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To Study the Efficacy and Safety of TIPS (Trans Intrahepatic Portosystemic Shunt) Versus Self Expanding Metallic Stent (SEMS) in the Management of Refractory Variceal Bleed in Cirrhotics.

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ClinicalTrials.gov Identifier: NCT03827681
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:

A total of 50 patients will be enrolled and will be randomized into either Group A(TIPS) or Group B (SEMS).

Primary end point of the study will be to compare efficacy of TIPS versus SEMS for survival at 6 week or Early re Bleed. All enrolled patients will also undergo HVPG measurement at baseline to stratify risk of failure to control bleed or early re-bleed.

Patient will be monitored for 5 days for re bleed, complications of therapy, worsening of Liver function tests and scores and efficacy of either treatment modality over other. Patient will be followed for 6 weeks to see for the primary end point.


Condition or disease Intervention/treatment Phase
Liver Cirrhoses Procedure: Trans Intrahepatic Portosystemic Shunt Procedure: Self Expanding Metallic Stent Drug: Vasoactive Agent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Study the Efficacy and Safety of TIPS (Trans Intrahepatic Portosystemic Shunt) Versus Self Expanding Metallic Stent (SEMS) in the Management of Refractory Variceal Bleed in Cirrhotics.
Actual Study Start Date : February 6, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Cirrhosis

Arm Intervention/treatment
Experimental: TIPS + Vasoactive Drug Procedure: Trans Intrahepatic Portosystemic Shunt
  • The most common approach is through the right internal jugular approach.
  • After infiltrating the puncture site with 2% lignocaine and puncturing the vein a guide wire is advanced into the IVC followed by a 9F/10F vascular sheath.
  • A wedged venogram is performed with a peripherally placed hepatic vein catheter, which may identify a portion of the portal vein to facilitate subsequent puncture.`
  • A stiff guide wire is then passed through the catheter and the vascular sheath is advanced into the right hepatic vein. With the vascular sheath in place a rigid needle with 15-20 degrees of distal angulation is advanced over the guide wire and through the vascular sheath to enter the hepatic vein.

Drug: Vasoactive Agent
Vasoactive Agent

Active Comparator: SEMS + Vasoactive Drug Procedure: Self Expanding Metallic Stent
  • At upper endoscopy, a 0.35 Superstiff radiological guidewire with a soft tip (supplied with the stent insertion kit) is delivered into the stomach under direct vision and the endoscope is removed.
  • The stent delivery device is then advanced over the guidewire into the stomach, and the distal portion of the stent delivery system is withdrawn to allow inflation of the gastric balloon.
  • The gastric balloon is then inflated with 100 mL of air, and the whole delivery system is withdrawn until resistance is felt, which signifies that the balloon is impacting at the cardia, thus anchoring the distal end of the stent during deployment.
  • After stent deployment, the gastric balloon is deflated and the stent delivery system is withdrawn. The stent is then examined endoscopically. When deployed, the stent is 135 mm long and 25 mm wide.

Drug: Vasoactive Agent
Vasoactive Agent




Primary Outcome Measures :
  1. Survival in both groups [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Re-bleeding in both groups for 5 days from end of therapy [ Time Frame: 5 days ]
  2. Rebleeding in both groups [ Time Frame: 6 weeks ]
  3. Decompensation in both groups in the form of ascites or Hepatic Encephalopathy [ Time Frame: 6 weeks ]
  4. Adverse events in both groups [ Time Frame: 6 weeks ]
  5. Worsening of liver severity score in both groups. [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Consecutive patients of cirrhosis aged 18-70 years presenting with acute variceal Bleeding, who on endoscopy fail to control bleed or rebleeds within 5 days will be randomized.

Exclusion Criteria:

  • Bleeding from non-variceal source
  • Coagulopathy related bleed
  • Bleeding from Gastric varices
  • Any malignancy including HCC
  • Main Portal vein thrombosis
  • Patients in refractory shock
  • Patients with severe cardiopulmonary disease
  • Grade 4 Hepatic encephalopathy
  • MELD > 25
  • Multiorgan failure
  • Active sepsis
  • Pregnancy
  • Failure to give consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827681


Contacts
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Contact: Dr Shushrut Singh, MD 01146300000 drsushrut20@gmail.com

Locations
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India
Institute of Liver & Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Dr Shushrut Singh, MD         
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03827681    
Other Study ID Numbers: ILBS-Cirrhosis-20
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases