Gastric VaricesPUoA-EIoTANCT03045783
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 evaluate the efficacy 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
- 912 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Jul 2019
- 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
- 18 y.o. ≤age≤75 y.o.;
- Diagnosis of esophageal gastric varices by gastroscopy;
- Cirrhotic gastroesophageal variceal bleeding underwent endoscopic injection of tissue adhesive;
Who cannot join
- age <18 y.o. or age > 75 y.o.;
- Never had the variceal bleeding episode before;
- Do not have endoscopic injection of tissue adhesive;
- The cefotiam contraindications: such as allergies, pregnancy etc;
- combined with other malignant tumor (not exclude patients with hepatocellular carcinoma who don't not need treatment at the moment);
- Known infection before endoscopic treatment (Fever, microbial cultures positive, et al.);
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- Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics;
- Acute variceal bleeding within 5 days;
- Refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Multicenter Randomized Controlled Trial
The purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.
Read the detailed description
Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection. However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.This study is a randomized controlled trial. The purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.
- 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：Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic use of antibiotics group | Experimental | Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous Receives: Drug: Cefotiam |
| On-demand group | No intervention | Routine endoscopic examination and treatment. Antibiotics are not used during 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 (5)
Rebleeding rate
Patients will be followed up and 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
All clinical events
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, portal vein thrombosis, or death.
Measured: 2 months
Serum endotoxin
Measured: before and the first day after endoscopic treatment
inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta，IL-2R, IL-10
Measured: before and the first day after endoscopic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study startDec 2016
- Primary completionMar 2019 (estimated)
- Study completionJul 2019 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 912 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lanzhou University Second Hospital, Beijing Ditan Hospital, Shandong Provincial Hospital, Renmin Hospital of Wuhan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of Anhui Medical University
- Responsible party
- Principal investigator, Shiyao Chen, Shanghai Zhongshan Hospital
- Investigators
- Shiyao CHEN, M.D., Principal investigator, Zhongshan Hospital, Fudan University, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045783
- Sponsor's protocol ID
- CSY-LCF2-2016
- Acronym
- PUoA-EIoTA
- Status last verified
- Feb 2017
- First submitted
- 4 Jan 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03045783
- Acronym / sponsor ID
- PUoA-EIoTA / CSY-LCF2-2016
- Conditions
- Gastric Varices, Cirrhosis
- Keywords
- gastric varices, endoscopic injection of tissue adhesive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 912 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Lanzhou University Second Hospital, Beijing Ditan Hospital, Shandong Provincial Hospital, Renmin Hospital of Wuhan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of Anhui Medical University
- Study start
- Dec 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 7 Feb 2017 (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 evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.
Detailed description
Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection. However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.This study is a randomized controlled trial. The purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic use of antibiotics group | Experimental | Drug: CefotiamProphylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous |
| On-demand group | No intervention | –Routine endoscopic examination and treatment. Antibiotics are not used during endoscopic treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 y.o. ≤age≤75 y.o.;
- Diagnosis of esophageal gastric varices by gastroscopy;
- Cirrhotic gastroesophageal variceal bleeding underwent endoscopic injection of tissue adhesive;
Key exclusion criteria (9 listed)
- age <18 y.o. or age > 75 y.o.;
- Never had the variceal bleeding episode before;
- Do not have endoscopic injection of tissue adhesive;
- The cefotiam contraindications: such as allergies, pregnancy etc;
- combined with other malignant tumor (not exclude patients with hepatocellular carcinoma who don't not need treatment at the moment);
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：Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous | Drug | 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
5 secondary outcomes
Rebleeding rate
Time frame: 2 months
Mortality rate
Time frame: 2 months
All clinical events
Time frame: 2 months
Serum endotoxin
Time frame: before and the first day after endoscopic treatment
inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta，IL-2R, IL-10
Time frame: before and the first day after endoscopic treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: No
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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, M.D. principal investigator
Zhongshan Hospital, Fudan University, 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 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 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 7 Feb 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?
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?
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 7 Feb 2017.