Esophageal and Gastric VaricesNCT04210297
Development and Validation of an Noninvasive Model for Predicting High Risk Esophageal Varices in Cirrhosis
An observational study of Esophageal and Gastric Varices, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The aim of the study is to develop and validate a new noninvasive method based on routine examination during clinical practice for predicting high risk esophageal varices in cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal and Gastric Varices
- How many people
- 245 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We queried the cirrhotic patients treated in Qilu Hospital Affiliated to Shandong University and Jinan Central Hospital Affiliated to Shandong University.
The inclusion criteria:
- patients who were diagnosed with liver cirrhosis.
- patients who underwent the abdominal contrast-enhanced CT examination.
- patients who received endoscopic screening.
- patients with written informed consent.
The exclusion criteria:
- patients who previously underwent endoscopic therapy, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy, partial splenic embolization (PSE), hepatectomy, balloon-occluded retrograde transvenous obliteration, or liver transplantation.
- patients with liver cancer.
- patients with severe ascites or hepatic encephalopathy.
- lacks abdominal contrast-enhanced CT within 1 month of endoscopy.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology,Qilu Hospital,Shandong University
Jinan, Shandong, 250012
About this study
The aim of the study is to develop and validate a new noninvasive method based on routine examination during clinical practice for predicting high risk esophageal varices in cirrhosis.
Read the detailed description
Portal hypertension is the main consequence of cirrhosis. Variceal bleeding is the principal and life-threatening complication of portal hypertension. Endoscopic screening is the golden standard to detect esophageal varices. However, endoscopy is limited by its invasiveness, cost and the discomfort it imposes on patients. With the goal of circumventing these disadvantages, we intend to develop an noninvasive method for predicting high risk esophageal varices.
- Conditions
- Esophageal and Gastric Varices
- Keywords
- noninvasive, portal hypertension, radiomics
- Medical subject headings
- Esophageal and Gastric Varices, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | Training cohort consists of the cirrhotic patients who collected from January 2018 to December 2019 of Qilu Hospital retrospectively. | |
| Internal validation cohort | Internal validation cohort consists of the cirrhotic patients who enrolled from January 2020 of Qilu Hospital prospectively. | |
| External validation cohort | External validation cohort consists of the cirrhotic patients who enrolled from January 2020 in Jinan Central Hospital prospectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
The golden standard is endoscopic examination.Compare the accuracy of the noninvasive model with the endoscopic examination.
Measured: through study completion, up to 2 years
sensitivity
the sensitivity of predicting high risk esophageal varices of the noninvasive model.
Measured: through study completion, up to 2 years
specificity
the specificity of predicting high risk esophageal varices of the noninvasive model.
Measured: through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Jan 2018
- Primary completion1 Oct 2019
- Study completion1 Jan 2021
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 Esophageal and Gastric VaricesStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Jinan Central Hospital
- Responsible party
- Principal investigator, Yanjing Gao, Qilu Hospital of Shandong University
- Investigators
- Yanjing Gao, PhD.MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210297
- Sponsor's protocol ID
- LinMaxwell2018
- Status last verified
- May 2021
- First submitted
- 15 Dec 2019
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lin Y, Li L, Yu D, Liu Z, Zhang S, Wang Q, Li Y, Cheng B, Qiao J, Gao Y. A novel radiomics-platelet nomogram for the prediction of gastroesophageal varices needing treatment in cirrhotic patients. Hepatol Int. 2021 Aug;15(4):995-1005. doi: 10.1007/s12072-021-10208-4. Epub 2021 Jun 11.
PubMed 34115257
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Noninvasive Model for Predicting High Risk Esophageal Varices in Cirrhosis
- ClinicalTrials.gov ID
- NCT04210297
- Acronym / sponsor ID
- LinMaxwell2018
- Conditions
- Esophageal and Gastric Varices
- Keywords
- noninvasive, portal hypertension, radiomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Jinan Central Hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 24 Dec 2019 (actual)
- 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 aim of the study is to develop and validate a new noninvasive method based on routine examination during clinical practice for predicting high risk esophageal varices in cirrhosis.
Detailed description
Portal hypertension is the main consequence of cirrhosis. Variceal bleeding is the principal and life-threatening complication of portal hypertension. Endoscopic screening is the golden standard to detect esophageal varices. However, endoscopy is limited by its invasiveness, cost and the discomfort it imposes on patients. With the goal of circumventing these disadvantages, we intend to develop an noninvasive method for predicting high risk esophageal varices.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | –Training cohort consists of the cirrhotic patients who collected from January 2018 to December 2019 of Qilu Hospital retrospectively. |
| Internal validation cohort | – | –Internal validation cohort consists of the cirrhotic patients who enrolled from January 2020 of Qilu Hospital prospectively. |
| External validation cohort | – | –External validation cohort consists of the cirrhotic patients who enrolled from January 2020 in Jinan Central Hospital prospectively. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We queried the cirrhotic patients treated in Qilu Hospital Affiliated to Shandong University and Jinan Central Hospital Affiliated to Shandong University.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy
Time frame: through study completion, up to 2 years
The golden standard is endoscopic examination.Compare the accuracy of the noninvasive model with the endoscopic examination.
sensitivity
Time frame: through study completion, up to 2 years
the sensitivity of predicting high risk esophageal varices of the noninvasive model.
specificity
Time frame: through study completion, up to 2 years
the specificity of predicting high risk esophageal varices of the noninvasive model.
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 14 May 2021.
- Derived from this study: PubMed 34115257Lin Y, Li L, Yu D, Liu Z, Zhang S, Wang Q, Li Y, Cheng B, Qiao J, Gao Y. A novel radiomics-platelet nomogram for the prediction of gastroesophageal varices needing treatment in cirrhotic patients. Hepatol Int. 2021 Aug;15(4):995-1005. doi: 10.1007/s12072-021-10208-4. Epub 2021 Jun 11.
- 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.
Yanjing Gao, PhD.MD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal and Gastric Varices, run by Qilu Hospital of Shandong University 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?
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 14 May 2021. 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?
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?
Accuracy (time frame: through study completion, up to 2 years). The study lists 3 primary outcomes in all. 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 NCT04210297, 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 14 May 2021.