Topical Application of Sucralfate in Promoting Healing of Esophageal Ulcers After Esophageal Varices Ligation

ConditionUlcer Healing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cheng-Kung University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Sucralfate

    Drug

    3g 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

60 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Standard groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

post-EVL ulcers

total sum of size of post-EVL ulcers at the esophagogastric junction on the second-look EGD on day 5

Time frame
5 days

Secondary outcomes

1

esophageal ulcer bleeding

esophageal ulcer bleeding requiring endoscopic hemostasis

Time frame
14 days
2

esophageal varices rebleeding

esophageal varices rebleeding within 14 days

Time frame
14 days
3

total packed RBC transfusion during hospitalization

total packed RBC transfusion during hospitalization

Time frame
14 days
4

length of hospitalization

length of hospitalization

Time frame
14 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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