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Two-dimensional Shear-Wave Elastography Evaluate Esophageal Varices Bleeding Risk of Liver Cirrhosis
| Condition or disease | Intervention/treatment |
|---|---|
| Liver Cirrhosis Esophageal Varices Liver Stiffness | Diagnostic Test: Gastroscopy |
Variceal bleeding is a fatal complication in patients with liver cirrhosis. A screening esophagogastroduodenoscopy (EGD) is recommended in all patients with cirrhosis to identify those patients at risk of variceal bleeding. However, this technique is invasive, uncomfortable and costly. Moreover, with the development of noninvasive technology for early diagnosis of liver cirrhosis, half of these patients will not develop varices within 10 years and therefore will undergo unnecessary EGD screening. Thus, the need for noninvasive screening methods for varices in patients with cirrhosis is urgent.
2D-SWE is a promising new type of shear wave-based ultrasound technique for measuring LS. The shear waves are generated directly within the tissue by acoustic radiation force impulse, allowing the measurement of stiffness in patients with ascites. In addition, the LS values can be obtained on the basis of anatomic information to avoid major vessels and control major measurement bias. 2D-SWE has been reported to have high reliability and reproducibility in assessing liver stiffness. Several studies compared TE with 2D-SWE in predicting fibrosis stages and portal hypertension, which suggested that 2D-SWE has a higher technical success rate and a better diagnostic value for portal hypertension than TE.The purpose of this retrospective study was to investigate the diagnostic performance of 2D-SWE for predicting the presence of esophageal varices and high-risk varices in patients with liver cirrhosis.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 3 Years |
| Official Title: | West China Hospital, Sichuan University |
| Actual Study Start Date : | September 1, 2016 |
| Estimated Primary Completion Date : | September 1, 2022 |
| Estimated Study Completion Date : | September 1, 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Cirrhosis patients
Patients were diagnosed by liver biopsy, CT or ultrasound
|
Diagnostic Test: Gastroscopy
Gastroscopy
|
- Liver Stiffness [ Time Frame: 1 day (At 2D-SWE scanning time) ]Liver stiffness assessed by 2D-SWE
- Varices stage [ Time Frame: 1 day (At gastroscopy performed time) ]Gastroscopy was used to assess varices stage
| Ages Eligible for Study: | 16 Years to 80 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Cirrhosis were diagnosed by liver biopsy, CT and ultrasound before enrolled
- Age was 16-80
Exclusion Criteria:
- With bleeding history
- With EVL history, BRTO or TIPS history
- With NSBB history
- With ascites
- With splenectomy or splenic embolism, history
- With liver cancer
| Contact: Yuling Yan, Phd | +86 13648056747 | yuling.yan@scu.edu.cn |
| China, Sichuan | |
| West China Hospital of Sichuan Univerisity | Recruiting |
| Chengdu, Sichuan, China | |
| Contact: Yuling Yan, PhD +86 13648056747 | |
| Principal Investigator: | Xuefeng Luo | West China Hospital of Sicuan Univerisity |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 16, 2019 | ||||
| First Posted Date | June 18, 2019 | ||||
| Last Update Posted Date | June 18, 2019 | ||||
| Actual Study Start Date | September 1, 2016 | ||||
| Estimated Primary Completion Date | September 1, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Two-dimensional Shear-Wave Elastography Evaluate Esophageal Varices Bleeding Risk of Liver Cirrhosis | ||||
| Official Title | West China Hospital, Sichuan University | ||||
| Brief Summary | The purpose of this retrospective study was to investigate the diagnostic performance of 2D-SWE for predicting the presence of esophageal varices and high-risk varices in patients with liver cirrhosis. | ||||
| Detailed Description |
Variceal bleeding is a fatal complication in patients with liver cirrhosis. A screening esophagogastroduodenoscopy (EGD) is recommended in all patients with cirrhosis to identify those patients at risk of variceal bleeding. However, this technique is invasive, uncomfortable and costly. Moreover, with the development of noninvasive technology for early diagnosis of liver cirrhosis, half of these patients will not develop varices within 10 years and therefore will undergo unnecessary EGD screening. Thus, the need for noninvasive screening methods for varices in patients with cirrhosis is urgent. 2D-SWE is a promising new type of shear wave-based ultrasound technique for measuring LS. The shear waves are generated directly within the tissue by acoustic radiation force impulse, allowing the measurement of stiffness in patients with ascites. In addition, the LS values can be obtained on the basis of anatomic information to avoid major vessels and control major measurement bias. 2D-SWE has been reported to have high reliability and reproducibility in assessing liver stiffness. Several studies compared TE with 2D-SWE in predicting fibrosis stages and portal hypertension, which suggested that 2D-SWE has a higher technical success rate and a better diagnostic value for portal hypertension than TE.The purpose of this retrospective study was to investigate the diagnostic performance of 2D-SWE for predicting the presence of esophageal varices and high-risk varices in patients with liver cirrhosis. |
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| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | 3 Years | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | compensated cirrhosis | ||||
| Condition |
|
||||
| Intervention | Diagnostic Test: Gastroscopy
Gastroscopy
|
||||
| Study Groups/Cohorts | Cirrhosis patients
Patients were diagnosed by liver biopsy, CT or ultrasound
Intervention: Diagnostic Test: Gastroscopy
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
500 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | September 1, 2023 | ||||
| Estimated Primary Completion Date | September 1, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 16 Years to 80 Years (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03989973 | ||||
| Other Study ID Numbers | 2D-SWE evaluate varices | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | luo xuefeng, West China Hospital | ||||
| Study Sponsor | West China Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | West China Hospital | ||||
| Verification Date | June 2019 | ||||
