Clinical trial NCT04724148: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Portal Hypertension
Pain
Keywords: hepatic venous pressure gradient
fentanyl
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
Collaborators: name: LanZhou University
name: Lishui hospital of Zhejiang University
name: The First Affiliated Hospital with Nanjing Medical University
name: Zhejiang University
First posted: 2021-01-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Accuracy of HVPG
timeFrame: 1~2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
Study officials:
affiliation: LanZhou University
name: Xiaolong Qi, MD
role: STUDY_CHAIR
affiliation: LanZhou University
name: Xun Li, MD
role: STUDY_CHAIR
affiliation: LanZhou University
name: Haijun Zhang, MD
role: STUDY_DIRECTOR
affiliation: LanZhou University
name: Lei Li, MD
role: STUDY_DIRECTOR
affiliation: Lishui hospital of Zhejiang University
name: Zhongwei Zhao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lishui hospital of Zhejiang University
name: Jiansong Ji, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lishui hospital of Zhejiang University
name: Chuan guang Wang, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Lishui hospital of Zhejiang University
name: Wei Wu
role: PRINCIPAL_INVESTIGATOR
affiliation: Lishui hospital of Zhejiang University
name: Lili Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: LanZhou University
name: Yulan Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LanZhou University
name: YuJiang Yin
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Wei Yang, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang University
name: Zi Niu Yu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Wentao Wu, master
role: PRINCIPAL_INVESTIGATOR
affiliation: LanZhou University
name: Xujun Yang, master
role: PRINCIPAL_INVESTIGATOR
affiliation: LanZhou University
name: Shuangxi Li
role: PRINCIPAL_INVESTIGATOR
affiliation: LanZhou University
name: Fangyu Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Weizhong Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.