Helicobacter Pylori InfectionMOTIVATIONNCT05046990
Arrangement of Collecting Venules for the Endoscopic Diagnosis of Helicobacter Pylori
An observational study of Helicobacter Pylori Infection, run by Hospital Clinic of Barcelona at 5 sites in 3 countries.
Trial summary
To perform a prospective, observational, international, multicentre, in vivo study to assess the performance of regular arrangement of collecting venules (RAC) for the exclusion of Helicobacter pylori (Hp) infection using white light high definition (HD) endoscopy without any kind of zoom or magnification. 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?
- Regular Arrangement of Collecting Venules
- How many people
- 1,000 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 1 Dec 2021to 30 Sep 2023
- 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
- Adult, Older adult
Study population: Patients older than 18 years without previous history of Hp infection or eradication undergoing a gastroscopy in each center
Who may be able to join
- Patients older than 18 years without previous history of Hp infection or eradication undergoing a gastroscopy
Who cannot join
- Patients taking oral anticoagulants (acenocoumarol and new anticoagulants as dabigatran, rivaroxaban, apixaban and edoxaban), NSAIDs or with intake of antibiotics in the last 4 weeks, but aspirin at a dose of 100 mg per day will be included
- Diseases that affect the gastric mucosa and preclude the evaluation of the collecting venules pattern (portal hypertension, gastric lymphoma)
- History of previous gastric cancer or patients in surveillance for preneoplastic lesions (atrophic gastritis/IM),
- Previous gastric surgery,
- Active bleeding or presence of blood or food that would impede a complete mucosal evaluation.
- Negative to participate in the study or inability to provide signed consent
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Spain3 sites, 1 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Gloria Fernandez-Esparrach, PHD, +34932275400, mgfernan@clinic.cat
- Completed
Hospital de Mérida
Mérida, Badajoz, 06800
- Active, not recruiting
Hospital de Viladecans
Viladecans, Barcelona, 08840
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint Luc
Brussels, 1080
Rodrigo GARCES-DURAN, PHD, +32456126169, rodrigogduran@hotmail.com
Germany1 site, 1 recruiting
- Recruiting
München University Hospital
Munich, Bavaria, 80331
Riccardo Vasapolli, MD
About this study
Official title: Arrangement of Collecting Venules for the Endoscopic Diagnosis of Helicobacter Pylori Infection (MOTIVATION): International Multicentre Study Outside Asia
To perform a prospective, observational, international, multicentre, in vivo study to assess the performance of regular arrangement of collecting venules (RAC) for the exclusion of Helicobacter pylori (Hp) infection using white light high definition (HD) endoscopy without any kind of zoom or magnification.
Gold standard will be mucosal biopsies (Sydney protocol) or urease test. Immunohistochemistry (IHC) should be performed in case of a negative histologic study for Hp in patients taking proton pump inhibitors (PPIs).
Read more
Participants will perform a training test with 20 pictures of the distal part of the lesser curvature before starting the inclusion of cases.
Secondary objectives are:
- To assess whether age, sex and PPIs, have an influence on the results of RAC.
- To assess the correlation of atrophic gastritis and intestinal metaplasia (confirmed in histopathological samples) and RAC.
- To assess reproducibility of RAC on real time examinations with different operators and in different countries with different Hp infection prevalence.
Primary and secondary variables
The primary study variable is:
- Endoscopic detection of RAC.
Secondary variables will be considered:
- Sex
- Age
- PPI intake in the last two weeks
- Centre
- Country
- Hp prevalence
- Endoscopist
- Type of endoscope
- Significant findings (need of histological confirmation)
- Atrophic gastritis
- Intestinal metaplasia
- Erosive gastritis
- Benign gastric ulcer
- Gastric adenoma
- Gastric cancer
Read the detailed description
This is a prospective, multicentre, international study without a control group.
Training phase Before starting the inclusion of patients, 20 HD images previously collected by the principal investigator will be sent to each of the study investigators. Pictures will clearly show the RAC pattern present or absent at the level of the distal gastric lesser curvature. In case of doubtful RAC, the pattern shall be considered negative. Investigators will be able to discuss their questions and doubts after the training phase (videoconference).
Endoscopic examination Upper endoscopy will be performed with HD endoscopes and a high-definition screen. Two endoscopists will participate in each hospital. The examination will be performed according to the protocol of each centre. Visualisation of the entire oesophageal, gastric and duodenal surface will be performed as in routine clinical practice. The presence of RAC will be assessed during the gastric exploration with sufficient insufflation and its detection will be considered as the presence of a regular starfish-shaped erythematous punctation in the lower part of the lesser curvature of the gastric body, close to the incisura angularis.
In case of the presence of residues in the gastric cavity that prevent the correct visualisation of the area, water washings shall be performed for the correct characterisation of the mucosa. At least one photo of the described gastric region shall be taken with the image processor system to maintain its high-definition quality. All the data (name, date of birth, clinical record number, date of exploration…) will be removed from the picture to ensure the anonymisation. Subsequently, the photographs will be downloaded and saved in a folder on a network drive of each hospital.
After characterisation of the gastric mucosa, the Hp infection status will be assessed by taking biopsies with a standard forceps for anatomopathological study according to Sydney's protocol (2 in the antrum, 1 in the incisura and 2 in the body). Ideally, biopsies for a urease test will also be obtained.
Histopathological examination Samples shall be fixed in formalin and analysed by the Anatomical Pathology service for histological examination by haematoxylin and eosin (H\&E) and special staining for Hp (e.g. modified Giemsa). In patients taking PPI, if Hp is negative in the H\&E histological study, the study will be completed by immunohistochemical (IHC) staining.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Regular Arrangement of Collecting Venules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Arrangement of Collecting VenulesDiagnostic test
This is a prospective, multicentre, international study without a control group.
| Study group | Role | What they receive |
|---|---|---|
| RAC evaluation | Patients older than 18 years without previous history of Hp infection or eradication undergoing a gastroscopy Receives: Diagnostic Test: Regular Arrangement of Collecting Venules |
What is being measured
The primary outcome is the main question the study is designed to answer.
RAC performance
A total of 1000 consecutive patients with no history of Hp who come for gastroscopy will be included in the study to perform a prospective, observational, international, multicentre, in vivo study to assess the performance of regular arrangement of collecting venules (RAC).
Endoscopists will perform a training test with 20 pictures of the distal part of the lesser curvature before starting the inclusion of cases. 17 different centers will participate in the study and each of them will include between 50 and 100 patients.
Presence of RAC using white light high definition endoscopy without magnification determines the exclusion of Helicobacter pylori (Hp) infection. Gold standard diagnosis test for Hp infection will be histological results by mucosal biopsies (Sydney protocol) or urease test. Immunohistochemistry (IHC) should be performed in case of a negative histologic study for Hp in patients taking proton pump inhibitors (PPIs).
Measured: 12 months
Secondary outcomes (3)
Baseline characteristics
To assess whether age, sex and PPIs, have an influence on the results of RAC in all patients.
Measured: 12 months
Histological correlation
To assess the correlation of atrophic gastritis and intestinal metaplasia (confirmed in histopathological samples) and RAC in all patients.
Measured: 12 months
Reproducibility
To assess reproducibility of RAC on real time examinations with different operators and in different countries with different Hp infection prevalence.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Dec 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gloria Fernandez-Esparrach, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046990
- Sponsor's protocol ID
- HCB-RAC-MOTIVATION
- Acronym
- MOTIVATION
- Status last verified
- Dec 2022
- First submitted
- 6 Sep 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garces-Duran R, Galdin-Ferreyra M, Delgado-Guillena PG, Cuatrecasas M, Cordova H, Garcia-Rodriguez A, Rodrigo-Calvo MT, Jimeno-Ramiro M, Araujo IK, Gines A, Llach J, Fernandez-Esparrach G. Diagnosis of Helicobacter pylori Infection by the Arrangement of Collecting Venules Using White Light Endoscopy: Evaluation of Interobserver Agreement. Dig Dis. 2022;40(3):376-384. doi: 10.1159/000518100. Epub 2021 Jun 30.
PubMed 34348294Garces-Duran R, Garcia-Rodriguez A, Cordova H, Cuatrecasas M, Gines A, Gonzalez-Suarez B, Araujo I, Llach J, Fernandez-Esparrach G. Association between a regular arrangement of collecting venules and absence of Helicobacter pylori infection in a European population. Gastrointest Endosc. 2019 Sep;90(3):461-466. doi: 10.1016/j.gie.2019.05.027. Epub 2019 May 17.
PubMed 31108089
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arrangement of Collecting Venules for the Endoscopic Diagnosis of Helicobacter Pylori Infection (MOTIVATION): International Multicentre Study Outside Asia
- ClinicalTrials.gov ID
- NCT05046990
- Acronym / sponsor ID
- MOTIVATION / HCB-RAC-MOTIVATION
- Conditions
- Helicobacter Pylori Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 16 Sep 2021 (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.
To perform a prospective, observational, international, multicentre, in vivo study to assess the performance of regular arrangement of collecting venules (RAC) for the exclusion of Helicobacter pylori (Hp) infection using white light high definition (HD) endoscopy without any kind of zoom or magnification.
Gold standard will be mucosal biopsies (Sydney protocol) or urease test. Immunohistochemistry (IHC) should be performed in case of a negative histologic study for Hp in patients taking proton pump inhibitors (PPIs).
Participants will perform a training test with 20 pictures of the distal part of the lesser curvature before starting the inclusion of cases.
Secondary objectives are:
- To assess whether age, sex and PPIs, have an influence on the results of RAC.
- To assess the correlation of atrophic gastritis and intestinal metaplasia (confirmed in histopathological samples) and RAC.
- To assess reproducibility of RAC on real time examinations with different operators and in different countries with different Hp infection prevalence.
Primary and secondary variables
The primary study variable is:
- Endoscopic detection of RAC.
Secondary variables will be considered:
- Sex
- Age
- PPI intake in the last two weeks
- Centre
- Country
- Hp prevalence
- Endoscopist
- Type of endoscope
- Significant findings (need of histological confirmation)
- Atrophic gastritis
- Intestinal metaplasia
- Erosive gastritis
- Benign gastric ulcer
- Gastric adenoma
- Gastric cancer
Detailed description
This is a prospective, multicentre, international study without a control group.
Training phase Before starting the inclusion of patients, 20 HD images previously collected by the principal investigator will be sent to each of the study investigators. Pictures will clearly show the RAC pattern present or absent at the level of the distal gastric lesser curvature. In case of doubtful RAC, the pattern shall be considered negative. Investigators will be able to discuss their questions and doubts after the training phase (videoconference).
Endoscopic examination Upper endoscopy will be performed with HD endoscopes and a high-definition screen. Two endoscopists will participate in each hospital. The examination will be performed according to the protocol of each centre. Visualisation of the entire oesophageal, gastric and duodenal surface will be performed as in routine clinical practice. The presence of RAC will be assessed during the gastric exploration with sufficient insufflation and its detection will be considered as the presence of a regular starfish-shaped erythematous punctation in the lower part of the lesser curvature of the gastric body, close to the incisura angularis.
In case of the presence of residues in the gastric cavity that prevent the correct visualisation of the area, water washings shall be performed for the correct characterisation of the mucosa. At least one photo of the described gastric region shall be taken with the image processor system to maintain its high-definition quality. All the data (name, date of birth, clinical record number, date of exploration…) will be removed from the picture to ensure the anonymisation. Subsequently, the photographs will be downloaded and saved in a folder on a network drive of each hospital.
After characterisation of the gastric mucosa, the Hp infection status will be assessed by taking biopsies with a standard forceps for anatomopathological study according to Sydney's protocol (2 in the antrum, 1 in the incisura and 2 in the body). Ideally, biopsies for a urease test will also be obtained.
Histopathological examination Samples shall be fixed in formalin and analysed by the Anatomical Pathology service for histological examination by haematoxylin and eosin (H\&E) and special staining for Hp (e.g. modified Giemsa). In patients taking PPI, if Hp is negative in the H\&E histological study, the study will be completed by immunohistochemical (IHC) staining.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAC evaluation | – | Diagnostic Test: Regular Arrangement of Collecting VenulesPatients older than 18 years without previous history of Hp infection or eradication undergoing a gastroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years without previous history of Hp infection or eradication undergoing a gastroscopy in each center
Key inclusion criteria (1 listed)
- Patients older than 18 years without previous history of Hp infection or eradication undergoing a gastroscopy
Key exclusion criteria (6 listed)
- Patients taking oral anticoagulants (acenocoumarol and new anticoagulants as dabigatran, rivaroxaban, apixaban and edoxaban), NSAIDs or with intake of antibiotics in the last 4 weeks, but aspirin at a dose of 100 mg per day will be included
- Diseases that affect the gastric mucosa and preclude the evaluation of the collecting venules pattern (portal hypertension, gastric lymphoma)
- History of previous gastric cancer or patients in surveillance for preneoplastic lesions (atrophic gastritis/IM),
- Previous gastric surgery,
- Active bleeding or presence of blood or food that would impede a complete mucosal evaluation.
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 |
|---|---|---|
| Regular Arrangement of Collecting VenulesThis is a prospective, multicentre, international study without a control group. | Diagnostic test | RAC evaluation |
Primary outcome
RAC performance
Time frame: 12 months
A total of 1000 consecutive patients with no history of Hp who come for gastroscopy will be included in the study to perform a prospective, observational, international, multicentre, in vivo study to assess the performance of regular arrangement of collecting venules (RAC). Endoscopists will perform a training test with 20 pictures of the distal part of the lesser curvature before starting the inclusion of cases. 17 different centers will participate in the study and each of them will include between 50 and 100 patients. Presence of RAC using white light high definition endoscopy without magnification determines the exclusion of Helicobacter pylori (Hp) infection. Gold standard diagnosis test for Hp infection will be histological results by mucosal biopsies (Sydney protocol) or urease test. Immunohistochemistry (IHC) should be performed in case of a negative histologic study for Hp in patients taking proton pump inhibitors (PPIs).
3 secondary outcomes
Baseline characteristics
Time frame: 12 months
Histological correlation
Time frame: 12 months
Reproducibility
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 34348294Garces-Duran R, Galdin-Ferreyra M, Delgado-Guillena PG, Cuatrecasas M, Cordova H, Garcia-Rodriguez A, Rodrigo-Calvo MT, Jimeno-Ramiro M, Araujo IK, Gines A, Llach J, Fernandez-Esparrach G. Diagnosis of Helicobacter pylori Infection by the Arrangement of Collecting Venules Using White Light Endoscopy: Evaluation of Interobserver Agreement. Dig Dis. 2022;40(3):376-384. doi: 10.1159/000518100. Epub 2021 Jun 30.
- Background: PubMed 31108089Garces-Duran R, Garcia-Rodriguez A, Cordova H, Cuatrecasas M, Gines A, Gonzalez-Suarez B, Araujo I, Llach J, Fernandez-Esparrach G. Association between a regular arrangement of collecting venules and absence of Helicobacter pylori infection in a European population. Gastrointest Endosc. 2019 Sep;90(3):461-466. doi: 10.1016/j.gie.2019.05.027. Epub 2019 May 17.
- 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.
Gloria Fernandez-Esparrach, PhD principal investigator
Hospital Clinic of Barcelona
5 sites in 3 countries: 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 Clinic of Barcelona at 5 sites in 3 countries.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Belgium, Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gloria Fernandez-Esparrach, PhD (+34932275400, mgfernan@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RAC performance (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05046990, which also lists 2 linked publications.
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 1 Mar 2023.