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Status unknownNCT02740166Updated Apr 15, 2016

Preventing Recurrent Bleeding After Eradication of Esophageal Varices

A Phase 4 interventional study of propranolol in Esophageal Varices, sponsored by Kaohsiung Veterans General Hospital.. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-04-15.

Sponsored by Kaohsiung Veterans General Hospital. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
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Study 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.

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.

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Conditions studied

  • Esophageal Varices

Keywords

  • Esophageal Varices; propranolol; banding ligation
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In context

Esophageal and Gastric Varices

169 studies on the registry are indexed under Esophageal and Gastric Varices; 41 are open to participants now.

This study's planned enrollment of 212 is above the median of 104 across 109 interventional studies indexed under Esophageal and Gastric Varices.

Browse Esophageal and Gastric Varices studies →

Lead sponsor

Kaohsiung Veterans General Hospital. is the lead sponsor of 102 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
212 participants (estimated)

Study arms

  • No intervention
    Banding ligation group

    Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices.

  • Experimental
    Propranolol group

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

    Drug: propranolol

Interventions

  • Drugpropranolol

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

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What researchers measure

Primary outcomes

  1. recurrent esophageal variceal bleeding

    recurrent esophageal variceal bleeding after eradication of esophageal varices

    Time frame: 6 years

  2. mortality or liver transplantation

    mortality or liver transplantation after eradication of esophageal varices

    Time frame: 6 years

Secondary outcomes

  1. adverse effects

    adverse effects associated with non-selective beta-blockers and banding ligation

    Time frame: 6 years

07

Study locations

1 of 1 sites recruiting
  • Kaohsiung Veterans General Hospital
    Kaohsiung, 813, Taiwan
    • Wen-Chi Chen, MD · Contact · wcchen@vghks.gov.tw · +886-7-3422121
    • Wen-Chi Chen, MD · Principal investigator
    Recruiting
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References and documents

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 18626050 ↗
  • 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. doi: 10.1053/jhep.2000.16236. PubMed 10960435 ↗
  • de 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 15726659 ↗
  • 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. PubMed 19481079 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02740166
Lead sponsor
Kaohsiung Veterans General Hospital.
Responsible party
Wen-Chi Chen (Division of Gastroenterology and Hepatology, Kaohsiung Veterans General Hospital.) — Principal investigator
First posted
Apr 15, 2016
Start date
Jun 2013
Primary completion
Jan 2018 (estimated)
Last update
Apr 15, 2016

Study contacts

Wen-Chi Chen, MD
Contact
wcchen@vghks.gov.tw
886-7-3422121 ext. 2139
Wen-Chi Chen, MD
principal investigator · Kaohsiung Veterans General Hospital.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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