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Early Diagnosis of Oxaliplatin-induced Portal Hypertension

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04524650
Enrollment
370
Registered
2020-08-24
Start date
2020-08-31
Completion date
2022-09-30
Last updated
2020-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Gastroesophageal Varices, Received Oxaliplatin-based Chemotherapy

Keywords

portal hypertension, splenomegaly, colorectal carcinoma, oxaliplatin, hepatotoxicity

Brief 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.

Interventions

DIAGNOSTIC_TESTthe level of vWF

the peripheral level of vWF

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the severity of portal hypertension1 day (the same time as diagnosis)High portal pressure

Countries

China

Contacts

Primary ContactXiaoquan HUANG
huang.xiaoquan@zs-hospital.sh.cn008618801733835

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026