The prospective validation of a scoring system to assess mucosal cleanliness during upper endoscopy (EGD).

BACKGROUND AND AIMS: Cleanliness of the mucosa of the upper gastrointestinal (UGI) tract is critical for performing a high-quality esophagogastroduodenoscopy (EGD). The aim of this study was to validate a recently developed UGI cleanliness scale (the PEACE system) in the detection of clinically significant lesions (CSL) in the UGI tract. METHODS: Patients who underwent a complete diagnostic EGD were prospectively enrolled between August 2021 to October 2022. The UGI tract (esophagus, stomach, and duodenum) cleanliness was scored 0-3 for each segment. The primary outcomes were the detection of CSL and PEACE scores. RESULTS: Of 995 patients enrolled from 5 centers in the study adequate cleanliness (AQ; all scores of >2) was found in 929 patients. In multivariate regression analysis, AQ was associated with the number of diagnosed CSLs (OR 1.78 95% CI 1.06-3.01, p=0.03). Other factors related with CSL detection were: duration of EGD (OR 1.29 95% CI 1.23-1.35, p<0.001), male gender (OR 1.33 95% CI 1.04-1.71, p=0.025), and EGD indication (dyspepsia, alarm symptoms, gastritis surveillance, other indications vs GERD) (OR 0.43 95% CI 0.31-0.6, p<0.001; OR 0.44 95% CI 0.28-0.67, p<0.001; OR 0.44 95% CI 0.25-0.76, p=0.004 and OR 0.44 95% CI 0.31-0.62, p<0.001 respectively). 27 patients were diagnosed with UGI neoplasia - all in patients with adequate cleanliness of the UGI tract. CONCLUSIONS: Adequate cleanliness of the UGI tract as assessed with the PEACE system was associated with a significantly higher detection rate of CSLs during EGD. The relationship of this scale with UGI neoplasia detection warrants further investigation.

Potential benefits of one­time gastroscopy in search for precancerous conditions.

INTRODUCTION: Precancerous conditions for esophageal (EA) and gastric adenocarcinoma (GA) are Barrett's esophagus (BE) and atrophic gastritis (AG), respectively. Their surveillance is crucial for the detection of early lesions. OBJECTIVES: The study aimed to assess whether one­timeesophagogastroduodenoscopy (EGD) in search for precancerous conditions would be effective in the population with low­to­moderate esophageal and gastric cancer risk. PATIENTS AND METHODS: A total of 5984 individuals who underwent diagnostic EGD in 3 endoscopic centers, from March 2018 to October 2019, were analyzed to assess the age of occurrence of precancerous conditions and cancers. Age distribution of the patients with malignant gastric and esophageal tumors registered in the national cancer registry from 2014 to 2017 was analyzed. RESULTS: In comparison with individuals below 40 years old, the risk of EA and GA diagnosis increased at the age of 60 to 64 years (odds ratio [OR], 12.1; 95% CI, 1.5-98.6), gastric and esophageal dysplasia at the age of 55 to 59 years (OR, 3.6; 95% CI, 1.3-9.7), and BE and AG at the age of 40 to 44 years (OR, 1.6; 95% CI, 1.04-2.4). The number of procedures per 1 cancer that could be potentially avoided was 236, 235, 290, 360, 394, and 344 for the age groups of 40-44 years, 45-49 years, 50-54 years, 55-59 years, 60-64 years, and 65-69 years, respectively. The assessed potential benefit­to­harm ratio was 47, 38, 31, 28, and 32 for the age groups of 40-49 years, 50-54 years, 55-59 years, 60-64 years, and 65-69 years, respectively. CONCLUSIONS: One­time EGD in search for precancerous conditions could be potentially applicable in individuals between 40 and 69 years of age.

Heterotopic Gastric Mucosa in the Proximal Esophagus: Prospective Study and Systematic Review on Relationships with Endoscopic Findings and Clinical Data.

Cervical inlet patches (CIP) are common endoscopic findings with uncertain pathogenesis and clinical significance. We aimed to perform a systematic review and prospective study of clinical data and endoscopic findings related to CIP. It was a prospective single-center study conducted between 10/01/2017 and 9/01/2018. Forty patients with histopathologically confirmed CIP were compared with 222 individuals in the reference group. The systematic review was executed in accordance with the PRISMA guideline. Alcohol consumption tended to be higher among patients with CIP (3.0 ± 4.6 vs. 1.9 ± 5.0 standard drinks/week CIP patients and reference group, respectively; p < 0.001). Dysphagia was more frequent among patients with CIP (25% vs. 1.4%, CIP patients and reference group, respectively; p < 0.001), and sore throat and hoarseness were less frequent in patients with CIP (17.5% vs. 26.6% CIP patients and reference group, respectively; p < 0.01). In the multivariate regression analysis, the only risk factor of CIP occurrence was dysphagia (OR 21.9, 95%CI 4.9-98.6; p < 0.001). Sore throat and hoarseness were a reverse-risk factor of CIP diagnosis (OR 0.3, 95%CI 0.1-0.93; p = 0.04). Clinical data and coexisting endoscopic findings were not related to CIP. In the presented study, dysphagia was related to CIP occurrence, and sore throat and hoarseness tended to be less frequent among patients with CIP.

The relation of esophagogastroduodenoscopy time and novel upper gastrointestinal quality measures.

OBJECTIVES: Various measures of esophagogastroduodenoscopy (EGD) quality have been proposed so far and the examination time was one of the first. The aim of the study was to compare the procedure time with novel novel quality measures - composite detection rate (CDR) and endoscopist biopsy rate (EBR). METHODS: It was prospective observational study. A total of 880 diagnostic EGDs conducted from 01.2019 to 07.2019 have been enrolled in the study. RESULTS: Median EGD time was 4.2 min. Procedures of longer duration were marked with higher CDR (26.3% vs. 11.8%; P < 0.0001), higher EBR (44.9% vs. 12.3%; P < 0.0001), and better upper gastrointestinal neoplasm (UGN) detection (1.8% vs. 0%; P = 0.004) in comparison with procedures of shorter duration. The procedures were divided into 4 groups based on the time quartiles (group 1 <3.3 min; group 2 3.3-4.2 min; group 3 4.2-5.3 min; group 4 >5.3 min). The odds ratios of groups 2, 3, and 4 for biopsy rate were 2.42 (95% CI, 1.33-4.55), 4.33 (95% CI, 2.46-7.94), and 5.51 (95% CI, 3.18-10.03), respectively, in comparison with group 1. The odds ratios of groups 2, 3, and 4 for CDR were 3.18 (95% CI, 2.03-4.97), 5.46 (95% CI, 3.51-8.50), and 23.44 (95% CI, 14.3-38.4), respectively, in comparison with group 1. CONCLUSIONS: The procedure time is related to novel metrics - CDR and EBR. It is also related to UGN. Based on our findings it could be concluded that EGD should not last less than 4.2 min.

The role of endoscopic and demographic features in the diagnosis of gastric precancerous conditions.

INTRODUCTION: The diagnosis of atrophic gastritis (AG) and intestinal metaplasia (IM) is a crucial screening and surveillance strategy for gastric adenocarcinoma. OBJECTIVES: The main objective was to assess the performance of endoscopic diagnosis of gastric precancerous conditions in a real­life scenario. PATIENTS AND METHODS: A total of 2099 gastroscopies with biopsy to evaluate gastritis performed in 3 endoscopic centers from March 2018 to October 2019 were retrospectively analyzed. Endoscopic data regarding gastritis, atrophy, and intestinal metaplasia were compared with histopathological reports. RESULTS: The endoscopic diagnosis sensitivity was 69.5% for AG and 19.4% for IM. The specificity of endoscopic detection of AG was 69.5% and of IM, 97.9%. The endoscopic detection of gastritis was a risk factor for AG and IM diagnosis (odds ratio [OR], 5.1; 95% CI, 1.9-14.1 and OR, 14.5; 95% CI, 5.9-35.8, respectively) and the patient's age was a risk factor for AG, IM, dysplasia, and advanced stage of AG (ASAG) diagnosis (OR, 1.05; 95% CI, 1.04-1.06; OR, 1.035; 95% CI, 1.03-1.04; OR, 1.04; 95% CI, 1.02-1.06; and OR, 1.05; 95% CI, 1.02-1.09, respectively). The age threshold of 45 or 40 years with endoscopically diagnosed gastritis for obtaining biopsy would result in 96.3% and 95% ASAG or dysplasia diagnosis sensitivity, and in the reduction of the number of biopsies by 20.2% and 20.5%, respectively. CONCLUSIONS: The application of the age threshold with or without an endoscopic diagnosis of gastritis could reduce the number of mapping biopsies to detect advanced stages of atrophic gastritis or dysplasia with high sensitivity.

Scoring system assessing mucosal visibility of upper gastrointestinal tract: The POLPREP scale.

BACKGROUND AND AIM: The proper visibility of mucosa during esophagogastroduodenoscopy (EGD) is crucial for the detection of early upper gastrointestinal tract lesions. In contrast to colonoscopy, no validated scoring system for the assessment of upper gastrointestinal mucosal cleanliness has been developed so far. The aim of the study was to create and validate standardized grading system (POLPREP) to assess the mucosal cleanliness during EGD. METHODS: To assess the visibility of mucosa during EGD, 4-point scale was developed (0-3). Twelve operators assessed 18 images of esophagus, stomach, and duodenum twice (in 2 weeks interval). In validation round, the images and endoscopy reports of 443 EGDs performed in six centers were assessed. RESULTS: The inter-observer accordance of POLPREP was 0.8 (intra-class correlation coefficient; 0.79 consultants, 0.85 trainees). The intra-observer repeatability was 0.64 (Fleiss kappa value; 0.64 consultants, 0.64 trainees). The lesions detection rate was significantly higher in clean (scores 2 and 3; 19.7%) than in "unclean" segments (score 1; 7.7%, P = 0.049). Score 3 was associated with over three-fold higher lesion detection than score 1 (odds ratio 3.2, 95% confidence interval 1.1-9; P = 0.03). CONCLUSIONS: The proposed POLPREP scale allows for unified assessment of upper gastrointestinal tract mucosal cleanliness. The higher cleanliness scores are related with greater upper gastrointestinal pathologies detection.

Composite detection rate as an upper gastrointestinal endoscopy quality measure correlating with detection of neoplasia.

BACKGROUND: Esophagogastroduodenoscopy (EGD) is commonly used diagnostic method with no widely accepted quality measure. We assessed quality indicator-composite detection rate (CDR)-consisting of detection of at least one of the following: cervical inlet patch, gastric polyp and post-ulcer duodenal bulb deformation. The aim of the study was to validate CDR according to detection rate of upper gastrointestinal neoplasms (UGN). METHODS: It was a multicenter, prospective, observational study conducted from January 2019 to October 2019. The endoscopic reports from 2896 symptomatic patients who underwent diagnostic EGD were analyzed. The EGDs were performed in three endoscopy units located in tertiary university hospital, private outpatient clinic and local hospital. RESULTS: 64 UGNs were detected. The mean CDR was 21.9%. The CDR correlated with UGN detection rate (R = 0.49, p = 0.045). Based on CDR quartiles, operators were divided into group 1 with CDR < 10%, group 2 with CDR 10-17%, group 3 with CDR 17.1-26%, and group 4 with CDR > 26%. Detection rate of UGN was significantly higher in the group 4 in comparison to group 1 (OR 4.4; 95% CI 2.2 - 9.0). In the multivariate regression model, patient age, male gender and operator's CDR > 26% were independent risk factors of UGN detection (OR 1.03; 95% CI 1.01 - 1.05, OR 2; 95% CI 1.2 - 3.5, and OR 5.7 95% CI 1.5 - 22.3, respectively). CONCLUSIONS: The CDR is associated with the detection of upper gastrointestinal neoplasms. This parameter may be a useful quality measure of EGD to be applied in general setting.

Influence of narrow-band imaging (NBI) and enhanced operator's attention during esophagus inspection on cervical inlet patches detection.

PURPOSE: Heterotopic gastric mucosa in the upper esophagus (cervical inlet patches - CIP) may be easily missed during esophagogastroduodenoscopy (EGD) due to low awareness of this usually, but not invariably, benign lesion. Narrow-band imaging (NBI) emphasizes contrast between normal esophageal mucosa and CIP. The purpose of this study was to investigate how NBI use and enhanced attention of operator during inspection of upper esophagus impacts cervical inlet patch detection rate (CIPDR). MATERIALS AND METHODS: This is a prospective, randomized study in which we enrolled 1000 patients, qualified for diagnostic EGD. The trial was divided into two parts; the first, when 6 operators performed EGD with standard attention (SA), and the second, when the same operators were asked to step up with attention at CIP (enhanced attention - EA). In both parts of the study, patients were randomized to NBI and white light endoscopy (WLE) in 1:1 ratio. The study is registered in ClinicalTrials.gov (No. NCT03015571). RESULTS: Differences in CIPDR between WLE and NBI in SA and EA were not statistically different (5.6% vs 7.6%; p â€‹= â€‹0.3, and 7.6% vs 11.6%; p â€‹= â€‹0.1, respectively). In multivariate regression analysis, the only factors improving CIPDR were NBI with EA (NBIEA, OR 3.31; 95%CI 1.57-6.98; p â€‹= â€‹0.003) and sedation (OR 1.97; 95%CI 1.27-3.05; p â€‹= â€‹0.002). CONCLUSIONS: The use of NBI combined with EA significantly improves CIPDR.

Is narrow-band imaging a useful tool in screening colonoscopy performed by an experienced endoscopist? A prospective randomised study on 533 patients.

INTRODUCTION: The detection of adenomas is the basic goal for colorectal cancer screening programs; therefore, every possibility to improve the adenoma detection rate is valuable. AIM: To answer the question of whether narrow-band imaging (NBI) can enhance detection quality in screening for colonoscopy. MATERIAL AND METHODS: A group of 533 patients (202 men: 331 women; average age: 56.1 years) included in a colorectal cancer screening program were randomised into two groups (NBI n = 266 and white light (WL) n = 267). Five hundred and twenty-seven patients were finally included in the assessment. Examinations were performed by three experienced colonoscopists. The NBI was used only at the withdrawal of the instrument. RESULTS: Comparing WL and NBI colonoscopies, differences in the mean number of detected polyps per patient (1.36 ±2.79 WL vs. 1.65 ±2.11 NBI; p = 0.012), polyp detection rate (PDR) (48.5% WL vs. 57.2% NBI; p = 0.049), PDR for polyps ≤ 5 mm (44.7% WL vs. 54% NBI; p = 0.033), and PDR for left-sided polyps (43.3% WL vs. 52.7% NBI; p = 0.033) were observed. The difference in adenoma detection rate (ADR) as well as in adenomas/patient was not significant. Narrow-band imaging enhanced significantly one of three operators' ADR (15.6% WL vs. 25.7% NBI; p = 0.038). CONCLUSIONS: It seems that NBI improves only detection of hyperplastic polyps, especially those that are diminutive and left-sided. However, after analysis of particular endoscopists, it can clearly be seen that some of them may benefit from NBI.

Andecaliximab [Anti-matrix Metalloproteinase-9] Induction Therapy for Ulcerative Colitis: A Randomised, Double-Blind, Placebo-Controlled, Phase 2/3 Study in Patients With Moderate to Severe Disease.

BACKGROUND AND AIMS: Matrix metalloproteinase-9 [MMP9] is implicated in the pathogenesis of ulcerative colitis [UC] via disruption of intestinal barrier integrity and function. A phase 2/3 combined trial was designed to examine the efficacy, safety, and pharmacokinetics of the anti-MMP9 antibody, andecaliximab [formerly GS-5745], in patients with moderately to severely active UC. METHODS: Patients were randomised [1:1:1] to receive placebo, 150 mg andecaliximab every 2 weeks [Q2W], or 150 mg andecaliximab weekly [QW], via subcutaneous administration. The primary endpoint was endoscopy/bleeding/stool [EBS]-defined clinical remission [endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and at least a 1-point decrease from baseline in stool frequency to achieve a subscore of 0 or 1] at Week 8. The phase 2/3 trial met prespecified futility criteria and was terminated before completion. This study describes results from the 8-week induction phase. RESULTS: Neither 150 mg andecaliximab Q2W or QW resulted in a significant increase vs placebo in the proportion of patients achieving EBS clinical remission at Week 8. Remission rates [95% confidence intervals] were 7.3% [2.0%-17.6%], 7.4% [2.1%-17.9%], and 1.8% [0.0%-9.6%] in the placebo, andecaliximab Q2W, and andecaliximab QW groups, respectively. Similarly, Mayo Clinic Score response, endoscopic response, and mucosal [histological] healing did not differ among groups. Rates of adverse events were comparable among andecaliximab and placebo. CONCLUSIONS: Eight weeks of induction treatment with 150 mg andecaliximab in patients with UC did not induce clinical remission or response. Andecaliximab was well tolerated and pharmacokinetic properties were consistent with those previously reported.

[Comparison of technical aspects of colonoscopy in various gastroenterologic centres]. / Porównanie aspektów technicznych kolonoskopii w róznych osrodkach gastrologicznych.

There are ongoing multicenter European trials analyzing, among other factors, technical aspects of colonoscopy in various countries. The aim of the study was to compare the techniques of preparation and performance of colonoscopy in the Department of Gastroenterology at Medical University of Silesia in Katowice and other gastroenterology centers throughout Europe. The trial was conducted between January 1st 2001 and May 30th 2001 in 18 centers in 9 European countries. 307 consecutive patients, who signed consent forms, were recruited in Katowice, while 5697 patients were enrolled in other centers. The data were collected in a dedicated sheet, prepared in the coordinating center in Lausanne (Switzerland). The part concerning methods of bowel preparation was filled in before colonoscopy and the remaining questions (sedation, number of persons involved, duration, completeness, diagnosis, complications) were answered after the procedure. The data from all centers were analyzed in Lausanne and the results were sent back to the participants. The comparison of results from Katowice and other centers was performed in Katowice. We found out, that the type of cleansing the gut did not influence the quality of bowel preparation. Colonoscopy was performed under deep sedation (in the presence of anesthesiologist and anesthesiology nurse) more frequently in Katowice than in other centers. Differences between Katowice and the rest of centers in the other technical aspects of colonoscopy were of minor importance.

[Comparison of diagnostic methods for Helicobacter pylori detection and identification of cagA gene in clinical specimens]. / Porównawcza ocena metod diagnostycznych stwierdzajacych zakazenie Helicobacter pylori i identyfikacja genu cagA w badanym materiale.

Helicobacter pylori (H. pylori) is the principal cause of peptic ulcer disease and important risk factor in gastric cancer. Gastric mucosal biopsy specimens taken from 110 patients were examined by polymerase chain reaction (PCR), culture and urease test. The ureA gene was detected in 52 out of 110 examined samples. The cagA gene was detected in 35 (67.3%) out of these 52 specimens (ureA+). This gene was presented in all of patients with stomach ulcer, in 75.0% of patients with duodenitis, 69.6% of patients with duodenal ulcer and 58.3% of patients with gastritis. H. pylori was detected by culture in 24 (25.3%) out of 95 samples. These results were confirmed by PCR. H. pylori was detected additionally in 20 samples only by PCR. This bacterium was detected more frequently by PCR than by culture (46.3% vs 25.3%). Results obtained by using three methods: culture, urease test and PCR were concordant in 47.0% (39 out of 83 patients). In 16 (19.3%) cases H. pylori was detected by two methods: urease test and PCR. Infection was detected only by PCR in 3 (3.6%) cases and in 25 cases (30.1%) only by urease test.

[Estimation of appropriateness of colonoscopy using RAND/UCLA method]. / Ocena zasadnosci przeprowadzania kolonoskopii z wykorzystaniem metody RAND/UCLA.

Multicenter European trials estimating appropriateness of colonoscopy are one of the hot topics in gastroenterology. The aim of the study was the estimation of appropriateness of colonoscopy and usefulness of panel experts criteria (elaborated according to RAND/UCLA method) in Department of Gastroenterology of Medical University of Silesia in Katowice and other gastroenterology centers throughout Europe. The trial was conducted between January 1st 2001 and May 30th 2001 in 18 centers in 9 European countries. 307 patients, who signed informed consent, were recruited in Katowice, while 5697 patients were enrolled in the other centers. The data have been collected in a prospective manner on a dedicated sheet, prepared in the coordinating centre in Lausanne (Switzerland). The part of the sheet with evaluation of appropriateness of colonoscopy was filled in before the procedure. The endoscopic (and histopathologic if necessary) diagnosis was collected after the procedure. The data from all centers were analyzed in Lausanne and the results were sent to the participants. The comparison of results from Katowice and of all the other centers was performed in Katowice. We found out, that self-estimation (made by colonoscopist), but also what is much more important the estimation done according to objective criteria of the panel of experts were significantly higher in our department, than in the other participating centers. The overestimation of self-judgment has been significantly higher in the other centers, than in our department. The higher percentage of therapeutic colonoscopies in our department can be responsible for such results.