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

Gastric Slow Wave and Autonomic Nervous Function in Cirrhotic Patients With

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Varices in Cirrhosis of the Liver
• Intervention / Treatment: Diagnostic test: Electrogastrogram(EGG); Diagnostic test: Heart Rate Variability(HRV)

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • First Affiliated Hospital of Nanjing Medical Universit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

20 patients with cirrhotic esophageal varices who were admitted to the First Affiliated Hospital of Nanjing Medical University since May 2019. Eight patients with gastric polyps were randomly selected as controls.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with cirrhosis of esophageal varices	Diagnostic test: Electrogastrogram(EGG); Heart Rate Variability; Diagnostic test: Heart Rate Variability(HRV); Heart Rate Variability
Patients with gastric polyps	Diagnostic test: Electrogastrogram(EGG); Heart Rate Variability; Diagnostic test: Heart Rate Variability(HRV); Heart Rate Variability

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Actual): July 24, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Liver Diseases; Fibrosis; Esophageal Diseases; Hypertension, Portal; Liver Cirrhosis; Esophageal and Gastric Varices
• Other Study ID Numbers: 2019-SR-086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No