Porto-Sinusoidal Vascular DiseaseNCT06635122
TIPS for Platinum-Related Porto-Sinusoidal Vascular Disease With Variceal Bleeding
An observational study of Porto-Sinusoidal Vascular Disease and Cirrhosis Due to Hepatitis B, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Platinum-based compounds are associated with several adverse effects, including Porto-Sinusoidal Vascular Disease (PSVD). Therapeutic strategies for platinum-related PSVD are based on the management of complications seen in cirrhotic portal hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Porto-Sinusoidal Vascular Disease, Cirrhosis Due to Hepatitis B, Esophageal Variceal Rebleeding
- What is being tested?
- Transjugular intrahepatic portosystemic shunt and Endoscopic treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Oct 2025
- 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: Patients confirmed diagnosis of Platinum-Related Porto-Sinusoidal Vascular Disease or Cirrhosis Due to Hepatitis B in Xijing Hospital and Shanghai Zhongshan Hospital during Jan 2010 to Jun 2024
Who may be able to join
- Patients aged 18 to 75 years and confirmed diagnosis of Platinum-Related Porto-Sinusoidal Vascular Disease or Cirrhosis Due to Hepatitis B
- Acute esophagogastric variceal bleeding or history of gastroesophageal variceal bleeding episodes
- The patients was received endoscopic variceal ligation/histoacryl injection therapy or TIPS treatment
- At least one postoperative follow-up data
Who cannot join
- Primary tumor recurrence and metastasis
- Hepatocellular carcinoma or other malignant tumors
- Common contraindications of TIPS
- HIV, AIDS, Serious acute and chronic disease
- Pregnant or breast-feeding woman
- Without postoperative follow-up data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case-Control Study of Transjugular Intrahepatic Portosystemic Shunt in Treating Platinum-Related Porto-Sinusoidal Vascular Disease With Esophagogastric Variceal Bleeding
Platinum-based compounds are associated with several adverse effects, including Porto-Sinusoidal Vascular Disease (PSVD). Therapeutic strategies for platinum-related PSVD are based on the management of complications seen in cirrhotic portal hypertension. Currently, a combination of non-selective beta-blockers (NSBB) and endoscopic therapies, such as endoscopic band ligation and endoscopic cyanoacrylate injection, is recommended as the primary approach for the secondary prevention of variceal rebleeding, with Transjugular Intrahepatic Portosystemic Shunt (TIPS) reserved for cases in which first-line treatments fail.
However, previous research indicates that endoscopic treatments for the secondary prevention of esophagogastric variceal bleeding show suboptimal efficacy in PSVD patients. In contrast, TIPS has demonstrated comparable rebleeding control but with a lower incidence of liver-related complications and reduced mortality in PSVD patients compared to cirrhotic patients with similar liver function. Based on these findings, the investigators hypothesize that TIPS may be a safer option for this cohort, offering lower rebleeding rates than endoscopic therapy, reduced incidences of hepatic encephalopathy and liver insufficiency, and improved survival rates compared to patients with cirrhosis.
Read the detailed description
Platinum-based compounds are widely employed in chemotherapy regimens, yet they are associated with a range of adverse effects, most notably Porto-Sinusoidal Vascular Disease (PSVD). PSVD can trigger portal hypertensive complications, including esophagogastric varices and ascites.
Platinum-related PSVD constitutes a variant of intrahepatic presinusoidal portal hypertension, manifesting clinical symptoms analogous to those of liver cirrhosis. There is a scarcity of clinical data pertaining to these patients, and therapeutic strategies should be extrapolated from the management of complications associated with cirrhotic portal hypertension. Presently, the combination of non-selective beta-blockers (NSBB) with endoscopic therapies is advocated as the primary therapeutic modality for the secondary prevention of variceal bleeding, with transjugular intrahepatic portosystemic shunt (TIPS) being employed subsequent to the failure of firstline treatments.
A study by Shanghai Zhongshan Hospital revealed that patients with gastroesophageal variceal bleeding following oxaliplatin-based chemotherapy required more frequent endoscopic treatments to prevent rebleeding compared to those with cirrhosis, and exhibited higher rates of rebleeding and mortality. This suggests the suboptimal efficacy of endoscopic treatments for secondary prevention in this patient population. Additionally, findings from a retrospective study conducted by our institution demonstrated that PSVD patients treated with TIPS for variceal bleeding achieved rebleeding control comparable to cirrhotic patients with similar liver function. However, PSVD patients experienced a lower incidence of liver-related complications, such as overt hepatic encephalopathy and hepatic insufficiency, along with a reduced mortality rate.
Therefore, it is postulated that patients with platinum-related PSVD and esophagogastric varices may experience a lower rebleeding rate following TIPS intervention compared to those receiving endoscopic treatment, without an increased risk of hepatic encephalopathy. TIPS may present a safer treatment option for this cohort, with a reduced incidence of hepatic encephalopathy and liver insufficiency, and improved survival rates compared to patients with cirrhosis.
- Conditions
- Porto-Sinusoidal Vascular Disease, Cirrhosis Due to Hepatitis B, Esophageal Variceal Rebleeding, Gastric Variceal Bleeding
- Being tested
- Transjugular intrahepatic portosystemic shunt, Endoscopic treatment
- Medical subject headings
- Idiopathic Noncirrhotic Portal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transjugular intrahepatic portosystemic shuntProcedure or surgery
Transjugular intrahepatic portosystemic shunt (TIPS) is a procedure that uses imaging guidance to connect the portal vein to the hepatic vein in the liver. The TIPS-dedicated stent (Gore, Arizona, USA)was emplaced within the liver and gradually expanded utilizing a balloon with a diameter ranging from 6 to 10 millimeters, aiming for a decrease in portal-venous pressure gradient to less than 12 mmHg or achieve a reduction of 25 to 50% relative to the baseline pressure.
Endoscopic treatmentProcedure or surgery
Endoscopic variceal ligation, endoscopic injection sclerotherapy, endoscopic variceal histoacryl injection therapy , or a combination of several methods were selected according to the location, size, and shape of the patient's varicose veins.Treatment failure can be transferred to TIPS therapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: TIPS for PSVD | This group of PSVD patients received TIPS treatment.TIPS is an artificial channel within the liver that establishes communication between the inflow portal vein and the outflow hepatic vein. Receives: Procedure: Transjugular intrahepatic portosystemic shunt | |
| Control group: Endoscopic therapy for PSVD | This group of PSVD patients received endoscopic treatment.Endoscopic treatment includes endoscopic variceal ligation, endoscopic injection sclerotherapy and endoscopic variceal histoacryl injection therapy Receives: Procedure: Endoscopic treatment | |
| Control Group: TIPS for Cirrhosis Due to Hepatitis B | This group of Cirrhosis Due to Hepatitis B patients received TIPS treatment. Receives: Procedure: Transjugular intrahepatic portosystemic shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of clinically significant variceal rebleeding
Recurrent melena or hematemesis resulting in either hospital admission, blood transfusion, drop in hemoglobin of at least 3 g/L, or death within 6 weeks after rebleeding.
Measured: 12 months
Secondary outcomes (5)
Cumulative incidence of death
all cause mortality
Measured: 12 months
Cumulative incidence of hepatic encephalopathy (HE)
HE is classified as covert HE and overt HE
Measured: 12 months
Cumulative incidence of patients with other decompensation events
Decompensation was defined as hepatic ascites, abdominal ascites jaundice and infection
Measured: 12 months
Cumulative incidence of liver function damage
Measured: 12 months
Cumulative incidence of treatment related complications
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 posted10 Oct 2024
- Study start1 Jul 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Porto-Sinusoidal Vascular DiseaseStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Principal investigator, Tie Jun, Air Force Military Medical University, China
- Investigators
- Jun Tie, M.D.,Ph.D., Principal investigator, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635122
- Sponsor's protocol ID
- KY20242274-C-1
- Status last verified
- Aug 2024
- First submitted
- 5 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-Control Study of Transjugular Intrahepatic Portosystemic Shunt in Treating Platinum-Related Porto-Sinusoidal Vascular Disease With Esophagogastric Variceal Bleeding
- ClinicalTrials.gov ID
- NCT06635122
- Acronym / sponsor ID
- KY20242274-C-1
- Conditions
- Porto-Sinusoidal Vascular Disease, Cirrhosis Due to Hepatitis B, Esophageal Variceal Rebleeding, Gastric Variceal Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 10 Oct 2024 (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.
Platinum-based compounds are associated with several adverse effects, including Porto-Sinusoidal Vascular Disease (PSVD). Therapeutic strategies for platinum-related PSVD are based on the management of complications seen in cirrhotic portal hypertension. Currently, a combination of non-selective beta-blockers (NSBB) and endoscopic therapies, such as endoscopic band ligation and endoscopic cyanoacrylate injection, is recommended as the primary approach for the secondary prevention of variceal rebleeding, with Transjugular Intrahepatic Portosystemic Shunt (TIPS) reserved for cases in which first-line treatments fail.
However, previous research indicates that endoscopic treatments for the secondary prevention of esophagogastric variceal bleeding show suboptimal efficacy in PSVD patients. In contrast, TIPS has demonstrated comparable rebleeding control but with a lower incidence of liver-related complications and reduced mortality in PSVD patients compared to cirrhotic patients with similar liver function. Based on these findings, the investigators hypothesize that TIPS may be a safer option for this cohort, offering lower rebleeding rates than endoscopic therapy, reduced incidences of hepatic encephalopathy and liver insufficiency, and improved survival rates compared to patients with cirrhosis.
Detailed description
Platinum-based compounds are widely employed in chemotherapy regimens, yet they are associated with a range of adverse effects, most notably Porto-Sinusoidal Vascular Disease (PSVD). PSVD can trigger portal hypertensive complications, including esophagogastric varices and ascites.
Platinum-related PSVD constitutes a variant of intrahepatic presinusoidal portal hypertension, manifesting clinical symptoms analogous to those of liver cirrhosis. There is a scarcity of clinical data pertaining to these patients, and therapeutic strategies should be extrapolated from the management of complications associated with cirrhotic portal hypertension. Presently, the combination of non-selective beta-blockers (NSBB) with endoscopic therapies is advocated as the primary therapeutic modality for the secondary prevention of variceal bleeding, with transjugular intrahepatic portosystemic shunt (TIPS) being employed subsequent to the failure of firstline treatments.
A study by Shanghai Zhongshan Hospital revealed that patients with gastroesophageal variceal bleeding following oxaliplatin-based chemotherapy required more frequent endoscopic treatments to prevent rebleeding compared to those with cirrhosis, and exhibited higher rates of rebleeding and mortality. This suggests the suboptimal efficacy of endoscopic treatments for secondary prevention in this patient population. Additionally, findings from a retrospective study conducted by our institution demonstrated that PSVD patients treated with TIPS for variceal bleeding achieved rebleeding control comparable to cirrhotic patients with similar liver function. However, PSVD patients experienced a lower incidence of liver-related complications, such as overt hepatic encephalopathy and hepatic insufficiency, along with a reduced mortality rate.
Therefore, it is postulated that patients with platinum-related PSVD and esophagogastric varices may experience a lower rebleeding rate following TIPS intervention compared to those receiving endoscopic treatment, without an increased risk of hepatic encephalopathy. TIPS may present a safer treatment option for this cohort, with a reduced incidence of hepatic encephalopathy and liver insufficiency, and improved survival rates compared to patients with cirrhosis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group: TIPS for PSVD | – | Procedure: Transjugular intrahepatic portosystemic shuntThis group of PSVD patients received TIPS treatment.TIPS is an artificial channel within the liver that establishes communication between the inflow portal vein and the outflow hepatic vein. |
| Control group: Endoscopic therapy for PSVD | – | Procedure: Endoscopic treatmentThis group of PSVD patients received endoscopic treatment.Endoscopic treatment includes endoscopic variceal ligation, endoscopic injection sclerotherapy and endoscopic variceal histoacryl injection therapy |
| Control Group: TIPS for Cirrhosis Due to Hepatitis B | – | Procedure: Transjugular intrahepatic portosystemic shuntThis group of Cirrhosis Due to Hepatitis B patients received TIPS treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients confirmed diagnosis of Platinum-Related Porto-Sinusoidal Vascular Disease or Cirrhosis Due to Hepatitis B in Xijing Hospital and Shanghai Zhongshan Hospital during Jan 2010 to Jun 2024
Key inclusion criteria (4 listed)
- Patients aged 18 to 75 years and confirmed diagnosis of Platinum-Related Porto-Sinusoidal Vascular Disease or Cirrhosis Due to Hepatitis B
- Acute esophagogastric variceal bleeding or history of gastroesophageal variceal bleeding episodes
- The patients was received endoscopic variceal ligation/histoacryl injection therapy or TIPS treatment
- At least one postoperative follow-up data
Key exclusion criteria (6 listed)
- Primary tumor recurrence and metastasis
- Hepatocellular carcinoma or other malignant tumors
- Common contraindications of TIPS
- HIV, AIDS, Serious acute and chronic disease
- Pregnant or breast-feeding woman
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 |
|---|---|---|
| Transjugular intrahepatic portosystemic shuntTransjugular intrahepatic portosystemic shunt (TIPS) is a procedure that uses imaging guidance to connect the portal vein to the hepatic vein in the liver. The TIPS-dedicated stent (Gore, Arizona, USA)was emplaced within the liver and gradually expanded utilizing a balloon with a diameter ranging from 6 to 10 millimeters, aiming for a decrease in portal-venous pressure gradient to less than 12 mmHg or achieve a reduction of 25 to 50% relative to the baseline pressure. | Procedure or surgery | Control Group: TIPS for Cirrhosis Due to Hepatitis B, Experimental group: TIPS for PSVD |
| Endoscopic treatmentEndoscopic variceal ligation, endoscopic injection sclerotherapy, endoscopic variceal histoacryl injection therapy , or a combination of several methods were selected according to the location, size, and shape of the patient's varicose veins.Treatment failure can be transferred to TIPS therapy. | Procedure or surgery | Control group: Endoscopic therapy for PSVD |
Primary outcome
Cumulative incidence of clinically significant variceal rebleeding
Time frame: 12 months
Recurrent melena or hematemesis resulting in either hospital admission, blood transfusion, drop in hemoglobin of at least 3 g/L, or death within 6 weeks after rebleeding.
5 secondary outcomes
Cumulative incidence of death
Time frame: 12 months
Cumulative incidence of hepatic encephalopathy (HE)
Time frame: 12 months
Cumulative incidence of patients with other decompensation events
Time frame: 12 months
Cumulative incidence of liver function damage
Time frame: 12 months
Cumulative incidence of treatment related complications
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 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Porto-Sinusoidal Vascular Disease
Not yet recruitingObservational study
Study on Clinicopathological Features, Influencing Factors and Clinical Outcomes in Patients With PSVD
Porto-Sinusoidal Vascular Diseases
Not yet recruiting
Multiparametric Ultrasound for the Noninvasive Diagnosis of Porto-sinusoidal Vascular Liver Disorder
Porto-sinusoidal Vascular Liver Disorder, Liver Cirrhosis
RecruitingObservational study
TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
TIPS, Portal Hypertension
RecruitingObservational study
Non-invasive Tools for PSVD Diagnosis
Non-Cirrhotic Portal Hypertension, Porto-Sinusoidal Vascular Diseases
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.
Jun Tie, M.D.,Ph.D. principal investigator
Air Force Military Medical University, China
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 Porto-Sinusoidal Vascular Disease and Cirrhosis Due to Hepatitis B, run by Air Force Military Medical University, China 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 6 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 15 Oct 2024. 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?
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?
Cumulative incidence of clinically significant variceal 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?
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 15 Oct 2024.