Liver CirrhosisNCT05515861
Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices
A study testing Endoscopic ultrasound in people with Liver Cirrhosis and Gastric Varix, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
The aim of this study is to explore whether using endoscopic ultrasound (EUS) to assess gastric varices (GV) and giving additional treatment according to the diameter and blood flow of residual after endoscopic cyanoacrylate injection for GV can reduce the rate of GV rebleeding, mortality, the risk of adverse events… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Gastric Varix, Portal Hypertension
- What is being tested?
- Endoscopic ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Sep 2022to Jun 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age≥18 years;
- cirrhosis diagnosis is based on liver biopsy, medical history, and physical, biochemical, or radiological findings;
- receive endoscopic cyanoacrylate injection for gastric varices for secondary prophylaxis for the first time;
- patients or a designated relative provide informed consent for the procedures.
Who cannot join
- with contraindications to endoscopic treatment;
- combined with malignant tumors, hepatic encephalopathy, hepatorenal syndrome, cavernous transformation of the portal vein or multiple organ failure; with spontaneous shunts that the diameter is large than 5 mm;
- previously received endoscopic treatment, interventional treatment or surgical surgery for GV, including transjugular intrahepatic portosystemic shunt (TIPS), balloon-occluded retrograde transvenous obliteration (BRTO), etc;
- pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Endoscopic Ultrasound in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices
The aim of this study is to explore whether using endoscopic ultrasound (EUS) to assess gastric varices (GV) and giving additional treatment according to the diameter and blood flow of residual after endoscopic cyanoacrylate injection for GV can reduce the rate of GV rebleeding, mortality, the risk of adverse events, and cost-effectiveness.
This study is a multicenter prospective, open-label, randomized controlled study, including 5 study centers: Renmin Hospital of Wuhan University, Beijing Friendship Hospital, Capital Medical University, The Southwest Hospital of Army Medical University, Affiliated Hospital of Zunyi Medical University and Shanxi Coal Center Hospital. The total sample size is 150 patients, with 75 patients in the EUS evaluation group and 75 patients in the control group, respectively.
Read more
The patients who meet the inclusion and exclusion criteria are randomly assigned to EUS evaluation group and control group by using block randomization. The EUS evaluation group uses EUS to observe the diameter and blood flow of residual variceal veins after endoscopic cyanoacrylate injection for GV to evaluate the embolization effect. Endoscopic cyanoacrylate injection is performed again if the diameter of variceal vein is larger than 5 mm and with blood flow signal. After the injection, the blood flow signal is confirmed disappear by EUS. The control group return to the ward after endoscopic cyanoacrylate injection, without EUS evaluation. During the study, the patients are followed up for at least 12 months, and they are requested to return to the hospital for follow-up at 1 month, 3 months, 6 months and 12 months after the treatment, respectively. The data of baseline, treatment, postoperative and follow-up of the two groups are need to collect.
The primary outcome of this study is rebleeding rate. Secondary outcomes are eradication rate of GV, mortality rate, retreatment, and cost-effectiveness.
Read the detailed description
Patients are considered eligible when they meet the following criteria: (1) age≥18 years; (2) cirrhosis diagnosis is based on liver biopsy, medical history, and physical, biochemical, or radiological findings; (3) receive endoscopic cyanoacrylate injection for GV for secondary prophylaxis for the first time; (4) patients or a designated relative provide informed consent for the procedures. Exclusion criteria are as follows: (1) with contraindications to endoscopic treatment; (2)combine with malignant tumors, hepatic encephalopathy, hepatorenal syndrome, cavernous transformation of the portal vein or multiple organ failure; (3) with spontaneous shunts that the diameter is large than 5 mm; (4)previously received endoscopic treatment, interventional treatment or surgical surgery for GV, including transjugular intrahepatic portosystemic shunt (TIPS), balloon-occluded retrograde transvenous obliteration (BRTO), etc; (5) pregnant.
- Conditions
- Liver Cirrhosis, Gastric Varix, Portal Hypertension
- Being tested
- Endoscopic ultrasound
- Keywords
- endoscopic ultrasound, gastric varices, rebleeding
- Medical subject headings
- Liver Cirrhosis, 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.
Endoscopic ultrasoundProcedure or surgery
Using endoscopic ultrasound (EUS) to observe the diameter and blood flow of residual variceal veins after endoscopic cyanoacrylate injection for gastric varices to evaluate the embolization effect. Endoscopic cyanoacrylate injection is performed again if the diameter of variceal vein is larger than 5 mm and with blood flow signal. After the injection, the blood flow signal is confirmed disappear by endoscopic ultrasound. Patients in the EUS group required endoscopic ultrasound assessment at each stage of the follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| EUS group | Experimental | The EUS group uses endoscopic ultrasound to observe the diameter and blood flow of residual variceal veins after endoscopic cyanoacrylate injection for gastric varices to evaluate the embolization effect. Receives: Procedure: Endoscopic ultrasound |
| Control group | No intervention | The control group doesn't perform endoscopic ultrasound after endoscopic cyanoacrylate injection for gastric varices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding
Rebleeding is defined as recurrent melena or hematemesis and is evaluated via endoscopy whenever possible.
Measured: 12 months
Secondary outcomes (4)
Mortality
Including all-cause mortality.
Measured: 12 months
The eradication rate of gastric varices
Eradication of the gastric varices is defined as absence of gastric varices on endoscopy or absence of blood flow of gastric varices on endoscopic ultrasound.
Measured: 12 months
Calculating the total cost of treatment
Cost-effectiveness
Measured: 12 months
number of treatment sessions
Cost-effectiveness
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Friendship Hospital, Southwest Hospital, China, Zunyi Medical College, Shanxi Coal Center Hospital
- Responsible party
- Principal investigator, ChenMingkai, Renmin Hospital of Wuhan University
- Investigators
- Mingkai Chen, Study director, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515861
- Sponsor's protocol ID
- WDRY2022-K042
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sarin SK, Lahoti D, Saxena SP, Murthy NS, Makwana UK. Prevalence, classification and natural history of gastric varices: a long-term follow-up study in 568 portal hypertension patients. Hepatology. 1992 Dec;16(6):1343-9. doi: 10.1002/hep.1840160607.
PubMed 1446890Kim T, Shijo H, Kokawa H, Tokumitsu H, Kubara K, Ota K, Akiyoshi N, Iida T, Yokoyama M, Okumura M. Risk factors for hemorrhage from gastric fundal varices. Hepatology. 1997 Feb;25(2):307-12. doi: 10.1053/jhep.1997.v25.pm0009021939.
PubMed 9021939Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
PubMed 27786365D'Amico G, Pagliaro L, Bosch J. The treatment of portal hypertension: a meta-analytic review. Hepatology. 1995 Jul;22(1):332-54. doi: 10.1002/hep.1840220145. No abstract available.
PubMed 7601427Kahana LM, Cole FM, Richardson H. Clinical aspects of atypical mycobacterial infection. Can Med Assoc J. 1975 Feb 8;112(3):321-4.
PubMed 1109749Bosch J, Garcia-Pagan JC. Prevention of variceal rebleeding. Lancet. 2003 Mar 15;361(9361):952-4. doi: 10.1016/S0140-6736(03)12778-X.
PubMed 12648985Rice JP, Lubner M, Taylor A, Spier BJ, Said A, Lucey MR, Musat A, Reichelderfer M, Pfau PR, Gopal DV. CT portography with gastric variceal volume measurements in the evaluation of endoscopic therapeutic efficacy of tissue adhesive injection into gastric varices: a pilot study. Dig Dis Sci. 2011 Aug;56(8):2466-72. doi: 10.1007/s10620-011-1616-z. Epub 2011 Feb 19.
PubMed 21336602Henry Z, Patel K, Patton H, Saad W. AGA Clinical Practice Update on Management of Bleeding Gastric Varices: Expert Review. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1098-1107.e1. doi: 10.1016/j.cgh.2021.01.027. Epub 2021 Jan 22.
PubMed 33493693Lee YT, Chan FK, Ng EK, Leung VK, Law KB, Yung MY, Chung SC, Sung JJ. EUS-guided injection of cyanoacrylate for bleeding gastric varices. Gastrointest Endosc. 2000 Aug;52(2):168-74. doi: 10.1067/mge.2000.107911.
PubMed 10922086Iwase H, Suga S, Morise K, Kuroiwa A, Yamaguchi T, Horiuchi Y. Color Doppler endoscopic ultrasonography for the evaluation of gastric varices and endoscopic obliteration with cyanoacrylate glue. Gastrointest Endosc. 1995 Feb;41(2):150-4. doi: 10.1016/s0016-5107(05)80599-1. No abstract available.
PubMed 7721004Rajoriya N, Forrest EH, Gray J, Stuart RC, Carter RC, McKay CJ, Gaya DR, Morris AJ, Stanley AJ. Long-term follow-up of endoscopic Histoacryl glue injection for the management of gastric variceal bleeding. QJM. 2011 Jan;104(1):41-7. doi: 10.1093/qjmed/hcq161. Epub 2010 Sep 25.
PubMed 20871126Lo GH, Liang HL, Chen WC, Chen MH, Lai KH, Hsu PI, Lin CK, Chan HH, Pan HB. A prospective, randomized controlled trial of transjugular intrahepatic portosystemic shunt versus cyanoacrylate injection in the prevention of gastric variceal rebleeding. Endoscopy. 2007 Aug;39(8):679-85. doi: 10.1055/s-2007-966591.
PubMed 17661241Lo GH, Lai KH, Cheng JS, Chen MH, Chiang HT. A prospective, randomized trial of butyl cyanoacrylate injection versus band ligation in the management of bleeding gastric varices. Hepatology. 2001 May;33(5):1060-4. doi: 10.1053/jhep.2001.24116.
PubMed 11343232Hung HH, Chang CJ, Hou MC, Liao WC, Chan CC, Huang HC, Lin HC, Lee FY, Lee SD. Efficacy of non-selective beta-blockers as adjunct to endoscopic prophylactic treatment for gastric variceal bleeding: a randomized controlled trial. J Hepatol. 2012 May;56(5):1025-1032. doi: 10.1016/j.jhep.2011.12.021. Epub 2012 Jan 17.
PubMed 22266602Huang YH, Yeh HZ, Chen GH, Chang CS, Wu CY, Poon SK, Lien HC, Yang SS. Endoscopic treatment of bleeding gastric varices by N-butyl-2-cyanoacrylate (Histoacryl) injection: long-term efficacy and safety. Gastrointest Endosc. 2000 Aug;52(2):160-7. doi: 10.1067/mge.2000.104976.
PubMed 10922085
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endoscopic Ultrasound in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices
- ClinicalTrials.gov ID
- NCT05515861
- Acronym / sponsor ID
- WDRY2022-K042
- Conditions
- Liver Cirrhosis, Gastric Varix, Portal Hypertension
- Keywords
- endoscopic ultrasound, gastric varices, rebleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Collaborators
- Beijing Friendship Hospital, Southwest Hospital, China, Zunyi Medical College, Shanxi Coal Center Hospital
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 25 Aug 2022 (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 this study is to explore whether using endoscopic ultrasound (EUS) to assess gastric varices (GV) and giving additional treatment according to the diameter and blood flow of residual after endoscopic cyanoacrylate injection for GV can reduce the rate of GV rebleeding, mortality, the risk of adverse events, and cost-effectiveness.
This study is a multicenter prospective, open-label, randomized controlled study, including 5 study centers: Renmin Hospital of Wuhan University, Beijing Friendship Hospital, Capital Medical University, The Southwest Hospital of Army Medical University, Affiliated Hospital of Zunyi Medical University and Shanxi Coal Center Hospital. The total sample size is 150 patients, with 75 patients in the EUS evaluation group and 75 patients in the control group, respectively.
The patients who meet the inclusion and exclusion criteria are randomly assigned to EUS evaluation group and control group by using block randomization. The EUS evaluation group uses EUS to observe the diameter and blood flow of residual variceal veins after endoscopic cyanoacrylate injection for GV to evaluate the embolization effect. Endoscopic cyanoacrylate injection is performed again if the diameter of variceal vein is larger than 5 mm and with blood flow signal. After the injection, the blood flow signal is confirmed disappear by EUS. The control group return to the ward after endoscopic cyanoacrylate injection, without EUS evaluation. During the study, the patients are followed up for at least 12 months, and they are requested to return to the hospital for follow-up at 1 month, 3 months, 6 months and 12 months after the treatment, respectively. The data of baseline, treatment, postoperative and follow-up of the two groups are need to collect.
The primary outcome of this study is rebleeding rate. Secondary outcomes are eradication rate of GV, mortality rate, retreatment, and cost-effectiveness.
Detailed description
Patients are considered eligible when they meet the following criteria: (1) age≥18 years; (2) cirrhosis diagnosis is based on liver biopsy, medical history, and physical, biochemical, or radiological findings; (3) receive endoscopic cyanoacrylate injection for GV for secondary prophylaxis for the first time; (4) patients or a designated relative provide informed consent for the procedures. Exclusion criteria are as follows: (1) with contraindications to endoscopic treatment; (2)combine with malignant tumors, hepatic encephalopathy, hepatorenal syndrome, cavernous transformation of the portal vein or multiple organ failure; (3) with spontaneous shunts that the diameter is large than 5 mm; (4)previously received endoscopic treatment, interventional treatment or surgical surgery for GV, including transjugular intrahepatic portosystemic shunt (TIPS), balloon-occluded retrograde transvenous obliteration (BRTO), etc; (5) pregnant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS group | Experimental | Procedure: Endoscopic ultrasoundThe EUS group uses endoscopic ultrasound to observe the diameter and blood flow of residual variceal veins after endoscopic cyanoacrylate injection for gastric varices to evaluate the embolization effect. |
| Control group | No intervention | –The control group doesn't perform endoscopic ultrasound after endoscopic cyanoacrylate injection for gastric varices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age≥18 years;
- cirrhosis diagnosis is based on liver biopsy, medical history, and physical, biochemical, or radiological findings;
- receive endoscopic cyanoacrylate injection for gastric varices for secondary prophylaxis for the first time;
- patients or a designated relative provide informed consent for the procedures.
Key exclusion criteria (4 listed)
- with contraindications to endoscopic treatment;
- combined with malignant tumors, hepatic encephalopathy, hepatorenal syndrome, cavernous transformation of the portal vein or multiple organ failure; with spontaneous shunts that the diameter is large than 5 mm;
- previously received endoscopic treatment, interventional treatment or surgical surgery for GV, including transjugular intrahepatic portosystemic shunt (TIPS), balloon-occluded retrograde transvenous obliteration (BRTO), etc;
- pregnant.
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 ultrasoundUsing endoscopic ultrasound (EUS) to observe the diameter and blood flow of residual variceal veins after endoscopic cyanoacrylate injection for gastric varices to evaluate the embolization effect. Endoscopic cyanoacrylate injection is performed again if the diameter of variceal vein is larger than 5 mm and with blood flow signal. After the injection, the blood flow signal is confirmed disappear by endoscopic ultrasound. Patients in the EUS group required endoscopic ultrasound assessment at each stage of the follow-up period. | Procedure or surgery | EUS group |
Primary outcome
Rebleeding
Time frame: 12 months
Rebleeding is defined as recurrent melena or hematemesis and is evaluated via endoscopy whenever possible.
4 secondary outcomes
Mortality
Time frame: 12 months
The eradication rate of gastric varices
Time frame: 12 months
Calculating the total cost of treatment
Time frame: 12 months
number of treatment sessions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Results publication: PubMed 1446890Sarin SK, Lahoti D, Saxena SP, Murthy NS, Makwana UK. Prevalence, classification and natural history of gastric varices: a long-term follow-up study in 568 portal hypertension patients. Hepatology. 1992 Dec;16(6):1343-9. doi: 10.1002/hep.1840160607.
- Results publication: PubMed 9021939Kim T, Shijo H, Kokawa H, Tokumitsu H, Kubara K, Ota K, Akiyoshi N, Iida T, Yokoyama M, Okumura M. Risk factors for hemorrhage from gastric fundal varices. Hepatology. 1997 Feb;25(2):307-12. doi: 10.1053/jhep.1997.v25.pm0009021939.
- Results publication: PubMed 27786365Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
- Results publication: PubMed 7601427D'Amico G, Pagliaro L, Bosch J. The treatment of portal hypertension: a meta-analytic review. Hepatology. 1995 Jul;22(1):332-54. doi: 10.1002/hep.1840220145. No abstract available.
- Results publication: PubMed 1109749Kahana LM, Cole FM, Richardson H. Clinical aspects of atypical mycobacterial infection. Can Med Assoc J. 1975 Feb 8;112(3):321-4.
- Results publication: PubMed 12648985Bosch J, Garcia-Pagan JC. Prevention of variceal rebleeding. Lancet. 2003 Mar 15;361(9361):952-4. doi: 10.1016/S0140-6736(03)12778-X.
- Results publication: PubMed 21336602Rice JP, Lubner M, Taylor A, Spier BJ, Said A, Lucey MR, Musat A, Reichelderfer M, Pfau PR, Gopal DV. CT portography with gastric variceal volume measurements in the evaluation of endoscopic therapeutic efficacy of tissue adhesive injection into gastric varices: a pilot study. Dig Dis Sci. 2011 Aug;56(8):2466-72. doi: 10.1007/s10620-011-1616-z. Epub 2011 Feb 19.
- Results publication: PubMed 33493693Henry Z, Patel K, Patton H, Saad W. AGA Clinical Practice Update on Management of Bleeding Gastric Varices: Expert Review. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1098-1107.e1. doi: 10.1016/j.cgh.2021.01.027. Epub 2021 Jan 22.
- Results publication: PubMed 10922086Lee YT, Chan FK, Ng EK, Leung VK, Law KB, Yung MY, Chung SC, Sung JJ. EUS-guided injection of cyanoacrylate for bleeding gastric varices. Gastrointest Endosc. 2000 Aug;52(2):168-74. doi: 10.1067/mge.2000.107911.
- Results publication: PubMed 7721004Iwase H, Suga S, Morise K, Kuroiwa A, Yamaguchi T, Horiuchi Y. Color Doppler endoscopic ultrasonography for the evaluation of gastric varices and endoscopic obliteration with cyanoacrylate glue. Gastrointest Endosc. 1995 Feb;41(2):150-4. doi: 10.1016/s0016-5107(05)80599-1. No abstract available.
- Results publication: PubMed 20871126Rajoriya N, Forrest EH, Gray J, Stuart RC, Carter RC, McKay CJ, Gaya DR, Morris AJ, Stanley AJ. Long-term follow-up of endoscopic Histoacryl glue injection for the management of gastric variceal bleeding. QJM. 2011 Jan;104(1):41-7. doi: 10.1093/qjmed/hcq161. Epub 2010 Sep 25.
- Results publication: PubMed 17661241Lo GH, Liang HL, Chen WC, Chen MH, Lai KH, Hsu PI, Lin CK, Chan HH, Pan HB. A prospective, randomized controlled trial of transjugular intrahepatic portosystemic shunt versus cyanoacrylate injection in the prevention of gastric variceal rebleeding. Endoscopy. 2007 Aug;39(8):679-85. doi: 10.1055/s-2007-966591.
- Individual participant dataSharing planned: Yes
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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.
Mingkai Chen study director
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound in people with Liver Cirrhosis and Gastric Varix, run by Renmin Hospital of Wuhan 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?
The sponsor lists 4 inclusion and 4 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 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingkai Chen (+8613720330580, kaimingchen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rebleeding (time frame: 12 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 NCT05515861, which also lists 16 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 Aug 2022.