Back to results

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

Primary Purpose

Decompensated Cirrhosis, Bleeding Varices

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

TIPS treatment

Medical treatment

About this trial

This is an interventional treatment trial for Decompensated Cirrhosis focused on measuring transjugular intrahepatic portosystemic shunt, TIPS, variceal bleeding, liver cirrhosis, hepatitis B

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

Patients not fulfilling inclusion criteria
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

Sites / Locations

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIPS treatment

Medical treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of survival without liver transplantation

Secondary Outcome Measures

Number of participants failed to control acute variceal bleeding within 5 days, 6 weeks and 1 year

Number of bleeding related death

Number of other portal hypertension related complications on follow-up (ascites, hepatorenal syndrome, hepatic encephalopathy)

Full Information

NCT ID

NCT01370161

First Posted

June 7, 2011

Last Updated

January 15, 2019

Sponsor

Air Force Military Medical University, China

1. Study Identification

Unique Protocol Identification Number

NCT01370161

Brief Title

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

Official Title

Early Transjugular Intrahepatic Portosystemic Shunt With Polytetrafluoroethylene Covered Stents Versus Standard Medical Therapy for Acute Variceal Bleeding in Patients With Advanced Cirrhosis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

September 30, 2018 (Actual)

Study Completion Date

September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Air Force Military Medical University, China

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Decompensated Cirrhosis, Bleeding Varices

Keywords

transjugular intrahepatic portosystemic shunt, TIPS, variceal bleeding, liver cirrhosis, hepatitis B

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

132 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TIPS treatment

Arm Type

Experimental

Arm Description

Arm Title

Medical treatment

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

TIPS treatment

Other Intervention Name(s)

Transjugular intrahepatic portosystemic shunt (TIPS)

Intervention Description

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. 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. After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted.

Intervention Type

Drug

Intervention Name(s)

Medical treatment

Other Intervention Name(s)

Non-selective beta blocker + Endoscopic variceal ligation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of survival without liver transplantation

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Number of participants failed to control acute variceal bleeding within 5 days, 6 weeks and 1 year

Time Frame

1 years

Title

Number of bleeding related death

Time Frame

2 years

Title

Number of other portal hypertension related complications on follow-up (ascites, hepatorenal syndrome, hepatic encephalopathy)

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Exclusion Criteria: Patients not fulfilling inclusion criteria 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guohong Han, PhD & MD

Organizational Affiliation

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

20573925

Citation

Garcia-Pagan JC, Caca K, Bureau C, Laleman W, Appenrodt B, Luca A, Abraldes JG, Nevens F, Vinel JP, Mossner J, Bosch J; Early TIPS (Transjugular Intrahepatic Portosystemic Shunt) Cooperative Study Group. Early use of TIPS in patients with cirrhosis and variceal bleeding. N Engl J Med. 2010 Jun 24;362(25):2370-9. doi: 10.1056/NEJMoa0910102.

Results Reference

background

PubMed Identifier

31153882

Citation

Lv Y, Yang Z, Liu L, Li K, He C, Wang Z, Bai W, Guo W, Yu T, Yuan X, Zhang H, Xie H, Yao L, Wang J, Li T, Wang Q, Chen H, Wang E, Xia D, Luo B, Li X, Yuan J, Han N, Zhu Y, Niu J, Cai H, Xia J, Yin Z, Wu K, Fan D, Han G; AVB-TIPS Study Group. Early TIPS with covered stents versus standard treatment for acute variceal bleeding in patients with advanced cirrhosis: a randomised controlled trial. Lancet Gastroenterol Hepatol. 2019 Aug;4(8):587-598. doi: 10.1016/S2468-1253(19)30090-1. Epub 2019 May 29.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs