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Impact of Fentanyl Analgesia on the Accuracy of HVPG Measurements in Patients With Portal Hypertension

Primary Purpose

Liver Cirrhosis, Portal Hypertension, Pain

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fentanyl
Sponsored by
Hepatopancreatobiliary Surgery Institute of Gansu Province
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring hepatic venous pressure gradient, fentanyl

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with cirrhosis and portal hypertension undergoing elective TIPS placement
  • ASAⅠ~Ⅲ

Exclusion Criteria:

  • Patients with portal vein thrombosis and vein-to-vein communications
  • Refusal of consent
  • Presence of allergy to fentanyl

Sites / Locations

  • The First Hospital of Lanzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Injecting 1~2mg/kg fentanyl intravenously.

Arm Description

Measuring HVPG after the preparation of TIPS in patients with portal hypertension; Measuring HVPG again 5 minutes later after injecting 1~2mg/kg fentanyl intravenously.

Outcomes

Primary Outcome Measures

Accuracy of HVPG
To assess whether fentanyl would affect the accuracy of hepatic venous pressure gradient measurements in patients with cirrhosis.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2021
Last Updated
April 23, 2023
Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
Collaborators
LanZhou University, Lishui hospital of Zhejiang University, The First Affiliated Hospital with Nanjing Medical University, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04724148
Brief Title
Impact of Fentanyl Analgesia on the Accuracy of HVPG Measurements in Patients With Portal Hypertension
Official Title
Impact of Fentanyl Analgesia on the Accuracy of Hepatic Venous Pressure Gradient Measurements in Patients With Portal Hypertension:a Prospective, Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
Collaborators
LanZhou University, Lishui hospital of Zhejiang University, The First Affiliated Hospital with Nanjing Medical University, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Portal hypertension is a common complication of chronic liver disease and is associated with most clinical consequences of cirrhosis. The most reliable method for assessing portal hypertension is the measurement of the hepatic venous pressure gradient (HVPG). The HVPG is the gold-standard methods for assessing clinically significant portal hypertension and becoming increasingly used clinically. It is useful in the differential diagnosis of portal hypertension and provides a prognostic index in cirrhotic patients. Many patients are painful and reluctant to undergo serial HVPG measurements. But interventionists are reluctant to use analgesics because they always pay more attention to the accuracy of HVPG measurements.Although Adam F. et al concluded that low-dose midazolam sedation is an option for patients undergoing serial hepatic venous pressure measurements (Hepatology 1999), the effects of using opioid analgesics alone on hepatic venous pressure measurements have not yet been defined. The objective of this study was to evaluate the effects of fentanyl on the HVPG.
Detailed Description
Portal hypertension is a common complication of chronic liver disease and is associated with most clinical consequences of cirrhosis. The most reliable method for assessing portal hypertension is the measurement of the hepatic venous pressure gradient (HVPG). The HVPG is the gold-standard methods for assessing clinically significant portal hypertension and becoming increasingly used clinically. It is useful in the differential diagnosis of portal hypertension and provides a prognostic index in cirrhotic patients. Many patients are painful and reluctant to undergo serial HVPG measurements. But interventionists are reluctant to use analgesics because they always pay more attention to the accuracy of HVPG measurements. May be since it is difficult to monitor HVPG for anesthesiologist during liver surgery, there are very few and controversial studies on the effects of sedation and analgesics on HVPG. M. Susan Mandell et al concluded that desflurane alters HVPG measurements, whereas propofol did not change it (Anesth Analg 2003). However, Enric Reverter et al considered that deep sedation with propofol and remifentanil adds substantial variability and uncertainty to HVPG measurements (Liver International 2013). Although Adam F. et al concluded that low-dose midazolam sedation is an option for patients undergoing serial hepatic venous pressure measurements (Hepatology 1999), the effects of using opioid analgesics alone on hepatic venous pressure measurements have not yet been defined. The objective of this study was to evaluate the effects of fentanyl on the HVPG measurements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Portal Hypertension, Pain
Keywords
hepatic venous pressure gradient, fentanyl

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Injecting 1~2mg/kg fentanyl intravenously.
Arm Type
Experimental
Arm Description
Measuring HVPG after the preparation of TIPS in patients with portal hypertension; Measuring HVPG again 5 minutes later after injecting 1~2mg/kg fentanyl intravenously.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
To assess the accuracy of HVPG in TIPS after injecting a dose of 1~2 mg/kg fentanyl.
Primary Outcome Measure Information:
Title
Accuracy of HVPG
Description
To assess whether fentanyl would affect the accuracy of hepatic venous pressure gradient measurements in patients with cirrhosis.
Time Frame
1~2 hours

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: Patients with cirrhosis and portal hypertension undergoing elective TIPS placement ASAⅠ~Ⅲ Exclusion Criteria: Patients with portal vein thrombosis and vein-to-vein communications Refusal of consent Presence of allergy to fentanyl
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaolong Qi, MD
Phone
+8618588602600
Ext
+8618588602600
Email
qixiaolong@vip.163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haijun Zhang, MD
Phone
+8618215160461
Ext
+8618215160461
Email
zhanghj19@lzu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaolong Qi, MD
Organizational Affiliation
LanZhou University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xun Li, MD
Organizational Affiliation
LanZhou University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Haijun Zhang, MD
Organizational Affiliation
LanZhou University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lei Li, MD
Organizational Affiliation
LanZhou University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zhongwei Zhao, MD
Organizational Affiliation
Lishui hospital of Zhejiang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiansong Ji, PHD
Organizational Affiliation
Lishui hospital of Zhejiang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chuan guang Wang, Master
Organizational Affiliation
Lishui hospital of Zhejiang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Wu
Organizational Affiliation
Lishui hospital of Zhejiang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lili Yang
Organizational Affiliation
Lishui hospital of Zhejiang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yulan Li, MD
Organizational Affiliation
LanZhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
YuJiang Yin
Organizational Affiliation
LanZhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Yang, master
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zi Niu Yu, MD
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wentao Wu, master
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xujun Yang, master
Organizational Affiliation
LanZhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shuangxi Li
Organizational Affiliation
LanZhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fangyu Xu
Organizational Affiliation
LanZhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weizhong Zhou, MD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xun Li, MD
First Name & Middle Initial & Last Name & Degree
Xun Li, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
10094948
Citation
Steinlauf AF, Garcia-Tsao G, Zakko MF, Dickey K, Gupta T, Groszmann RJ. Low-dose midazolam sedation: an option for patients undergoing serial hepatic venous pressure measurements. Hepatology. 1999 Apr;29(4):1070-3. doi: 10.1002/hep.510290421.
Results Reference
background
PubMed Identifier
23763484
Citation
Reverter E, Blasi A, Abraldes JG, Martinez-Palli G, Seijo S, Turon F, Berzigotti A, Balust J, Bosch J, Garcia-Pagan JC. Impact of deep sedation on the accuracy of hepatic and portal venous pressure measurements in patients with cirrhosis. Liver Int. 2014 Jan;34(1):16-25. doi: 10.1111/liv.12229. Epub 2013 Jun 13.
Results Reference
background
PubMed Identifier
14633521
Citation
Mandell MS, Durham J, Kumpe D, Trotter JF, Everson GT, Niemann CU. The effects of desflurane and propofol on portosystemic pressure in patients with portal hypertension. Anesth Analg. 2003 Dec;97(6):1573-1577. doi: 10.1213/01.ANE.0000090741.63156.1B.
Results Reference
background
PubMed Identifier
30616313
Citation
Chinese Portal Hypertension Diagnosis and Monitoring Study Group (CHESS); Minimally Invasive Intervention Collaborative Group, Chinese Society of Gastroenterology; Emergency Intervention Committee, Chinese College of Interventionalists; Hepatobiliary Diseases Collaborative Group, Chinese Society of Gastroenterology; Spleen and Portal Hypertension Group, Chinese Society of Surgery; Fatty Liver and Alcoholic Liver Disease Group, Chineses Society of Hepatology; Chinese Research Hospital Association for the Study of the Liver; Hepatobiliary and Pancreatic Diseases Prevention and Control Committee, Chinese Preventive Medicine Association; Chinese Society of Digital Medicine; Chinese Society of Clinical Epidemiology and Evidence Based Medicine. [Consensus on clinical application of hepatic venous pressure gradient in China (2018)]. Zhonghua Gan Zang Bing Za Zhi. 2018 Nov 20;26(11):801-812. doi: 10.3760/cma.j.issn.1007-3418.2018.11.001. No abstract available. Chinese.
Results Reference
background
PubMed Identifier
30215362
Citation
Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.
Results Reference
background
PubMed Identifier
30457484
Citation
Qi X, An W, Liu F, Qi R, Wang L, Liu Y, Liu C, Xiang Y, Hui J, Liu Z, Qi X, Liu C, Peng B, Ding H, Yang Y, He X, Hou J, Tian J, Li Z. Virtual Hepatic Venous Pressure Gradient with CT Angiography (CHESS 1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension. Radiology. 2019 Feb;290(2):370-377. doi: 10.1148/radiol.2018180425. Epub 2018 Nov 20.
Results Reference
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Impact of Fentanyl Analgesia on the Accuracy of HVPG Measurements in Patients With Portal Hypertension

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