Ulcer HealingNCT07679191
Topical Application of Sucralfate in Promoting Healing of Esophageal Ulcers After Esophageal Varices Ligation
A study testing Sucralfate in people with Ulcer Healing, run by National Cheng-Kung University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer Healing
- What is being tested?
- Sucralfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cirrhotic patients aged ≥ 18 years who accept endoscopy for esophageal variceal bleeding
Who cannot join
- no need of endoscopic hemostasis
- allergy to sucralfate
- other etiology of bleeding than EV bleeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Hsueh-Chien Chiang contact
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Ulcer Healing
- Being tested
- Sucralfate
- Keywords
- Esophageal varices, Post-ligation ulcer, Sucralfate
- Medical subject headings
- Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucralfateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Drug: Sucralfate |
| Standard group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-EVL ulcers
total sum of size of post-EVL ulcers at the esophagogastric junction on the second-look EGD on day 5
Measured: 5 days
Secondary outcomes (5)
esophageal ulcer bleeding
esophageal ulcer bleeding requiring endoscopic hemostasis
Measured: 14 days
esophageal varices rebleeding
esophageal varices rebleeding within 14 days
Measured: 14 days
total packed RBC transfusion during hospitalization
total packed RBC transfusion during hospitalization
Measured: 14 days
length of hospitalization
length of hospitalization
Measured: 14 days
cirrhosis related mortality
cirrhosis related mortality
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ulcer HealingStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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, patinet in the intervention group will receive 3g of sucralfate powder through the endoscopy precisely on the EV ligation bands. 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsueh-Chien Chiang, National Cheng-Kung University Hospital
- Investigators
- Hsueh-Chien Chiang, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679191
- Sponsor's protocol ID
- B-BR-115-050
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after publication
Publications
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.
PubMed 36174643Seo 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.
PubMed 29249128Maruyama 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.
PubMed 22666604Chen 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.
PubMed 40993012
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Application of Sucralfate in Promoting Healing of Esophageal Ulcers After Esophageal Varices Ligation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07679191
- Acronym / sponsor ID
- B-BR-115-050
- Conditions
- Ulcer Healing
- Keywords
- Esophageal varices, Post-ligation ulcer, Sucralfate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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, patinet in the intervention group will receive 3g of sucralfate powder through the endoscopy precisely on the EV ligation bands. 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: SucralfateAfter 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. |
| Standard group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- cirrhotic patients aged ≥ 18 years who accept endoscopy for esophageal variceal bleeding
Key exclusion criteria (3 listed)
- no need of endoscopic hemostasis
- allergy to sucralfate
- other etiology of bleeding than EV bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sucralfate3g 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. | Drug | Intervention Group |
Primary outcome
post-EVL ulcers
Time frame: 5 days
total sum of size of post-EVL ulcers at the esophagogastric junction on the second-look EGD on day 5
5 secondary outcomes
esophageal ulcer bleeding
Time frame: 14 days
esophageal varices rebleeding
Time frame: 14 days
total packed RBC transfusion during hospitalization
Time frame: 14 days
length of hospitalization
Time frame: 14 days
cirrhosis related mortality
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 36174643Gralnek 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.
- Background: PubMed 29249128Seo 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.
- Background: PubMed 22666604Maruyama 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.
- Background: PubMed 40993012Chen 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.
- Individual participant dataSharing planned: Yes. after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hsueh-Chien Chiang contact
Hsueh-Chien Chiang principal investigator
National Cheng-Kung University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Sucralfate in people with Ulcer Healing, run by National Cheng-Kung University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsueh-Chien Chiang, MD (+886910890307, scion456scion@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-EVL ulcers (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07679191, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.