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8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding

NCT ID: NCT02477384

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2021-07-31

Brief Summary

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The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.

Detailed Description

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For the prevention of recurrent esophageal variceal bleeding, previous clinical studies and meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt (TIPS) have lower rebleeding rates compared with endoscopic therapy. However, TIPS is associated with higher rates of portosystemic encephalopathy and does not show survival benefit. TIPS with a small-diameter may achieve sufficient portal decompression and reduce the incidence of hepatic encephalopathy. The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm ePTFE-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.

Conditions

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Portal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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8mm-TIPS

Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.

Group Type ACTIVE_COMPARATOR

8mm-TIPS

Intervention Type PROCEDURE

8mm ePTFE-covered stent

Intervention Type DEVICE

EVL plus propranolol

Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.

Group Type ACTIVE_COMPARATOR

Endoscopic variceal ligation

Intervention Type PROCEDURE

Propranolol

Intervention Type DRUG

Interventions

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8mm-TIPS

Intervention Type PROCEDURE

Endoscopic variceal ligation

Intervention Type PROCEDURE

Propranolol

Intervention Type DRUG

8mm ePTFE-covered stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Cirrhosis
2. Patients who had bled from esophageal varices (≥5days and ≤28days)
3. Child-Pugh B or Child-Pugh C≤13

Exclusion Criteria

1. THE presence of gastric varices
2. Non-cirrhotic portal hypertension
3. Portal vein thrombosis
4. The history of hepatic encephalopathy
5. Total bilirubin ≥51.3 umol/L
6. Previous treatment of TIPS or surgery
7. Proven malignancy including hepatocellular carcinoma
8. Contraindications to TIPS、EVL or propranolol
9. End-stage renal disease under renal replacement therapy;
10. Cardiorespiratory failure
11. Pregnancy or patients not giving informed consent for endoscopic procedures
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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luo xuefeng

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Hospital

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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Wang X, Liu G, Wu J, Xiao X, Yan Y, Guo Y, Yang J, Li X, He Y, Yang L, Luo X. Small-Diameter Transjugular Intrahepatic Portosystemic Shunt versus Endoscopic Variceal Ligation Plus Propranolol for Variceal Rebleeding in Advanced Cirrhosis. Radiology. 2023 Aug;308(2):e223201. doi: 10.1148/radiol.223201.

Reference Type DERIVED
PMID: 37606572 (View on PubMed)

Simonetti RG, Perricone G, Robbins HL, Battula NR, Weickert MO, Sutton R, Khan S. Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD000553. doi: 10.1002/14651858.CD000553.pub3.

Reference Type DERIVED
PMID: 33089892 (View on PubMed)

Other Identifiers

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8mm-TIPS

Identifier Type: -

Identifier Source: org_study_id