Gastroesophageal Varices HemorrhageNCT04524676
Oxaliplatin-induced Portal Hypertension
A study testing Individualized Treatment in people with Gastroesophageal Varices Hemorrhage and Colorectal Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Varices Hemorrhage, Colorectal Cancer, Received Oxaliplatin-based Chemotherapy
- What is being tested?
- Individualized Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology and Hepatology
Shanghai, Shanghai Municipality, 200032
Xiaoquan HUANG, 008618801733835, huang.xiaoquan@zs-hospital.sh.cn
Shiyao CHEN
About this study
Official title: Construction and Evaluation of the Early Identification and Individualized Treatment 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, we aim to evaluate the efficacy of individualized treatment in patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.
- Conditions
- Gastroesophageal Varices Hemorrhage, Colorectal Cancer, Received Oxaliplatin-based Chemotherapy
- Being tested
- Individualized Treatment
- Keywords
- portal hypertension, gastroesophageal variceal bleeding, colorectal carcinoma, splenomegaly, oxaliplatin
- Medical subject headings
- Colorectal Neoplasms, Hypertension, Portal, Splenomegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized TreatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Treatment Group | Experimental | Not described Receives: Procedure: Individualized Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year rebleeding rate
1-year rebleeding rate
Measured: 1 year
Secondary outcomes (2)
1-year death rate
1-year death rate
Measured: 1 year
Complications of portal hypertension
The occurrence of complications of portal hypertension including ascites, liver failure, et al.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start31 Aug 2020 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Varices HemorrhageStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyao Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524676
- Sponsor's protocol ID
- PLAEGV
- Status last verified
- Aug 2020
- First submitted
- 20 Aug 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32380558Aloia 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.
PubMed 17075116Iwai 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.
PubMed 28876454Ward 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.
PubMed 18779617
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Evaluation of the Early Identification and Individualized Treatment for Oxaliplatin-induced Portal Hypertension
- ClinicalTrials.gov ID
- NCT04524676
- Acronym / sponsor ID
- PLAEGV
- Conditions
- Gastroesophageal Varices Hemorrhage, Colorectal Cancer, Received Oxaliplatin-based Chemotherapy
- Keywords
- portal hypertension, gastroesophageal variceal bleeding, colorectal carcinoma, splenomegaly, oxaliplatin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 31 Aug 2020 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized Treatment Group | Experimental | Procedure: Individualized Treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized TreatmentPatients 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. | Procedure or surgery | Individualized Treatment Group |
Primary outcome
1-year rebleeding rate
Time frame: 1 year
1-year rebleeding rate
2 secondary outcomes
1-year death rate
Time frame: 1 year
Complications of portal hypertension
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Results publication: PubMed 32380558Huang 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 publication: PubMed 17075116Aloia 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 publication: PubMed 28876454Iwai 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 publication: PubMed 18779617Ward 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Gastroenterology and Hepatology
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Treatment in people with Gastroesophageal Varices Hemorrhage and Colorectal Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year rebleeding rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04524676, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.