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Hypertension, Portal

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Vascular Diseases

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Liver Diseases

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Oxaliplatin

Patients under evaluation including hepatic venous pressure gradient (HVPG) and contrast-enhanced computed tomography of portal venous. For those patients with a HVPG ≥12mmHg or with extraluminal para-gastric vein will under transjugular intrahepatic portosystemic shunt and others receive endoscopic treatment.

Individualized Treatment

Xiaoquan HUANG

Shiyao CHEN

Oxaliplatin has been used as the first choice for the adjuvant chemotherapy of colorectal cancer and it has significantly improved the outcomes in patients with colorectal cancer. However, hepatotoxicity is the potentially problematic adverse effect of oxaliplatin. The pathological evaluation of non-tumoral liver from patients with advanced colorectal cancer undergoing neoadjuvant oxaliplatin-based treatment has provided histological evidence of hepatic sinusoidal injury. Oxaliplatin-induced sinusoidal injury can persist for more than 1 year after the completion of chemotherapy, and the increase in splenic volume may be a predictor of irreversible sinusoidal damage. In this current study, we aim to evaluate the efficacy of individualized treatment in patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.

Oxaliplatin-induced Portal Hypertension

Construction and Evaluation of the Early Identification and Individualized Treatment for Oxaliplatin-induced Portal Hypertension

The occurrence of complications of portal hypertension including ascites, liver failure, et al.

Shanghai Zhongshan Hospital

Professor

Gastrointestinal Neoplasms

Digestive System Neoplasms

Patients in the endoscopic treatment group receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices.

Patients in the TIPS group receive transjugular intrahepatic portosystem stent-shunt.

Patients in the endoscopic treatment receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices

Endoscopic treatment

Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt

TIPS

Xiaoquan HUANG, M.D.

Liyuan NI

Shiyao CHENCHEN, M.D. & Ph.D

In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.

Oxaliplatin is used as the first-line chemotherapy for colorectal cancer. However, oxaliplatin-induced hepatotoxicity could lead to sinusoidal injury and portal hypertension in the long term. Variceal bleeding, as the most common complication of portal hypertension, threaten these patents' life. Endoscopic treatment and Transjugular Intrahepatic Portosystemic Shunt (TIPS) are both recommended management of gastroesophageal variceal bleeding. In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.

Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding

Endoscopic Treatment vs Transjugular Intrahepatic Portosystemic Shunt in the Management of Oxaliplatin Related Gastroesophageal Variceal Bleeding: A Multicenter, Randomized, Controlled Clinical Trial

Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours

Other complications of portal hypertension such as the progression of ascites, liver failure, etc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Oxaliplatin-induced Portal Hypertension	NCT04524676	Gastroesophagea... Colorectal Canc... Received Oxalip...	Individualized ...	18 Years - 75 Years	Shanghai Zhongshan Hospital
Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding	NCT05141617	Gastroesophagea... Gastrointestina... Received Oxalip...	Endoscopic trea... TIPS	18 Years - 75 Years	Shanghai Zhongshan Hospital

Spots Global Cancer Trial Database for gastroesophageal variceal bleeding