Gastric Variceal BleedingPhase 4NCT00735358
Comparison of Endoscopic Injection of Conventional and Double Doses Cyanoacrylate for Gastric Variceal Hemorrhage
A Phase 4 study testing Cyanoacrylate in people with Gastric Variceal Bleeding, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
The recent practice guideline recommends endoscopic injection of cyanoacrylate (GVO) is the preferred method to treat acute gastric variceal bleeding. The rebleeding rate remains high following GVO.We hypothesized that a double-dose of cyanoacrylate may obliterate the varices more effectively and achieve better… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Variceal Bleeding
- What is being tested?
- Cyanoacrylate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Oct 2007
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with liver cirrhosis and/or hepatoma
- Aged 18 to 80, who had endoscopy-proven acute GVB
- Clinical signs of hematemesis, coffee ground vomitus, hematochezia, or melena
- Endoscopic signs of active bleeding from the GV
- Adherent blood clots, white nipple signs, or erosions on the GV
- The presence of distinct large GV with red-color signs and absence of EV and other bleeding sources
- Who or their legally authorized representatives gave informed consent
Who cannot join
- Patients had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt (TIPS) for GVB
- Had a terminal illness of any major organ system, such as heart failure, uremia, chronic pulmonary disease, or non-hepatic malignancy.
About this study
The recent practice guideline recommends endoscopic injection of cyanoacrylate (GVO) is the preferred method to treat acute gastric variceal bleeding. The rebleeding rate remains high following GVO.We hypothesized that a double-dose of cyanoacrylate may obliterate the varices more effectively and achieve better hemostasis.
Read the detailed description
Although outcome of variceal hemorrhage has been improved in the last two decades, variceal hemorrhage is still the most serious complication of portal hypertension and chronic liver disease. Occurrence of gastric varices (GV) rupture is less often than esophageal varices (EV) but it is characteristic of higher rebleeding rate and mortality and represents an even tougher problem than EV hemorrhage. Facing these challenges, there is no consensus on the best treatment of GV hemorrhage and therefore it is mainly empirical. Endoscopic treatment is an alternative in the management of GVH. Injection sclerotherapy has been applied to arrest GV hemorrhage but it is associated with a high rebleeding rate (50~90%) and thus is regarded as only a temporary hemostatic measure. The advantage of endoscopic variceal ligation for EV hemorrhage has been documented, however, endoscopic variceal ligation for GVH is not as promising because of its high rebleeding rate around 50%. Endoscopic injection of N-butyl-2-cyanoacrylate, a so-called "tissue glue", was more effective for GV hemorrhage than other sclerosants and endoscopic ligation, however, its rebleeding rate is still high around 30~50%. The theoretical advantages of tissue glue derives from its unique ability to plug the varix lumen immediately. Each injection of tissue glue in conventional use was usually prepared by a mixture of 0.5 ml cyanoacrylate and 0.5 ml Lipiodol. Therefore, we hypothesized that double dose cyanoacrylate (1 ml cyanoacrylate mixed with 1 ml Lipiodal) may obliterate the varices in further distance and broader area and that may achieve more effective hemostatic results than conventional dose. Therefore we designed a randomized trial to test the hypothesis.
- Conditions
- Gastric Variceal Bleeding
- Being tested
- Cyanoacrylate
- Keywords
- gastric variceal bleeding, cyanoacrylate, rebleeding, complication, survival, acute gastric variceal bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyanoacrylateProcedure or surgery
Cyanoacrylate 0.5 ml, endoscopic injection of gastric varix at each shot
CyanoacrylateProcedure or surgery
Cyanoacrylate 1 ml, endoscopic injection for gastric varices at each shot
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Single dose cyanoacrylate in one shot Receives: Procedure: Cyanoacrylate |
| B | Experimental | Double doses cyanoacrylate in one shot Receives: Procedure: Cyanoacrylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding
Measured: 2 year
Secondary outcomes (1)
Survival
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startSep 2005
- Primary completionAug 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric Variceal BleedingStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735358
- Sponsor's protocol ID
- 95DHA0100359
- Status last verified
- Aug 2008
- First submitted
- 12 Aug 2008
- Last updated
- 6 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hou MC, Lin HC, Lee HS, Liao WC, Lee FY, Lee SD. A randomized trial of endoscopic cyanoacrylate injection for acute gastric variceal bleeding: 0.5 mL versus 1.0 mL. Gastrointest Endosc. 2009 Oct;70(4):668-75. doi: 10.1016/j.gie.2009.02.005. Epub 2009 Jun 25.
PubMed 19559427
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endoscopic Injection of Conventional and Double Doses Cyanoacrylate for Gastric Variceal Hemorrhage
- ClinicalTrials.gov ID
- NCT00735358
- Acronym / sponsor ID
- 95DHA0100359
- Conditions
- Gastric Variceal Bleeding
- Keywords
- gastric variceal bleeding, cyanoacrylate, rebleeding, complication, survival, acute gastric variceal bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Sep 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 14 Aug 2008 (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.
The recent practice guideline recommends endoscopic injection of cyanoacrylate (GVO) is the preferred method to treat acute gastric variceal bleeding. The rebleeding rate remains high following GVO.We hypothesized that a double-dose of cyanoacrylate may obliterate the varices more effectively and achieve better hemostasis.
Detailed description
Although outcome of variceal hemorrhage has been improved in the last two decades, variceal hemorrhage is still the most serious complication of portal hypertension and chronic liver disease. Occurrence of gastric varices (GV) rupture is less often than esophageal varices (EV) but it is characteristic of higher rebleeding rate and mortality and represents an even tougher problem than EV hemorrhage. Facing these challenges, there is no consensus on the best treatment of GV hemorrhage and therefore it is mainly empirical. Endoscopic treatment is an alternative in the management of GVH. Injection sclerotherapy has been applied to arrest GV hemorrhage but it is associated with a high rebleeding rate (50~90%) and thus is regarded as only a temporary hemostatic measure. The advantage of endoscopic variceal ligation for EV hemorrhage has been documented, however, endoscopic variceal ligation for GVH is not as promising because of its high rebleeding rate around 50%. Endoscopic injection of N-butyl-2-cyanoacrylate, a so-called "tissue glue", was more effective for GV hemorrhage than other sclerosants and endoscopic ligation, however, its rebleeding rate is still high around 30~50%. The theoretical advantages of tissue glue derives from its unique ability to plug the varix lumen immediately. Each injection of tissue glue in conventional use was usually prepared by a mixture of 0.5 ml cyanoacrylate and 0.5 ml Lipiodol. Therefore, we hypothesized that double dose cyanoacrylate (1 ml cyanoacrylate mixed with 1 ml Lipiodal) may obliterate the varices in further distance and broader area and that may achieve more effective hemostatic results than conventional dose. Therefore we designed a randomized trial to test the hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: CyanoacrylateSingle dose cyanoacrylate in one shot |
| B | Experimental | Procedure: CyanoacrylateDouble doses cyanoacrylate in one shot |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with liver cirrhosis and/or hepatoma
- Aged 18 to 80, who had endoscopy-proven acute GVB
- Clinical signs of hematemesis, coffee ground vomitus, hematochezia, or melena
- Endoscopic signs of active bleeding from the GV
- Adherent blood clots, white nipple signs, or erosions on the GV
Key exclusion criteria (2 listed)
- Patients had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt (TIPS) for GVB
- Had a terminal illness of any major organ system, such as heart failure, uremia, chronic pulmonary disease, or non-hepatic malignancy.
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 |
|---|---|---|
| CyanoacrylateCyanoacrylate 0.5 ml, endoscopic injection of gastric varix at each shot | Procedure or surgery | A |
| CyanoacrylateCyanoacrylate 1 ml, endoscopic injection for gastric varices at each shot | Procedure or surgery | B |
Primary outcome
Rebleeding
Time frame: 2 year
1 secondary outcome
Survival
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2010.
- Derived from this study: PubMed 19559427Hou MC, Lin HC, Lee HS, Liao WC, Lee FY, Lee SD. A randomized trial of endoscopic cyanoacrylate injection for acute gastric variceal bleeding: 0.5 mL versus 1.0 mL. Gastrointest Endosc. 2009 Oct;70(4):668-75. doi: 10.1016/j.gie.2009.02.005. Epub 2009 Jun 25.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyanoacrylate in people with Gastric Variceal Bleeding, run by Taipei Veterans General Hospital, 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 6 Oct 2010. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rebleeding (time frame: 2 year). 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 NCT00735358, which also lists 1 linked publication.
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 Oct 2010.