Back to resultsOxaliplatin-induced Portal Hypertension
Primary Purpose
Gastroesophageal Varices Hemorrhage, Colorectal Cancer, Received Oxaliplatin-based Chemotherapy
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Individualized Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Varices Hemorrhage focused on measuring portal hypertension, gastroesophageal variceal bleeding, colorectal carcinoma, splenomegaly, oxaliplatin
Eligibility Criteria
Inclusion Criteria:
- Sign written informed consent
- Male or female patients aged 18-75
- diagnosed as portal hypertension by contrast-enhanced computed tomography
- and confirmed gastroesophageal varices by upper digestive endoscopy;
- had a history of oxaliplatin-based chemotherapy after 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
- Other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.
Sites / Locations
- Department of Gastroenterology and Hepatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Individualized Treatment Group
Arm Description
Outcomes
Primary Outcome Measures
1-year rebleeding rate
1-year rebleeding rate
Secondary Outcome Measures
1-year death rate
1-year death rate
Complications of portal hypertension
The occurrence of complications of portal hypertension including ascites, liver failure, et al.
Full Information
NCT ID
NCT04524676
First Posted
August 20, 2020
Last Updated
August 20, 2020
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04524676
Brief Title
Oxaliplatin-induced Portal Hypertension
Official Title
Construction and Evaluation of the Early Identification and Individualized Treatment for Oxaliplatin-induced Portal Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2020 (Anticipated)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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, we aim to evaluate the efficacy of individualized treatment in patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Varices Hemorrhage, Colorectal Cancer, Received Oxaliplatin-based Chemotherapy
Keywords
portal hypertension, gastroesophageal variceal bleeding, colorectal carcinoma, splenomegaly, oxaliplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Individualized Treatment Group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Individualized Treatment
Intervention Description
Patients under evaluation including hepatic venous pressure gradient (HVPG) and contrast-enhanced computed tomography of portal venous. For those patients with a HVPG ≥12mmHg or with extraluminal para-gastric vein will under transjugular intrahepatic portosystemic shunt and others receive endoscopic treatment.
Primary Outcome Measure Information:
Title
1-year rebleeding rate
Description
1-year rebleeding rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
1-year death rate
Description
1-year death rate
Time Frame
1 year
Title
Complications of portal hypertension
Description
The occurrence of complications of portal hypertension including ascites, liver failure, et al.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sign written informed consent
Male or female patients aged 18-75
diagnosed as portal hypertension by contrast-enhanced computed tomography
and confirmed gastroesophageal varices by upper digestive endoscopy;
had a history of oxaliplatin-based chemotherapy after 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
Other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.
Facility Information:
Facility Name
Department of Gastroenterology and Hepatology
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoquan HUANG
Phone
008618801733835
Email
huang.xiaoquan@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Shiyao CHEN
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32380558
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 Sep;52(9):727-735. doi: 10.1055/a-1157-8611. Epub 2020 May 7.
Results Reference
result
PubMed Identifier
17075116
Citation
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.
Results Reference
result
PubMed Identifier
28876454
Citation
Iwai T, Yamada T, Koizumi M, Shinji S, Yokoyama Y, Takahashi G, Takeda K, Hara K, Ohta K, Uchida E. Oxaliplatin-induced increase in splenic volume; irreversible change after adjuvant FOLFOX. J Surg Oncol. 2017 Dec;116(7):947-953. doi: 10.1002/jso.24756. Epub 2017 Sep 6.
Results Reference
result
PubMed Identifier
18779617
Citation
Ward J, Guthrie JA, Sheridan MB, Boyes S, Smith JT, Wilson D, Wyatt JI, Treanor D, Robinson PJ. Sinusoidal obstructive syndrome diagnosed with superparamagnetic iron oxide-enhanced magnetic resonance imaging in patients with chemotherapy-treated colorectal liver metastases. J Clin Oncol. 2008 Sep 10;26(26):4304-10. doi: 10.1200/JCO.2008.16.1893.
Results Reference
result
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Oxaliplatin-induced Portal Hypertension
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