Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding

Gastrointestinal Cancer Clinical Trial

Official title:

Endoscopic Treatment vs Transjugular Intrahepatic Portosystemic Shunt in the Management of Oxaliplatin Related Gastroesophageal Variceal Bleeding: A Multicenter, Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05141617
• Other study ID #: PLAEGV-TRE
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Xiaoquan HUANG, M.D.
• Phone: 008618801733835
• Email: huang.xiaoquan[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Varices Hemorrhage
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Hemorrhage
• Received Oxaliplatin-based Chemotherapy

Intervention

Procedure:
• Endoscopic treatment
Patients in the endoscopic treatment receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices
• TIPS
Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt

Locations

Country	Name	City	State
China	Department of Gastroenterology and Hepatology	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Anhui Provincial Hospital, First Affiliated Hospital of Wenzhou Medical University, Shanghai Minhang Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-week re-bleeding	Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours	24 weeks
Secondary	8-week re-bleeding	Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours	8 weeks
Secondary	8-week mortality	death	8 weeks
Secondary	8-week adverse events	Other complications of portal hypertension such as the progression of ascites, liver failure, etc.	8 weeks
Secondary	24-week mortality	death	24 weeks
Secondary	24-week adverse events	Other complications of portal hypertension such as the progression of ascites, liver failure, etc.	24 weeks