Esophageal and Gastric VaricesNCT02719119
Trial of Monthly Versus Bi-weekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
A study testing monthly Endoscopic Variceal Ligation (EVL) and bi-weekly Endoscopic Variceal Ligation (EVL) in people with Esophageal and Gastric Varices, run by West China Hospital at 1 site in China.
Trial summary
Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in order to compare the long-term results of EVL… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal and Gastric Varices
- What is being tested?
- monthly Endoscopic Variceal Ligation (EVL) and bi-weekly Endoscopic Variceal Ligation (EVL)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Feb 2018
- 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
- acute or recent bleeding from esophageal varices;
- portal hypertension caused by cirrhosis;
- age between 18 and 80 yr.
Who cannot join
- history of endoscopic, pharmacological, interventional or surgical treatment of esophageal varices;
- presence of liver failure with a serum total bilirubin concentration greater than 3 mg/dL;
- presence of hepatocellular carcinoma or other malignancy;
- an association with a cerebral vascular accident, uremia, acute coronary syndrome, or other severe illness;
- history of gastric variceal bleeding;
- encephalopathy of stage II or worse;
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- failure to control initial variceal bleeding;
- death within 48 h of admission;
- refusal to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Xuefeng Luo, MD, +862885422389
About this study
Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in order to compare the long-term results of EVL when performed at two different results from monthly and bi-weekly treatments.
Read the detailed description
Endoscopic variceal ligation (EVL) is a safe and simple procedure now being used on a widening scale. A lot of patients who undergo endoscopic treatment for esophageal varices eventually require additional treatment for recurrent varices. Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in order to compare the long-term results of EVL when performed at two different results from monthly and bi-weekly treatments.
- Conditions
- Esophageal and Gastric Varices
- Being tested
- monthly Endoscopic Variceal Ligation (EVL), bi-weekly Endoscopic Variceal Ligation (EVL)
- Medical subject headings
- Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monthly Endoscopic Variceal Ligation (EVL)Procedure or surgery
Patients in this group will underwent endoscopic variceal ligation monthly.
bi-weekly Endoscopic Variceal Ligation (EVL)Procedure or surgery
Patients in this group will underwent endoscopic variceal ligation bi-weekly.
| Study group | Role | What they receive |
|---|---|---|
| monthly EVL | Experimental | Elective band ligation was applied after premedication with hyoscine-N-butylbromide (20 mg intramuscularly). A multiband ligator and video endoscopes were utilized. Ligation was initiated at or slightly below the bleeding point. During each treatment session, each varix was ligated with one or two elastic bands. Variceal obliteration success was when all varices disappeared or residual varices were too small to be ligated further. Once esophageal varices were obliterated, surveillance endoscopy was performed every 3 months for 1 year and then every 6 months to check for recurrent varices. Patients in this group will underwent endoscopic variceal ligation monthly. Receives: Procedure: monthly Endoscopic Variceal Ligation (EVL) |
| bi-weekly EVL | Experimental | Elective band ligation was applied after premedication with hyoscine-N-butylbromide (20 mg intramuscularly). A multiband ligator and video endoscopes were utilized. Ligation was initiated at or slightly below the bleeding point. During each treatment session, each varix was ligated with one or two elastic bands. Variceal obliteration success was when all varices disappeared or residual varices were too small to be ligated further. Once esophageal varices were obliterated, surveillance endoscopy was performed every 3 months for 1 year and then every 6 months to check for recurrent varices. Patients in this group will underwent endoscopic variceal ligation bi-weekly. Receives: Procedure: bi-weekly Endoscopic Variceal Ligation (EVL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
variceal rebleeding rate
Measured: 2 years
Secondary outcomes (5)
gastrointestinal rebleeding rate
Measured: 2 years
variceal obliteration rate
Measured: 2 years
number of sessions required to abstain variceal obliteration
Measured: 2 years
adverse events
Measured: 2 years
mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal and Gastric VaricesStudies of the same condition, open and under way.
- More trials run by West China 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, luo xuefeng, West China Hospital
- Investigators
- li yang, MD, Study chair, department of gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719119
- Sponsor's protocol ID
- monthly versus bi-weekly EVL
- Status last verified
- Apr 2017
- First submitted
- 19 Mar 2016
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Monthly Versus Bi-weekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
- ClinicalTrials.gov ID
- NCT02719119
- Acronym / sponsor ID
- monthly versus bi-weekly EVL
- Conditions
- Esophageal and Gastric Varices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 25 Mar 2016 (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.
Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in order to compare the long-term results of EVL when performed at two different results from monthly and bi-weekly treatments.
Detailed description
Endoscopic variceal ligation (EVL) is a safe and simple procedure now being used on a widening scale. A lot of patients who undergo endoscopic treatment for esophageal varices eventually require additional treatment for recurrent varices. Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in order to compare the long-term results of EVL when performed at two different results from monthly and bi-weekly treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monthly EVL | Experimental | Procedure: monthly Endoscopic Variceal Ligation (EVL)Elective band ligation was applied after premedication with hyoscine-N-butylbromide (20 mg intramuscularly). A multiband ligator and video endoscopes were utilized. Ligation was initiated at or slightly below the bleeding point. During each treatment session, each varix was ligated with one or two elastic bands. Variceal obliteration success was when all varices disappeared or residual varices were too small to be ligated further. Once esophageal varices were obliterated, surveillance endoscopy was performed every 3 months for 1 year and then every 6 months to check for recurrent varices. Patients in this group will underwent endoscopic variceal ligation monthly. |
| bi-weekly EVL | Experimental | Procedure: bi-weekly Endoscopic Variceal Ligation (EVL)Elective band ligation was applied after premedication with hyoscine-N-butylbromide (20 mg intramuscularly). A multiband ligator and video endoscopes were utilized. Ligation was initiated at or slightly below the bleeding point. During each treatment session, each varix was ligated with one or two elastic bands. Variceal obliteration success was when all varices disappeared or residual varices were too small to be ligated further. Once esophageal varices were obliterated, surveillance endoscopy was performed every 3 months for 1 year and then every 6 months to check for recurrent varices. Patients in this group will underwent endoscopic variceal ligation bi-weekly. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acute or recent bleeding from esophageal varices;
- portal hypertension caused by cirrhosis;
- age between 18 and 80 yr.
Key exclusion criteria (9 listed)
- history of endoscopic, pharmacological, interventional or surgical treatment of esophageal varices;
- presence of liver failure with a serum total bilirubin concentration greater than 3 mg/dL;
- presence of hepatocellular carcinoma or other malignancy;
- an association with a cerebral vascular accident, uremia, acute coronary syndrome, or other severe illness;
- history of gastric variceal bleeding;
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 |
|---|---|---|
| monthly Endoscopic Variceal Ligation (EVL)Patients in this group will underwent endoscopic variceal ligation monthly. | Procedure or surgery | monthly EVL |
| bi-weekly Endoscopic Variceal Ligation (EVL)Patients in this group will underwent endoscopic variceal ligation bi-weekly. | Procedure or surgery | bi-weekly EVL |
Primary outcome
variceal rebleeding rate
Time frame: 2 years
5 secondary outcomes
gastrointestinal rebleeding rate
Time frame: 2 years
variceal obliteration rate
Time frame: 2 years
number of sessions required to abstain variceal obliteration
Time frame: 2 years
adverse events
Time frame: 2 years
mortality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
li yang, MD study chair
department of gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monthly Endoscopic Variceal Ligation (EVL) and bi-weekly Endoscopic Variceal Ligation (EVL) in people with Esophageal and Gastric Varices, run by West China 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 3 inclusion and 9 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 Apr 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact XUEFENG LUO, MD (+862885422389, luo_xuefeng@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variceal rebleeding rate (time frame: 2 years). 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 Apr 2017.