Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02740166
Other study ID # VGHKS13-CT6-06
Secondary ID
Status Recruiting
Phase Phase 4
First received April 12, 2016
Last updated April 12, 2016
Start date June 2013

Study information

Verified date April 2016
Source Kaohsiung Veterans General Hospital.
Contact Wen-Chi Chen, MD
Phone 886-7-3422121
Email wcchen@vghks.gov.tw
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical 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. This study aims at comparing the rebleeding rate and adverse effects in patients using or without using propranolol after eradication of esophageal varices.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 212
Est. completion date
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
propranolol
Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.

Locations

Country Name City State
Taiwan Kaohsiung Veterans General Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

de la Peña J, Brullet E, Sanchez-Hernández E, Rivero M, Vergara M, Martin-Lorente JL, Garcia Suárez C. Variceal ligation plus nadolol compared with ligation for prophylaxis of variceal rebleeding: a multicenter trial. Hepatology. 2005 Mar;41(3):572-8. — View Citation

Gonzalez R, Zamora J, Gomez-Camarero J, Molinero LM, Bañares 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. — View Citation

Kumar 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. — View Citation

Lo 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary recurrent esophageal variceal bleeding recurrent esophageal variceal bleeding after eradication of esophageal varices 6 years Yes
Primary mortality or liver transplantation mortality or liver transplantation after eradication of esophageal varices 6 years Yes
Secondary adverse effects adverse effects associated with non-selective beta-blockers and banding ligation 6 years Yes
See also
  Status Clinical Trial Phase
Recruiting NCT06017102 - Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices N/A
Recruiting NCT03624517 - Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal Varices Phase 4
Recruiting NCT03989973 - Two-dimensional Shear-Wave Elastography Evaluate Esophageal Varices Bleeding Risk of Liver Cirrhosis
Completed NCT05485714 - Non-invasive Prediction of Esophageal Varices in Patients With Non-Alcoholic Fatty Liver Disease With Advanced Fibrosis
Completed NCT01851252 - MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy Phase 1
Completed NCT01360515 - A Study of Disposable Transnasal Esophagoscope N/A
Recruiting NCT04602663 - Optimal Time for Follow up After Variceal Band Ligation N/A
Recruiting NCT04499898 - Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding Phase 2/Phase 3
Completed NCT00331188 - Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding Phase 3
Enrolling by invitation NCT02767206 - Evaluation of Gastroesophageal Varices by Transnasal Endoscopy. N/A
Enrolling by invitation NCT05781828 - Noninvasive Methods For Prediction of Esophageal Varices in Children
Not yet recruiting NCT05199038 - Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed : A Randomized Controlled Study Phase 4
Completed NCT01893541 - PROPRANOLOL PLUS LIGATION REDUCES RECURRENCE OF ESOPHAGEAL VARICES? Phase 4
Terminated NCT00485290 - Effect of Meal on Portal and Esophagus Variceal Pressure N/A
Completed NCT01079416 - Study of Capsule Endoscopy to Determine the Accuracy for Detection of Esophageal Varices N/A
Completed NCT01188733 - Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis Phase 1/Phase 2
Not yet recruiting NCT04254822 - HVPG-Guided Therapy vs Carvedilol Plus Endotherapy for the Prevention of Esophageal Variceal Rebleeding in Cirrhotic Patients N/A
Recruiting NCT03212872 - Blood Ammonia as Predictor for Esophageal Varices and Risk of Bleeding N/A
Completed NCT03748563 - Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of EGV in Patients With Cirrhosis N/A
Completed NCT01059396 - Study on B-blockers to Prevent Decompensation of Cirrhosis With HTPortal Phase 4