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Completed

NCT Number: NCT04125875

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

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.

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Key information

Conditions

Esophageal Varices in Cirrhosis of the Liver

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Nanjing Medical Universit

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrogastrogram(EGG)

Diagnostic Test

Heart Rate Variability

Heart Rate Variability(HRV)

Diagnostic Test

Heart Rate Variability

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

    Time frame: 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 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Gastric Slow Wave and Autonomic Nervous Function in Cirrhotic Patients With

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 14, 2019
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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