Gastric Slow Wave and Autonomic Nervous Function in Cirrhotic Patients With Esophageal Varices After Ligation-A Clinical Research

Esophageal Varices in Cirrhosis of the Liver Clinical Trial

Official title:

Gastric Slow Wave and Autonomic Nervous Function in Cirrhotic Patients With

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04125875
• Other study ID #: 2019-SR-086
• Status: Completed
• Start date: May 23, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2019
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is intended to include 20 patients with esophageal varices caused by liver cirrhosis who were admitted to the first affiliated hospital of nanjing medical university from May 2019, and randomly select 8 patients with gastric polyps as the control group.General clinical data, imaging data, endoscopic data and laboratory indicators were collected.Electrogastrogram (EGG) and Heart Rate Variability (HRV) were performed before and 24 hours after operation in patients with cirrhotic esophageal varices, and the dyspepsia scale was filled out.Electrogastrogram (EGG) and cardiac variability (HRV) were performed in patients with gastric polyps 24 hours before and after surgery, and the dyspepsia scale was filled.EGG uses the surface electrode to record gastric myoelectric activity, and evaluates the patient's gastric rhythm by normal slow wave ratio, overspeed ratio, overslow ratio, and rhythm disorder ratio.The HRV evaluates the balance state of the patient's autonomic nervous system with High Frequency (HF)/Low Frequency (LF).SPSS software was used for paired sample analysis of experimental results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 31, 2019
• Est. primary completion date: July 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years old with cirrhosis of esophageal varices who underwent endoscopic ligation

• Signed informed consent

Exclusion Criteria:

• Hemorrhage in the digestive tract, unstable vital signs

• Hepatic encephalopathy

• Unwilling to cooperate with the examiner

• Skin allergies

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Esophageal Varices in Cirrhosis of the Liver
• Liver Cirrhosis

Intervention

Diagnostic Test:
• Electrogastrogram(EGG)
Heart Rate Variability
• Heart Rate Variability(HRV)
Heart Rate Variability

Locations

Country	Name	City	State
China	First Affiliated Hospital of Nanjing Medical Universit	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric Slow Wave of patients before the surgery, Change from Baseline Gastric Slow Wave 1 day after the surgery ,Change from Baseline Gastric Slow Wave 5 days after the surgery	EGG evaluate patient's gastric electrical rhythm by normal slow wave ratio, overspeed ratio, overslow ratio, and rhythm disorder ratio Evaluating patient's gastric electrical rhythm by normal slow wave ratio, overspeed ratio, overslow ratio, and rhythm disorder ratio Evaluating patient's gastric electrical rhythm by normal slow wave ratio, overspeed ratio, overslow ratio, and rhythm disorder ratio Evaluating patient's gastric electrical rhythm by normal slow wave ratio, overspeed ratio, overslow ratio, and rhythm disorder ratio	before the surgery, 1 day after the surgery, and 5 days after surgery
Secondary	LF/HF of patients before the surgery, Change from Baseline LF/HF 1 day after the surgery ,Change from Baseline LF/HF 5 days after the surgery	HRV assesses the balance of the patient's autonomic nervous system with high frequency (HF) / low frequency (LF)	before the surgery, 1 day afterthe surgery, and 5 days after surgery