The Predictive Value of Alarm Symptoms in Patients With Dyspepsia Based on Roman IV

January 10, 2019 updated by: Second Affiliated Hospital of Xi'an Jiaotong University
Functional dyspepsia is one of the most common gastrointestinal disorders (FGIDs) encountered in clinical practice.Clinical diagnosis is notoriously unreliable in diagnosing the underlying cause of dyspepsia,but a number of alarm features have been suggested as indicating patients at higher risk for serious disease. The predictive value of alarm symptoms still require more researches. Rome IV introduced more precisely define the minimal thresholds for frequency and severity of each individual symptom, primarily for scientific purposes,but data still need to be collected to define thresholds based on the frequency and/or severity of symptoms that impair quality of life.A cross-sectional study was conducted to assess the predictive value of alarm symptoms in patients with dyspepsia based on Roman IV.Through endoscopy results to determine whether dyspepsia is organic or functional, benign or malignant, through contacts with the basic data, to determine the alarm symptoms

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Functional dyspepsia is one of the most common gastrointestinal disorders (FGIDs) encountered in clinical practice. Functional dyspepsia is a clinical syndrome characterized by chronic and recurrent gastroduodenal symptoms in the absence of any organic or metabolic disease that is likely to explain the symptoms.Functional dyspepsia has a high incidence in the population.Clinical diagnosis is notoriously unreliable in diagnosing the underlying cause of dyspepsia,but a number of alarm features have been suggested as indicating patients at higher risk for serious disease.However, previous studies noted that the sensitivity of alarm features for predicting cases with upper GI malignancies is unsatisfactory. The predictive value of alarm symptoms still require more researches. Rome IV was introduced in 2016. Rome IV introduced more precisely define the minimal thresholds for frequency and severity of each individual symptom, primarily for scientific purposes,but data still need to be collected to define thresholds based on the frequency and/or severity of symptoms that impair quality of life.A cross-sectional study was conducted to assess the predictive value of alarm symptoms in patients with dyspepsia based on Roman IV.All patients who were satisfied with the inclusion criteria and exclusion criteria in the department of the second affiliated hospital of Xi'an jiaotong university, Xijing Hospital, Tangdu Hospital, Xi'an No.3 Hospital, and received investigation.Inclusion criteria included:Symptoms of upper digestive tract for more than 6 months or 3 monthes（postprandial fullness, early satiation,epigastric pain, and epigastric burning）;Older than 18;From March 2018 to January 2011，received gastroscope and upper abdominal B ultrasound examination;agreeing the informed consent.Data collection:Basic information：name, age, height, weight, gender, marriage;Dyspepsia: symptoms of indigestion, duration of indigestion, and weekly incidence of indigestion;Abnormal symptoms: weight loss, anemia, anorexia, vomiting, blackstool, dysphagia;Lifestyle habits: spicy food, smoking, drinking, sleep quality, daily exercise time;Family history, helicobacter pylori infection, abdominal color ultrasound results,Cost.Through endoscopy results to determine whether dyspepsia is organic or functional, benign or malignant, through contacts with the basic data, to determine the alarm symptoms.Further more, this study was proved by the ethical committee of second hospital of Xi'an jiaotong university.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanxi
      • Xi'an, Shanxi, China, 710004
        • Recruiting
        • The second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

From March 2018 to August 2018 ，patient went to the Gastroenterology clinics of the second affiliated hospital of xi'an jiaotong university, Xijing Hospital, Tangdu Hospital, Xi'an No.3 Hospital, and received gastroscopy.

Description

Inclusion criteria:

  1. Aged 18 years and older;
  2. Presence of dyspeptic symptoms according with Rome IV criteria (Discomfort was characterized by the presence of one or more symptoms that included bothersome postprandial fullness, bothersome early satiation, bothersome epigastric pain, bothersome epigastric burning, Symptoms had to be present for at least 3 months within the preceding 6 months);
  3. From March 2018 to January 2019, patient went to the Gastroenterology clinics of the second affiliated hospital of xi'an jiaotong university, Xijing Hospital, Tangdu Hospital, Xi'an No.3 Hospital, and received gastroscopy;
  4. Upper abdominal ultrasonography, blood routine examination, liver function test were conducted within six months.

Exclusion criteria:

  1. History of esophagitis or ulcer disease or other organic upper gastrointestinal disease, pancreaticobiliary disease, metabolic disease(abnormal thyroid function, diabetes );
  2. Were pregnant, might become pregnant, or were lactating;
  3. Major abdominal surgery;
  4. Severe neurological disorder, psychological diseases; or with severe hepatic, renal or respiratory dysfunction;
  5. Known or suspected liver dysfunction, including NASH, HBV or HCV-related hepatitis;
  6. History of gastroscope within 1 year;

(6) Current antidepressant, steroids or NSAID use; (7) Patients who had only reflux-related symptoms or who had predominantly reflux-related symptoms; (8) Not willing to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Dyspepsia
All patients who were satisfied with the inclusion criteria and exclusion criteria in the department of the second affiliated hospital of Xi'an jiaotong university,Xijing Hospital, Tangdu Hospital, Xi'an No.3 Hospital, and received investigation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of organic dyspepsia.
Time Frame: 3 months
To collect the results of gastroscopy in patients who meet inclusion criteria, and to calculate the incidence of organic dyspepsia to analyze the predictive value of alarm symptoms.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of gastric cancer
Time Frame: 3 months
To collect the results of gastroscopy in patients who meet inclusion criteria, and to calculate the incidence of gastric cancer to analyze the predictive value of alarm symptoms.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital of Xi'an Jiaotong University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xijing Hospital
Tang-Du Hospital
Xi'an No.3 Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jinhai Wang, MD, The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an, Shaanxi, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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