Optimal concentration of Lugol's solution for detecting early esophageal carcinoma: A randomized controlled trial.

BACKGROUND AND AIM: Lugol chromoendoscopy is the standard technique to detect an esophageal squamous cell carcinoma (ESCC). However, a high concentration of Lugol's solution can induce mucosal injury and adverse events. We aimed to investigate the optimal concentration of Lugol's solution to reduce mucosal injury and adverse events without degrading image quality. METHODS: This was a two-phase double-blind randomized controlled trial. In phase I, 200 eligible patients underwent esophagogastroduodenoscopy and then were randomly (1:1:1:1:1) sprayed with 1.2%, 1.0%, 0.8%, 0.6%, or 0.4% Lugol's solution. Image quality, gastric mucosal injury, adverse events, and operation satisfaction were compared to investigate the minimal effective concentration. In phase II, 42 cases of endoscopic mucosectomy for early ESCC were included. The patients were randomly assigned (1:1) to the minimal effective (0.6%) or conventional (1.2%) concentration of Lugol's solution for further comparison of the effectiveness. RESULTS: In phase I, the gastric mucosal injury was significantly reduced in 0.6% group (P < 0.05). Furthermore, there was no statistical significance in image quality between 0.6% and higher concentrations of Lugol's solution (P > 0.05, respectively). It also showed that the operation satisfaction decreased in 1.2% group compared with the lower concentration groups (P < 0.05). In phase II, the complete resection rate was 100% in both groups, while 0.6% Lugol's solution showed higher operation satisfaction (W = 554.500, P = 0.005). CONCLUSIONS: The study indicates that 0.6% might be the optimal concentration of Lugol's solution for early detection and delineation of ESCC, considering minimal mucosal injury and satisfied image. The registry of clinical trials: ClinicalTrials.gov (NCT03180944).

Magnified and enhanced computed virtual chromoendoscopy in gastric neoplasia: a feasibility study.

AIM: To evaluate the feasibility of a new computed virtual chromoendoscopy (CVC) device (M i-scan) in the diagnosis of gastric neoplasia. METHODS: Patients with superficial lesions no larger than 1.0 cm found during high definition endoscopy were included. Those with advanced or obviously protruded or depressed lesions, lesions larger than 1.0 cm and/or lesions which were not amenable to observation by zoom function were excluded. The endoscopist was required to give the real-time descriptions of surface pit patterns of the lesions, based on surface pattern classification of enhanced magnification endoscopy. According to previous reports, types I-III represent non-neoplastic lesions, and types IV-V represent neoplastic lesions. Diagnosis with M i-scan and biopsy was performed before histopathological diagnosis. Magnified images of gastric lesions with and without enhancement were collected for further analysis. The diagnostic yield of real-time M i-scan and effects on magnification image quality by tone enhancement (TE), surface enhancement (SE) and color enhancement (CE) were calculated. The selected images were sent to another endoscopist. The endoscopist rated the image quality of each lesion at 3 levels. Ratings of image quality were based on visualization of pit pattern, vessel and demarcation line. RESULTS: One hundred and eighty-three patients were recruited. Five patients were excluded for advanced gastric lesions, 1 patient was excluded for poor preparation and 2 patients were excluded for superficial lesions larger than 1.0 cm; 132 patients were excluded for no lesions found by high definition endoscopy. In the end, 43 patients with 43 lesions were included. Histopathology revealed 10 inflammation, 14 atrophy, 10 metaplasia, 1 low grade dysplasia (LGD), 5 high grade dysplasia (HGD) and 3 cancers. For 7 lesions classified into type I, histopathology revealed 6 atrophy and 1 metaplasia; for 10 lesions classified into type II, histopathology revealed 2 inflammation, 7 atrophy and 1 metaplasia; for 10 lesions classified into type III, histopathology revealed 1 inflammation, 8 metaplasia and 1 LGD; for 9 lesions classified into type IV, histopathology revealed 4 inflammation, 1 atrophy and 4 HGD; for 7 lesions classified into type V, histopathology revealed 3 inflammation, 1 HGD and 3 cancers. A total of 172 still images, including 43 images by white light (MWL) and 129 images by M i-scan (43 with TE, 43 with SE and 43 with CE), were selected and sent to the endoscopist who did the analysis. General image quality of M i-scan with TE and SE was significantly better than that of MWL (TE, 4.55 ± 1.07; SE, 4.30 ± 1.02; MWL, 3.25 ± 0.99; P < 0.001). Visualization of pit pattern was significantly improved by M i-scan with SE (1.93 ± 0.25 vs 1.50 ± 0.50, P < 0.001). Microvessel visualization was significantly improved by M i-scan with TE (1.23 ± 0.78 vs 0.76 ± 0.73, P < 0.001). Demarcation line visualization was improved by M i-scan with both TE and SE (TE, 1.75 ± 0.52; SE, 1.56 ± 0.59; MWL, 0.98 ± 0.44; P < 0.001). M i-scan with CE did not show any significant improvements of image quality in general or in the 3 key parameters. Although M i-scan with TE and SE slightly increased the diagnostic yield of MWL, there was no significant difference (P > 0.1). CONCLUSION: Although digital enhancement improves the image quality of magnification endoscopy, its value in improving the diagnostic yield seems to be limited.

High-definition magnifying endoscopy with i-scan in the diagnosis of Helicobacter pylori infection: a pilot study.

OBJECTIVE: This study aimed to compare the diagnostic value and image quality of high-definition magnifying white light endoscopy (M-WLE) and high-definition magnifying endoscopy with i-scan (M-i-scan) for Helicobacter pylori (H.pylori) infection. METHODS: Patients complaining of dyspepsia who underwent esophagogastroduodenoscopy at the Endoscopy Unit of Qilu Hospital (Jinan, Shandong Province, China) from January to March, 2011 were prospectively recruited. The greater curvature of the stomach was carefully observed using both M-WLE and M-i-scan. The gastric mucosal classification and image quality scores were recorded. The relationship between gastric mucosal classification and final diagnosis of H.pylori infection was determined. RESULTS: A total of 84 patients were recruited in this study. The accuracy and specificity of the combination of types 2-3 patterns predicting H.pylori infection were significantly higher for M-i-scan than those for M-WLE (accuracy: 94.0% vs 84.5%, P=0.046; and specificity: 93.5% vs 80.6%, P=0.032), while the sensitivity of the two modes was the same. The M-i-scan provided a better image quality for H.pylori infection than M-WLE (P<0.001). CONCLUSION: The M-i-scan may be superior to M-WLE for the prediction of H.pylori infection, but its diagnostic sensitivity needs to be improved.

Microalterations of esophagus in patients with non-erosive reflux disease: in-vivo diagnosis by confocal laser endomicroscopy and its relationship with gastroesophageal reflux.

OBJECTIVES: Objectively diagnosing non-erosive reflux disease (NERD) is still a challenge. We aimed to evaluate the use of in-vivo confocal laser endomicroscopy (CLE) to examine the microalterations of the esophagus in patients with NERD and its relationship with reflux episodes monitored by multiple intraluminal impedance-pH (MII-pH). METHODS: Patients with gastroesophageal reflux symptoms completed reflux disease questionnaires. NERD was determined by negative gastroscopy. Patients without reflux symptoms were recruited as controls. Pilot clinical study was followed by prospective controlled blinded study. All subjects were examined by white-light mode of the endoscopy followed by the standard CLE mode and then MII-pH monitoring. The microalterations seen on CLE images and the correlation between CLE features and reflux episodes were evaluated, the correlation between CLE and transmission electron microscope (TEM) data was also analyzed. RESULTS: On CLE images, NERD patients had more intrapapillary capillary loops (IPCLs) per image than did controls (8.29 ± 3.52 vs. 5.69 ± 2.31, P=0.010), as well as the diameter of IPCLs (19.48 ± 3.13 vs. 15.87 ± 2.21 µm, P=0.041) and intercellular spaces of squamous cells (3.40 ± 0.82 vs. 1.90 ± 0.53 µm, P=0.042). The receiver operating characteristic analysis indicated that IPCLs number (optimal cutoff >6 per image, area under the curve (AUC) 0.722, 95% confidence interval (CI) 0.592-0.853, sensitivity 67.7%, specificity 71.6%), IPCLs diameter (optimal cutoff >17.2 µm, AUC 0.847, 95% CI 0.747-0.947, sensitivity 81%, specificity 76%), and the intercellular spaces of squamous cells (optimal cutoff >2.40 µm, AUC 0.935, 95% CI 0.875-0.995, sensitivity 85.7%, specificity 90.5%) diagnosed NERD with reasonable accuracy. Combined features of dilatation of intercellular space plus increased IPCLs provided 100% specificity in the diagnosis of NERD patients. The intercellular spaces of squamous cells observed on CLE were highly related to that on TEM findings (r=0.75, P<0.001). Multivariate progressive regression analysis showed that acidic reflux, especially in the supine position, was related to the increased number and dilation of IPCLs in the squamous epithelium (ß=0.063, t=2.895, P=0.038 and ß=0.156, t=1.023, P=0.04). CONCLUSIONS: CLE represents a useful and potentially significant improvement over standard endoscopy to examine the microalterations of the esophagus in vivo. Acidic reflux is responsible for the microalterations in the esophagus of patients with NERD.