Early Diagnosis of Oxaliplatin-induced Portal Hypertension

NCT ID: NCT04524650

Last Updated: 2020-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

370 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-31

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Varices Colorectal Cancer Received Oxaliplatin-based Chemotherapy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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stage 0

without liver function injury or splenomegaly

the level of vWF

Intervention Type DIAGNOSTIC_TEST

the peripheral level of vWF

stage 1

occurrence of liver function injury (ALT or AST \> 2 ULN (upper limit of normal)

the level of vWF

Intervention Type DIAGNOSTIC_TEST

the peripheral level of vWF

stage 2

occurrence of splenomegaly or reduced platelet count (\<150 X10\^9/L)

the level of vWF

Intervention Type DIAGNOSTIC_TEST

the peripheral level of vWF

stage 3

occurrence of portal hypertension and/or gastroesophageal varices

the level of vWF

Intervention Type DIAGNOSTIC_TEST

the peripheral level of vWF

Interventions

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the level of vWF

the peripheral level of vWF

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shiyao Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Gastroenterology and Hepatology

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Xiaoquan HUANG

Role: CONTACT

008618801733835

References

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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.

Reference Type RESULT
PMID: 32380558 (View on PubMed)

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.

Reference Type RESULT
PMID: 17075116 (View on PubMed)

Other Identifiers

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PLAEGV-DIA

Identifier Type: -

Identifier Source: org_study_id

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