Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589531
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-07
Brief Title:
Small Diameter TIPS in Patients with Severe Liver Atrophy and Variceal Bleeding
Sponsor:
None
Organization:
None
Study Overview
Official Title:
6 Mm Shunt Transjugular Intrahepatic Portosystemic Shunt in Patients with Severe Liver Atrophy and Variceal BleedingA Prospective Single-center Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Portal hypertension is the most common complication in patients with end-stage liver cirrhosis Portal hypertension-related complications such as variceal bleeding often lead to a poor prognosis Transjugular intrahepatic portosystemic shunt TIPS is an effective treatment strategy for managing portal hypertension-related variceal bleeding However the appropriate diameter of the covered stent during the TIPS procedure remains a subject of debate To date there is a lack of strong evidence regarding the most suitable covered stent diameter
In theory a shunt with a larger diameter can result in better stent patency but it can also lead to reduced liver function and a higher incidence of hepatic encephalopathy HE after the TIPS procedure Therefore the choice of covered stent diameter needs to consider the factors of shunt efficacy and postoperative liver function At present the diameters of TIPS-dedicated stents are typically either 8 or 10 mm Whether stents with these two diameters can meet all the requirements of TIPS procedures is currently unknown Different races cirrhosis etiologies and liver volumes may require different TIPS diameters For example in China most cases of liver cirrhosis are caused by hepatitis B resulting in the patient having a smaller liver volume Therefore in most Chinese studies the diameters of TIPS stents are mainly 8 mm Previous studies have shown that TIPS with an 8-mm covered stent has a shunt effect similar to that of a 10-mm covered stent however the incidence of postoperative HE is significantly reduced with an 8-mm stent 27 vs 4314 Nevertheless an 8-mm covered TIPS still has a high incidence of HE
The residual liver volume is small for patients with severe atrophic cirrhosis of the liver and whether this necessitates a covered TIPS with a smaller diameter requires further study However there is still no dedicated TIPS stent that is lt8 mm in diameter In this study we propose an innovative strategy for the creation of a 6-mm shunt to determine if it can achieve a shunt effect similar to that of an 8-mm covered TIPS and reduce the incidence of HE in patients with severe atrophic liver cirrhosis
In theory a shunt with a larger diameter can result in better stent patency but it can also lead to reduced liver function and a higher incidence of hepatic encephalopathy HE after the TIPS procedure Therefore the choice of covered stent diameter needs to consider the factors of shunt efficacy and postoperative liver function At present the diameters of TIPS-dedicated stents are typically either 8 or 10 mm Whether stents with these two diameters can meet all the requirements of TIPS procedures is currently unknown Different races cirrhosis etiologies and liver volumes may require different TIPS diameters For example in China most cases of liver cirrhosis are caused by hepatitis B resulting in the patient having a smaller liver volume Therefore in most Chinese studies the diameters of TIPS stents are mainly 8 mm Previous studies have shown that TIPS with an 8-mm covered stent has a shunt effect similar to that of a 10-mm covered stent however the incidence of postoperative HE is significantly reduced with an 8-mm stent 27 vs 4314 Nevertheless an 8-mm covered TIPS still has a high incidence of HE
The residual liver volume is small for patients with severe atrophic cirrhosis of the liver and whether this necessitates a covered TIPS with a smaller diameter requires further study However there is still no dedicated TIPS stent that is lt8 mm in diameter In this study we propose an innovative strategy for the creation of a 6-mm shunt to determine if it can achieve a shunt effect similar to that of an 8-mm covered TIPS and reduce the incidence of HE in patients with severe atrophic liver cirrhosis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None