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CTRI Number  CTRI/2024/01/062094 [Registered on: 31/01/2024] Trial Registered Prospectively
Last Modified On: 22/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to correlate hepatic venous doppler findings and mean portal vein velocity with severity of liver disease in cirrhotic patients. 
Scientific Title of Study   A study to correlate hepatic venous doppler findings and mean portal vein velocity with severity of liver disease in cirrhotic patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr.Potluri Anuroop 
Designation  PG student ,MD RADIO DIAGNOSIS  
Affiliation  D Y Patil Medical College and Hospital 
Address  USG room, ground floor,radiology department,D.Y. Patil hospital and research center,sonal colony, scheme No.4, laxminarayan nagar, kadamwadi, kolhapur, maharashtra 416003

Kolhapur
MAHARASHTRA
416003
India 
Phone  9573761282  
Fax    
Email  potluri.anuroop98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Niranjan bapusaheb patil  
Designation  Professor, MD Radio diagnosis 
Affiliation  D Y Patil medical college and hospital 
Address  USG room, ground floor,radiology department,D.Y. Patil hospital and research center,sonal colony, scheme No.4, laxminarayan nagar, kadamwadi, kolhapur, maharashtra 416003

Kolhapur
MAHARASHTRA
416003
India 
Phone  9573761282  
Fax    
Email  nbpatil10@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr.Potluri Anuroop 
Designation  PG student,MD Radio diagnosis 
Affiliation  D Y Patil medical college and hospital 
Address  USG room, ground floor,radiology department,D.Y. Patil hospital and research center,sonal colony, scheme No.4, laxminarayan nagar, kadamwadi, kolhapur, maharashtra 416003

Kolhapur
MAHARASHTRA
416003
India 
Phone  9573761282  
Fax    
Email  potluri.anuroop98@gmail.com  
 
Source of Monetary or Material Support  
D. Y. Patil medical college and hospital, kolhapur 
 
Primary Sponsor  
Name  Dr Potluri Anuroop 
Address  USG room, ground floor,radiology department,D.Y. Patil hospital and research center,sonal colony, scheme No.4, laxminarayan nagar, kadamwadi, kolhapur, maharashtra 416003 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Potluri Anuroop  D.Y. Patil hospital and research center  USG room, ground floor,radiology department,D.Y. Patil hospital and research center,sonal colony, scheme No.4, laxminarayan nagar, kadamwadi, kolhapur, maharashtra 416003
Kolhapur
MAHARASHTRA 
9573761282

potluri.anuroop98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee D.Y.Patil medical college,kolhapur.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K742||Hepatic fibrosis with hepatic sclerosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients with liver cirrhosis getting admitted in Dr.D.Y.Patil medical college hospital,kolhapur
Patients of all age groups with liver cirrhosis
Patients of any etilogy with liver cirrhosis 
 
ExclusionCriteria 
Details  Patients with any liver masses
patients with hepatocellular carcinoma
patients with inferior vene cava thrombosis
patients with heart failure
patients with portal vein thrombosis
patients with portal cavernoma
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
correlation between heaptic venous doppler findings and mean portal vein velocity with severity of liver disease in cirrhotic patients by child pughs score  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   10/02/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Ø  Diagnosis of liver cirrhosis will be made based on a combination of biochemical findings as well as typical Bmode ultrasound features such as shrunken liver size with irregular outline, ascites, and portal hypertension.

 Laboratory parameters that will be done include prothrombin time/international normalized ratio (INR), serum bilirubin and serum albumin. Hepatic encephalopathy will be graded based on the West Haven Grading System from Grade 0 to Grade 4. Ascites will be graded according to ultrasonography findings into 3 categories: Absent, mild, and moderate to severe.

Ø  For cirrhotic patients, disease severity will be assessed using the Child pughs  score, which took into account five conventional clinical (hepatic encephalopathy and ascites) and laboratory (albumin, prothrombin time, and bilirubin values) parameters

Ø  With the patient in the supine position, B’mode ultrasound of the hepatic parenchyma  will be done under the guidance of Dr.Pradeep patil, Professor-Dept of Radiodiagnosis first to assess the liver span, echogenicity, echotexture, and surface nodularity. Pulsed Doppler evaluation of HV will be then performed in the transverse plane and the probe manipulated (either through an intercostal approach or a subcostal approach over the right hypochondrium), until the star’like confluence of the HVs to the IVC is visualized. The HV evaluation will be done after nonforced (quiet) expiration. Doppler signals will be in general, obtained from the right or middle HVs at a distance of 3–6 cm from the junction of the HV and the IVC to increase the impact of hepatic parenchyma changes on the HVWs instead of the IVC flow. The HVW assessments will be made at angles of insonation <60°.

 

The HVW will be classified into three groups according to the Doppler signal characteristics:

1. Type 0, triphasic waveform; the presence of a short phase of reversed flow

2. Type I, biphasic waveform; decreased amplitude of the phasic oscillations without the short phase of reversed flow

      3. Type II, monophasic waveform; complete flat waveform

Ø  The RPV will be chosen for evaluation as the left portal vein can be subjected to paraumbilical recanalization in some cases of cirrhosis and within the liver. The RPV will be interrogated with the patient in shallow normal respiration and the mean portal vein velocity (MPVV) will be obtained.

·       Then correlation of hepatic vein waveforms changes and mean portal vein velocity with Child-Pugh class will be evaluated.

 
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