Gastric VaricesNCT02693951
Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices
A study testing Cefotiam in people with Gastric Varices and Cirrhosis, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The purpose of the study is to assess the efficiency and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Varices, Cirrhosis
- What is being tested?
- Cefotiam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Sep 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of understanding the purpose and risks of the study and informed consent to participate in the study;
- age between 18-75 years old;
- Diagnosis of esophageal gastric varices by gastroscopy
- Preparation of endoscopic injection of tissue adhesive
Who cannot join
- No esophageal gastric varices bleeding history;
- Esophageal varices or gastric varices which temporarily won't be treated by endoscopic therapy;
- The cefotiam contraindications: such as allergies, pregnancy etc;
- Patients with the other malignant tumor except liver cancer;
- The preoperative diagnosis of infection;
- The large amount of ascites;
- The acute bleeding period (< 5 days);
- Patients refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Chengfeng Liu, Doctor, 86-15201927474, 09301010167@fudan.edu.cn
Shiyao Chen, MD
About this study
Official title: Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Randomized Controlled Trial
The purpose of the study is to assess the efficiency and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.
Read the detailed description
At present, there is still a controversy about the application of antibiotics in the treatment of patients with non acute hemorrhage of esophageal varices. This study is a randomized controlled trial. Patients randomly enter two treatment groups:
- the prophylactic use of antibiotics group and
- the non-prophylactic use of antibiotics group
Treatment allocation is by block randomization with an equal number for both groups. The incidence of infection after endoscopic treatment will be analyzed.
- Conditions
- Gastric Varices, Cirrhosis
- Being tested
- Cefotiam
- Keywords
- gastric varices, endoscopic injection of tissue adhesive
- Medical subject headings
- Esophageal and Gastric Varices, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefotiamDrug
Also called HaiTiShu
Prophylactic use of antibiotics group: Half an hour before endoscopic treatment, cefotiam 2.0g intravenous
| Study group | Role | What they receive |
|---|---|---|
| the prophylactic use of antibiotics group | Experimental | Half an hour before endoscopic treatment, cefotiam 2.0g intravenous Receives: Drug: Cefotiam |
| Control | No intervention | Routine endoscopic examination and treatment. Antibiotics are not used before endoscopic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of infection after endoscopic treatment
Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment.
Measured: 1 week
Secondary outcomes (2)
Rebleeding rate
Patients will receive an endoscopic examination after patients have been followed up for 2 months.
Measured: 2 months
Mortality rate
The investigators observe the mortality events during 2 months
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2017 (estimated)
- Study completionSep 2017 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT02693951
- Sponsor's protocol ID
- CSY-LCF-2016
- Status last verified
- Jan 2017
- First submitted
- 18 Feb 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02693951
- Acronym / sponsor ID
- CSY-LCF-2016
- Conditions
- Gastric Varices, Cirrhosis
- Keywords
- gastric varices, endoscopic injection of tissue adhesive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 29 Feb 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.
The purpose of the study is to assess the efficiency and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.
Detailed description
At present, there is still a controversy about the application of antibiotics in the treatment of patients with non acute hemorrhage of esophageal varices. This study is a randomized controlled trial. Patients randomly enter two treatment groups:
- the prophylactic use of antibiotics group and
- the non-prophylactic use of antibiotics group
Treatment allocation is by block randomization with an equal number for both groups. The incidence of infection after endoscopic treatment will be analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the prophylactic use of antibiotics group | Experimental | Drug: CefotiamHalf an hour before endoscopic treatment, cefotiam 2.0g intravenous |
| Control | No intervention | –Routine endoscopic examination and treatment. Antibiotics are not used before endoscopic treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Capable of understanding the purpose and risks of the study and informed consent to participate in the study;
- age between 18-75 years old;
- Diagnosis of esophageal gastric varices by gastroscopy
- Preparation of endoscopic injection of tissue adhesive
Key exclusion criteria (8 listed)
- No esophageal gastric varices bleeding history;
- Esophageal varices or gastric varices which temporarily won't be treated by endoscopic therapy;
- The cefotiam contraindications: such as allergies, pregnancy etc;
- Patients with the other malignant tumor except liver cancer;
- The preoperative diagnosis of infection;
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 |
|---|---|---|
| CefotiamAlso: HaiTiShuProphylactic use of antibiotics group: Half an hour before endoscopic treatment, cefotiam 2.0g intravenous | Drug | the prophylactic use of antibiotics group |
Primary outcome
The incidence of infection after endoscopic treatment
Time frame: 1 week
Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment.
2 secondary outcomes
Rebleeding rate
Time frame: 2 months
Mortality rate
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
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Esophageal Varices
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 Cefotiam in people with Gastric Varices and Cirrhosis, 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 4 inclusion and 8 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 6 Jan 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 Shiyao Chen, Professor (86-13601767310, chen.shiyao@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of infection after endoscopic treatment (time frame: 1 week). 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 6 Jan 2017.