Back to resultsEUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.
Primary Purpose
Cirrhosis Portal
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EUS guided portal pressure gradient measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Cirrhosis Portal
Eligibility Criteria
Inclusion Criteria:
- Age between 18 to 75 years old
- Informed consent available
- Suffering from chronic hepatitis induced cirrhosis
Suffering from oesophageal varices and received EVL as a result of
- Primary variceal prophylaxis during a variceal surveillance program on oesophagogastroduodenoscopy (OGD) or
- Secondary variceal prophylaxis after EVL in patients with active oesophageal variceal bleeding
- Or bleeding gastric varices that have received endoscopic canoacrylate injection
Exclusion Criteria:
- Medical Child-Pugh Class C Uncorrected platelet count <50,000 INR > 1.5 (natural) History of hepatic encephalopathy Current or history of hepatocellular carcinoma
- Anatomical Main portal vein thrombosis Anatomic alterations of the hepatic vasculature that prevent access to the portal vein or intrahepatic portion of the hepatic veins (identified at screening and/or during the endoscopic procedure).
Previous history of spontaneous bacterial peritonitis within the previous three months Portopulmonary hypertension Cardiac decompensation
- Endoscopically Confirmed Exclusion Criteria Presence of ascites in the path of the needle that prevents apposition of the gastrointestinal tract and liver.
Presence of gastric or duodenal ulcers, dieulafoy's lesion or cancers
Sites / Locations
- Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EUS guided portal pressure gradient measurement
Arm Description
At index OGD, the presence and severity of OV, GV and portal hypertensive gastropathy would be recorded. After endoscopic treatment of varices, recruited patients would undergo 1st measurement of EUS-PPG within 10-14 days after index OGD. The patients would then be enrolled into a variceal surveillance program and be started on B-blockers if not already prescribed. The patients would then be scheduled for another follow-up OGD at 3 months with measurement of the 2nd EUS-PPG. Finally, a third follow-up OGD and EUS-PPG would be performed in 1-year after 1st EUS-PPG. Endoscopic findings attributed to chronic cirrhosis would be assessed in the 3 months and 1 year OGD and the presence and severity of OV, GV and portal hypertensive gastropathy would be recorded.
Outcomes
Primary Outcome Measures
Presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy
The number of patients with a high EUS-PPGM at 3 months will be correlated with the presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy.
Secondary Outcome Measures
Other outcome measurements
The value of Day 0, 3 months or 1year EUS-PPG would be correlated with the severity of cirrhosis, re-bleeding, number of sessions of repeated EVL and mortality at 1 year. Safety of the procedure would also be assessed as 30-day adverse events.
Full Information
NCT ID
NCT05597488
First Posted
October 20, 2022
Last Updated
August 30, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05597488
Brief Title
EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.
Official Title
EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the current study is to assess if EUS-PPGM could predict the treatment response and outcomes of varices to endoscopic variceal ligation (EVL) in patients with chronic hepatitis. The hypothesis is that a high EUS-PPGM value at 3 months correlates with the presence of varices requiring EVL in patients that have received primary or secondary variceal prophylaxis on 1 year follow-up upper endoscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis Portal
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EUS guided portal pressure gradient measurement
Arm Type
Experimental
Arm Description
At index OGD, the presence and severity of OV, GV and portal hypertensive gastropathy would be recorded. After endoscopic treatment of varices, recruited patients would undergo 1st measurement of EUS-PPG within 10-14 days after index OGD. The patients would then be enrolled into a variceal surveillance program and be started on B-blockers if not already prescribed. The patients would then be scheduled for another follow-up OGD at 3 months with measurement of the 2nd EUS-PPG. Finally, a third follow-up OGD and EUS-PPG would be performed in 1-year after 1st EUS-PPG. Endoscopic findings attributed to chronic cirrhosis would be assessed in the 3 months and 1 year OGD and the presence and severity of OV, GV and portal hypertensive gastropathy would be recorded.
Intervention Type
Device
Intervention Name(s)
EUS guided portal pressure gradient measurement
Intervention Description
EUS-guided PPGM is performed under monitored anaesthesia. The linear array echoendoscope is passed from the mouth into the stomach and duodenum, as with a standard exam. Under endoscopic ultrasound guidance, a 25 gauge EUS needle (Echotip, Cook Medical, USA) primed with heparin 100 USP/ml is then placed across the stomach or duodenal wall and through the liver parenchyma into the portal vein (Figure 3). A pressure measurement is then obtained from the compact pressure transducer attached to the handle of the needle (Figure 4). Three separate measurements are made with re-priming of heparin (less than 0.5 ml). The needle is then removed from the portal vein and liver, if necessary. The process is repeated for the hepatic vein (Figure 5). The EUS - PPG is calculated by subtracting the average of the three hepatic vein pressure measurements from the average of the 3 direct portal vein pressure measurements.
Primary Outcome Measure Information:
Title
Presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy
Description
The number of patients with a high EUS-PPGM at 3 months will be correlated with the presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Other outcome measurements
Description
The value of Day 0, 3 months or 1year EUS-PPG would be correlated with the severity of cirrhosis, re-bleeding, number of sessions of repeated EVL and mortality at 1 year. Safety of the procedure would also be assessed as 30-day adverse events.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 to 75 years old
Informed consent available
Suffering from chronic hepatitis induced cirrhosis
Suffering from oesophageal varices and received EVL as a result of
Primary variceal prophylaxis during a variceal surveillance program on oesophagogastroduodenoscopy (OGD) or
Secondary variceal prophylaxis after EVL in patients with active oesophageal variceal bleeding
Or bleeding gastric varices that have received endoscopic canoacrylate injection
Exclusion Criteria:
Medical Child-Pugh Class C Uncorrected platelet count <50,000 INR > 1.5 (natural) History of hepatic encephalopathy Current or history of hepatocellular carcinoma
Anatomical Main portal vein thrombosis Anatomic alterations of the hepatic vasculature that prevent access to the portal vein or intrahepatic portion of the hepatic veins (identified at screening and/or during the endoscopic procedure).
Previous history of spontaneous bacterial peritonitis within the previous three months Portopulmonary hypertension Cardiac decompensation
- Endoscopically Confirmed Exclusion Criteria Presence of ascites in the path of the needle that prevents apposition of the gastrointestinal tract and liver.
Presence of gastric or duodenal ulcers, dieulafoy's lesion or cancers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Teoh
Phone
852-35052956
Email
anthonyteoh@surgery.cuhk.edu.hk
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Y Teoh, FRCSEd(Gen)
Phone
35052956
Email
anthonyteoh@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Anthony Y Teoh, FRCSEd(Gen)
12. IPD Sharing Statement
Plan to Share IPD
No
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EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.
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