Clinical trial NCT05141617: Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding
Official title: Endoscopic Treatment vs Transjugular Intrahepatic Portosystemic Shunt in the Management of Oxaliplatin Related Gastroesophageal Variceal Bleeding: A Multicenter, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Wenzhou Medical University
name: Shanghai Minhang Central Hospital
name: Anhui Provincial Hospital
First posted: 2021-12-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 24-week re-bleeding
timeFrame: 24 weeks
Secondary outcomes:
measure: 8-week re-bleeding
timeFrame: 8 weeks
measure: 8-week mortality
timeFrame: 8 weeks
measure: 8-week adverse events
timeFrame: 8 weeks
measure: 24-week mortality
timeFrame: 24 weeks
measure: 24-week adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Gastroenterology and Hepatology
state: Shanghai
Study officials:
affiliation: Fudan University
name: Shiyao CHENCHEN, M.D. & Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.