Gastroesophageal Varices HemorrhageNCT05141617
Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding
A study testing Endoscopic treatment and TIPS in people with Gastroesophageal Varices Hemorrhage and Gastrointestinal Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Varices Hemorrhage, Gastrointestinal Cancer, Received Oxaliplatin-based Chemotherapy
- What is being tested?
- Endoscopic treatment and TIPS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2021to 31 Dec 2023
- 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
- Having received oxaliplatin-based chemotherapy for at least one cycle
- History of variceal bleeding (including hematemesis or melena)
- Portal hypertension confirmed by CT or MRI
- Esophageal and / or gastric varices confirmed by endoscopy
- Informed consent signed
Who cannot join
- With serious life-threatening diseases of circulation / blood / respiratory system
- With known causes of liver cirrhosis (hepatitis B, hepatitis C, autoimmune, schistosomiasis, non-alcoholic fatty liver disease, and etc.)
- With contraindications of endoscopic treatments and TIPS;
- Participation refused
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
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: Endoscopic Treatment vs Transjugular Intrahepatic Portosystemic Shunt in the Management of Oxaliplatin Related Gastroesophageal Variceal Bleeding: A Multicenter, Randomized, Controlled Clinical Trial
In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.
Read the detailed description
Oxaliplatin is used as the first-line chemotherapy for colorectal cancer. However, oxaliplatin-induced hepatotoxicity could lead to sinusoidal injury and portal hypertension in the long term. Variceal bleeding, as the most common complication of portal hypertension, threaten these patents' life. Endoscopic treatment and Transjugular Intrahepatic Portosystemic Shunt (TIPS) are both recommended management of gastroesophageal variceal bleeding. In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.
- Conditions
- Gastroesophageal Varices Hemorrhage, Gastrointestinal Cancer, Received Oxaliplatin-based Chemotherapy
- Being tested
- Endoscopic treatment, TIPS
- Keywords
- portal hypertension, Gastrointestinal Cancer, oxaliplatin, gastroesophageal variceal bleeding, endoscopic treatment, Transjugular Intrahepatic Portosystemic Shunt
- Medical subject headings
- Gastrointestinal Neoplasms, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic treatmentProcedure or surgery
Patients in the endoscopic treatment receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices
TIPSProcedure or surgery
Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic treatment group | Experimental | Patients in the endoscopic treatment group receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices. Receives: Procedure: Endoscopic treatment |
| TIPS group | Experimental | Patients in the TIPS group receive transjugular intrahepatic portosystem stent-shunt. Receives: Procedure: TIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-week re-bleeding
Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours
Measured: 24 weeks
Secondary outcomes (5)
8-week re-bleeding
Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours
Measured: 8 weeks
8-week mortality
death
Measured: 8 weeks
8-week adverse events
Other complications of portal hypertension such as the progression of ascites, liver failure, etc.
Measured: 8 weeks
24-week mortality
death
Measured: 24 weeks
24-week adverse events
Other complications of portal hypertension such as the progression of ascites, liver failure, etc.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start3 Nov 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Shanghai Minhang Central Hospital, Anhui Provincial Hospital
- Responsible party
- Principal investigator, Shiyao Chen, Shanghai Zhongshan Hospital
- Investigators
- Shiyao CHENCHEN, M.D. & Ph.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141617
- Sponsor's protocol ID
- PLAEGV-TRE
- Status last verified
- Nov 2021
- First submitted
- 1 Nov 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 32380558
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Treatment vs Transjugular Intrahepatic Portosystemic Shunt in the Management of Oxaliplatin Related Gastroesophageal Variceal Bleeding: A Multicenter, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05141617
- Acronym / sponsor ID
- PLAEGV-TRE
- Conditions
- Gastroesophageal Varices Hemorrhage, Gastrointestinal Cancer, Received Oxaliplatin-based Chemotherapy
- Keywords
- portal hypertension, Gastrointestinal Cancer, oxaliplatin, gastroesophageal variceal bleeding, endoscopic treatment, Transjugular Intrahepatic Portosystemic Shunt
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Shanghai Minhang Central Hospital, Anhui Provincial Hospital
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Dec 2021 (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.
In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.
Detailed description
Oxaliplatin is used as the first-line chemotherapy for colorectal cancer. However, oxaliplatin-induced hepatotoxicity could lead to sinusoidal injury and portal hypertension in the long term. Variceal bleeding, as the most common complication of portal hypertension, threaten these patents' life. Endoscopic treatment and Transjugular Intrahepatic Portosystemic Shunt (TIPS) are both recommended management of gastroesophageal variceal bleeding. In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic treatment group | Experimental | Procedure: Endoscopic treatmentPatients in the endoscopic treatment group receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices. |
| TIPS group | Experimental | Procedure: TIPSPatients in the TIPS group receive transjugular intrahepatic portosystem stent-shunt. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having received oxaliplatin-based chemotherapy for at least one cycle
- History of variceal bleeding (including hematemesis or melena)
- Portal hypertension confirmed by CT or MRI
- Esophageal and / or gastric varices confirmed by endoscopy
- Informed consent signed
Key exclusion criteria (4 listed)
- With serious life-threatening diseases of circulation / blood / respiratory system
- With known causes of liver cirrhosis (hepatitis B, hepatitis C, autoimmune, schistosomiasis, non-alcoholic fatty liver disease, and etc.)
- With contraindications of endoscopic treatments and TIPS;
- Participation refused
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 |
|---|---|---|
| Endoscopic treatmentPatients in the endoscopic treatment receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices | Procedure or surgery | Endoscopic treatment group |
| TIPSPatients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt | Procedure or surgery | TIPS group |
Primary outcome
24-week re-bleeding
Time frame: 24 weeks
Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours
5 secondary outcomes
8-week re-bleeding
Time frame: 8 weeks
8-week mortality
Time frame: 8 weeks
8-week adverse events
Time frame: 8 weeks
24-week mortality
Time frame: 24 weeks
24-week adverse events
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- 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.
- 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.
Shiyao CHENCHEN, M.D. & Ph.D principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic treatment and TIPS in people with Gastroesophageal Varices Hemorrhage and Gastrointestinal 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 4 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 2 Dec 2021. 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?
Contact Xiaoquan HUANG, M.D. (008618801733835, huang.xiaoquan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-week re-bleeding (time frame: 24 weeks). 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 NCT05141617, which also lists 1 linked publication.
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 2 Dec 2021.