Cirrhosis, LiverNCT04957875
Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis
An observational study of Cirrhosis, Liver and Portal Hypertension, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
Trial summary
Cirrhotic patients with AVB across 34 university medical centers in 30 cities in China from February 2013 to May 2020 who underwent endoscopy within 24 hours were included in this study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Liver, Portal Hypertension, Varice Bleed
- What is being tested?
- emergency endoscopic therapy
- Type of treatment
- Medical device
- How many people
- 3,300 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2019to 2 Jun 2020
- 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: Complete demographic and clinical data of patients with cirrhosis associated with AVB who underwent emergency endoscopy within 24 hours between February 2013 and May 2020 across 34 university hospitals from 30 cities in China was retrospectively reviewed. Two independent investigators (Liu C and Huang Y) reviewed the medical records, including demographic, laboratory, clinical and endoscopic data.
Who may be able to join
- established diagnosis of cirrhosis (based on liver biopsy or the combination of clinical, biochemical, and imaging findings)
- witnessed or reported evidence of gastrointestinal haemorrhage (hematemesis, melenemesis, or hematochezia)
- esophageal or gastric varices confirmed endoscopically as the source of bleeding
Who cannot join
- severe dysfunction of a major extrahepatic organ (e.g., heart failure, pulmonary disease, and terminal malignancy except hepatocellular carcinoma)
- history of endoscopic therapy for varices (ligation or sclerotherapy) within three months
- incomplete or missing data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis (CHESS1905): a Nationwide Cohort Study
Cirrhotic patients with AVB across 34 university medical centers in 30 cities in China from February 2013 to May 2020 who underwent endoscopy within 24 hours were included in this study. Patients were divided into an urgent endoscopy group (endoscopy <6h after admission) and an early endoscopy group (endoscopy 6-24h after admission). Outcomes included the incidence of 5-day rebleeding, in-hospital mortality, need for intensive care unit (ICU) and the length of hospital stay after the endoscopy management. Multivariable analysis was performed to identify risk factors for rebleeding. A propensity score matching (PSM) analysis was performed to achieve a balance at baseline between the urgent and early groups.
- Conditions
- Cirrhosis, Liver, Portal Hypertension, Varice Bleed
- Being tested
- emergency endoscopic therapy
- 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.
emergency endoscopic therapyDevice
When cirrhotic patients presented with AVB to the emergency department, emergency physicians consulted gastroenterologists on duty to assess the patient for suitability for endoscopy, usually after initial stabilization. Performance of endoscopy and its timing was at the discretion of the gastroenterologist on call. Therapeutic endoscopy for AVB was performed within 24 hours after consultation by an experienced attending endoscopist, using standard forward-viewing upper gastrointestinal video endoscopes at individual centers. Written informed consent for endoscopy was obtained before each procedure. The standard of care at all hospitals was to administer a vasoactive agent and antibiotics upon the patient's presentation. Packed red blood cells were transfused at the discretion of the attending gastroenterologist.
| Study group | Role | What they receive |
|---|---|---|
| urgent endoscopy group | endoscopy <6h after admission Receives: Device: emergency endoscopic therapy | |
| early endoscopy group | endoscopy 6-24h after admission Receives: Device: emergency endoscopic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of 5-day rebleeding after emergency endoscopy
Measured: 6 months
Secondary outcomes (3)
the in-hospital mortality
Measured: 6 months
need for ICU
Measured: 6 months
the length of hospital stay
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start16 Dec 2019
- Primary completion16 Dec 2019
- Study completion2 Jun 2020
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 Cirrhosis, LiverStudies 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
- Retrospective
- Enrolment
- 3,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Collaborators
- LanZhou University, Beijing Shijitan Hospital, Capital Medical University, Beijing 302 Hospital, Tianjin Third Central Hospital, Shenyang Sixth People's Hospital, Shanxi Bethune Hospital, Linyi People's Hospital, Sir Run Run Shaw Hospital
- Responsible party
- Principal investigator, Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957875
- Sponsor's protocol ID
- CHESS1905
- Status last verified
- Apr 2023
- First submitted
- 1 Jul 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018 Aug;69(2):406-460. doi: 10.1016/j.jhep.2018.03.024. Epub 2018 Apr 10. No abstract available.
PubMed 29653741Lau JYW, Yu Y, Tang RSY, Chan HCH, Yip HC, Chan SM, Luk SWY, Wong SH, Lau LHS, Lui RN, Chan TT, Mak JWY, Chan FKL, Sung JJY. Timing of Endoscopy for Acute Upper Gastrointestinal Bleeding. N Engl J Med. 2020 Apr 2;382(14):1299-1308. doi: 10.1056/NEJMoa1912484.
PubMed 32242355Chen PH, Chen WC, Hou MC, Liu TT, Chang CJ, Liao WC, Su CW, Wang HM, Lin HC, Lee FY, Lee SD. Delayed endoscopy increases re-bleeding and mortality in patients with hematemesis and active esophageal variceal bleeding: a cohort study. J Hepatol. 2012 Dec;57(6):1207-13. doi: 10.1016/j.jhep.2012.07.038. Epub 2012 Aug 8.
PubMed 22885718
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
- Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis (CHESS1905): a Nationwide Cohort Study
- ClinicalTrials.gov ID
- NCT04957875
- Acronym / sponsor ID
- CHESS1905
- Conditions
- Cirrhosis, Liver, Portal Hypertension, Varice Bleed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,300 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Collaborators
- LanZhou University, Beijing Shijitan Hospital, Capital Medical University, Beijing 302 Hospital, Tianjin Third Central Hospital, Shenyang Sixth People's Hospital, Shanxi Bethune Hospital, Linyi People's Hospital, Sir Run Run Shaw Hospital
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 12 Jul 2021 (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.
Cirrhotic patients with AVB across 34 university medical centers in 30 cities in China from February 2013 to May 2020 who underwent endoscopy within 24 hours were included in this study. Patients were divided into an urgent endoscopy group (endoscopy <6h after admission) and an early endoscopy group (endoscopy 6-24h after admission). Outcomes included the incidence of 5-day rebleeding, in-hospital mortality, need for intensive care unit (ICU) and the length of hospital stay after the endoscopy management. Multivariable analysis was performed to identify risk factors for rebleeding. A propensity score matching (PSM) analysis was performed to achieve a balance at baseline between the urgent and early groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| urgent endoscopy group | – | Device: emergency endoscopic therapyendoscopy <6h after admission |
| early endoscopy group | – | Device: emergency endoscopic therapyendoscopy 6-24h after admission |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Complete demographic and clinical data of patients with cirrhosis associated with AVB who underwent emergency endoscopy within 24 hours between February 2013 and May 2020 across 34 university hospitals from 30 cities in China was retrospectively reviewed. Two independent investigators (Liu C and Huang Y) reviewed the medical records, including demographic, laboratory, clinical and endoscopic data.
Key inclusion criteria (3 listed)
- established diagnosis of cirrhosis (based on liver biopsy or the combination of clinical, biochemical, and imaging findings)
- witnessed or reported evidence of gastrointestinal haemorrhage (hematemesis, melenemesis, or hematochezia)
- esophageal or gastric varices confirmed endoscopically as the source of bleeding
Key exclusion criteria (3 listed)
- severe dysfunction of a major extrahepatic organ (e.g., heart failure, pulmonary disease, and terminal malignancy except hepatocellular carcinoma)
- history of endoscopic therapy for varices (ligation or sclerotherapy) within three months
- incomplete or missing data
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 |
|---|---|---|
| emergency endoscopic therapyWhen cirrhotic patients presented with AVB to the emergency department, emergency physicians consulted gastroenterologists on duty to assess the patient for suitability for endoscopy, usually after initial stabilization. Performance of endoscopy and its timing was at the discretion of the gastroenterologist on call. Therapeutic endoscopy for AVB was performed within 24 hours after consultation by an experienced attending endoscopist, using standard forward-viewing upper gastrointestinal video endoscopes at individual centers. Written informed consent for endoscopy was obtained before each procedure. The standard of care at all hospitals was to administer a vasoactive agent and antibiotics upon the patient's presentation. Packed red blood cells were transfused at the discretion of the attending gastroenterologist. | Device | early endoscopy group, urgent endoscopy group |
Primary outcome
the incidence of 5-day rebleeding after emergency endoscopy
Time frame: 6 months
3 secondary outcomes
the in-hospital mortality
Time frame: 6 months
need for ICU
Time frame: 6 months
the length of hospital stay
Time frame: 6 months
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 25 Apr 2023.
- Background: PubMed 29653741European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018 Aug;69(2):406-460. doi: 10.1016/j.jhep.2018.03.024. Epub 2018 Apr 10. No abstract available.
- Background: PubMed 32242355Lau JYW, Yu Y, Tang RSY, Chan HCH, Yip HC, Chan SM, Luk SWY, Wong SH, Lau LHS, Lui RN, Chan TT, Mak JWY, Chan FKL, Sung JJY. Timing of Endoscopy for Acute Upper Gastrointestinal Bleeding. N Engl J Med. 2020 Apr 2;382(14):1299-1308. doi: 10.1056/NEJMoa1912484.
- Background: PubMed 22885718Chen PH, Chen WC, Hou MC, Liu TT, Chang CJ, Liao WC, Su CW, Wang HM, Lin HC, Lee FY, Lee SD. Delayed endoscopy increases re-bleeding and mortality in patients with hematemesis and active esophageal variceal bleeding: a cohort study. J Hepatol. 2012 Dec;57(6):1207-13. doi: 10.1016/j.jhep.2012.07.038. Epub 2012 Aug 8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cirrhosis, Liver and Portal Hypertension, run by Hepatopancreatobiliary Surgery Institute of Gansu Province 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 3 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 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 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?
the incidence of 5-day rebleeding after emergency endoscopy (time frame: 6 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 NCT04957875, 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 25 Apr 2023.