Clinical trial · Interventional
Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding
Endoscopic Treatment vs Transjugular Intrahepatic Portosystemic Shunt in the Management of Oxaliplatin Related Gastroesophageal Variceal Bleeding: A Multicenter, Randomized, Controlled Clinical Trial
NCT05141617CI-TRIAL-00055338unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
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
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 |
|---|---|---|---|
| Gastroesophageal Varices Hemorrhage | — | UNRESOLVED | — |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Received Oxaliplatin-based Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic treatment | Procedure | — | UNRESOLVED |
| TIPS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endoscopic treatment group
- description
- Patients in the endoscopic treatment group receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices.
- interventionNames
- Procedure: Endoscopic treatment
- type
- EXPERIMENTAL
- label
- TIPS group
- description
- Patients in the TIPS group receive transjugular intrahepatic portosystem stent-shunt.
- interventionNames
- Procedure: TIPS
Primary outcomes (1)
- measure
- 24-week re-bleeding
- timeFrame
- 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Having received oxaliplatin-based chemotherapy for at least one cycle 2. History of variceal bleeding (including hematemesis or melena) 3. Portal hypertension confirmed by CT or MRI 4. Esophageal and / or gastric varices confirmed by endoscopy 5. Informed consent signed Exclusion Criteria: 1. With serious life-threatening diseases of circulation / blood / respiratory system 2. With known causes of liver cirrhosis (hepatitis B, hepatitis C, autoimmune, schistosomiasis, non-alcoholic fatty liver disease, and etc.) 3. With contraindications of endoscopic treatments and TIPS; 4. Participation refused
References
Publications (1)
- 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