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Status unknownNCT03479528Updated Jan 14, 2019

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

An observational study in Dyspepsia, sponsored by Second Affiliated Hospital of Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-14.

Sponsored by Second Affiliated Hospital of Xi'an Jiaotong University · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dyspepsia

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Keywords

  • Dyspepsia,alarm symptoms,Roman IV
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.

04

Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
800 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. The incidence of organic dyspepsia.

    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.

    Time frame: 3 months

Secondary outcomes

  1. The incidence of gastric cancer

    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.

    Time frame: 3 months

06

Study locations

1 of 1 sites recruiting
  • The second affiliated hospital of xi'an jiaotong university
    Xi'an, Shanxi 710004, China
    Recruiting
07

References and documents

Publications

  • Wei Z, Yang Q, Yang Q, Yang J, Tantai X, Xing X, Xiao C, Pan Y, Liu N, Wang J. Rome III, Rome IV, and Potential Asia Symptom Criteria for Functional Dyspepsia Do Not Reliably Distinguish Functional From Organic Disease. Clin Transl Gastroenterol. 2020 Dec;11(12):e00278. doi: 10.14309/ctg.0000000000000278. PubMed 33512804 ↗
  • Wei ZC, Yang Q, Yang Q, Yang J, Tantai XX, Xing X, Xiao CL, Pan YL, Wang JH, Liu N. Predictive value of alarm symptoms in patients with Rome IV dyspepsia: A cross-sectional study. World J Gastroenterol. 2020 Aug 14;26(30):4523-4536. doi: 10.3748/wjg.v26.i30.4523. PubMed 32874062 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03479528
Lead sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborators
Xijing Hospital, Tang-Du Hospital, Xi'an No.3 Hospital
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Mar 1, 2018
Primary completion
Jan 31, 2019 (estimated)
Completion
Jan 31, 2019 (estimated)
Last update
Jan 14, 2019

Study contacts

Jinhai Wang, MD
Contact
jinhaiwang@hotmail.com
+86-29-18700932477
Zhongcao Wei
Contact
1977816504@qq.com
+86-29-18700932477
Jinhai Wang, MD
study director · The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an, Shaanxi, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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