Gastroesophageal VariceNCT01592578
The Research of the Evaluation of Clinical Procedures in Gastroesophageal Varices in Patients With Liver Cirrhosis
A study testing Ligation and Cyanoacrylate and Ligation plus Sclerotherapy and Cyanoacrylate Group in people with Gastroesophageal Varice, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of two different endoscopic treatment in gastroesophageal varices in patients with liver cirrhosis: ligation versus ligation plus sclerotherapy in addition to cyanoacrylates Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Gastroesophageal Varice
- What is being tested?
- Ligation and Cyanoacrylate and Ligation plus Sclerotherapy and Cyanoacrylate Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Aug 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 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with portal hypertension caused by liver cirrhosis who presented with an acute or recent episode of gastroesophageal variceal bleeding and have previously received endoscopic treatments of ligation and cyanoacrylate. Diagnosis of liver cirrhosis or mixed cirrhosis was based on results of liver biopsy or biochemical tests and liver imaging by ultrasonography.
- The extent of the varices range from Moderate to Severe.
- The age of the patients range from 18 to 72 years old.
Who cannot join
- Patients who had other causes for portal hypertention(CTPV,Budd-Chiari syndrome,etc.)
- Patients with severe systemic disease (renal failure, heart failure,carcinoma other than liver cancer,etc.)
- Patients who had contraindications for ligation,sclerotherapy or cyanoacrylate.
- Patients who have previously received shunt or devascularization operation,TIPS.
- Patients who had portosystemic shunt according to the results of CT scan.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032
Jie Chen, doctor, 86-13764633539, Angelin8716@yahoo.com.cn , 0556289@fudan.edu.cn
Shiyao Chen, Professor
About this study
Official title: A Randomized Controlled Trial of Ligation Versus Ligation Plus Sclerotherapy in Addition to Cyanoacrylate in Patients With Gastroesophageal Varices
The purpose of this study is to evaluate the efficacy of two different endoscopic treatment in gastroesophageal varices in patients with liver cirrhosis: ligation versus ligation plus sclerotherapy in addition to cyanoacrylates
Read the detailed description
Gastroesophageal variceal bleeding, which often results from portal hypertention, is known as one of the most frequent death causes of patients with liver cirrhosis. When a patient has bleeding episode, it's very likely that he/she will develop another one in the future. Endoscopic treatments such as ligation, sclerotherapy or cyanocrylates are proved to decrease the risk of re-bleeding. The purpose of this study is to evaluate the efficacy of two different endoscopic treatments in patients who have both gastric and esophageal varices with liver cirrhosis: In addition to cyanoacrylates, ligation versus ligation plus sclerotherapy.
- Conditions
- Gastroesophageal Varice
- Being tested
- Ligation and Cyanoacrylate, Ligation plus Sclerotherapy and Cyanoacrylate Group
- Keywords
- gastroesophgeal variceal bleeding, liver cirrhosis, portal hypertension
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligation and CyanoacrylateProcedure or surgery
Patients will be treated with ligation for esophageal varices and cyanoacrylate for gastric varices when necessary.
Ligation plus Sclerotherapy and Cyanoacrylate GroupProcedure or surgery
Patients will receive sclerotherapy after first ligation for esophageal varices and cyanoacrylate for gastric varices when necessary
| Study group | Role | What they receive |
|---|---|---|
| Ligation and Cyanoacrylate Group | Active comparator | Not described Receives: Procedure: Ligation and Cyanoacrylate |
| Ligation plus Sclerotherapy and Cyanoacrylate Group | Experimental | Not described Receives: Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate of variceal hemorrhage
recurrence rate of variceal hemorrhage
Measured: Participants will be followed for up to 6 months starting from the date of randomization.
Secondary outcomes (4)
eradication rate of the gastroesophageal varices
We intend to set eradication rate of the gastroesophageal varices as one of our secondary outcomes. Participants will be followed for up to 6 months starting from the date of randomization.Eradication of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.
Measured: Participants will be followed for up to 6 months starting from the date of randomization.Eradication of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.
recurrence rate of the gastroesophageal varices
We intend to set recurrence rate of gastroesophageal varices as one of our secondary outcomes. Participants will be followed for up to 6 months starting from the date of randomization.Recurrence rate of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.
Measured: Participants will be followed for up to 6 months starting from the date of randomization.Recurrence rate of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.
mortality rate during the follow-up period
mortality rate during the follow-up period
Measured: Participants will be followed for up to 6 months starting from the date of randomization.
incidence rate of complications associated with endoscopic treatments
We intend to set incidence rate of complications associated with endoscopic treatments,to be specific,which include trasient fever, transient dysphagia, transient arrhythmias, ulceration, perforation, stricture, rebleeding, aspiration pneumonia, sepsis, peritonitis and chest pain. Participants will be followed for up to 6 months starting from the date of randomization.
Measured: Participants will be followed for up to 6 months starting from the date of randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
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 Gastroesophageal VariceStudies 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 (estimated)
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, professor, Study director, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592578
- Sponsor's protocol ID
- CSY-CJ-2012
- Status last verified
- May 2012
- First submitted
- 1 May 2012
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen J, Zeng XQ, Ma LL, Li B, Tseng YJ, Lian JJ, Gao H, Wang J, Luo TC, Chen SY. Randomized controlled trial comparing endoscopic ligation with or without sclerotherapy for secondary prophylaxis of variceal bleeding. Eur J Gastroenterol Hepatol. 2016 Jan;28(1):95-100. doi: 10.1097/MEG.0000000000000499.
PubMed 26517621
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Ligation Versus Ligation Plus Sclerotherapy in Addition to Cyanoacrylate in Patients With Gastroesophageal Varices
- ClinicalTrials.gov ID
- NCT01592578
- Acronym / sponsor ID
- CSY-CJ-2012
- Conditions
- Gastroesophageal Varice
- Keywords
- gastroesophgeal variceal bleeding, liver cirrhosis, portal hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 7 May 2012 (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 study is to evaluate the efficacy of two different endoscopic treatment in gastroesophageal varices in patients with liver cirrhosis: ligation versus ligation plus sclerotherapy in addition to cyanoacrylates
Detailed description
Gastroesophageal variceal bleeding, which often results from portal hypertention, is known as one of the most frequent death causes of patients with liver cirrhosis. When a patient has bleeding episode, it's very likely that he/she will develop another one in the future. Endoscopic treatments such as ligation, sclerotherapy or cyanocrylates are proved to decrease the risk of re-bleeding. The purpose of this study is to evaluate the efficacy of two different endoscopic treatments in patients who have both gastric and esophageal varices with liver cirrhosis: In addition to cyanoacrylates, ligation versus ligation plus sclerotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ligation and Cyanoacrylate Group | Active comparator | Procedure: Ligation and Cyanoacrylate |
| Ligation plus Sclerotherapy and Cyanoacrylate Group | Experimental | Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with portal hypertension caused by liver cirrhosis who presented with an acute or recent episode of gastroesophageal variceal bleeding and have previously received endoscopic treatments of ligation and cyanoacrylate. Diagnosis of liver cirrhosis or mixed cirrhosis was based on results of liver biopsy or biochemical tests and liver imaging by ultrasonography.
- The extent of the varices range from Moderate to Severe.
- The age of the patients range from 18 to 72 years old.
Key exclusion criteria (5 listed)
- Patients who had other causes for portal hypertention(CTPV,Budd-Chiari syndrome,etc.)
- Patients with severe systemic disease (renal failure, heart failure,carcinoma other than liver cancer,etc.)
- Patients who had contraindications for ligation,sclerotherapy or cyanoacrylate.
- Patients who have previously received shunt or devascularization operation,TIPS.
- Patients who had portosystemic shunt according to the results of CT scan.
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 |
|---|---|---|
| Ligation and CyanoacrylatePatients will be treated with ligation for esophageal varices and cyanoacrylate for gastric varices when necessary. | Procedure or surgery | Ligation and Cyanoacrylate Group |
| Ligation plus Sclerotherapy and Cyanoacrylate GroupPatients will receive sclerotherapy after first ligation for esophageal varices and cyanoacrylate for gastric varices when necessary | Procedure or surgery | Ligation plus Sclerotherapy and Cyanoacrylate Group |
Primary outcome
recurrence rate of variceal hemorrhage
Time frame: Participants will be followed for up to 6 months starting from the date of randomization.
recurrence rate of variceal hemorrhage
4 secondary outcomes
eradication rate of the gastroesophageal varices
Time frame: Participants will be followed for up to 6 months starting from the date of randomization.Eradication of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.
recurrence rate of the gastroesophageal varices
Time frame: Participants will be followed for up to 6 months starting from the date of randomization.Recurrence rate of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.
mortality rate during the follow-up period
Time frame: Participants will be followed for up to 6 months starting from the date of randomization.
incidence rate of complications associated with endoscopic treatments
Time frame: Participants will be followed for up to 6 months starting from the date of randomization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2013.
- Derived from this study: PubMed 26517621Chen J, Zeng XQ, Ma LL, Li B, Tseng YJ, Lian JJ, Gao H, Wang J, Luo TC, Chen SY. Randomized controlled trial comparing endoscopic ligation with or without sclerotherapy for secondary prophylaxis of variceal bleeding. Eur J Gastroenterol Hepatol. 2016 Jan;28(1):95-100. doi: 10.1097/MEG.0000000000000499.
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, professor study director
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ligation and Cyanoacrylate and Ligation plus Sclerotherapy and Cyanoacrylate Group in people with Gastroesophageal Varice, 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 3 inclusion and 5 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 29 Apr 2013. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate of variceal hemorrhage (time frame: Participants will be followed for up to 6 months starting from the date of randomization.). 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 NCT01592578, 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 29 Apr 2013.