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

NCT04125875 | Completed

• 1 other identifier: 2019-SR-086
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Varices in Cirrhosis of the Liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Patients with cirrhosis of esophageal varices

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

Patients with gastric polyps

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

Interventions

Electrogastrogram(EGG) DIAGNOSTIC_TEST

Heart Rate Variability

Patients with cirrhosis of esophageal varices; Patients with gastric polyps

Heart Rate Variability(HRV) DIAGNOSTIC_TEST

Heart Rate Variability

Patients with cirrhosis of esophageal varices; Patients with gastric polyps

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical Universit

Nanjing, Jiangsu, 210029, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: October 14, 2019
• Study Start: May 23, 2019
• Primary Completion: July 24, 2019
• Study Completion: July 31, 2019
• Last Updated: October 14, 2019

Record last verified: 2019-08

Locations

CN (1)