Portal HypertensionNCT03783065
HVPG-guided Laparoscopic Versus Endoscopic Therapy for Variceal Rebleeding in Portal Hypertension: A Multicenter Randomized Controlled Trial (CHESS1803)
A study testing Propranolol, Laparoscopic splenectomy and pericardial devascularization and Endoscopic therapy in people with Portal Hypertension and Variceal Rebleeding, run by Nanfang Hospital, Southern Medical University at 4 sites in China.
Trial summary
The development of portal hypertension is a vital event in the natural progression of cirrhosis and is associated with severe complications including gastroesophageal varices bleeding. Cirrhotic patients with hemorrhagic shock and/or liver failure caused by variceal bleeding face a mortality of 5-20%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Portal Hypertension, Variceal Rebleeding
- What is being tested?
- Propranolol, Laparoscopic splenectomy and pericardial devascularization and Endoscopic therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesChina
- Study dates
- 2 Jan 2019to 28 Oct 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically and/or pathologically diagnosed cirrhosis with portal hypertension
- History of varicial bleeding without receiving endoscopic treatment
- HVPG values between 16-20 mmHg
- ECOG score ≤ 2 or KPS score ≥ 60 during screening
- Voluntarily participated in the study and able to provide written informed consent, understand and willing to comply with the requirements of the study
- Child-Pugh class A or B
Who cannot join
- Pregnant or breastfeeding women
- Prior known or suspected malignancy (hepatocellular carcinoma, cholangiocarcinoma etc.)
- Limited coagulation situation (Quick< 50%, PTT> 50 sec, thrombocyte count <50000 / μl or disturbed thrombocyte function)
- Massive ascites
- Child-Pugh class C
- Refuse or inadequate for HVPG measurement
- Other situations whose existence judged inadequate for participation by the investigators
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Not yet recruiting
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality
Zhiwei Li, MD
Zhiwei Li, MD
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu
Xun Li, M.D.
Xun Li, M.D.
- Not yet recruiting
Shunde Hospital, Southern Medical University
Shunde, Guangdong
Weidong Wang, MD
Weidong Wang, MD
- Recruiting
Xingtai People's Hospital
Xingtai, Hebei
Changzeng Zuo, MD
Changzeng Zuo, MD
About this study
The development of portal hypertension is a vital event in the natural progression of cirrhosis and is associated with severe complications including gastroesophageal varices bleeding. Cirrhotic patients with hemorrhagic shock and/or liver failure caused by variceal bleeding face a mortality of 5-20%.
Hepatic venous pressure gradient (HVPG) is the recommended golden standard for portal pressure assessment globally with favorable consistency and repeatability. Reducing the HVPG to levels of 12mmHg or below is associated with protection of variceal hemorrhage. An HVPG> 16mmHg indicates a higher risk of death and HVPG ≥ 20mmHg predicts failure to control bleeding, early rebleeding, and death during acute variceal hemorrhage.
Read more
The management of portal hypertension has showed a trend of diversification with the development of medication, endoscopy, radiological intervention and liver transplantation. Although medication and endoscopic therapy have achieved preferable effects and are recommended as standard of care for the prevention of variceal rebleeding, patients with HVPG≥ 16mmHg still have a high risk of treatment failure and a high rate of rebleeding. Recent years, early TIPS is recommended as the first-line therapy for the prevention of rebleeding in cirrhotic patients with HVPG≥ 20mmHg. However, for those with HVPG values between 16 to 20mmHg, there is still lack of strong evidence to demonstrate the best practice for the management.
With the rapid advancement of laparoscopic device and technique, the utility of laparoscopic splenectomy and pericardial devascularization showed less surgical trauma, bleeding and complications while retaining dependable effects compared to traditional open surgery, especially for portal hypertension with hypersplenism. In the study, the investigators aim to conduct a multicenter randomized controlled trial to compare the safety and effectiveness of HVPG-guided (16 to 20mmHg) laparoscopic versus endoscopic therapy for variceal rebleeding in patients with portal hypertension.
Read the detailed description
The development of portal hypertension is a vital event in the natural progression of cirrhosis and is associated with severe complications including gastroesophageal varices bleeding. Cirrhotic patients with hemorrhagic shock and/or liver failure caused by variceal bleeding face a mortality of 5-20%.
Hepatic venous pressure gradient (HVPG) is the recommended golden standard for portal pressure assessment globally with favorable consistency and repeatability. Reducing the HVPG to levels of 12mmHg or below is associated with protection of variceal hemorrhage. An HVPG> 16mmHg indicates a higher risk of death and HVPG ≥ 20mmHg predicts failure to control bleeding, early rebleeding, and death during acute variceal hemorrhage.
The management of portal hypertension has showed a trend of diversification with the development of medication, endoscopy, radiological intervention and liver transplantation. Although medication and endoscopic therapy have achieved preferable effects and are recommended as standard of care for the prevention of variceal rebleeding, patients with HVPG≥ 16mmHg still have a high risk of treatment failure and a high rate of rebleeding. Recent years, early TIPS is recommended as the first-line therapy for the prevention of rebleeding in cirrhotic patients with HVPG≥ 20mmHg. However, for those with HVPG values between 16 to 20mmHg, there is still lack of strong evidence to demonstrate the best practice for the management.
With the rapid advancement of laparoscopic device and technique, the utility of laparoscopic splenectomy and pericardial devascularization showed less surgical trauma, bleeding and complications while retaining dependable effects compared to traditional open surgery, especially for portal hypertension with hypersplenism. In the study, the investigators aim to conduct a multicenter (Shunde Hospital of Southern Medical University, Xingtai People's Hospital, The Fifth Medical Center of Chinese PLA General Hospital, The First Hospital of Lanzhou University) randomized controlled trial to compare the safety and effectiveness of HVPG-guided (16 to 20mmHg) laparoscopic versus endoscopic therapy for variceal rebleeding in patients with portal hypertension.
- Conditions
- Portal Hypertension, Variceal Rebleeding
- Being tested
- Propranolol, Laparoscopic splenectomy and pericardial devascularization, Endoscopic therapy
- Keywords
- Variceal Rebleeding, Hepatic venous pressure gradient, Laparoscopic Therapy, Endoscopic Therapy
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Propranolol was administrated orally while keeping monitoring heart rate and blood pressure daily.
Laparoscopic splenectomy and pericardial devascularizationProcedure or surgery
Including splenectomy and pericardial devascularizaion under laparoscopy
Endoscopic therapyProcedure or surgery
Either endoscopic variceal ligation (EVL) or cyanoacrylate injection was applied according to the condition of varices
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Procedure: Laparoscopic splenectomy and pericardial devascularization Drug: Propranolol Receives: Drug: Propranolol; Procedure: Laparoscopic splenectomy and pericardial devascularization |
| Control group | Active comparator | Procedure: Endoscopic therapy Drug: Propranolol Receives: Drug: Propranolol; Procedure: Endoscopic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variceal rebleeding
The occurrence rate of gastroesophageal varices rebleeding within 1-year follow-up
Measured: 1 year
Secondary outcomes (5)
Overall survival
The number of participants still alive 1 year after the therapy
Measured: 1 year
Hepatocellular carcinoma occurrence
The occurrence rate of hepatocellular carcinoma 1 year after the therapy
Measured: 1 year
Venous thrombosis
The occurrence rate of venous thrombosis upon each follow-up
Measured: 1 year
Quality of life score
The quality of life score measured using the 36-item Short Form Health Survey (SF-36) questionnaire upon each follow-up.
Measured: 1 year
Karnofsky score
The Karnofsky score categorized into low (score 10-40), intermediate (50-70), and high (80-100) upon each follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start2 Jan 2019
- Primary completion28 Oct 2019
- Study completion28 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Medical University, China, Xingtai People's Hospital, Beijing 302 Hospital, LanZhou University
- Responsible party
- Principal investigator, Xiaolong Qi, Nanfang Hospital, Southern Medical University
- Investigators
- Weidong Wang, MD, Principal investigator, Southern Medical University, ChinaChangzeng Zuo, MD, Principal investigator, Xingtai People's HospitalXun Li, MD, Principal investigator, LanZhou UniversityXiaolong Qi, MD, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783065
- Sponsor's protocol ID
- CHESS1803
- Status last verified
- Aug 2021
- First submitted
- 19 Dec 2018
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD data including age, gender, height, weight, ethnic, past history (including time of bleeding), dignosis, co-morbidity, medication, labortory test results (including blood routine, blood ammonia, clotting time, liver function and renal function), ultrasonic results (including spleen diameter, portal vein diameter, portal vein velocity, splenic vein velocity, etc.), transient elastography results (including liver and spleen stiffness), esophagogastroduodenoscopy results, Child-pugh score, QOL and KPS scores and time of all outcome events will be shared upon publication of this study.
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 25177367Garcia-Tsao G, Bosch J. Management of varices and variceal hemorrhage in cirrhosis. N Engl J Med. 2010 Mar 4;362(9):823-32. doi: 10.1056/NEJMra0901512. No abstract available.
PubMed 20200386Garcia-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 27786365de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
PubMed 26047908Bosch J, Abraldes JG, Berzigotti A, Garcia-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1.
PubMed 19724251Saad WE. Endovascular management of gastric varices. Clin Liver Dis. 2014 Nov;18(4):829-51. doi: 10.1016/j.cld.2014.07.005. Epub 2014 Oct 16.
PubMed 25438286de Souza AR, La Mura V, Reverter E, Seijo S, Berzigotti A, Ashkenazi E, Garcia-Pagan JC, Abraldes JG, Bosch J. Patients whose first episode of bleeding occurs while taking a beta-blocker have high long-term risks of rebleeding and death. Clin Gastroenterol Hepatol. 2012 Jun;10(6):670-6; quiz e58. doi: 10.1016/j.cgh.2012.02.011. Epub 2012 Feb 22.
PubMed 22366180Shao R, Li Z, Wang J, Qi R, Liu Q, Zhang W, Mao X, Song X, Li L, Liu Y, Zhao X, Liu C, Li X, Zuo C, Wang W, Qi X. Hepatic venous pressure gradient-guided laparoscopic splenectomy and pericardial devascularisation versus endoscopic therapy for secondary prophylaxis for variceal rebleeding in portal hypertension (CHESS1803): study protocol of a multicenter randomised controlled trial in China. BMJ Open. 2020 Jun 23;10(6):e030960. doi: 10.1136/bmjopen-2019-030960.
PubMed 32580978
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HVPG-guided Laparoscopic Versus Endoscopic Therapy for Variceal Rebleeding in Portal Hypertension: A Multicenter Randomized Controlled Trial (CHESS1803)
- ClinicalTrials.gov ID
- NCT03783065
- Acronym / sponsor ID
- CHESS1803
- Conditions
- Portal Hypertension, Variceal Rebleeding
- Keywords
- Variceal Rebleeding, Hepatic venous pressure gradient, Laparoscopic Therapy, Endoscopic Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Southern Medical University, China, Xingtai People's Hospital, Beijing 302 Hospital, LanZhou University
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Oct 2022 (estimated)
- First posted
- 20 Dec 2018 (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 development of portal hypertension is a vital event in the natural progression of cirrhosis and is associated with severe complications including gastroesophageal varices bleeding. Cirrhotic patients with hemorrhagic shock and/or liver failure caused by variceal bleeding face a mortality of 5-20%.
Hepatic venous pressure gradient (HVPG) is the recommended golden standard for portal pressure assessment globally with favorable consistency and repeatability. Reducing the HVPG to levels of 12mmHg or below is associated with protection of variceal hemorrhage. An HVPG> 16mmHg indicates a higher risk of death and HVPG ≥ 20mmHg predicts failure to control bleeding, early rebleeding, and death during acute variceal hemorrhage.
The management of portal hypertension has showed a trend of diversification with the development of medication, endoscopy, radiological intervention and liver transplantation. Although medication and endoscopic therapy have achieved preferable effects and are recommended as standard of care for the prevention of variceal rebleeding, patients with HVPG≥ 16mmHg still have a high risk of treatment failure and a high rate of rebleeding. Recent years, early TIPS is recommended as the first-line therapy for the prevention of rebleeding in cirrhotic patients with HVPG≥ 20mmHg. However, for those with HVPG values between 16 to 20mmHg, there is still lack of strong evidence to demonstrate the best practice for the management.
With the rapid advancement of laparoscopic device and technique, the utility of laparoscopic splenectomy and pericardial devascularization showed less surgical trauma, bleeding and complications while retaining dependable effects compared to traditional open surgery, especially for portal hypertension with hypersplenism. In the study, the investigators aim to conduct a multicenter randomized controlled trial to compare the safety and effectiveness of HVPG-guided (16 to 20mmHg) laparoscopic versus endoscopic therapy for variceal rebleeding in patients with portal hypertension.
Detailed description
The development of portal hypertension is a vital event in the natural progression of cirrhosis and is associated with severe complications including gastroesophageal varices bleeding. Cirrhotic patients with hemorrhagic shock and/or liver failure caused by variceal bleeding face a mortality of 5-20%.
Hepatic venous pressure gradient (HVPG) is the recommended golden standard for portal pressure assessment globally with favorable consistency and repeatability. Reducing the HVPG to levels of 12mmHg or below is associated with protection of variceal hemorrhage. An HVPG> 16mmHg indicates a higher risk of death and HVPG ≥ 20mmHg predicts failure to control bleeding, early rebleeding, and death during acute variceal hemorrhage.
The management of portal hypertension has showed a trend of diversification with the development of medication, endoscopy, radiological intervention and liver transplantation. Although medication and endoscopic therapy have achieved preferable effects and are recommended as standard of care for the prevention of variceal rebleeding, patients with HVPG≥ 16mmHg still have a high risk of treatment failure and a high rate of rebleeding. Recent years, early TIPS is recommended as the first-line therapy for the prevention of rebleeding in cirrhotic patients with HVPG≥ 20mmHg. However, for those with HVPG values between 16 to 20mmHg, there is still lack of strong evidence to demonstrate the best practice for the management.
With the rapid advancement of laparoscopic device and technique, the utility of laparoscopic splenectomy and pericardial devascularization showed less surgical trauma, bleeding and complications while retaining dependable effects compared to traditional open surgery, especially for portal hypertension with hypersplenism. In the study, the investigators aim to conduct a multicenter (Shunde Hospital of Southern Medical University, Xingtai People's Hospital, The Fifth Medical Center of Chinese PLA General Hospital, The First Hospital of Lanzhou University) randomized controlled trial to compare the safety and effectiveness of HVPG-guided (16 to 20mmHg) laparoscopic versus endoscopic therapy for variceal rebleeding in patients with portal hypertension.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Propranolol, Procedure: Laparoscopic splenectomy and pericardial devascularizationProcedure: Laparoscopic splenectomy and pericardial devascularization Drug: Propranolol |
| Control group | Active comparator | Drug: Propranolol, Procedure: Endoscopic therapyProcedure: Endoscopic therapy Drug: Propranolol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically and/or pathologically diagnosed cirrhosis with portal hypertension
- History of varicial bleeding without receiving endoscopic treatment
- HVPG values between 16-20 mmHg
- ECOG score ≤ 2 or KPS score ≥ 60 during screening
- Voluntarily participated in the study and able to provide written informed consent, understand and willing to comply with the requirements of the study
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding women
- Prior known or suspected malignancy (hepatocellular carcinoma, cholangiocarcinoma etc.)
- Limited coagulation situation (Quick< 50%, PTT> 50 sec, thrombocyte count <50000 / μl or disturbed thrombocyte function)
- Massive ascites
- Child-Pugh class C
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 |
|---|---|---|
| PropranololPropranolol was administrated orally while keeping monitoring heart rate and blood pressure daily. | Drug | Control group, Experimental group |
| Laparoscopic splenectomy and pericardial devascularizationIncluding splenectomy and pericardial devascularizaion under laparoscopy | Procedure or surgery | Experimental group |
| Endoscopic therapyEither endoscopic variceal ligation (EVL) or cyanoacrylate injection was applied according to the condition of varices | Procedure or surgery | Control group |
Primary outcome
Variceal rebleeding
Time frame: 1 year
The occurrence rate of gastroesophageal varices rebleeding within 1-year follow-up
5 secondary outcomes
Overall survival
Time frame: 1 year
Hepatocellular carcinoma occurrence
Time frame: 1 year
Venous thrombosis
Time frame: 1 year
Quality of life score
Time frame: 1 year
Karnofsky score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- 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 20200386Garcia-Tsao G, Bosch J. Management of varices and variceal hemorrhage in cirrhosis. N Engl J Med. 2010 Mar 4;362(9):823-32. doi: 10.1056/NEJMra0901512. No abstract available.
- Background: 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.
- Background: PubMed 26047908de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
- Background: PubMed 19724251Bosch J, Abraldes JG, Berzigotti A, Garcia-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1.
- Background: PubMed 25438286Saad WE. Endovascular management of gastric varices. Clin Liver Dis. 2014 Nov;18(4):829-51. doi: 10.1016/j.cld.2014.07.005. Epub 2014 Oct 16.
- Background: PubMed 22366180de Souza AR, La Mura V, Reverter E, Seijo S, Berzigotti A, Ashkenazi E, Garcia-Pagan JC, Abraldes JG, Bosch J. Patients whose first episode of bleeding occurs while taking a beta-blocker have high long-term risks of rebleeding and death. Clin Gastroenterol Hepatol. 2012 Jun;10(6):670-6; quiz e58. doi: 10.1016/j.cgh.2012.02.011. Epub 2012 Feb 22.
- Derived from this study: PubMed 32580978Shao R, Li Z, Wang J, Qi R, Liu Q, Zhang W, Mao X, Song X, Li L, Liu Y, Zhao X, Liu C, Li X, Zuo C, Wang W, Qi X. Hepatic venous pressure gradient-guided laparoscopic splenectomy and pericardial devascularisation versus endoscopic therapy for secondary prophylaxis for variceal rebleeding in portal hypertension (CHESS1803): study protocol of a multicenter randomised controlled trial in China. BMJ Open. 2020 Jun 23;10(6):e030960. doi: 10.1136/bmjopen-2019-030960.
- Individual participant dataSharing planned: Yes. IPD data including age, gender, height, weight, ethnic, past history (including time of bleeding), dignosis, co-morbidity, medication, labortory test results (including blood routine, blood ammonia, clotting time, liver function and renal function), ultrasonic results (including spleen diameter, portal vein diameter, portal vein velocity, splenic vein velocity, etc.), transient elastography results (including liver and spleen stiffness), esophagogastroduodenoscopy results, Child-pugh score, QOL and KPS scores and time of all outcome events will be shared upon publication of this study.
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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.
Weidong Wang, MD principal investigator
Southern Medical University, China
Changzeng Zuo, MD principal investigator
Xingtai People's Hospital
Xun Li, MD principal investigator
LanZhou University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propranolol, Laparoscopic splenectomy and pericardial devascularization and Endoscopic therapy in people with Portal Hypertension and Variceal Rebleeding, run by Nanfang Hospital, Southern Medical University at 4 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 6 inclusion and 7 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 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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, MD (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?
Variceal rebleeding (time frame: 1 year). 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 NCT03783065, which also lists 9 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 17 Aug 2021.