- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Hsueh-Chien Chiang, MD
- Telefoonnummer: +886910890307
- E-mail: scion456scion@gmail.com
Studie Contact Back-up
- Naam: Hsueh-Chien Chiang
- E-mail: scion456scion@gmail.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Geen tussenkomst: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
post-EVL ulcers
Tijdsspanne: 5 days
|
total sum of size of post-EVL ulcers at the esophagogastric junction on the second-look EGD on day 5
|
5 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
esophageal ulcer bleeding
Tijdsspanne: 14 days
|
esophageal ulcer bleeding requiring endoscopic hemostasis
|
14 days
|
|
esophageal varices rebleeding
Tijdsspanne: 14 days
|
esophageal varices rebleeding within 14 days
|
14 days
|
|
total packed RBC transfusion during hospitalization
Tijdsspanne: 14 days
|
total packed RBC transfusion during hospitalization
|
14 days
|
|
length of hospitalization
Tijdsspanne: 14 days
|
length of hospitalization
|
14 days
|
|
cirrhosis related mortality
Tijdsspanne: 14 days
|
cirrhosis related mortality
|
14 days
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Hsueh-Chien Chiang, National Cheng-Kung University Hospital
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- B-BR-115-050
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .