| 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
|
|
|
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
|
|
|
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. |