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Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding

NCT ID: NCT05141617

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-03

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Gastroesophageal Varices Hemorrhage Gastrointestinal Cancer Received Oxaliplatin-based Chemotherapy

Keywords

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portal hypertension Gastrointestinal Cancer oxaliplatin gastroesophageal variceal bleeding endoscopic treatment Transjugular Intrahepatic Portosystemic Shunt

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Endoscopic treatment group

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

Group Type EXPERIMENTAL

Endoscopic treatment

Intervention Type PROCEDURE

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

TIPS group

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

Group Type EXPERIMENTAL

TIPS

Intervention Type PROCEDURE

Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt

Interventions

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Endoscopic treatment

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

Intervention Type PROCEDURE

TIPS

Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Shanghai Minhang Central Hospital

OTHER

Sponsor Role collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shiyao Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shiyao CHENCHEN, M.D. & Ph.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Department of Gastroenterology and Hepatology

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoquan HUANG, M.D.

Role: CONTACT

Phone: 008618801733835

Email: [email protected]

Facility Contacts

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Xiaoquan HUANG

Role: primary

References

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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.

Reference Type RESULT
PMID: 32380558 (View on PubMed)

Other Identifiers

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PLAEGV-TRE

Identifier Type: -

Identifier Source: org_study_id