Early Diagnosis of Oxaliplatin-induced Portal Hypertension

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Gastroesophageal Varices; Received Oxaliplatin-based Chemotherapy
• Intervention / Treatment: Diagnostic test: the level of vWF

• Study Type: Observational
• Enrollment (Anticipated): 370

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Department of gastroenterology and hepatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who had a history of colorectal cancer and received oxaliplatin-based chemotherapy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
stage 0; without liver function injury or splenomegaly	Diagnostic test: the level of vWF; the peripheral level of vWF
stage 1; occurrence of liver function injury (ALT or AST > 2 ULN (upper limit of normal)	Diagnostic test: the level of vWF; the peripheral level of vWF
stage 2; occurrence of splenomegaly or reduced platelet count (<150 X10^9/L)	Diagnostic test: the level of vWF; the peripheral level of vWF
stage 3; occurrence of portal hypertension and/or gastroesophageal varices	Diagnostic test: the level of vWF; the peripheral level of vWF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the severity of portal hypertension	High portal pressure	1 day (the same time as diagnosis)

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Publications and helpful links

General Publications

• 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 Sep;52(9):727-735. doi: 10.1055/a-1157-8611. Epub 2020 May 7.
• Aloia T, Sebagh M, Plasse M, Karam V, Levi 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 Oncol. 2006 Nov 1;24(31):4983-90. doi: 10.1200/JCO.2006.05.8156.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 31, 2020
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: oxaliplatin; portal hypertension; splenomegaly; hepatotoxicity; colorectal carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Hypertension; Hypertension, Portal
• Other Study ID Numbers: PLAEGV-DIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No