Liver CirrhosisNCT04639323
Endoscopic Ruler for the Assessment of Variceal Bleeding Risks (CHESS2005)
An observational study of Liver Cirrhosis and Portal Hypertension, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 7 sites in China.
Trial summary
The presence of varices is a serious complication of portal hypertension in liver disease. To prevent variceal haemorrhage, screening and surveillance aims to detect high-risk varices related to varices size and determine the need for primary prophylaxis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Portal Hypertension, Gastroesophageal Varices
- What is being tested?
- Endoscopic ruler
- How many people
- 266 participants
- Where
- 7 sitesChina
- Study dates
- 23 Dec 2020to 1 Jan 2025
- How long will I take part?
- 7 Days
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators prospectively recruit well-defined participants with liver cirrhosis from university hospitals. Esophagogastroduodenoscopy is performed by a dedicated endoscopist at each center. Varices size is evaluated by the endoscopist and endoscopic ruler.
Who may be able to join
- age between 18 and 75 years
- clinically evident or biopsy-confirmed cirrhosis
- Varices diagnosed by endoscopy
- written informed consent
Who cannot join
- red sign
- Active upper gastrointestinal bleeding
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
The Second Affiliated Hospital of Baotou Medical College
Baotou
Xianmei Meng, M.D.
- Not yet recruiting
The Third Xiangya Hospital of Central South University
Changsha
Xiaoyan Wang, M.D.
- Not yet recruiting
The first hospital of Lanzhou university
Lanzhou
Xiaolong Qi, M.D.
- Not yet recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing
Guoxin Zhang, M.D.
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang
Zhijie Feng, M.D.
- Not yet recruiting
Tianjin Second People's Hospital
Tianjin
Fengmei Wang, M.D.
- Recruiting
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan
Shengjuan Hu, M.D.
About this study
Official title: Endoscopic Ruler for the Assessment of Variceal Bleeding Risks in Portal Hypertension (CHESS2005): A Prospective Multicenter Trial
The presence of varices is a serious complication of portal hypertension in liver disease. To prevent variceal haemorrhage, screening and surveillance aims to detect high-risk varices related to varices size and determine the need for primary prophylaxis. Varices size evaluated by endoscopists might not be perfect reference, influenced by experience and machine. Endoscopic ruler is a novel tool to measure the varices size under the endoscopy. The investigators aim to evaluate the bias of varices size between endoscopists and endoscopic ruler as the reference.
- Being tested
- Endoscopic ruler
- Keywords
- Esophagogastroduodenoscopy, Endoscopic ruler, Varices size
- 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.
Endoscopic rulerDiagnostic test
Endoscopic ruler for varices in portal hypertension
Product uses: measuring the diameter of the veins under the endoscopy for the assessment of the risk of variceal haemorrhage in patients with portal hypertension
Black and white measuring rule is highly recognizable under the endoscopy
The width of each cell is 1 mm, and the measuring range is 0-10 mm
With smooth edge, safe and reliable
| Study group | Role | What they receive |
|---|---|---|
| Overall eligible participants | Eligible participants whose varix size will be measured by endoscopists and endoscopic ruler will receive standard esophagogastroduodenoscopy Receives: Diagnostic Test: Endoscopic ruler |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intraclass correlation coefficient (ICC) of the varix size and the kappa value of the varices bleeding risk between endoscopists and endoscopic ruler
Measured: 2020/11/13-2022/11/13
Secondary outcomes (5)
The ICC value of the varix size and the kappa value of the varices bleeding risk among endoscopists
Measured: 2020/11/13-2022/11/13
The bleeding rate of endoscopic ruler
Measured: 2020/11/13-2022/11/13
The timing of endoscopic ruler
Measured: 2020/11/13-2022/11/13
The correlation coefficient between varices size and hepatic venous pressure gradient
Measured: 2020/11/13-2022/11/13
The correlation coefficient between varices size and decompensated events
Measured: 2020/11/13-2022/11/13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start23 Dec 2020
- Primary completion1 Apr 2023
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 266 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Collaborators
- LanZhou University, Tianjin Second People's Hospital, The First Affiliated Hospital with Nanjing Medical University, People's Hospital of Ningxia Hui Autonomous Region, The Second Affiliated Hospital of Baotou Medical College, The Third Xiangya Hospital of Central South University, The Second Hospital of Hebei Medical University, The Affiliated Hospital Of Southwest Medical University, First Hospital of China Medical University
- Responsible party
- Principal investigator, Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Xiaolong Qi, M.D., Study chair, LanZhou UniversityFengmei Wang, M.D., Principal investigator, Tianjin Second People's HospitalGuoxin Zhang, M.D., Principal investigator, The First Affiliated Hospital with Nanjing Medical UniversityShengjuan Hu, M.D., Principal investigator, People's Hospital of Ningxia Hui Autonomous RegionXianmei Meng, M.D., Principal investigator, The Second Affiliated Hospital of Baotou Medical CollegeXiaoyan Wang, M.D., Principal investigator, The Third Xiangya Hospital of Central South UniversityZhijie Feng, M.D., Principal investigator, The Second Hospital of Hebei Medical UniversityMuhan Lv, M.D., Principal investigator, The Affiliated Hospital Of Southwest Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639323
- Sponsor's protocol ID
- CHESS2005
- Status last verified
- Apr 2023
- First submitted
- 15 Nov 2020
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.
PubMed 30215362Cremers I, Ribeiro S. Management of variceal and nonvariceal upper gastrointestinal bleeding in patients with cirrhosis. Ther Adv Gastroenterol. 2014 Sep;7(5):206-16. doi: 10.1177/1756283X14538688.
PubMed 25177367Bendtsen F, Skovgaard LT, Sorensen TI, Matzen P. Agreement among multiple observers on endoscopic diagnosis of esophageal varices before bleeding. Hepatology. 1990 Mar;11(3):341-7. doi: 10.1002/hep.1840110302.
PubMed 2312048Cales P, Pascal JP. Gastroesophageal endoscopic features in cirrhosis: comparison of intracenter and intercenter observer variability. Gastroenterology. 1990 Oct;99(4):1189. doi: 10.1016/0016-5085(90)90652-h. No abstract available.
PubMed 2203663
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ruler for the Assessment of Variceal Bleeding Risks in Portal Hypertension (CHESS2005): A Prospective Multicenter Trial
- ClinicalTrials.gov ID
- NCT04639323
- Acronym / sponsor ID
- CHESS2005
- Keywords
- Esophagogastroduodenoscopy, Endoscopic ruler, Varices size
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Collaborators
- LanZhou University, Tianjin Second People's Hospital, The First Affiliated Hospital with Nanjing Medical University, People's Hospital of Ningxia Hui Autonomous Region, The Second Affiliated Hospital of Baotou Medical College, The Third Xiangya Hospital of Central South University, The Second Hospital of Hebei Medical University, The Affiliated Hospital Of Southwest Medical University, First Hospital of China Medical University
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 20 Nov 2020 (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 presence of varices is a serious complication of portal hypertension in liver disease. To prevent variceal haemorrhage, screening and surveillance aims to detect high-risk varices related to varices size and determine the need for primary prophylaxis. Varices size evaluated by endoscopists might not be perfect reference, influenced by experience and machine. Endoscopic ruler is a novel tool to measure the varices size under the endoscopy. The investigators aim to evaluate the bias of varices size between endoscopists and endoscopic ruler as the reference.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall eligible participants | – | Diagnostic Test: Endoscopic rulerEligible participants whose varix size will be measured by endoscopists and endoscopic ruler will receive standard esophagogastroduodenoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators prospectively recruit well-defined participants with liver cirrhosis from university hospitals. Esophagogastroduodenoscopy is performed by a dedicated endoscopist at each center. Varices size is evaluated by the endoscopist and endoscopic ruler.
Key inclusion criteria (4 listed)
- age between 18 and 75 years
- clinically evident or biopsy-confirmed cirrhosis
- Varices diagnosed by endoscopy
- written informed consent
Key exclusion criteria (2 listed)
- red sign
- Active upper gastrointestinal 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 |
|---|---|---|
| Endoscopic rulerEndoscopic ruler for varices in portal hypertension Product uses: measuring the diameter of the veins under the endoscopy for the assessment of the risk of variceal haemorrhage in patients with portal hypertension Black and white measuring rule is highly recognizable under the endoscopy The width of each cell is 1 mm, and the measuring range is 0-10 mm With smooth edge, safe and reliable | Diagnostic test | Overall eligible participants |
Primary outcome
The intraclass correlation coefficient (ICC) of the varix size and the kappa value of the varices bleeding risk between endoscopists and endoscopic ruler
Time frame: 2020/11/13-2022/11/13
5 secondary outcomes
The ICC value of the varix size and the kappa value of the varices bleeding risk among endoscopists
Time frame: 2020/11/13-2022/11/13
The bleeding rate of endoscopic ruler
Time frame: 2020/11/13-2022/11/13
The timing of endoscopic ruler
Time frame: 2020/11/13-2022/11/13
The correlation coefficient between varices size and hepatic venous pressure gradient
Time frame: 2020/11/13-2022/11/13
The correlation coefficient between varices size and decompensated events
Time frame: 2020/11/13-2022/11/13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 30215362Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.
- Background: PubMed 25177367Cremers I, Ribeiro S. Management of variceal and nonvariceal upper gastrointestinal bleeding in patients with cirrhosis. Ther Adv Gastroenterol. 2014 Sep;7(5):206-16. doi: 10.1177/1756283X14538688.
- Background: PubMed 2312048Bendtsen F, Skovgaard LT, Sorensen TI, Matzen P. Agreement among multiple observers on endoscopic diagnosis of esophageal varices before bleeding. Hepatology. 1990 Mar;11(3):341-7. doi: 10.1002/hep.1840110302.
- Background: PubMed 2203663Cales P, Pascal JP. Gastroesophageal endoscopic features in cirrhosis: comparison of intracenter and intercenter observer variability. Gastroenterology. 1990 Oct;99(4):1189. doi: 10.1016/0016-5085(90)90652-h. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Xiaolong Qi, M.D. study chair
LanZhou University
Fengmei Wang, M.D. principal investigator
Tianjin Second People's Hospital
Guoxin Zhang, M.D. principal investigator
The First Affiliated Hospital with Nanjing Medical University
7 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 Portal Hypertension, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 7 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 4 inclusion and 2 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 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaolong Qi, M.D. (+86 18588602600, qixiaolong@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The intraclass correlation coefficient (ICC) of the varix size and the kappa value of the varices bleeding risk between endoscopists and endoscopic ruler (time frame: 2020/11/13-2022/11/13). 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 NCT04639323, which also lists 4 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 25 Apr 2023.