SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up

Who is this study for? Patients scheduled for upper GI endoscopy with indication for gastric biopsies
What treatments are being studied? Upper gastrointestinal endoscopy
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Introduction: Gastric atrophy and intestinal metaplasia are the principal precursors for gastric cancer and, therefore, are considered gastric premalignant conditions. Although current guidelines recommend surveillance of individuals with these conditions, the best method for its identification and staging (histological vs endoscopy) and the best time schedule for follow-up are still controversial.

Aims: To describe for the first-time patients with premalignant conditions both clinically (familial history), histologically (OLGA/OLGIM; complete/incomplete metaplasia) and endoscopically (EGGIM) using validated scales and to describe evolution of these parameters through time. To estimate prospectively the gastric cancer risk according to EGGIM stages. To define the best endoscopic surveillance follow-up for the several stages considering clinical, histological and endoscopic factors.

Methods: Multicenter study involving different gastroenterology departments from several countries. Consecutive patients older than 45 years scheduled for upper endoscopy in each of these centers will be evaluated by High-Resolution- endoscopy with virtual chromoendoscopy and EGGIM will be calculated. Guided biopsies (if areas suspicious of IM) and/or random biopsies (if no areas suspicious of IM) in antrum and corpus will be made and OLGA/OLGIM stages calculated. Patients will be evaluated in clinical consultation and database will be fulfilled. All patients will be eradicated for Helicobacter pylori infection if positive. At that occasion, all the patients with EGGIM\>5 and/or OLGA III/IV and/or OLGIM III/IV will be randomized for yearly (12 to 16 months) or every three years (32-40 months) endoscopic follow-up during a period of 6 years (SUPREME I). Endoscopic observational follow-up will be scheduled for patients with EGGIM 1-4 and OLGIM I/II at 3 and 6 years (SUPREME II). For individuals with no evidence of IM (EGGIM 0 and OLGIM 0, OLGA 0-II) a follow-up endoscopy 6 years after will be proposed (SUPREME III).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• Patients scheduled for upper GI endoscopy with indication for gastric biopsies, including those with known gastric pathology (e.g. auto-immune gastritis) or premalignant conditions (e.g patients under surveillance because of atrophic gastritis);

• Age above 45 years old

Locations
Other Locations
Portugal
IPO-Porto
RECRUITING
Porto
Contact Information
Primary
Pedro Pimentel-Nunes, MD PhD
pedro.nunes@ipoporto.min-saude.pt
+35122508400
Backup
Diogo Libanio, MD PhD
diogo.monteiro@ipoporto.min-saude.pt
+35122508400
Time Frame
Start Date: 2021-01-02
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 912
Treatments
Experimental: Yearly endoscopy
Upper gastrointestinal endoscopy every year (12-16 months)
Other: Endoscopy every 3 years
Upper gastrointestinal endoscopy every three years (32-40 months)
Sponsors
Leads: Instituto Portugues de Oncologia, Francisco Gentil, Porto

This content was sourced from clinicaltrials.gov