Gastroesophageal VaricesNCT03729921
Gastric Variceal Ligation Versus Gastric Variceal Obturation for Secondary Prophylaxis of Gastric Varices
A study testing gastric variceal ligation and gastric variceal obturation in people with Gastroesophageal Varices and Liver Cirrhosis, run by Shanghai Zhongshan Hospital.
Trial summary
The investigators establish a randomized controlled clinical trial, comparing the efficacy and prognosis of GVL and GVO in secondary prevention of GVs, especially in patients with portosystemic shunting, and exploring the endoscopic treatment selection of different types of GVs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Varices, Liver Cirrhosis
- What is being tested?
- gastric variceal ligation and gastric variceal obturation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age；Past history of gastroesophageal variceal hemorrhage confirmed by an endoscopic examination
Who cannot join
- Patients who are not suitable for endoscopic treatment judged by the clinician; Patients who are not suitable for the ligation treatment because of scar change by repeated glue injection; Patients with acute hemorrhage
About this study
Official title: Comparison of Efficacy and Safety of Gastric Variceal Ligation Versus Gastric Variceal Obturation for Secondary Prophylaxis of Gastric Varices
The investigators establish a randomized controlled clinical trial, comparing the efficacy and prognosis of GVL and GVO in secondary prevention of GVs, especially in patients with portosystemic shunting, and exploring the endoscopic treatment selection of different types of GVs.
Outcome expectations: Compared with glue injection, endoscopic ligation for secondary prevention of gastric varices is safe and effective, especially in patients with portosystemic shunting.
Read the detailed description
Gastric varices (GVs) is a common complication of portal hypertension, with an incidence of 20%. Though the bleeding rate of GVs (25%) is lower than that of Esophageal varices (EVs), the mortality rate is higher due to greater GVs rupture and less space for endoscopic intervention. In addition, in 30% of patients with GVs, the possibility of treatment failure exists.
Guidelines differ on endoscopic treatment for secondary prevention of GVs.Current studies suggest that EVL, due to its low incidence of complications, is suitable for GOV1, while it is still controversial for the treatment of gastric varices. Compared with glue, the advantage of ligation is that it can avoid serious complications caused by glue injection, such as ectopic embolization, large ulcer and sepsis. As there are few studies comparing GVL and GVO in secondary prevention of gastric varices, the treatment methods are different, and the treatment effect is controversial. In addition, the choice of treatment for different types of GVs needs further study.
The investigators establish a randomized controlled clinical trial, comparing the efficacy and prognosis of GVL and GVO in secondary prevention of GVs, especially in patients with portosystemic shunting, and exploring the endoscopic treatment selection of different types of GVs.
Outcome expectations: Compared with glue injection, endoscopic ligation for secondary prevention of gastric varices is safe and effective, especially in patients with portosystemic shunting.
- Conditions
- Gastroesophageal Varices, Liver Cirrhosis
- Being tested
- gastric variceal ligation, gastric variceal obturation
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric variceal ligationProcedure or surgery
The highest point of the variceal vein was used as the primary ligation site. If the input vein was not obvious, the edge of the variceal vein was ligated. The variceal veins were ligated with a 6-ring ligation device, and more than 18 rings rubber bands could be applied in one session. GVL was performed regularly until varices were obliterated or reduced to residual small varices, which could not be ligated. The residual small varices was treated by cyanoacrylate injection.
gastric variceal obturationProcedure or surgery
Gastric varices were uniformly treated via the sandwich technique, which starts with an injection of lauromacrogol, followed by N-butyl cyanoacrylate, then finished with flush of lauromacrogol. The number of injection sites and volume of lauromacrogol and cyanoacrylate used, directly correlated with the size of the varix. Multiple injection sites were chosen in attempt to obliterate the varix or varices in one session. Volume of lauromacrogol used ranged from 2-10ml, while that of cyanoacrylate ranged from 0.5-2ml, per injection site.
| Study group | Role | What they receive |
|---|---|---|
| gastric variceal obturation | Active comparator | gastric variceal obturation Receives: Procedure: gastric variceal obturation |
| gastric variceal ligation | Experimental | gastric variceal ligation Receives: Procedure: gastric variceal ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of rebleeding
New onset of hematemesis, coffee-ground vomitus, hematochezia,or melena,with an increasing pulse rate over 100 beats/min and decreasing blood pressure below 90 mmHg after a 24-hour period of stable vital signs and hemoglobin after endoscopic treatment.
Measured: 6 months
Secondary outcomes (3)
Rate of GV eradication
non-visualization of patent GV
Measured: 6 months
Incidence of complications
Huge ulcer on GV, spontaneous bacterial peritonitis, bacteremia
Measured: 6 months
mortality
Survival situation of patience
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729921
- Sponsor's protocol ID
- CSY-GVL&GVO
- Status last verified
- Nov 2018
- First submitted
- 31 Oct 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Gastric Variceal Ligation Versus Gastric Variceal Obturation for Secondary Prophylaxis of Gastric Varices
- ClinicalTrials.gov ID
- NCT03729921
- Acronym / sponsor ID
- CSY-GVL&GVO
- Conditions
- Gastroesophageal Varices, Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 5 Nov 2018 (actual)
- 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 investigators establish a randomized controlled clinical trial, comparing the efficacy and prognosis of GVL and GVO in secondary prevention of GVs, especially in patients with portosystemic shunting, and exploring the endoscopic treatment selection of different types of GVs.
Outcome expectations: Compared with glue injection, endoscopic ligation for secondary prevention of gastric varices is safe and effective, especially in patients with portosystemic shunting.
Detailed description
Gastric varices (GVs) is a common complication of portal hypertension, with an incidence of 20%. Though the bleeding rate of GVs (25%) is lower than that of Esophageal varices (EVs), the mortality rate is higher due to greater GVs rupture and less space for endoscopic intervention. In addition, in 30% of patients with GVs, the possibility of treatment failure exists.
Guidelines differ on endoscopic treatment for secondary prevention of GVs.Current studies suggest that EVL, due to its low incidence of complications, is suitable for GOV1, while it is still controversial for the treatment of gastric varices. Compared with glue, the advantage of ligation is that it can avoid serious complications caused by glue injection, such as ectopic embolization, large ulcer and sepsis. As there are few studies comparing GVL and GVO in secondary prevention of gastric varices, the treatment methods are different, and the treatment effect is controversial. In addition, the choice of treatment for different types of GVs needs further study.
The investigators establish a randomized controlled clinical trial, comparing the efficacy and prognosis of GVL and GVO in secondary prevention of GVs, especially in patients with portosystemic shunting, and exploring the endoscopic treatment selection of different types of GVs.
Outcome expectations: Compared with glue injection, endoscopic ligation for secondary prevention of gastric varices is safe and effective, especially in patients with portosystemic shunting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gastric variceal obturation | Active comparator | Procedure: gastric variceal obturationgastric variceal obturation |
| gastric variceal ligation | Experimental | Procedure: gastric variceal ligationgastric variceal ligation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years of age；Past history of gastroesophageal variceal hemorrhage confirmed by an endoscopic examination
Key exclusion criteria (1 listed)
- Patients who are not suitable for endoscopic treatment judged by the clinician; Patients who are not suitable for the ligation treatment because of scar change by repeated glue injection; Patients with acute hemorrhage
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 |
|---|---|---|
| gastric variceal ligationThe highest point of the variceal vein was used as the primary ligation site. If the input vein was not obvious, the edge of the variceal vein was ligated. The variceal veins were ligated with a 6-ring ligation device, and more than 18 rings rubber bands could be applied in one session. GVL was performed regularly until varices were obliterated or reduced to residual small varices, which could not be ligated. The residual small varices was treated by cyanoacrylate injection. | Procedure or surgery | gastric variceal ligation |
| gastric variceal obturationGastric varices were uniformly treated via the sandwich technique, which starts with an injection of lauromacrogol, followed by N-butyl cyanoacrylate, then finished with flush of lauromacrogol. The number of injection sites and volume of lauromacrogol and cyanoacrylate used, directly correlated with the size of the varix. Multiple injection sites were chosen in attempt to obliterate the varix or varices in one session. Volume of lauromacrogol used ranged from 2-10ml, while that of cyanoacrylate ranged from 0.5-2ml, per injection site. | Procedure or surgery | gastric variceal obturation |
Primary outcome
Rate of rebleeding
Time frame: 6 months
New onset of hematemesis, coffee-ground vomitus, hematochezia,or melena,with an increasing pulse rate over 100 beats/min and decreasing blood pressure below 90 mmHg after a 24-hour period of stable vital signs and hemoglobin after endoscopic treatment.
3 secondary outcomes
Rate of GV eradication
Time frame: 6 months
Incidence of complications
Time frame: 6 months
mortality
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
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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 study testing gastric variceal ligation and gastric variceal obturation in people with Gastroesophageal Varices and Liver Cirrhosis, run by Shanghai Zhongshan Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Nov 2018. 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.
Are results available for this study?
Results are not available in the source record.
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?
Rate of rebleeding (time frame: 6 months). 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 Nov 2018.