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

Completed

• Conditions: Esophageal Varices in Cirrhosis of the Liver
• Interventions: Diagnostic Test: Electrogastrogram(EGG); Diagnostic Test: Heart Rate Variability(HRV)

• Registration Number: NCT04125875
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-23
• Primary Completion: 2019-07-24
• Study Completion: 2019-07-31
• Status Verified: 2019-08
• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-10-11
• Last Update Submitted: 2019-10-11
• Study First Posted: 2019-10-14
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

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Exclusion Criteria

• Hemorrhage in the digestive tract, unstable vital signs
• Hepatic encephalopathy
• Unwilling to cooperate with the examiner
• Skin allergies

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with cirrhosis of esophageal varices	Electrogastrogram(EGG)	-
Patients with gastric polyps	Electrogastrogram(EGG)	-
Patients with cirrhosis of esophageal varices	Heart Rate Variability(HRV)	-
Patients with gastric polyps	Heart Rate Variability(HRV)	-

Primary Outcome Measures

Name	Time	Method
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	before the surgery, 1 day after the surgery, and 5 days after 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

Secondary Outcome Measures

Name	Time	Method
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	before the surgery, 1 day afterthe surgery, and 5 days after surgery	HRV assesses the balance of the patient's autonomic nervous system with high frequency (HF) / low frequency (LF)

Trial Locations

Locations (1)

First Affiliated Hospital of Nanjing Medical Universit; 🇨🇳 Nanjing, Jiangsu, China