About this trial
Patients with EV bleeding often suffered from hematemesis, Tarry stool, and blood loss. Standard treatment for bleeding esophageal varices includes hemodynamic stabilization, pharmacological control, and endoscopic intervention. For endoscopic intervention, endoscopic variceal ligation (EVL) is the first-line therapy with 95% initial hemostasis success rate. However, after variceal ligation, esophageal ulcers form 3 days later. These ulcers expose underlying vessels in friable esophageal mucosa, exacerbated by portal hypertension and coagulopathy in cirrhosis patients. Bleeding peaks around day 5-10 when bands detach. Among these patients, 7-9% of patients experience recurrent bleeding as a result. Recurrent bleeding from esophageal ulcers carries an extremely high mortality rate, particularly in patients with advanced stage cirrhosis. Therefore, how to promote esophageal ulcer healing and prevent ulcer rebleeding is an important clinical issue.
Proton pump inhibitors (PPIs) are the primary drugs for preventing and treating gastric ulcers, but clinical evidence for their role in preventing post-ligation esophageal ulcers is insufficient. Sucralfate, a complex of aluminum hydroxide and sucrose octa sulfate, can bind to the wound base. This protective barrier can prevent the wound from further environmental injury. Sucralfate has been widely used for wounds and ulcer treatment, e.g., skin wounds, oral ulcers, and peptic ulcers. Our recent clinical trial also proved topical sucralfate can prevent postpolypectomy bleeding. Therefore, this study aimed to investigate whether the topical administration of sucralfate after standard endoscopic hemostasis can promote the esophageal ulcer healing and reduce the rebleeding event.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
cirrhotic patients aged ≥ 18 years who accept endoscopy for esophageal variceal bleeding
Disqualifiers
no need of endoscopic hemostasis
allergy to sucralfate
other etiology of bleeding than EV bleeding
Trial design
Parallel
Treatments tested in this trial
Sucralfate
Drug3g of sucralfate powder through the endoscopy precisely on the EV ligation bands in the intervention group. Followingly, patients in the intervention group will receive oral sucralfate suspension 1g four times a day for 5 days.
Treatment groups
Trial outcomes
Primary outcomes
post-EVL ulcers
total sum of size of post-EVL ulcers at the esophagogastric junction on the second-look EGD on day 5
Secondary outcomes
esophageal ulcer bleeding
esophageal ulcer bleeding requiring endoscopic hemostasis
esophageal varices rebleeding
esophageal varices rebleeding within 14 days
total packed RBC transfusion during hospitalization
total packed RBC transfusion during hospitalization
length of hospitalization
length of hospitalization
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: