TIPS for Platinum-Related Porto-Sinusoidal Vascular Disease With Variceal Bleeding

NCT06635122 | Active Not Recruiting

• 1 other identifier: KY20242274-C-1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Porto-Sinusoidal Vascular Disease; Cirrhosis Due to Hepatitis B; Esophageal Variceal Rebleeding; Gastric Variceal Bleeding

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (5)

• Cumulative incidence of death

  12 months

• Cumulative incidence of hepatic encephalopathy (HE)

  12 months

• Cumulative incidence of patients with other decompensation events

  12 months

• Cumulative incidence of liver function damage

  12 months

• Cumulative incidence of treatment related complications

  12 months

Study Arms (3)

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.

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

Procedure: Endoscopic treatment

Control Group: TIPS for Cirrhosis Due to Hepatitis B

This group of Cirrhosis Due to Hepatitis B patients received TIPS treatment.

Procedure: Transjugular intrahepatic portosystemic shunt

Interventions

Transjugular intrahepatic portosystemic shunt PROCEDURE

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.

Control Group: TIPS for Cirrhosis Due to Hepatitis B; Experimental group: TIPS for PSVD

Endoscopic treatment PROCEDURE

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.

Control group: Endoscopic therapy for PSVD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Idiopathic Noncirrhotic Portal Hypertension

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Hypertension, Portal; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Jun Tie, M.D.,Ph.D.

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of clinical research

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: October 10, 2024
• Study Start: July 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-08

Locations

CN (1)