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Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding

Primary Purpose

Gastroesophageal Varices Hemorrhage, Gastrointestinal Cancer, Received Oxaliplatin-based Chemotherapy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endoscopic treatment
TIPS
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Varices Hemorrhage focused on measuring portal hypertension, Gastrointestinal Cancer, oxaliplatin, gastroesophageal variceal bleeding, endoscopic treatment, Transjugular Intrahepatic Portosystemic Shunt

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gastroenterology and HepatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Endoscopic treatment group

TIPS group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 2021
Last Updated
November 20, 2021
Sponsor
Shanghai Zhongshan Hospital
Collaborators
First Affiliated Hospital of Wenzhou Medical University, Shanghai Minhang Central Hospital, Anhui Provincial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05141617
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
First Affiliated Hospital of Wenzhou Medical University, Shanghai Minhang Central Hospital, Anhui Provincial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Varices Hemorrhage, Gastrointestinal Cancer, Received Oxaliplatin-based Chemotherapy
Keywords
portal hypertension, Gastrointestinal Cancer, oxaliplatin, gastroesophageal variceal bleeding, endoscopic treatment, Transjugular Intrahepatic Portosystemic Shunt

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic treatment group
Arm Type
Experimental
Arm Description
Patients in the endoscopic treatment group receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices.
Arm Title
TIPS group
Arm Type
Experimental
Arm Description
Patients in the TIPS group receive transjugular intrahepatic portosystem stent-shunt.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic treatment
Intervention Description
Patients in the endoscopic treatment receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices
Intervention Type
Procedure
Intervention Name(s)
TIPS
Intervention Description
Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt
Primary Outcome Measure Information:
Title
24-week re-bleeding
Description
Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
8-week re-bleeding
Description
Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours
Time Frame
8 weeks
Title
8-week mortality
Description
death
Time Frame
8 weeks
Title
8-week adverse events
Description
Other complications of portal hypertension such as the progression of ascites, liver failure, etc.
Time Frame
8 weeks
Title
24-week mortality
Description
death
Time Frame
24 weeks
Title
24-week adverse events
Description
Other complications of portal hypertension such as the progression of ascites, liver failure, etc.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoquan HUANG, M.D.
Phone
008618801733835
Email
huang.xiaoquan@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyao CHENCHEN, M.D. & Ph.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology and Hepatology
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoquan HUANG
Phone
008618801733835
Email
huang.xiaoquan@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Shiyao CHEN
First Name & Middle Initial & Last Name & Degree
Xiaoquan HUANG
First Name & Middle Initial & Last Name & Degree
Liyuan NI

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32380558
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.
Results Reference
result

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Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding

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