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- Ensaio Clínico NCT07679191
Topical Application of Sucralfate in Promoting Healing of Esophageal Ulcers After Esophageal Varices Ligation
Topical Application of Sucralfate in Promoting Healing of Esophageal Ulcers After Esophageal Varices Ligation: A Randomized Controlled 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Liver cirrhosis is with high prevalence in Taiwan at around 1-2% of the adult population. Cirrhosis scars the liver, obstructing blood flow through the portal vein and raising pressure, so collateral veins dilate in the lower third esophagus. As a result, liver cirrhosis commonly leads to esophageal varices (EV) through portal hypertension. Up to 80-90% of cirrhotic patients develop varices. Esophageal varices may rupture and bleed when hepatic venous pressure gradient exceeds 12 mmHg. About one-third cirrhosis patients suffer from EV bleeding, which is associated with high mortality per episode and high rebleeding rates.
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Hsueh-Chien Chiang, MD
- Número de telefone: +886910890307
- E-mail: scion456scion@gmail.com
Estude backup de contato
- Nome: Hsueh-Chien Chiang
- E-mail: scion456scion@gmail.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- cirrhotic patients aged ≥ 18 years who accept endoscopy for esophageal variceal bleeding
Exclusion Criteria:
- no need of endoscopic hemostasis
- allergy to sucralfate
- other etiology of bleeding than EV bleeding
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention Group
After the standard endoscopic EV ligation, patients will be randomly assigned to either a standard group (ST group) or an intervention group (ET group).
After then, 3g of sucralfate powder will be delivered 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.
On the 5th day after EV ligation, all enrolled patients will receive a 2nd-look endoscopy to evaluate the esophageal ulcers and the status of esophageal varices.
|
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.
|
|
Sem intervenção: Standard group
After the standard endoscopic EV ligation, patients will be randomly assigned to either a standard group (ST group) or an intervention group (ET group).
On the 5th day after EV ligation, all enrolled patients will receive a 2nd-look endoscopy to evaluate the esophageal ulcers and the status of esophageal varices.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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post-EVL ulcers
Prazo: 5 days
|
total sum of size of post-EVL ulcers at the esophagogastric junction on the second-look EGD on day 5
|
5 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
esophageal ulcer bleeding
Prazo: 14 days
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esophageal ulcer bleeding requiring endoscopic hemostasis
|
14 days
|
|
esophageal varices rebleeding
Prazo: 14 days
|
esophageal varices rebleeding within 14 days
|
14 days
|
|
total packed RBC transfusion during hospitalization
Prazo: 14 days
|
total packed RBC transfusion during hospitalization
|
14 days
|
|
length of hospitalization
Prazo: 14 days
|
length of hospitalization
|
14 days
|
|
cirrhosis related mortality
Prazo: 14 days
|
cirrhosis related mortality
|
14 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hsueh-Chien Chiang, National Cheng-Kung University Hospital
Publicações e links úteis
Publicações Gerais
- Gralnek IM, Camus Duboc M, Garcia-Pagan JC, Fuccio L, Karstensen JG, Hucl T, Jovanovic I, Awadie H, Hernandez-Gea V, Tantau M, Ebigbo A, Ibrahim M, Vlachogiannakos J, Burgmans MC, Rosasco R, Triantafyllou K. Endoscopic diagnosis and management of esophagogastric variceal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Nov;54(11):1094-1120. doi: 10.1055/a-1939-4887. Epub 2022 Sep 29.
- Seo YS. Prevention and management of gastroesophageal varices. Clin Mol Hepatol. 2018 Mar;24(1):20-42. doi: 10.3350/cmh.2017.0064. Epub 2017 Dec 18.
- Maruyama H, Yokosuka O. Pathophysiology of portal hypertension and esophageal varices. Int J Hepatol. 2012;2012:895787. doi: 10.1155/2012/895787. Epub 2012 May 15.
- Chen CJ, Wu CC, Wei SL, Lin LJ, Lee WC, Chiang CJ, Chien RN, Lu SN. National strategy for elimination of liver diseases in Taiwan. J Formos Med Assoc. 2025 Dec;124 Suppl 2:S74-S83. doi: 10.1016/j.jfma.2025.09.008. Epub 2025 Sep 24.
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Outros números de identificação do estudo
- B-BR-115-050
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