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

NCT04724148 | Unknown

• 1 other identifier: Fentanyl and HVPG
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Portal Hypertension; Pain

Keywords

hepatic venous pressure gradient; fentanyl

Outcome Measures

Primary Outcomes (1)

• Accuracy of HVPG

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

  1~2 hours

Study Arms (1)

Injecting 1~2mg/kg fentanyl intravenously.

EXPERIMENTAL

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

Drug: Fentanyl

Interventions

Fentanyl DRUG

To assess the accuracy of HVPG in TIPS after injecting a dose of 1\~2 mg/kg fentanyl.

Injecting 1~2mg/kg fentanyl intravenously.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead
• LanZhou University: collaborator
• Lishui hospital of Zhejiang University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Zhejiang University: collaborator

Study Sites (1)

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 10094948 BACKGROUND

• 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.

  PMID: 23763484 BACKGROUND

• 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.

  PMID: 14633521 BACKGROUND

• 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.

  PMID: 30616313 BACKGROUND

• 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.

  PMID: 30215362 BACKGROUND

• 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.

  PMID: 30457484 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiaolong Qi, MD

  LanZhou University

  STUDY CHAIR

• Xun Li, MD

  LanZhou University

  STUDY CHAIR

• Haijun Zhang, MD

  LanZhou University

  STUDY DIRECTOR

• Lei Li, MD

  LanZhou University

  STUDY DIRECTOR

• Zhongwei Zhao, MD

  Lishui hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

• Jiansong Ji, PHD

  Lishui hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

• Chuan guang Wang, Master

  Lishui hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

• Wei Wu

  Lishui hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

• Lili Yang

  Lishui hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

• Yulan Li, MD

  LanZhou University

  PRINCIPAL INVESTIGATOR

• YuJiang Yin

  LanZhou University

  PRINCIPAL INVESTIGATOR

• Wei Yang, master

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Zi Niu Yu, MD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

• Wentao Wu, master

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Xujun Yang, master

  LanZhou University

  PRINCIPAL INVESTIGATOR

• Shuangxi Li

  LanZhou University

  PRINCIPAL INVESTIGATOR

• Fangyu Xu

  LanZhou University

  PRINCIPAL INVESTIGATOR

• Weizhong Zhou, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaolong Qi, MD

CONTACT

+8618588602600; qixiaolong@vip.163.com

Haijun Zhang, MD

CONTACT

+8618215160461; zhanghj19@lzu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Institute of Portal Hypertension

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 26, 2021
• Study Start: January 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

CN (1)