To Evaluate the Best Metric for Inspection Time During a Diagnostic and/or Surveillance Upper Gastrointestinal Endoscopy (Age ≥ 18 Years, Informed Consent), Between Total Inspection Time Versus Withdrawal Time, for the Identification of Malignant Lesions

Gastric cancer is the fifth cause of cancer-related mortality worldwide. Gastric carcinogenesis involves the progression from premalignant conditions such as atrophic gastritis and intestinal metaplasia to premalignant lesions like dysplasia, and ultimately carcinoma. Most diagnoses of gastric cancer are made at advanced stages, with a five-year relative survival rate of 36%. Therefore, early detection of premalignant conditions and lesions is crucial, as it allows for timely surveillance and treatment, which can improve patient survival. Upper gastrointestinal endoscopy (UGE) is the first-line examination for diagnosing upper gastrointestinal tract pathology, particularly oncological conditions. The European Society of Gastrointestinal Endoscopy (ESGE) and the United European Gastroenterology (UEG) have established that UGE quality is a priority, identifying specific quality parameters, such as the duration of the procedure, which is the most extensively studied parameter. According to ESGE recommendations, all UGE reports should include the procedure time (goal: ≥90% of reports), which should be seven minutes or longer for surveillance of intestinal metaplasia. This time threshold follows a study that established a causal relationship between longer procedures (≥ seven minutes) and a higher detection rate of premalignant gastric conditions and lesions. Subsequent observational studies have generally shown that setting a minimum procedure time increases the detection rate of lesions. The definition of procedure time varies between studies, being described as the time from intubation to extubation, but also as the time for withdrawing the endoscope from the second portion of the duodenum (D2) to extubation, also known as withdrawal time. The hypothesis under study is that a better definition of the most appropriate time for a diagnostic UGE could standardize reports, improve malignant lesion detection rates, and reduce the rate of undiagnosed cancers, without any additional risk to patients. Existing studies have been retrospective or comparative between different temporal cohorts, with no prospective or randomised comparative studies, nor any studies comparing the two existing metrics. Therefore, the aim of this study is to evaluate the best metric for inspection time during a diagnostic and/or surveillance UGE, between total inspection time versus withdrawal time, for the identification of malignant lesions.

NCT Number	NCT06696209
Lead Sponsor	Portuguese Oncology Institute, Coimbra
Conditions	Premalignant Conditions, Malignant Lesions, Gastric, Esophageal, Duodenal
Enrollment	1,290 participants
Start Date	2025-03-07
Primary Completion	2026-01-01 (estimated)
Study Completion	2026-01-01 (estimated)
Updated on ClinicalTrials.gov	2025-06-04