Ignite Creation Date:
2024-05-06 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05046990
Status:
RECRUITING
Last Update Posted:
2023-03-01
First Post:
2021-09-06
Brief Title:
Arrangement of Collecting Venules for the Endoscopic Diagnosis of Helicobacter Pylori
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Arrangement of Collecting Venules for the Endoscopic Diagnosis of Helicobacter Pylori Infection MOTIVATION International Multicentre Study Outside Asia
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOTIVATION
Brief 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
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
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 Sydneys 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 HE and special staining for Hp eg modified Giemsa In patients taking PPI if Hp is negative in the HE histological study the study will be completed by immunohistochemical IHC staining
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 Sydneys 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 HE and special staining for Hp eg modified Giemsa In patients taking PPI if Hp is negative in the HE histological study the study will be completed by immunohistochemical IHC staining
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None