Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for Acute Variceal Bleeding in Patients With Advanced Cirrhosis

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

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2018-09-30

Brief Summary

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The purpose of this study is to determine whether early use of transjugular intrahepatic portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to prolong the survival in patients with advanced cirrhosis and acute variceal bleeding.

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Detailed Description

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Conditions

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Decompensated Cirrhosis Bleeding Varices

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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TIPS treatment

Initial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.TIPS will be performed as soon as possible once the patients are enrolled in the study, always within the first 72 hours after the diagnostic endoscopy (preferably in the first 24 hours).Vasoactive drugs will be continued until the TIPS is performed and antibiotics will be continued for 5-7 days.

Group Type EXPERIMENTAL

TIPS treatment

Intervention Type PROCEDURE

1. A 8 mm Fluency stent will be used. The aim will be to reduce the portal pressure gradient (PPG) below to 12 mm Hg or 25-75% of baseline.
2. Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of large portosystemic collaterals feeding the varices.
3. After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted.

Medical treatment

Initial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.Patients will be treated with non-selective beta-blockers (propranolol)on day 5. In case of contraindications or intolerance to beta-blockers, patients will not receive pharmacological treatment (beta-blockers) and the only treatment to prevent rebleeding will be endoscopic band ligation.

Group Type ACTIVE_COMPARATOR

Medical treatment

Intervention Type DRUG

Patients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (propranolol) will be started with an initial dose of 40 mg, the dose of propranolol will be increased/decreased step by step to achieve a baseline heart rate of 55 bpm, or 25% reduction of basal heart rate or up to the maximum tolerated dose of propranolol.

The second elective session of endoscopic band ligation will be performed within the first 7-14 days after the initial endoscopic treatment. The following sessions will be performed at 14 +/- 3 days intervals until variceal eradication. Once eradication is achieved, endoscopic monitoring will be performed every 6 months. If varices reappear, new band ligation will be performed.

Interventions

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TIPS treatment

1. A 8 mm Fluency stent will be used. The aim will be to reduce the portal pressure gradient (PPG) below to 12 mm Hg or 25-75% of baseline.
2. Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of large portosystemic collaterals feeding the varices.
3. After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted.

Intervention Type PROCEDURE

Medical treatment

Patients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (propranolol) will be started with an initial dose of 40 mg, the dose of propranolol will be increased/decreased step by step to achieve a baseline heart rate of 55 bpm, or 25% reduction of basal heart rate or up to the maximum tolerated dose of propranolol.

The second elective session of endoscopic band ligation will be performed within the first 7-14 days after the initial endoscopic treatment. The following sessions will be performed at 14 +/- 3 days intervals until variceal eradication. Once eradication is achieved, endoscopic monitoring will be performed every 6 months. If varices reappear, new band ligation will be performed.

Intervention Type DRUG

Other Intervention Names

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Transjugular intrahepatic portosystemic shunt (TIPS) Non-selective beta blocker + Endoscopic variceal ligation

Eligibility Criteria

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Inclusion Criteria

* History of cirrhosis (clinical or by liver biopsy)
* Admission due to acute bleeding from oesophageal or gastric (GOV1 or GOV2) varices
* Child-Pugh Class C (Child-Pugh score less than or equal to 13) or Child-Pugh class B
* Signed written informed consent

* Pregnancy or breast-feeding
* Confirmed hepatocellular carcinoma
* Creatinine greater than 3 mg/dl
* Terminal hepatic failure (Child-Pugh score greater than 13)
* Previous treatment with TIPS or combined pharmacological and endoscopic treatment to prevent rebleeding
* Fundal or ectopic gastric variceal bleeding (IGV1 or IGV2)
* Complete portal vein thrombosis or portal cavernoma
* Congestive heart failure New York Heart Association (NYHA) greater than III or medical history of pulmonary hypertension
* Spontaneous recurrent hepatic encephalopathy

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No