Esophageal VaricesPhase 4NCT02740166
Preventing Recurrent Bleeding After Eradication of Esophageal Varices
A Phase 4 study testing propranolol in people with Esophageal Varices, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
Esophageal variceal bleeding is a severe complication of portal hypertension. Banding ligation plus non-selective beta-blockers is the current recommendation for prevention of recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is not well defined. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Esophageal Varices
- What is being tested?
- propranolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2013to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 20 to 80 years
- Cirrhotic patients with acute or recent esophageal variceal bleeding proven by an endoscopy
- Stable hemodynamic condition for at least 3 days after banding ligation
Who cannot join
- Hepatocellular carcinoma or other malignancy
- Stroke or active sepsis
- Chronic kidney disease under renal replacement therapy
- Contraindications to non-selective beta-blockers
- A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery
- Serum total bilirubin >10 mg/dL
Show all 17Show fewer
- Grade III/IV hepatic encephalopathy
- Refractory ascites
- Hepato-renal syndrome
- Pregnancy
- Severe heart failure (NYHA Fc III/IV)
- Bronchial asthma or chronic obstructive pulmonary disease
- Second or third degree atrioventricular block
- Sick sinus syndrome
- Pacemaker use
- Severe hypotension
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, Kaohsiung, 813
Wen-Chi Chen, MD, +886-7-3422121 ext. 2139, wcchen@vghks.gov.tw
Wen-Chi Chen, MD
About this study
Official title: Banding Ligation Plus Propranolol Versus Banding Ligation to Prevent Rebleeding of Esophageal Varices
Esophageal variceal bleeding is a severe complication of portal hypertension. Banding ligation plus non-selective beta-blockers is the current recommendation for prevention of recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is not well defined. This study aims at comparing the rebleeding rate and adverse effects in patients using or without using propranolol after eradication of esophageal varices.
Read the detailed description
Cirrhotic patients with acute or recent esophageal variceal bleeding undergo banding ligation at 1-month interval until eradication of esophageal varices. Patients start propranolol (start with 30 mg daily) at 6th day after control of acute bleeding till eradication of esophageal varices, aiming at decreasing pulse rate to 25% or to 55 bpm while systolic pressure is above 85 mmHg. Patients randomized to propranolol group continue propranolol after eradication of esophageal varices. Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices. Patients are followed to evaluate the incidence of rebleeding, adverse effects and survival.
- Conditions
- Esophageal Varices
- Being tested
- propranolol
- Keywords
- Esophageal Varices; propranolol; banding ligation
- 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.
propranololDrug
Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.
| Study group | Role | What they receive |
|---|---|---|
| Banding ligation group | No intervention | Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices. |
| Propranolol group | Experimental | Patients randomized to propranolol group continue propranolol after eradication of esophageal varices. Receives: Drug: propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent esophageal variceal bleeding
recurrent esophageal variceal bleeding after eradication of esophageal varices
Measured: 6 years
mortality or liver transplantation
mortality or liver transplantation after eradication of esophageal varices
Measured: 6 years
Secondary outcomes (1)
adverse effects
adverse effects associated with non-selective beta-blockers and banding ligation
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJun 2013
- Primary completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Esophageal VaricesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Chi Chen, Kaohsiung Veterans General Hospital.
- Investigators
- Wen-Chi Chen, MD, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740166
- Sponsor's protocol ID
- VGHKS13-CT6-06
- Status last verified
- Apr 2016
- First submitted
- 12 Apr 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Gonzalez R, Zamora J, Gomez-Camarero J, Molinero LM, Banares R, Albillos A. Meta-analysis: Combination endoscopic and drug therapy to prevent variceal rebleeding in cirrhosis. Ann Intern Med. 2008 Jul 15;149(2):109-22. doi: 10.7326/0003-4819-149-2-200807150-00007.
PubMed 18626050Lo GH, Lai KH, Cheng JS, Chen MH, Huang HC, Hsu PI, Lin CK. Endoscopic variceal ligation plus nadolol and sucralfate compared with ligation alone for the prevention of variceal rebleeding: a prospective, randomized trial. Hepatology. 2000 Sep;32(3):461-5. doi: 10.1053/jhep.2000.16236.
PubMed 10960435de la Pena J, Brullet E, Sanchez-Hernandez E, Rivero M, Vergara M, Martin-Lorente JL, Garcia Suarez C. Variceal ligation plus nadolol compared with ligation for prophylaxis of variceal rebleeding: a multicenter trial. Hepatology. 2005 Mar;41(3):572-8. doi: 10.1002/hep.20584.
PubMed 15726659Kumar A, Jha SK, Sharma P, Dubey S, Tyagi P, Sharma BC, Sarin SK. Addition of propranolol and isosorbide mononitrate to endoscopic variceal ligation does not reduce variceal rebleeding incidence. Gastroenterology. 2009 Sep;137(3):892-901, 901.e1. doi: 10.1053/j.gastro.2009.05.049. Epub 2009 May 27.
PubMed 19481079Chen WC, Yang TC, Lee PC, Wang YP, Hou MC, Lee FY. A Randomized Controlled Trial of Propranolol Use During Ligation Program for Secondary Prophylaxis of Esophageal Variceal Bleeding. Am J Gastroenterol. 2024 Feb 1;119(2):278-286. doi: 10.14309/ajg.0000000000002457. Epub 2023 Sep 11.
PubMed 37543755
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Banding Ligation Plus Propranolol Versus Banding Ligation to Prevent Rebleeding of Esophageal Varices
- ClinicalTrials.gov ID
- NCT02740166
- Acronym / sponsor ID
- VGHKS13-CT6-06
- Conditions
- Esophageal Varices
- Keywords
- Esophageal Varices; propranolol; banding ligation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2018 (estimated)
- First posted
- 15 Apr 2016 (estimated)
- 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.
Esophageal variceal bleeding is a severe complication of portal hypertension. Banding ligation plus non-selective beta-blockers is the current recommendation for prevention of recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is not well defined. This study aims at comparing the rebleeding rate and adverse effects in patients using or without using propranolol after eradication of esophageal varices.
Detailed description
Cirrhotic patients with acute or recent esophageal variceal bleeding undergo banding ligation at 1-month interval until eradication of esophageal varices. Patients start propranolol (start with 30 mg daily) at 6th day after control of acute bleeding till eradication of esophageal varices, aiming at decreasing pulse rate to 25% or to 55 bpm while systolic pressure is above 85 mmHg. Patients randomized to propranolol group continue propranolol after eradication of esophageal varices. Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices. Patients are followed to evaluate the incidence of rebleeding, adverse effects and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Banding ligation group | No intervention | –Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices. |
| Propranolol group | Experimental | Drug: propranololPatients randomized to propranolol group continue propranolol after eradication of esophageal varices. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 20 to 80 years
- Cirrhotic patients with acute or recent esophageal variceal bleeding proven by an endoscopy
- Stable hemodynamic condition for at least 3 days after banding ligation
Key exclusion criteria (17 listed)
- Hepatocellular carcinoma or other malignancy
- Stroke or active sepsis
- Chronic kidney disease under renal replacement therapy
- Contraindications to non-selective beta-blockers
- A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery
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 |
|---|---|---|
| propranololPatients randomized to propranolol group continue propranolol after eradication of esophageal varices. | Drug | Propranolol group |
Primary outcome
recurrent esophageal variceal bleeding
Time frame: 6 years
recurrent esophageal variceal bleeding after eradication of esophageal varices
mortality or liver transplantation
Time frame: 6 years
mortality or liver transplantation after eradication of esophageal varices
1 secondary outcome
adverse effects
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Background: PubMed 18626050Gonzalez R, Zamora J, Gomez-Camarero J, Molinero LM, Banares R, Albillos A. Meta-analysis: Combination endoscopic and drug therapy to prevent variceal rebleeding in cirrhosis. Ann Intern Med. 2008 Jul 15;149(2):109-22. doi: 10.7326/0003-4819-149-2-200807150-00007.
- Background: PubMed 10960435Lo GH, Lai KH, Cheng JS, Chen MH, Huang HC, Hsu PI, Lin CK. Endoscopic variceal ligation plus nadolol and sucralfate compared with ligation alone for the prevention of variceal rebleeding: a prospective, randomized trial. Hepatology. 2000 Sep;32(3):461-5. doi: 10.1053/jhep.2000.16236.
- Background: PubMed 15726659de la Pena J, Brullet E, Sanchez-Hernandez E, Rivero M, Vergara M, Martin-Lorente JL, Garcia Suarez C. Variceal ligation plus nadolol compared with ligation for prophylaxis of variceal rebleeding: a multicenter trial. Hepatology. 2005 Mar;41(3):572-8. doi: 10.1002/hep.20584.
- Background: PubMed 19481079Kumar A, Jha SK, Sharma P, Dubey S, Tyagi P, Sharma BC, Sarin SK. Addition of propranolol and isosorbide mononitrate to endoscopic variceal ligation does not reduce variceal rebleeding incidence. Gastroenterology. 2009 Sep;137(3):892-901, 901.e1. doi: 10.1053/j.gastro.2009.05.049. Epub 2009 May 27.
- Derived from this study: PubMed 37543755Chen WC, Yang TC, Lee PC, Wang YP, Hou MC, Lee FY. A Randomized Controlled Trial of Propranolol Use During Ligation Program for Secondary Prophylaxis of Esophageal Variceal Bleeding. Am J Gastroenterol. 2024 Feb 1;119(2):278-286. doi: 10.14309/ajg.0000000000002457. Epub 2023 Sep 11.
- Individual participant dataSharing planned: Yes
Related trials for Esophageal Varices
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Not yet recruitingObservational study
Baveno VIII Criteria for Portal Hypertension in Egyptian Patients
Compensated Liver Disease, Esophageal Varices
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial Investigating the Impact of Fasting Duration on Postoperative Rebleeding Following Esophageal Variceal Ligation.
Esophageal Varices
Not yet recruitingObservational study
Clinical Trial to Evaluate the Effectiveness of Liver Shear Wave Quantization Detector Spleen Stiffness Value in the Diagnosis of Esophageal Varices
Chronic Liver Diseases, Spleen Stiffness
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. This study is not recruiting at the moment.
Wen-Chi Chen, MD principal investigator
Kaohsiung Veterans General Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propranolol in people with Esophageal Varices, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 3 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Chi Chen, MD (886-7-3422121 ext. 2139, wcchen@vghks.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrent esophageal variceal bleeding (time frame: 6 years). The study lists 2 primary outcomes in all. 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 NCT02740166, which also lists 5 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 15 Apr 2016.