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

NCT03479528 | Unknown

• 1 other identifier: 2018013
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dyspepsia

Keywords

Dyspepsia,alarm symptoms，Roman IV

Outcome Measures

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.

  3 months

Secondary Outcomes (1)

• The incidence of gastric cancer

  3 months

Study Arms (1)

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.

Eligibility Criteria

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

You may qualify if:

• Aged 18 years and older;
• 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);
• 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;
• Upper abdominal ultrasonography, blood routine examination, liver function test were conducted within six months.

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead
• Xijing Hospital: collaborator
• Tang-Du Hospital: collaborator
• Xi'an No.3 Hospital: collaborator

Study Sites (1)

The second affiliated hospital of xi'an jiaotong university

Xi’an, Shanxi, 710004, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 33512804 DERIVED

• 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.

  PMID: 32874062 DERIVED

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jinhai Wang, MD

  The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an, Shaanxi, China

  STUDY DIRECTOR

Central Study Contacts

Jinhai Wang, MD

CONTACT

+86-29-18700932477; jinhaiwang@hotmail.com

Zhongcao Wei

CONTACT

+86-29-18700932477; 1977816504@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 27, 2018
• Study Start: March 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: January 14, 2019

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)