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

1 juli 2026 uppdaterad av: Hsueh-Chien Chiang, National Cheng-Kung University Hospital

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

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Studiekontakt

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Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
post-EVL ulcers
Tidsram: 5 days
total sum of size of post-EVL ulcers at the esophagogastric junction on the second-look EGD on day 5
5 days

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
esophageal ulcer bleeding
Tidsram: 14 days
esophageal ulcer bleeding requiring endoscopic hemostasis
14 days
esophageal varices rebleeding
Tidsram: 14 days
esophageal varices rebleeding within 14 days
14 days
total packed RBC transfusion during hospitalization
Tidsram: 14 days
total packed RBC transfusion during hospitalization
14 days
length of hospitalization
Tidsram: 14 days
length of hospitalization
14 days
cirrhosis related mortality
Tidsram: 14 days
cirrhosis related mortality
14 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Hsueh-Chien Chiang, National Cheng-Kung University Hospital

Publikationer och användbara länkar

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juli 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

23 juni 2026

Först inskickad som uppfyllde QC-kriterierna

25 juni 2026

Första postat (Faktisk)

1 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juli 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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IPD-planbeskrivning

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IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL

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