| CTRI Number |
CTRI/2019/08/020937 [Registered on: 28/08/2019] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Result of surgical technique (Trans Intrahepatic Portosystemic Shunt (procedure)in liver disease (Cirrhosis). |
|
Scientific Title of Study
|
A Randomised Controlled Trial to Study the Efficacy of TIPS versus Self Expanding Metallic Stent in the management of failure to control upper gastrointestinal bleed or Re bleed in cirrhotics. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT03827681 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shushrut Singh |
| Designation |
Senior Resident,Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
3rd Floor, Faculty Room,Phase II,ILBS,D-1,Vasant Kunj, New Delhi-110070.
South
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
01146300025 |
| Email |
drsushrut20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiv Kumar Sarin |
| Designation |
Senior Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
3rd Floor, Faculty Room,Phase II,ILBS,D-1,Vasant Kunj, New Delhi-110070.
South
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
shivsarin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shiv Kumar Sarin |
| Designation |
Senior Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
3rd Floor, Faculty Room,Phase II,ILBS,D-1,Vasant Kunj, New Delhi-110070.
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
shivsarin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Liver and Biliary Sciences,D-1,Vasant Kunj, New Delhi-110070. |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
D-1,Vasant Kunj,New Delhi-110070 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shushrut Singh |
Institute of Liver and Biliary Science |
3rd Floor,Faculty room,3rd Floor, Phase II,D-1,Vasant Kunj, New Delhi-110070.
New Delhi
DELHI |
01146300000
01146300025
drsushrut20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SEMS with Vasoactive Drug |
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.
with
Vasoactive Agent
|
| Intervention |
TIPS with Vasoactive Agent |
The most common approach is through the right internal jugular approach.After infiltrating the puncture site with 2 percent lignocaine and puncturing the vein a guide wire is advanced into the IVC followed by a 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 to 20 degrees of distal angulation is advanced over the guide wire and through the vascular sheath to enter the hepatic vein.
with
Vasoactive Agent |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
1. Bleeding from non-variceal source
2. Coagulopathy related bleed
3. Bleeding from Gastric varices
4. Any malignancy including HCC
5. Main Portal vein thrombosis
6. Patients in refractory shock
7. Patients with severe cardiopulmonary disease
8. Grade 4 Hepatic encephalopathy
9. MELD > 25
10. Multiorgan failure
11. Active sepsis
12. Pregnancy
13. Failure to give consent
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Survival in both groups |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Re-bleeding in both groups for 5 days from end of therapy |
5 days and 6 weeks |
| Decompensation in both groups in the form of ascites or Hepatic Encephalopathy |
6 weeks |
| Adverse events in both groups |
6 weeks |
| Worsening of liver severity score in both groups. |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |