Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05141617

Collaborator

First Affiliated Hospital of Wenzhou Medical University (Other), Shanghai Minhang Central Hospital (Other), Anhui Provincial Hospital (Other)

100

Enrollment

Location

Arms

25.9

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Varices Hemorrhage Gastrointestinal Cancer Received Oxaliplatin-based Chemotherapy	Procedure: Endoscopic treatment Procedure: TIPS	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 3, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endoscopic treatment group Patients in the endoscopic treatment group receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices.	Procedure: Endoscopic treatment Patients in the endoscopic treatment receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices
Experimental: TIPS group Patients in the TIPS group receive transjugular intrahepatic portosystem stent-shunt.	Procedure: TIPS Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt

Arm

Intervention/Treatment

Experimental: Endoscopic treatment group

Patients in the endoscopic treatment group receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices.

Procedure: Endoscopic treatment

Patients in the endoscopic treatment receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices

Experimental: TIPS group

Patients in the TIPS group receive transjugular intrahepatic portosystem stent-shunt.

Procedure: TIPS

Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt

Outcome Measures

Primary Outcome Measures

24-week re-bleeding [24 weeks]
Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours

Secondary Outcome Measures

8-week re-bleeding [8 weeks]
Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours
8-week mortality [8 weeks]
death
8-week adverse events [8 weeks]
Other complications of portal hypertension such as the progression of ascites, liver failure, etc.
24-week mortality [24 weeks]
death
24-week adverse events [24 weeks]
Other complications of portal hypertension such as the progression of ascites, liver failure, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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