazole 80 mg for 3 days and then 40 mg for two months (PPI group) or sucralfate 6 mg a day for two months (non PPI group) after ESD. All ESD procedures ensured that every potential bleeding spots were thoroughly coagulated. Primary endpoint was incidence of bleeding that was defined as haematemesis or melena which needed endoscopic hemostasis and requirement of more than 2 units of blood. Other clinal variables includes degree of ulcer healing, pain score and hospital day. Results: 65 patients in the PPI group and 63 patients in the non PPI group were analyzed. There was no difference on age, ulcer size, Helicobacter pylori status, NSAID medication history between these groups. Bleeding occurred in 4 patients in the PPI group and 6 patients in the non PPI group (p = 0.89). Tumor size over 3 cm and location of tumor in upper body and posterior stomach were the independent predictor for the bleeding. No differences were found in terms of symptom score, ulcer healing rate, hospital stay days between these groups. Conclusion: The Effect of sucralfate was comparable to PPI treatment on reducing the risk of bleeding. Meticulous bleeding control during ESD and use of sucralfate is reasonable alternative to PPI for the management of the ulcer created after ESD with advantage of cost effectiveness.