Clinical trial · Observational
Early Diagnosis of Oxaliplatin-induced Portal Hypertension
Construction and Evaluation of the Early Identification for Oxaliplatin Induced Portal Hypertension
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Varices | — | UNRESOLVED | — |
| Received Oxaliplatin-based Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| the level of vWF | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- stage 0
- description
- without liver function injury or splenomegaly
- interventionNames
- Diagnostic Test: the level of vWF
- label
- stage 1
- description
- occurrence of liver function injury (ALT or AST \> 2 ULN (upper limit of normal)
- interventionNames
- Diagnostic Test: the level of vWF
- label
- stage 2
- description
- occurrence of splenomegaly or reduced platelet count (\<150 X10\^9/L)
- interventionNames
- Diagnostic Test: the level of vWF
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTHuang 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. PMID 32380558
- RESULTAloia 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. PMID 17075116