Clinical trial NCT06635122: TIPS for Platinum-Related Porto-Sinusoidal Vascular Disease With Variceal Bleeding
Official title: Case-Control Study of Transjugular Intrahepatic Portosystemic Shunt in Treating Platinum-Related Porto-Sinusoidal Vascular Disease With Esophagogastric Variceal Bleeding
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Porto-Sinusoidal Vascular Disease
Cirrhosis Due to Hepatitis B
Esophageal Variceal Rebleeding
Gastric Variceal Bleeding
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
First posted: 2024-10-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cumulative incidence of clinically significant variceal rebleeding
timeFrame: 12 months
Secondary outcomes:
measure: Cumulative incidence of death
timeFrame: 12 months
measure: Cumulative incidence of hepatic encephalopathy (HE)
timeFrame: 12 months
measure: Cumulative incidence of patients with other decompensation events
timeFrame: 12 months
measure: Cumulative incidence of liver function damage
timeFrame: 12 months
measure: Cumulative incidence of treatment related complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Air Force Military Medical University
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Jun Tie, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: