NCT05141617

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

November 3, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

2.2 years

First QC Date

November 1, 2021

Last Update Submit

November 20, 2021

Conditions

Gastroesophageal Varices HemorrhageGastrointestinal CancerReceived Oxaliplatin-based Chemotherapy

Keywords

portal hypertensionGastrointestinal Canceroxaliplatingastroesophageal variceal bleedingendoscopic treatmentTransjugular Intrahepatic Portosystemic Shunt

Outcome Measures

Primary Outcomes (1)

  • 24-week re-bleeding

    Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours

    24 weeks

Secondary Outcomes (5)

  • 8-week re-bleeding

    8 weeks

  • 8-week mortality

    8 weeks

  • 8-week adverse events

    8 weeks

  • 24-week mortality

    24 weeks

  • 24-week adverse events

    24 weeks

Study Arms (2)

Endoscopic treatment group

EXPERIMENTAL

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

Procedure: Endoscopic treatment

TIPS group

EXPERIMENTAL

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

Procedure: TIPS

Interventions

Endoscopic treatmentPROCEDURE

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

Endoscopic treatment group
TIPSPROCEDURE

Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt

TIPS group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology and Hepatology

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related 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. doi: 10.1055/a-1157-8611. Epub 2020 May 7.

    PMID: 32380558RESULT

MeSH Terms

Conditions

Gastrointestinal NeoplasmsHypertension, Portal

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical Procedures

Study Officials

  • Shiyao CHENCHEN, M.D. & Ph.D

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoquan HUANG, M.D.

CONTACT

008618801733835huang.xiaoquan@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 1, 2021

First Posted

December 2, 2021

Study Start

November 3, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations

CN(1)