Esophageal Varices in Cirrhosis of the LiverNCT04125875
Gastric Slow Wave and Autonomic Nervous Function in Cirrhotic Patients With Esophageal Varices After Ligation-A Clinical Research
An observational study of Esophageal Varices in Cirrhosis of the Liver, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Varices in Cirrhosis of the Liver
- What is being tested?
- Electrogastrogram(EGG) and Heart Rate Variability(HRV)
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2019to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients over 18 years old with cirrhosis of esophageal varices who underwent endoscopic ligation
- Signed informed consent
Who cannot join
- Hemorrhage in the digestive tract, unstable vital signs
- Hepatic encephalopathy
- Unwilling to cooperate with the examiner
- Skin allergies
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Nanjing Medical Universit
Nanjing, Jiangsu, 210029
About this study
Official title: 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.
- Being tested
- Electrogastrogram(EGG), Heart Rate Variability(HRV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrogastrogram(EGG)Diagnostic test
Heart Rate Variability
Heart Rate Variability(HRV)Diagnostic test
Heart Rate Variability
| Study group | Role | What they receive |
|---|---|---|
| Patients with cirrhosis of esophageal varices | Not described Receives: Diagnostic Test: Electrogastrogram(EGG); Diagnostic Test: Heart Rate Variability(HRV) | |
| Patients with gastric polyps | Not described Receives: Diagnostic Test: Electrogastrogram(EGG); Diagnostic Test: Heart Rate Variability(HRV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
HRV assesses the balance of the patient's autonomic nervous system with high frequency (HF) / low frequency (LF)
Measured: before the surgery, 1 day afterthe surgery, and 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start23 May 2019
- Primary completion24 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Varices in Cirrhosis of the LiverStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125875
- Sponsor's protocol ID
- 2019-SR-086
- Status last verified
- Aug 2019
- First submitted
- 5 Aug 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Slow Wave and Autonomic Nervous Function in Cirrhotic Patients With
- ClinicalTrials.gov ID
- NCT04125875
- Acronym / sponsor ID
- 2019-SR-086
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 23 May 2019 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients over 18 years old with cirrhosis of esophageal varices who underwent endoscopic ligation
- Signed informed consent
Key exclusion criteria (4 listed)
- Hemorrhage in the digestive tract, unstable vital signs
- Hepatic encephalopathy
- Unwilling to cooperate with the examiner
- Skin allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrogastrogram(EGG)Heart Rate Variability | Diagnostic test | Patients with cirrhosis of esophageal varices, Patients with gastric polyps |
| Heart Rate Variability(HRV)Heart Rate Variability | Diagnostic test | Patients with cirrhosis of esophageal varices, Patients with gastric polyps |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Varices in Cirrhosis of the Liver, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.