SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up

NCT04613570 | Recruiting

• 1 other identifier: SUPREME
• Study Type: interventional
• Target: 912
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Atrophic Gastritis; Intestinal Metaplasia; Gastric Dysplasia; Gastric Cancer

Keywords

atrophic gastritis; gastric cancer; intestinal metaplasia; gastric dysplasia; surveillance

Outcome Measures

Primary Outcomes (2)

• Dysplasia

  Proportion of patients with dysplasia (low or high-grade)

  6 years

• Carcinoma

  Proportion of patients with gastric adenocarcinoma

  6 years

Secondary Outcomes (3)

• Curative criteria

  6 years

• Non-curative criteria

  6 years

• Advanced gastric cancer

  6 years

Study Arms (2)

Yearly endoscopy

EXPERIMENTAL

Upper gastrointestinal endoscopy every year (12-16 months)

Diagnostic Test: Upper gastrointestinal endoscopy

Endoscopy every 3 years

OTHER

Upper gastrointestinal endoscopy every three years (32-40 months)

Diagnostic Test: Upper gastrointestinal endoscopy

Interventions

Upper gastrointestinal endoscopy DIAGNOSTIC_TEST

In all patient's complete gastroscopy first with White light and then with virtual chromoendoscopy will be made; * Suspicious lesions with dysplasia/cancer will be biopsied 1-2 fragments in a different vial; if an irregular area of mucosa (pattern C) with no clearly defined lesion then 1-2 guided biopsies fragments will be taken and sent in a different vial; * EGGIM (Endoscopic Grading of Gastric Intestinal Metaplasia) will be calculated according to previous description of this classification: * If EGGIM 0 (no endoscopically apparent IM) biopsies will be made in antrum, incisura and corpus according to Sydney-Houston protocol; * If EGGIM 1 or more guided biopsies of suspicious areas of IM should be made replacing the random biopsies in that particular area; * Antrum, incisura and corpus fragments should be sent in 3 separate vials;

Endoscopy every 3 years; Yearly endoscopy

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of previous gastrectomy;
• History of endoscopic resection of neoplastic lesion
• History of previous gastric dysplasia (even with no detectable lesion)
• Hereditary syndromes that increase gastric cancer risk (familial adenomatous polyposis; Lynch syndrome)
• Serious comorbidities (ASA 3 or more)
• Medication with anticoagulants

Sponsors & Collaborators

• Instituto Portugues de Oncologia, Francisco Gentil, Porto: lead

Study Sites (1)

IPO-Porto

Porto, 4200-072, Portugal

RECRUITING

MeSH Terms

Conditions

Gastritis, Atrophic; Stomach Neoplasms

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Pedro Pimentel-Nunes, MD PhD

  Instituto Português de Oncologia do Porto, Francisco Gentil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Pimentel-Nunes, MD PhD

CONTACT

+35122508400; pedro.nunes@ipoporto.min-saude.pt

Diogo Libanio, MD PhD

CONTACT

+35122508400; diogo.monteiro@ipoporto.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients with EGGIM \> 5 or OLGA/OLGIM III/IV (premalignant stomach group - SUPREME I) will be randomized to endoscopic surveillance every one (12 to 16 months) or three years (32-40 months);

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: November 3, 2020
• Study Start: January 2, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)