Early Diagnosis of Oxaliplatin-induced Portal Hypertension

Colorectal Cancer Clinical Trial

Official title:

Construction and Evaluation of the Early Identification for Oxaliplatin Induced Portal Hypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04524650
• Other study ID #: PLAEGV-DIA
• Status: Not yet recruiting
• Start date: August 31, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Xiaoquan HUANG
• Phone: 008618801733835
• Email: huang.xiaoquan[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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, the investigators aim to evaluate the values of potential biomarkers in diagnosing patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 370
• Est. completion date: September 30, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female patients aged 18-75

• Had a history of oxaliplatin-based chemotherapy for the treatment of colorectal cancer surgery;

Exclusion Criteria:

• Combined known etiologies of chronic liver disease, including hepatitis, primary biliary cirrhosis, schistosomiasis, and non-alcoholic fatty liver disease.

• With colorectal cancer required further anti-tumor treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Gastroesophageal Varices
• Hypertension
• Hypertension, Portal
• Received Oxaliplatin-based Chemotherapy

Intervention

Diagnostic Test:
• the level of vWF
the peripheral level of vWF

Locations

Country	Name	City	State
China	Department of Gastroenterology and Hepatology	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Aloia T, Sebagh M, Plasse M, Karam V, Lévi F, Giacchetti S, Azoulay D, Bismuth H, Castaing D, Adam R. Liver histology and surgical outcomes after preoperative chemotherapy with fluorouracil plus oxaliplatin in colorectal cancer liver metastases. J Clin On — View Citation

Huang X, Li F, Wang L, Xiao M, Ni L, Jiang S, Ji Y, Zhang C, Zhang W, Wang J, Chen S. Endoscopic treatment of gastroesophageal variceal bleeding after oxaliplatin-based chemotherapy in patients with colorectal cancer. Endoscopy. 2020 May 7. doi: 10.1055/a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the severity of portal hypertension	High portal pressure	1 day (the same time as diagnosis)