Gastric VaricesNCT01923064
Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices
A study testing Lipiodol and Lauromacrogol in people with Gastric Varices and Portal Hypertension, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The purpose of this randomized study to compare effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Varices, Portal Hypertension
- What is being tested?
- Lipiodol and Lauromacrogol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Dec 2013
- Phase
- Interventional
- 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 presented to our hospital with acute gastric variceal bleeding, with or without liver cirrhosis.
- The age of the patients range from 18 to 80 years old.
Who cannot join
- Patients who have contraindications for cyanoacrylate, lipiodol or lauromacrogol therapy.
- Patients who have abnormal portosystemic shunt according to the imaging results.
- Patients who have no previous upper gastrointestinal bleeding history.
- Patients who have multiple endoscopic treatments for esophagogastric varices before.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study to Compare Effect of Endoscopic Injection of a Mixture of Cyanoacrylate and Lipiodol Versus Cyanoacrylate and Lauromacrogol in Gastric Varices
The purpose of this randomized study to compare effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.
Read the detailed description
Gastroesophageal variceal bleeding is known as one of the most frequent death causes of patients with portal hypertension. When a patient has a bleeding episode, if no further prophylactic treatments is given, it's very likely that he/she will develop another rebleeding event in the future and maybe a terminal event. Gastric varices occur in 18-70% of patients with portal hypertension, which appear to be more severe, to require more transfusion and to have a higher mortality rate than esophageal variceal bleeding, with a high rate of rebleeding(38-89%). It has been recommended to use endoscopic cyanoacrylate injection as the first line treatment for hemostasis and secondary prophylaxis for gastric varices by general consensus. However, the efficacy and prevalence of complications between mixture of cyanoacrylate + lipiodol and cyanoacrylate + lauromacrogol have not yet been explored and reported. We conducted this study to evaluate the effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.
- Conditions
- Gastric Varices, Portal Hypertension
- Being tested
- Lipiodol, Lauromacrogol
- Medical subject headings
- Esophageal and Gastric Varices, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipiodolDrug
endoscopic injection of lipiodol + cyanoacrylate + lipiodol for gastric varices
LauromacrogolDrug
endoscopic injection of lauromacrogol + cyanoacrylate + lauromacrogol for gastric varices
| Study group | Role | What they receive |
|---|---|---|
| NBCA-lipiodol | Active comparator | Patients will receive injection of a mixture of cyanoacrylate and lipiodol to treat gastric varices Receives: Drug: Lipiodol |
| NBCA-lauromacrogol | Experimental | Patients will receive injection of the mixture of cyanoacrylate and lauromacrogol to treat gastric varices Receives: Drug: Lauromacrogol |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding rate of the puncture site
We tend to observe the immediate puncture site bleed on the injection of cyanoacrylate and lipiodol or lauromacrogol and withdrawal of needle catheter during endoscopic treatment of gastric varices.
Measured: time period since the beginning of the injection, until up to 24 hours after the procedure
Secondary outcomes (1)
Rebleeding rate after endoscopic treatment
Patients were followed up for 6 months to see if they experience relapse of bleeding, presenting melena, haematemesis or both.
Measured: 6 months from the date of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric VaricesStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyao Chen, Shanghai Zhongshan Hospital
- Investigators
- Shiyao Chen, MD, Study director, Zhongshan Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923064
- Sponsor's protocol ID
- chen2013
- Status last verified
- Jan 2016
- First submitted
- 7 Aug 2013
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Compare Effect of Endoscopic Injection of a Mixture of Cyanoacrylate and Lipiodol Versus Cyanoacrylate and Lauromacrogol in Gastric Varices
- ClinicalTrials.gov ID
- NCT01923064
- Acronym / sponsor ID
- chen2013
- Conditions
- Gastric Varices, Portal Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Aug 2013 (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 purpose of this randomized study to compare effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.
Detailed description
Gastroesophageal variceal bleeding is known as one of the most frequent death causes of patients with portal hypertension. When a patient has a bleeding episode, if no further prophylactic treatments is given, it's very likely that he/she will develop another rebleeding event in the future and maybe a terminal event. Gastric varices occur in 18-70% of patients with portal hypertension, which appear to be more severe, to require more transfusion and to have a higher mortality rate than esophageal variceal bleeding, with a high rate of rebleeding(38-89%). It has been recommended to use endoscopic cyanoacrylate injection as the first line treatment for hemostasis and secondary prophylaxis for gastric varices by general consensus. However, the efficacy and prevalence of complications between mixture of cyanoacrylate + lipiodol and cyanoacrylate + lauromacrogol have not yet been explored and reported. We conducted this study to evaluate the effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBCA-lipiodol | Active comparator | Drug: LipiodolPatients will receive injection of a mixture of cyanoacrylate and lipiodol to treat gastric varices |
| NBCA-lauromacrogol | Experimental | Drug: LauromacrogolPatients will receive injection of the mixture of cyanoacrylate and lauromacrogol to treat gastric varices |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presented to our hospital with acute gastric variceal bleeding, with or without liver cirrhosis.
- The age of the patients range from 18 to 80 years old.
Key exclusion criteria (4 listed)
- Patients who have contraindications for cyanoacrylate, lipiodol or lauromacrogol therapy.
- Patients who have abnormal portosystemic shunt according to the imaging results.
- Patients who have no previous upper gastrointestinal bleeding history.
- Patients who have multiple endoscopic treatments for esophagogastric varices before.
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 |
|---|---|---|
| Lipiodolendoscopic injection of lipiodol + cyanoacrylate + lipiodol for gastric varices | Drug | NBCA-lipiodol |
| Lauromacrogolendoscopic injection of lauromacrogol + cyanoacrylate + lauromacrogol for gastric varices | Drug | NBCA-lauromacrogol |
Primary outcome
bleeding rate of the puncture site
Time frame: time period since the beginning of the injection, until up to 24 hours after the procedure
We tend to observe the immediate puncture site bleed on the injection of cyanoacrylate and lipiodol or lauromacrogol and withdrawal of needle catheter during endoscopic treatment of gastric varices.
1 secondary outcome
Rebleeding rate after endoscopic treatment
Time frame: 6 months from the date of enrollment
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 5 Jan 2016.
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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.
Shiyao Chen, MD study director
Zhongshan Hospital, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipiodol and Lauromacrogol in people with Gastric Varices and Portal Hypertension, run by Shanghai Zhongshan Hospital at 1 site in China.
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 2 inclusion and 4 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 5 Jan 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 China. 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.
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?
bleeding rate of the puncture site (time frame: time period since the beginning of the injection, until up to 24 hours after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2016.