Aims
The European Society of Gastrointestinal Endoscopy (ESGE) recommends recording Upper Gastrointestinal Endoscopy (UGE) examination time with a minimum of seven minutes, since longer procedures allow the detection of more lesions; however, the definition of the time metric varies across studies. This study aims to compare total inspection time versus withdrawal time during diagnostic, surveillance or screening UGE for lesion identification. To our knowledge, it will be the first randomised clinical trial in this area, providing enhanced scientific evidence to optimize UGE quality indicators.
Methods
We are performing a randomised controlled trial in 10 international gastroenterology centres, started in 2025, including patients referred for screening, diagnostic and/or surveillance UGE. Patients were randomly assigned, by a computer generated software, and adequate allocation concealment, in a double-blinded, parallel 1:1 ratio, to one of two measurement groups: total inspection time (from intubation to extubation) or withdrawal time (from second portion of duodenum to extubation). The primary outcome was the detection rate of premalignant and malignant lesions (extensive intestinal metaplasia, dysplasia, carcinoma, neuroendocrine tumour, lymphoma or subepithelial lesion), defined as the total number of esophageal, gastric or duodenal lesions identified per randomisation group and confirmed histologically when required, while the secondary outcome was the rate of procedure-related complications. The trial was registered at ClinicalTrials.gov (NCT06696209).
Results
For the planned 1290 patients to include, 851 UGE procedures were included so far (53% female; mean age 59.3 ± 15.4 years). A total of 414 and 437 patients were evaluated in the total inspection time and withdrawal time groups, respectively. The mean total inspection time was 06:34 ± 04:04 minutes, and the mean withdrawal time was 04:52 ± 03:27 minutes.
The primary outcome revealed a significantly higher lesion detection rate in the total inspection time group compared with the withdrawal time group (26.6% vs. 20.1%; p =0.026). Main detected lesions were extensive gastric intestinal metaplasia (17.9% vs. 12.6%; p =0.03), gastric dysplasia (3.1% vs. 3.0%; p =0.89) and esophageal dysplasia (1.9% vs. 2.5%; p =0.56). There was only one complication in all procedures (bleeding event).
In the univariate analysis of factors that may influence the lesion detection rate, the following were statistically significant: total inspection time ≥7 minutes (37.3% vs. 14.1%; p<0.001), surveillance (vs. screening vs. diagnosis) as the indication for UGE (45.4% vs. 23.8% vs. 12.2%; p <0.001), endoscopist experience ≥5 years (28.7% vs. 10.8%; p <0.001), the use of an antifoaming agent (38.4% vs. 12.3%; p <0.001) and the application of virtual chromoendoscopy (35.5% vs. 2.8%; p <0.001). However, the use of any sedation type (with vs. without sedation; 23.2% vs. 23.8%, p=0.932), patient tolerance (good vs. intolerance; 23.3% vs. 22.7%, p=0.952) and an excellent GRACE visibility score (≥9 vs. <9; 26.0% vs. 20.5%, p=0.059) or adequate GRACE visibility score (≥2 per segment vs. <2 in any segment; 23.8% vs. 9.4%, p=0.058) showed no significant association with lesion detection.
Logistic regression revealed that surveillance as the indication for UGE (OR 3.3, 95% CI 2.2–4.9; p <0.001), endoscopist experience ≥5 years (OR 2.3, 95% CI 1.4–3.8; p <0.001) and the use of virtual chromoendoscopy (OR 8.8, 95% CI 4.1–18.7; p <0.001) were independently associated with higher lesion detection.
Conclusions
Our preliminary results indicate that a total inspection time ≥7 minutes provides a higher diagnostic yield than a withdrawal time ≥5 minutes in UGE, eventually related to the bidirectional evaluation performed during an UGE (both on insertion and during withdrawal), supporting its preferential use in clinical practice. By validating a total inspection time ≥7 minutes as the optimal time metric, our study already highlights easy clinical factors that can improve lesion detection, mainly in the stomach, such as the application of virtual chromoendoscopy, and eventually the use of an antifoaming agent to achieve at least an adequate GRACE score visibility ≥2 per segment.