CClinicalTrials.gg
Status unknownNCT00567216GVO-nadololUpdated Jun 8, 2010

Endoscopic Cyanoacrylate Obliteration vs. Nadolol Treatment in the Prevention of Gastric Variceal Rebleeding

A Phase 4 interventional study of Nadolol in Liver Cirrhosis and Hepatoma. and Gastric Variceal Bleeding, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-06-08.

Sponsored by Taipei Veterans General Hospital, Taiwan · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Gastric variceal bleeding has a very high rebleeding rate even after endoscopic variceal injection of cyanoacrylate (GVO) which is considered the first choice of endoscopic treatment. Beta-blocker (BB) is effective to lower portal pressure. We hypothesized combination of GVO and BB can further decrease the rebleeding rate.

Read the detailed description

Gastric varies (GV) rarely rupture. However should it occur, the outcome would be worse than rupture of esophageal varies (EV). Rupture of GV is characteristic of a higher rebleeding rate, a requirement for a larger amount of blood transfusion and a higher mortality. Up to date, the treatment of GV bleeding (GVB) is still sub-optimal in contrast to the treatment of EV bleeding. The management of GV has been focused on treatment of acute GVB. Various specific methods are used to control GVB and prevent rebleeding; however they were far from ideal. It is because GV are usually larger vessels formed in deeper submucosa and connect to the spontaneous gastrorenal shunt which creates a fast blood flow. Therefore, voluminous blood in the larger diameter GV leads to exsanguine bleeding when ruptured. A variety of endoscopic methods, which include injection of sclerosants, tissue adhesive (cyanoacrylate), thrombin and ligation with rubber bands, detachable nylon loop and steel snares, are applied to control acute GV bleeding with variable successful rates (50\~100%) and rebleeding rates (20\~90%). The successful rate of endoscopic cyanoacrylate injection to arrest active GVB is more consistent around 90\~100% and rebleeding rate is around 30\~40%. The recent International Consensus Meeting endorsed that endoscopic cyanoacrylate injection is the first line treatment for acute GVB. The embolic complications, either septic \& aseptic, are not uncommon. Expertise is also required to reduce the embolic complications and instrumental injuries. Therefore, the efficacy of specific treatment for GVB is sub-optimal, consecutive innovation of new methods are required to improve the prognosis of GVB. Non-selective beta-blocker is effective to reduce rebleeding from esophageal varices. However, its effect on gastric variceal hemorrhage has never been proven.

This is an important issues prompted by current portal hypertension experts. We have much experience in the treatment of gastric variceal bleeding and published fruitful results in high ranking journal. Therefore, we design a randomized trial to compare the effect of endoscopic cyanoacrylate injection obliteration versus non-selective beta-blocker in the secondary prevention of acute gastric variceal bleeding.

02

Conditions studied

  • Liver Cirrhosis and Hepatoma.
  • Gastric Variceal Bleeding

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03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 120 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.

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

04

Who can participate

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

Inclusion criteria

  • clinical diagnosis of liver cirrhosis and/or HCC, endoscopically proven gastric variceal bleeding

Exclusion criteria

Exclusion Criteria:

  • younger than 18 y/o or older than 80 y/o, terminal illness, other major systemic disease or malignancy
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • No intervention
    G

    Endoscopic injection of cyanoacrylate alone

  • Active comparator
    C

    Combination of GVO and nadolol

    Drug: Nadolol

Interventions

  • DrugNadolol

    Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period

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What researchers measure

Primary outcomes

  1. Rebleeding

    Time frame: 3 yr

Secondary outcomes

  1. Complication Survival

    Time frame: 3 yr

07

Study locations

1 of 1 sites recruiting
  • Veteran General Hospital-Taipei
    Taipei city, Taiwan 11217, China
    • Ming-Chih Hou, MD · Contact · mchou@vghtpe.gov.tw · 886-2-28712111
    • Ming-Chih Hou, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00567216
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Science Council, Taiwan
First posted
Dec 4, 2007
Start date
Apr 2007
Completion
Jul 2010 (estimated)
Last update
Jun 8, 2010

Study contacts

Ming-Chih Hou, MD
Contact
mchou@vghtpe.gov.tw
886-2-28712111 ext. 3763
Han-Chieh Lin, MD
Contact
hclin@vghtpe.gov.tw
886-2-28712111 ext. 3349
Ming-Chih Hou, MD
principal investigator · Taipei Veterans General Hospital, Taiwan

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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