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8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding in Patients With Child A Cirrhosis

NCT ID: NCT03094234

Last Updated: 2021-11-23

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-28

Study Completion Date

2022-03-28

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 in patients with Child A cirrhosis

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

SINGLE

Caregivers

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 DEVICE

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

EVL plus propranolol

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

Group Type ACTIVE_COMPARATOR

endoscopic variceal ligation (EVL)

Intervention Type PROCEDURE

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

Propranolol

Intervention Type DRUG

Appropriate dose of propranolol was administered to the patients.

Interventions

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8mm-TIPS

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

Intervention Type DEVICE

endoscopic variceal ligation (EVL)

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

Intervention Type PROCEDURE

Propranolol

Appropriate dose of propranolol was administered to the patients.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Cirrhosis Patients who had bled from esophageal varices (≥5days and ≤28days) Child-Pugh A -

Exclusion Criteria

The presence of gastric varices Non-cirrhotic portal hypertension Portal vein thrombosis The history of hepatic encephalopathy Total bilirubin ≥51.3 umol/L Previous treatment of TIPS or surgery Proven malignancy including hepatocellular carcinoma Contraindications to TIPS、EVL or propranolol End-stage renal disease under renal replacement therapy; Cardiorespiratory failure Pregnancy or patients not giving informed consent for endoscopic procedure

\-
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

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West china hospital

Chengdu, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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xuefeng luo

Role: primary

References

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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-ChildA

Identifier Type: -

Identifier Source: org_study_id