Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635122
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-05
Brief Title:
TIPS for Platinum-Related Porto-Sinusoidal Vascular Disease With Variceal Bleeding
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Case-Control Study of Transjugular Intrahepatic Portosystemic Shunt in Treating Platinum-Related Porto-Sinusoidal Vascular Disease With Esophagogastric Variceal Bleeding
Status:
ACTIVE_NOT_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:
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
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
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 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