Clinical Trials Logo

Clinical 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. 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


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05046990
Study type Observational
Source Hospital Clinic of Barcelona
Contact Gloria Fernandez-Esparrach, PhD
Phone +34932275400
Email mgfernan@clinic.cat
Status Recruiting
Phase
Start date December 1, 2021
Completion date September 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05061732 - Helicobacter Pylori Eradication and Follow-up Phase 4
Completed NCT03779074 - Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies Phase 3
Completed NCT06076681 - A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Phase 1/Phase 2
Recruiting NCT05329636 - Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy Phase 1/Phase 2
Recruiting NCT05065138 - Comparison of Helicobacter Pylori Eradication Effect Before and After Training of Gastroenterologists N/A
Completed NCT05049902 - Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication Phase 4
Not yet recruiting NCT06200779 - Tailored vs. Empirical Helicobacter Pylori Infection Treatment Phase 4
Not yet recruiting NCT06037122 - Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication
Completed NCT04617613 - Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait Phase 4
Completed NCT02873247 - Standardize Communication With General Practitioner & Patient for Improved Eradication of Helicobacter Pylori
Completed NCT02557932 - Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication Phase 3
Withdrawn NCT02552641 - Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole Phase 4
Recruiting NCT02249546 - Efficacy of Acetylcysteine-containing Triple Therapy in the First Line of Helicobacter Pylori Infection Phase 4
Completed NCT01933659 - Anti-H. Pylori Effect of Deep See Water Phase 3
Unknown status NCT01464060 - 14-day Quadruple Hybrid vs. Concomitant Therapies for Helicobacter Pylori Eradication Phase 4
Completed NCT00841490 - Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults N/A
Recruiting NCT05549115 - Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection N/A
Recruiting NCT05728424 - One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL Phase 3
Recruiting NCT05997433 - Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori(SHARE2302) N/A
Completed NCT04708405 - The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation