Helicobacter Pylori InfectionNCT04237220
Endoscopic Biopsy to Detect Helicobacter Pylori
An observational study of Helicobacter Pylori Infection, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
Helicobacter pylori (H. pylori) infection represents one of the most common chronic infections that affect humans.Endoscopy must be performed to take biopsies for detection of Helicobacter pylori in patients with alarm symptoms. The Sydney Protocol is the recommended strategy that guarantees maximum diagnostic yield. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- stomach biopsies
- How many people
- 67 participants
- Where
- 1 siteMexico
- Study dates
- 25 Jan 2020to 20 May 2020
- 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: Patients attending the outpatient Gastroenterology clinic and the Emergency Department of the "Dr. Jose Eleuterio González" University Hospital with a medical indication for performing upper gastrointestinal endoscopy for biopsy and detection of Helicobacter pylori infection.
Who may be able to join
- Older than 18 years
- Have a clinical file.
- Medical indication for upper gastrointestinal endoscopy and biopsy to detect Helicobacter pylori
Who cannot join
- Active gastrointestinal bleeding
- Antibiotic use in the last 30 days
- Hemodynamic instability
- Platelets <50,000 K/µL
- INR >1.5 or PT >50 sec
- Having received eradication treatment for Helicobacter pylori previously.
- History of gastric surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario Dr. Jose E. Gonzalez, Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 64460
About this study
Official title: Comparison of Two Methods for Endoscopic Biopsy to Detect Helicobacter Pylori
Helicobacter pylori (H. pylori) infection represents one of the most common chronic infections that affect humans.Endoscopy must be performed to take biopsies for detection of Helicobacter pylori in patients with alarm symptoms. The Sydney Protocol is the recommended strategy that guarantees maximum diagnostic yield. This is a prospective uncontrolled cross-sectional clinical trial.
Endoscopy must be performed to take biopsies for detection of Helicobacter pylori in patients with epigastric pain, weight loss, iron-deficiency anemia, individuals with dyspepsia over 60 years of age or younger with alarm symptoms (weight loss, dysphagia, vomiting, gastrointestinal bleeding, among others).
The Sydney Protocol is the recommended strategy that guarantees maximum diagnostic yield. Histology is expensive since it requires time for biopsy processing and trained personnel for staining and interpretation but it provides additional information on the degree of inflammation and complications such as atrophic gastritis, intestinal metaplasia, and malignancy. The modified Sydney protocol includes two biopsies from the antrum, two from the body, and one form the incisura.
Read the detailed description
The hypothesis is that the histopathological study of two biopsies obtained from the gastric antrum for the determination of Helicobacter pylori infection has a similar diagnostic yield compared to the gold standard (Sydney protocol). This is a prospective uncontrolled cross-sectional clinical trial.
Patients older than 18 years with a medical indication for performing upper gastrointestinal endoscopy for biopsy and detection of Helicobacter pylori infection in the period from january to May 2020.
A sample size of 67 patients was calculated using the diagnostic test comparison formula, in order to compare the sensitivity and specificity in patients with indications for a biopsy taken with the Sydney protocol from those taken only from the gastric antrum.
Expecting a sensitivity of 89% in the Sydney protocol With a Zα of 1.96 and a maximum amplitude of 7.5% (CI = 15), at least 67 study subjects are required with the two diagnostic tests.
Cold biopsies will be taken using an oval head clamp with a stiletto, 2.3 mm in diameter and 180 cm in length of the gastric mucosa with the current standardized method (Sydney protocol).
The samples will be sent to the pathology service in two bottles with formalin; in one, the two biopsies obtained from the antrum will be labeled as "bottle 1" and in the second bottle obtained from the body and the incisura will be labeled as "bottle 2"; this will be blinded for the pathologist who analyzes the slides.
Samples will be processed in a conventional manner, stained for interpretation with hematoxylin-eosin and Giemsa.
Upon obtaining the pathology report, the data will be analyzed in the SPSS statistical program by 2X2 contingency tables for the determination of the positive predictive value, the negative predictive value, and the sensitivity and specificity of the biopsies taken from the antrum compared to healthy population and those who possess the infection using the gold standard.
In addition, the diagnostic yield of the biopsies taken from the antrum of patients who use PPI or have atrophic gastritis will be analyzed separately.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- stomach biopsies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stomach biopsiesDiagnostic test
To determine the diagnostic performance in the detection of Helicobacter pylori in biopsies taken only from the gastric antrum for the determination of the positive predictive value, the negative predictive value, and sensitivity and specificity.
What is being measured
The primary outcome is the main question the study is designed to answer.
2 Antrum biopsy diagnostic performance
To determine the diagnostic performance in the detection of Helicobacter pylori in biopsies taken only from the gastric antrum for the determination of the positive predictive value, the negative predictive value, and sensitivity and specificity.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start25 Jan 2020
- Primary completion15 May 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Hector Eloy Tamez Perez, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Joel O. Jáquez, M.D., Study director, Hospital Universitario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237220
- Sponsor's protocol ID
- GA19-00004
- Status last verified
- May 2020
- First submitted
- 17 Jan 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Methods for Endoscopic Biopsy to Detect Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT04237220
- Acronym / sponsor ID
- GA19-00004
- Conditions
- Helicobacter Pylori Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 25 Jan 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 23 Jan 2020 (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.
Helicobacter pylori (H. pylori) infection represents one of the most common chronic infections that affect humans.Endoscopy must be performed to take biopsies for detection of Helicobacter pylori in patients with alarm symptoms. The Sydney Protocol is the recommended strategy that guarantees maximum diagnostic yield. This is a prospective uncontrolled cross-sectional clinical trial.
Endoscopy must be performed to take biopsies for detection of Helicobacter pylori in patients with epigastric pain, weight loss, iron-deficiency anemia, individuals with dyspepsia over 60 years of age or younger with alarm symptoms (weight loss, dysphagia, vomiting, gastrointestinal bleeding, among others).
The Sydney Protocol is the recommended strategy that guarantees maximum diagnostic yield. Histology is expensive since it requires time for biopsy processing and trained personnel for staining and interpretation but it provides additional information on the degree of inflammation and complications such as atrophic gastritis, intestinal metaplasia, and malignancy. The modified Sydney protocol includes two biopsies from the antrum, two from the body, and one form the incisura.
Detailed description
The hypothesis is that the histopathological study of two biopsies obtained from the gastric antrum for the determination of Helicobacter pylori infection has a similar diagnostic yield compared to the gold standard (Sydney protocol). This is a prospective uncontrolled cross-sectional clinical trial.
Patients older than 18 years with a medical indication for performing upper gastrointestinal endoscopy for biopsy and detection of Helicobacter pylori infection in the period from january to May 2020.
A sample size of 67 patients was calculated using the diagnostic test comparison formula, in order to compare the sensitivity and specificity in patients with indications for a biopsy taken with the Sydney protocol from those taken only from the gastric antrum.
Expecting a sensitivity of 89% in the Sydney protocol With a Zα of 1.96 and a maximum amplitude of 7.5% (CI = 15), at least 67 study subjects are required with the two diagnostic tests.
Cold biopsies will be taken using an oval head clamp with a stiletto, 2.3 mm in diameter and 180 cm in length of the gastric mucosa with the current standardized method (Sydney protocol).
The samples will be sent to the pathology service in two bottles with formalin; in one, the two biopsies obtained from the antrum will be labeled as "bottle 1" and in the second bottle obtained from the body and the incisura will be labeled as "bottle 2"; this will be blinded for the pathologist who analyzes the slides.
Samples will be processed in a conventional manner, stained for interpretation with hematoxylin-eosin and Giemsa.
Upon obtaining the pathology report, the data will be analyzed in the SPSS statistical program by 2X2 contingency tables for the determination of the positive predictive value, the negative predictive value, and the sensitivity and specificity of the biopsies taken from the antrum compared to healthy population and those who possess the infection using the gold standard.
In addition, the diagnostic yield of the biopsies taken from the antrum of patients who use PPI or have atrophic gastritis will be analyzed separately.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending the outpatient Gastroenterology clinic and the Emergency Department of the "Dr. Jose Eleuterio González" University Hospital with a medical indication for performing upper gastrointestinal endoscopy for biopsy and detection of Helicobacter pylori infection.
Key inclusion criteria (3 listed)
- Older than 18 years
- Have a clinical file.
- Medical indication for upper gastrointestinal endoscopy and biopsy to detect Helicobacter pylori
Key exclusion criteria (8 listed)
- Active gastrointestinal bleeding
- Antibiotic use in the last 30 days
- Hemodynamic instability
- Platelets <50,000 K/µL
- INR >1.5 or PT >50 sec
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 |
|---|---|---|
| stomach biopsiesTo determine the diagnostic performance in the detection of Helicobacter pylori in biopsies taken only from the gastric antrum for the determination of the positive predictive value, the negative predictive value, and sensitivity and specificity. | Diagnostic test | – |
Primary outcome
2 Antrum biopsy diagnostic performance
Time frame: 7 days
To determine the diagnostic performance in the detection of Helicobacter pylori in biopsies taken only from the gastric antrum for the determination of the positive predictive value, the negative predictive value, and sensitivity and specificity.
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 22 May 2020.
- Individual participant dataSharing planned: No
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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.
Joel O. Jáquez, M.D. study director
Hospital Universitario
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 Helicobacter Pylori Infection, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 3 inclusion and 8 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 22 May 2020. 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 Mexico. 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?
2 Antrum biopsy diagnostic performance (time frame: 7 days). 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 22 May 2020.