Liver CirrhosisNCT02593799
Non-invasive Prediction of Esophageal Varices in Liver Cirrhosis: A Multicenter Observational Study
An observational study of Liver Cirrhosis and Esophageal and Gastric Varices, run by General Hospital of Shenyang Military Region at 17 sites in China.
Trial summary
Esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. In the early stage of liver cirrhosis, the prediction of esophageal varices is very important for guiding the clinical decision making of primary prophylaxis of variceal bleeding. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhosis, Esophageal and Gastric Varices
- What is being tested?
- Endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 363 participants
- Where
- 17 sitesChina
- Study dates
- 1 May 2015to 31 Dec 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with liver cirrhosis who will firstly undergo the upper gastrointestinal endoscopy.
Who may be able to join
- A diagnosis of liver cirrhosis.
- Age and sex are not limited.
- Etiology of liver cirrhosis is not limited.
- Routine laboratory data.
- Upper gastrointestinal endoscopy.
Who cannot join
- Non-cirrhotic portal hypertension.
- Malignancy.
- Absent laboratory data.
- A previous diagnosis of esophageal varices.
- A previous history of variceal bleeding.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
ANSTEEL Group Hospital
Anshan, Liaoning
Shuangshan Hospital of Anshan City
Anshan, Liaoning
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Friendship Hospital of Dalian City
Dalian, Liaoning
Central Hospital of Dandong City
Dandong, Liaoning
Central Hospital of Fushun City
Fushun, Liaoning
General Hospital of Mining Industry Group Fuxin
Fuxin, Liaoning
First Affiliated Hospital of Liaoning Medical University
Jinzhou, Liaoning
General Hospital of Liaoyang City
Liaoyang, Liaoning
Central Hospital of Panjin City
Panjing, Liaoning
General Hospital of Liaohe Oil Field
Panjing, Liaoning
Department of Gastroenterology, General Hospital of Shenyang Military Area
Shenyang, Liaoning, 110840
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning
First Affiliated Hospital of Chinese Medical University
Shenyang, Liaoning
No. 1 of Department of Gastroenterology, Liaoning Provincial People's Hospital
Shenyang, Liaoning
No. 2 of Department of Gastroenterology, Liaoning Provincial People's Hospital
Shenyang, Liaoning
Shengjing Hospital of Chinese Medical University
Shenyang, Liaoning
About this study
Esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. In the early stage of liver cirrhosis, the prediction of esophageal varices is very important for guiding the clinical decision making of primary prophylaxis of variceal bleeding.
Read the detailed description
Esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. In the early stage of liver cirrhosis, the prediction of esophageal varices is very important for guiding the clinical decision making of primary prophylaxis of variceal bleeding. The investigators' recent systematic review evaluated the diagnostic accuracy of APRI, AAR, FIB-4, FI, King, Lok, Forns, and FibroIndex scores in predicting the presence of esophageal varices in liver cirrhosis. However, their diagnostic accuracy was low to moderate. Further study is warranted to establish a reliable score to predict the presence of high-risk esophageal varice in liver cirrhosis.
- Conditions
- Liver Cirrhosis, Esophageal and Gastric Varices
- Being tested
- Endoscopy
- Keywords
- Liver cirrhosis, Esophageal and Gastric Varices, Endoscopy
- Medical subject headings
- Liver Cirrhosis, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
Upper gastrointestinal endoscopy to evaluate the presence of any grade varices and high-risk varices.
| Study group | Role | What they receive |
|---|---|---|
| Patients with esophageal varices | Esophageal varices were confirmed by endoscopy. They were divided into "any grade" and "high-risk" varices. Receives: Procedure: Endoscopy | |
| Patients without esophageal varices | Patients without esophageal varices were divided into patients without "any grade" or "high-risk" varices. Receives: Procedure: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of biochemical data with esophageal varices in liver cirrhosis
The investigators firstly calculated the significant factors associated with the presence of esophageal varices, and then developed a score to predict the presence of esophageal varices in liver cirrhosis.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study start1 May 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
- Investigators
- Xiaozhong Guo, M.D., Principal investigator, Department of Gastroenterology, General Hospital of Shenyang Military Area
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593799
- Sponsor's protocol ID
- NIPEV-1
- Status last verified
- Feb 2019
- First submitted
- 30 Oct 2015
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Deng H, Qi X, Guo X. Diagnostic Accuracy of APRI, AAR, FIB-4, FI, King, Lok, Forns, and FibroIndex Scores in Predicting the Presence of Esophageal Varices in Liver Cirrhosis: A Systematic Review and Meta-Analysis. Medicine (Baltimore). 2015 Oct;94(42):e1795. doi: 10.1097/MD.0000000000001795.
PubMed 26496312Qi X, Guo X, Li H, Liu X, Deng H. Knowledge about non-invasive diagnostic tests for varices in liver cirrhosis: A questionnaire survey to the Gastroenterology Branch of the Liaoning Medical Association, China. Gastroenterol Rep (Oxf). 2016 May;4(2):141-7. doi: 10.1093/gastro/gov031. Epub 2015 Jul 9.
PubMed 26159631Qi X, Li Y, Wang R, Lin L, Li J, Wang L, Zheng S, Sun Y, Zhao L, Fu X, Wang M, Qiu X, Deng H, Hong C, Li Q, Li H, Guo X. Liaoning Score for Prediction of Esophageal Varices in Cirrhotic Patients Who Had Never Undergone Endoscopy: A Multicenter Cross-Sectional Study in Liaoning Province, China. Adv Ther. 2019 Aug;36(8):2167-2178. doi: 10.1007/s12325-019-00967-w. Epub 2019 May 15.
PubMed 31093864
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Prediction of Esophageal Varices in Liver Cirrhosis: A Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT02593799
- Acronym / sponsor ID
- NIPEV-1
- Conditions
- Liver Cirrhosis, Esophageal and Gastric Varices
- Keywords
- Liver cirrhosis, Esophageal and Gastric Varices, Endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 Nov 2015 (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.
Esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. In the early stage of liver cirrhosis, the prediction of esophageal varices is very important for guiding the clinical decision making of primary prophylaxis of variceal bleeding.
Detailed description
Esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. In the early stage of liver cirrhosis, the prediction of esophageal varices is very important for guiding the clinical decision making of primary prophylaxis of variceal bleeding. The investigators' recent systematic review evaluated the diagnostic accuracy of APRI, AAR, FIB-4, FI, King, Lok, Forns, and FibroIndex scores in predicting the presence of esophageal varices in liver cirrhosis. However, their diagnostic accuracy was low to moderate. Further study is warranted to establish a reliable score to predict the presence of high-risk esophageal varice in liver cirrhosis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with esophageal varices | – | Procedure: EndoscopyEsophageal varices were confirmed by endoscopy. They were divided into "any grade" and "high-risk" varices. |
| Patients without esophageal varices | – | Procedure: EndoscopyPatients without esophageal varices were divided into patients without "any grade" or "high-risk" varices. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with liver cirrhosis who will firstly undergo the upper gastrointestinal endoscopy.
Key inclusion criteria (5 listed)
- A diagnosis of liver cirrhosis.
- Age and sex are not limited.
- Etiology of liver cirrhosis is not limited.
- Routine laboratory data.
- Upper gastrointestinal endoscopy.
Key exclusion criteria (5 listed)
- Non-cirrhotic portal hypertension.
- Malignancy.
- Absent laboratory data.
- A previous diagnosis of esophageal varices.
- A previous history of 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 |
|---|---|---|
| EndoscopyUpper gastrointestinal endoscopy to evaluate the presence of any grade varices and high-risk varices. | Procedure or surgery | Patients with esophageal varices, Patients without esophageal varices |
Primary outcome
Correlation of biochemical data with esophageal varices in liver cirrhosis
Time frame: 18 months
The investigators firstly calculated the significant factors associated with the presence of esophageal varices, and then developed a score to predict the presence of esophageal varices in liver cirrhosis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Background: PubMed 26496312Deng H, Qi X, Guo X. Diagnostic Accuracy of APRI, AAR, FIB-4, FI, King, Lok, Forns, and FibroIndex Scores in Predicting the Presence of Esophageal Varices in Liver Cirrhosis: A Systematic Review and Meta-Analysis. Medicine (Baltimore). 2015 Oct;94(42):e1795. doi: 10.1097/MD.0000000000001795.
- Background: PubMed 26159631Qi X, Guo X, Li H, Liu X, Deng H. Knowledge about non-invasive diagnostic tests for varices in liver cirrhosis: A questionnaire survey to the Gastroenterology Branch of the Liaoning Medical Association, China. Gastroenterol Rep (Oxf). 2016 May;4(2):141-7. doi: 10.1093/gastro/gov031. Epub 2015 Jul 9.
- Derived from this study: PubMed 31093864Qi X, Li Y, Wang R, Lin L, Li J, Wang L, Zheng S, Sun Y, Zhao L, Fu X, Wang M, Qiu X, Deng H, Hong C, Li Q, Li H, Guo X. Liaoning Score for Prediction of Esophageal Varices in Cirrhotic Patients Who Had Never Undergone Endoscopy: A Multicenter Cross-Sectional Study in Liaoning Province, China. Adv Ther. 2019 Aug;36(8):2167-2178. doi: 10.1007/s12325-019-00967-w. Epub 2019 May 15.
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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.
Xiaozhong Guo, M.D. principal investigator
Department of Gastroenterology, General Hospital of Shenyang Military Area
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Esophageal and Gastric Varices, run by General Hospital of Shenyang Military Region at 17 sites 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 5 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: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of biochemical data with esophageal varices in liver cirrhosis (time frame: 18 months). 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 NCT02593799, which also lists 3 linked publications.
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 4 Feb 2019.