Endoscopic GI placement of capsule endoscopy to investigate the small bowel: a multicenter European retrospective series of 630 procedures in adult patients.

BACKGROUND AND AIMS: Small-bowel (SB) capsule endoscopy (CE) is a first-line procedure for exploring the SB. Endoscopic GI PlacemenT (EGIPT) of SB CE is sometimes necessary. Although experience with EGIPT is considerable in pediatric populations, we aimed to describe the safety, efficacy, and outcomes of EGIPT of SB CE in adult patients. METHODS: The international CApsule endoscopy REsearch (iCARE) group set up a retrospective multicenter study. Patients over age 18 years who underwent EGIPT of SB CE before May 2022 were included. Data were collected from medical records and capsule recordings. The primary endpoint was the technical success rate of the EGIPT procedures. RESULTS: Of 39,565 patients from 29 centers, 630 (1.6%) were included (mean age, 62.5 years; 55.9% women). The technical success of EGIPT was achieved in 610 procedures (96.8%). Anesthesia (moderate to deep sedation or general anesthesia) and centers with intermediate or high procedure loads were independent factors of technical success. Severe adverse events occurred in 3 patients (.5%). When technically successful, EGIPT was associated with a high SB CE completion rate (84.4%) and with a substantial diagnostic yield (61.1%). The completion rate was significantly higher when the capsule was delivered in the SB compared with when it was delivered in the stomach. CONCLUSIONS: EGIPT of SB CE is highly feasible and safe, with a high completion rate and diagnostic yield. When indicated, it should be performed with patients under anesthesia, and the capsule should be delivered in the duodenum rather than the stomach for better SB examination outcomes.

Small-bowel capsule endoscopy in patients with Meckel's diverticulum: clinical features, diagnostic workup, and findings. A European multicenter I-CARE study.

BACKGROUND AND AIMS: Meckel's diverticulum (MD) may remain silent or be associated with adverse events such as GI bleeding. The main aim of this study was to evaluate indicative small-bowel capsule endoscopy (SBCE) findings, and the secondary aim was to describe clinical presentation in patients with MD. METHODS: This retrospective European multicenter study included patients with MD undergoing SBCE from 2001 until July 2021. RESULTS: Sixty-nine patients with a confirmed MD were included. Median age was 32 years with a male-to-female ratio of approximately 3:1. GI bleeding or iron-deficiency anemia was present in nearly all patients. Mean hemoglobin was 7.63 ± 1.8 g/dL with a transfusion requirement of 52.2%. Typical capsule endoscopy (CE) findings were double lumen (n = 49 [71%]), visible entrance into the MD (n = 49 [71%]), mucosal webs (n = 30 [43.5%]), and bulges (n = 19 [27.5%]). Two or more of these findings were seen in 48 patients (69.6%). Ulcers were detected in 52.2% of patients (n = 36). In 63.8% of patients (n = 44), a combination of double lumen and visible entrance into the MD was evident, additionally revealing ulcers in 39.1% (n = 27). Mean percent SB (small bowel) transit time for the first indicative image of MD was 57% of the total SB transit time. CONCLUSIONS: Diagnosis of MD is rare and sometimes challenging, and a preoperative criterion standard does not exist. In SBCE, the most frequent findings were double-lumen sign and visible diverticular entrance, sometimes together with ulcers.

Impact of colonoscopy on working productivity: a prospective multicenter observational study.

BACKGROUND AND AIMS: Patients undergoing colonoscopy are often in the workforce. Therefore, colonoscopy may affect patients' work productivity in terms of missed working days and/or reduced working efficiency. We aimed to investigate the impact of colonoscopy on work productivity and factors influencing this impact. METHODS: We conducted a prospective, observational, multicenter study in 10 Italian hospitals between 2016 and 2017. We collected information on individual characteristics, work productivity, symptoms, and conditions before, during, and after the procedure from patients undergoing colonoscopy for several indications using validated tools. Outcomes were interference of preparation with work, absenteeism, and impaired work performance after the procedure. We fitted multivariate logistic regression models to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for potential predictors of the outcomes. RESULTS: Among 1137 subjects in the study, 30.5% reported at least 1 outcome. Impaired work performance was associated with bowel preparation regimen (full dose on the day of colonoscopy vs split dose: OR, 4.04; 95% CI, 1.43-11.5), symptoms during bowel preparation (high symptom score: OR, 3.21; 95% CI, 1.15-8.95), and pain during the procedure (OR, 2.47; 95% CI, 1.40-4.35). Increasing number of working hours and less comfortable jobs were associated with absenteeism (P for trend = .06) and impairment of working performance (P for trend = .01) and GI symptoms both before and after colonoscopy. CONCLUSIONS: Occupational and individual characteristics of patients should be considered when scheduling colonoscopy because this procedure may impair work productivity in up to one-third of patients. Split-dose bowel preparation, performing a painless colonoscopy, and preventing the occurrence of GI symptoms may minimize the impact of colonoscopy on work productivity.

Factors That Affect Adequacy of Colon Cleansing for Colonoscopy in Hospitalized Patients.

BACKGROUND & AIMS: Hospitalization is associated with inadequate colon cleansing before colonoscopy. We aimed to identify factors associated to inadequate colon cleansing among inpatients, and to derive and validate a model to identify inpatients with inadequate cleansing. METHODS: We performed a prospective observational study at 12 hospitals in Italy. Consecutive adult inpatients scheduled for colonoscopy for any indication were enrolled from February through May 2019 (derivation cohort, n = 1016) and from June through August 2019 (validation cohort, n = 508). Inadequate cleansing was defined as Boston bowel preparation scale scores below 2 in any colon segment. We performed multivariate logistic regression to identify factors associated with inadequate cleansing. RESULTS: In the combined cohorts, 1032 patients (68%) had adequate colon cleansing. Physicians' meetings to optimize bowel preparation (odds ratio [OR], 0.42; 95% CI, 0.27-0.65), written and oral instructions to patients (OR, 0.48; 95% CI, 0.36-0.65), admission to gastroenterology unit (OR, 0.71; 95% CI, 0.51-0.98), split-dose regimens (OR, 0.27; 95% CI, 0.20-0.35), a 1-liter polyethylene glycol-based bowel purge (OR, 0.39; 95% CI, 0.23-0.65), and 75% or more intake of bowel preparation (OR, 0.09; 95% CI, 0.05-0.15) significantly reduced odds of inadequate colon cleansing. Alternatively, bedridden status (OR, 2.14; 95% CI, 1.55-2.98), constipation (OR, 2.16; 95% CI, 1.55-3.0), diabetes mellitus (OR, 1.61; 95% CI, 1.18-2.20), use of anti-psychotic drugs (OR, 3.26; 95% CI, 1.62-6.56), and 7 or more days of hospitalization (OR, 1.02; 95% CI, 1.00-1.04) increased risk of inadequate colon cleansing. We developed a model to identify patients with inadequate cleaning using data from patients in the derivation cohort and tested it in the validation cohort. Calibration values were P = .218 for the discrimination cohort and P = .232 for the validation cohort. Discrimination values were c-statistic, 0.78 (95% CI, 0.74-0.81) for the discrimination cohort and c-statistic, 0.73 (95% CI, 0.69-0.78) for the validation cohort. We developed app for use by clinicians. CONCLUSIONS: In a prospective observational study, we identified setting-, patient- and preparation-related factors that affect colon cleansing among inpatients. We derived and validated a model to identify patients with inadequate preparation and developed an app for clinicians. ClinicalTrials.gov no: NCT03925506.

How to identify patients who are less likely to have metachronous neoplasms after a colon cancer: a predictive model.

BACKGROUND: Patients with prior colon cancer have increased risk of metachronous colorectal neoplasms; therefore, endoscopic surveillance is indicated. Current recommendations are not risk-stratified. We investigated predictive factors for colorectal neoplasms to build a model to spare colonoscopies for low-risk patients. METHODS: This was a multicenter, retrospective study including patients who underwent surgery for colon cancer in 2001 - 2008 (derivation cohort) and 2009 - 2013 (validation cohort). A predictive model for neoplasm occurrence at second surveillance colonoscopy was developed and validated. RESULTS: 421 and 203 patients were included in derivation and validation cohort, respectively. At second surveillance colonoscopy, 112 (26.6 %) and 55 (27.1 %) patients had metachronous neoplasms in derivation and validation groups; three cancers were detected in the latter. History of left-sided colon cancer (OR 1.64, 95 %CI 1.02 - 2.64), ≥ 1 advanced adenoma at index colonoscopy (OR 1.90, 95 %CI 1.05 - 3.43), and ≥ 1 adenoma at first surveillance colonoscopy (OR 2.06, 95 %CI 1.29 - 3.27) were independently predictive of metachronous colorectal neoplasms at second surveillance colonoscopy. For patients without such risk factors, diagnostic accuracy parameters were: 89.3 % (95 %CI 82.0 %-94.3 %) and 78.2 % (95 %CI 65.0 %-88.2 %) sensitivity, and 28.5 % (95 %CI 23.5 %-33.9 %) and 33.8 % (95 %CI 26.2 %-42.0 %) specificity in derivation and validation group, respectively. No cancer would be missed. CONCLUSIONS: Patients with prior left-sided colon cancer or ≥ 1 advanced adenoma at index colonoscopy or ≥ 1 adenoma at first surveillance colonoscopy had a significantly higher risk of neoplasms at second surveillance colonoscopy; patients without such factors had much lower risk and could safely skip the second surveillance colonoscopy. A prospective, multicenter validation study is needed.

Rate of non-response to ursodeoxycholic acid in a large real-world cohort of primary biliary cholangitis patients in Italy.

Background and aim: Response to ursodeoxycholic acid (UDCA) is crucial for the prediction of primary biliary cholangitis (PBC) prognosis, and different response criteria were validated and proposed by reference centers for PBC. To date, rates of non-response to UDCA from real-world series are lacking.Methods: Hepatology/Gastroenterology centers belonging to 'Club Epatologi Ospedalieri' (CLEO) and 'Associazione Italiana Gastroenterologi Ospedalieri' (AIGO) were invited to participate in the study, and asked to extract all patients followed for PBC, without any selection or exclusion, and fill in the database provided.Results: Thirty-four centers were enrolled throughout Italy, for a total of 713 patients. None of these centers, except one, had a hepatology outpatient clinic devoted to the care of patients with autoimmune liver diseases. After excluding 79 cases of PBC/autoimmune hepatitis overlaps, 634 patients were analyzed: mean age, 64.4 ± 12.0 years; 91.2% females; F/M 10.3/1. For patients with at least 1 year of UDCA treatment (583), rates of non-response to UDCA were evaluated according to the Paris-I/-II, Toronto and GLOBE criteria, and compared with those in the original cohorts: 27% vs 39% in Paris-I cohort; 39.6% vs 52% in Paris-II; 20.1% vs 43.5% in Toronto; 15.7% vs 30% in GLOBE (age-specific cutoffs). Mean alkaline phosphatase levels on UDCA treatment, and the age-adjusted prevalence of F3/F4 fibrosis, appeared lower in this PBC population than in reference cohorts.Conclusions: A mean ∼15% better response to UDCA is observed in a real-world PBC population, probably due to migration of some of most severe/advanced cases to PBC referral centers.

Higher adenoma recurrence rate after left- versus right-sided colectomy for colon cancer.

BACKGROUND: Patients with history of colonic resection for cancer have an increased risk of the development of metachronous malignant and premalignant lesions. Scanty data are reported on detection rates of premalignant lesions during colonoscopy surveillance in this setting. OBJECTIVE: To assess the risk of metachronous precancerous lesions developing in patients with previous colonic surgery for cancer according to the resection type. DESIGN: Retrospective study. SETTING: Two academic centers in Italy. PATIENTS: A total of 441 patients; 256 with previous left-sided colectomy (LCR) (LCR group) and 185 with previous right-sided colectomy (RCR) (RCR group). INTERVENTIONS: Second surveillance colonoscopy. MAIN OUTCOME MEASUREMENTS: Polyp and adenoma detection rates. RESULTS: At least 1 adenoma was diagnosed in 76 of 256 patients (30% adenoma detection rate) and in 35 of 185 patients (19% adenoma detection rate) in the LCR and RCR groups, respectively (P=.014), yielding an odds ratio of 1.83 (95% confidence interval, 1.16-2.89). Corresponding figures for the polyp detection rate were 39% and 25%, respectively (P=.002; odds ratio 1.97; 95% confidence interval, 1.30-3.00). LIMITATIONS: Retrospective study with colonoscopy baseline information missing. CONCLUSIONS: Patients who have undergone LCR are at higher risk of the development of adenomas than those who have undergone RCR. If this result is confirmed by large prospective studies, surveillance programs could be targeted according to the type of colonic resection, with longer intervals for patients with previous RCR compared with LCR.

Split dosing with a low-volume preparation is not inferior to split dosing with a high-volume preparation for bowel cleansing in patients with a history of colorectal resection: a randomized trial.

BACKGROUND AND STUDY AIM: The study compared the efficacy of bowel cleansing using a low-volume mixed preparation (15 mg bisacodyl plus 2 L polyethylene glycol [PEG] solution) versus a standard high-volume preparation (4 L PEG) in patients with previous colorectal resection. PATIENTS AND METHODS: A total of 120 patients with prior colorectal resection for cancer undergoing surveillance colonoscopy were randomized to receive either a split-dose low-volume (n = 60) or high-volume (n = 60) preparation for bowel cleansing. The quality of bowel preparation, rated according to a modified Ottawa Bowel Preparation scale (mOBPS), represented the primary outcome measure. Tolerability, safety, and lesion detection rates were secondary outcomes. RESULTS: No significant difference was observed between the low-volume and high-volume preparations in achievement of adequate cleansing (i. e. mOBPS ≤ 4; low-volume vs. high-volume group, 85.0 % vs. 81.7 %, P = 0.624). The low-volume preparation showed a higher success rate for cleansing of the right colon (P = 0.025); better tolerability in terms of intake of the whole amount of the preparation (P < 0.001) was also observed. According to the logistic regression analysis, the only predictors of unsuccessful cleansing were previous left colectomy (P = 0.012) and a longer elapsed time since the intervention (P = 0.034). Lesion detection rates were comparable between the groups. No serious adverse events were reported. CONCLUSION: A low-volume preparation is not inferior to a high-volume preparation for adequate bowel cleansing in patients with prior colorectal resection for cancer. If larger, multicenter, prospective studies confirm our findings, a low-volume preparation will represent a more tolerable option for such patients. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov identifier NCT01887158.

Device-assisted enteroscopy: Are we ready to dismiss the spiral?

Motorized spiral enteroscopy (MSE) is the latest advance in device-assisted enteroscopy. Adverse events related to MSE were discussed in a recent large systematic review and meta-analysis and were directly compared with those of balloon enteroscopy in a case-matched study and a randomized controlled trial. Following the real-life application of MSE, an unexpected safety issue emerged regarding esophageal injury and the technique has been withdrawn from the global market, despite encouraging results in terms of diagnostic and therapeutic yield. We conducted an Italian multicenter real-life prospective study, which was prematurely terminated after the withdrawal of MSE from the market. The primary goals were the evaluation of MSE performance (both diagnostic and therapeutic) and its safety in routine endoscopic practice, particularly in the early phase of introduction in the endoscopic unit. A subanalysis, which involved patients who underwent MSE after unsuccessful balloon enteroscopy, demonstrated, for the first time, the promising performance of MSE as a rescue procedure. Given its remarkable performance in clinical practice and its potential role as a backup technique following a previously failed enteroscopy, it may be more appropriate to refine and enhance MSE in the future rather than completely abandoning it.

Anesthesiologist-directed care for elective gastrointestinal endoscopy: results of an Italian multicentric prospective observational study.

BACKGROUND: Sedation, ranging from minimal, moderate and deep sedation to general anesthesia, improves patient comfort and procedure quality in gastrointestinal endoscopy (GIE). There are currently no comprehensive recommendations on sedation practice in diagnostic and therapeutic GIE. We aimed to investigate real-life sedation practice in elective GIE. METHODS: We performed a multicentric observational study across 14 Endoscopy Units in Italy. We recorded consecutive data on all diagnostic procedures performed with Anesthesiologist-directed care (ADC) and all therapeutic procedures performed with ADC or non-Anesthesiologist sedation (NAS) over a three-month period. RESULTS: Dedicated ADC is available five days/week in 28.6% (4/14), four days/week in 21.5% (3/14), three days/week in 35.7% (5/14), two days/week in 7.1% (1/14) and one day/week in 7.1% (1/14) of participating Centers. ADC use for elective diagnostic GIE varied from 18.2% to 75.1% of the total number of procedures performed with ADC among different Centers. ADC use for elective therapeutic GIE varied from 10.8% to 98.9% of the total number of elective therapeutic procedures performed among different Centers. CONCLUSIONS: Our study highlights the lack of standardization and consequent great variability in sedation practice for elective GIE, with ADC being potentially overused for diagnostic procedures and underused for complex therapeutic procedures. A collaborative effort involving Endoscopists, Anesthesiologist and Institutions is needed to optimize sedation practice in GIE.

SIED-GISCOR recommendations for colonoscopy in screening programs: Part I - Diagnostic.

The implementation of FIT programs reduces incidence and mortality from CRC in the screened subjects. The ultimate efficacy for CRC morbidity and mortality prevention in a FIT program depends on the colonoscopy in FIT+ subjects that has the task of detecting and removing these advanced lesions. Recently, there has been growing evidence on factors that influence the quality of colonoscopy specifically withing organized FIT programs, prompting to dedicated interventions in order to maximize the benefit/harm ratio of post-FIT colonoscopy. This document focuses on the diagnostic phase of colonoscopy, providing indications on how to standardise colonoscopy in FIT+ subjects, regarding timing of examination, management of antithrombotic therapy, bowel preparation, competence and sedation.

Management of radiation-induced rectal bleeding.

Pelvic radiation disease is one of the major complication after radiotherapy for pelvic cancers. The most commonly reported symptom is rectal bleeding which affects patients' quality of life. Therapeutic strategies for rectal bleeding are generally ignored and include medical, endoscopic, and hyperbaric oxygen treatments. Most cases of radiation-induced bleeding are mild and self-limiting, and treatment is normally not indicated. In cases of clinically significant bleeding (i.e. anaemia), medical therapies, including stool softeners, sucralfate enemas, and metronidazole, should be considered as first-line treatment options. In cases of failure, endoscopic therapy, mainly represented by argon plasma coagulation and hyperbaric oxygen treatments, are valid and complementary second-line treatment strategies. Although current treatment options are not always supported by high-quality studies, patients should be reassured that treatment options exist and success is achieved in most cases if the patient is referred to a dedicated centre.

Outcomes of Double Balloon-Enteroscopy in Elderly vs. Adult Patients: A Retrospective 16-Year Single-Centre Study.

Background and Aim: Double-balloon enteroscopy (DBE) is a well-established procedure for direct visualisation of the entire small bowel mucosa, and, in contrast with other imaging techniques, allows to perform biopsies and therapeutic interventions. The aim of this study was to evaluate the indications, diagnostic yield, therapeutic yield, and complications of DBE in a cohort of consecutive patients according to patients' age. Methods: We conducted a retrospective study of consecutive patients who underwent DBE in our endoscopy unit between January 2006 and December 2021. Results: A total of 387 consecutive patients who underwent 460 DBE procedures were included. Mean age of the patients was 63 years. The overall diagnostic yield was 67.6%; vascular lesions were the predominant endoscopic findings (31.5%), followed by polyps or neoplastic masses (17.6%). Older patients (≥65 years) showed statistically higher rates of clinically relevant findings than adult patients (18-65 years) (p = 0.001). Crohn's disease and polyps or neoplastic masses were more frequent in the younger group (p = 0.009 and p = 0.066, respectively), while vascular lesions and non-specific inflammation were the most common findings in the older group (p < 0.001 and p < 0.001, respectively). The therapeutic intervention rate was 31.7%. Rates of endoscopic treatment were significantly higher in the older group (p < 0.001). Total complications occurred in five procedures (1.1%). Conclusion: In clinical practice, DBE is an efficient diagnostic and therapeutic tool with a high safety profile, particularly in the elderly population.

Recent developments in small bowel endoscopy: the "black box" is now open!

Over the last few years, capsule endoscopy has been established as a fundamental device in the practicing gastroenterologist's toolbox. Its utilization in diagnostic algorithms for suspected small bowel bleeding, Crohn's disease, and small bowel tumors has been approved by several guidelines. The advent of double-balloon enteroscopy has significantly increased the therapeutic possibilities and release of multiple devices (single-balloon enteroscopy and spiral enteroscopy) aimed at improving the performance of small bowel enteroscopy. Recently, some important innovations have appeared in the small bowel endoscopy scene, providing further improvement to its evolution. Artificial intelligence in capsule endoscopy should increase diagnostic accuracy and reading efficiency, and the introduction of motorized spiral enteroscopy into clinical practice could also improve the therapeutic yield. This review focuses on the most recent studies on artificial-intelligence-assisted capsule endoscopy and motorized spiral enteroscopy.

New Generation Express View: An Artificial Intelligence Software Effectively Reduces Capsule Endoscopy Reading Times.

BACKGROUND: Reading capsule endoscopy (CE) is time-consuming. The Express View (EV) (IntroMedic, Seoul, Korea) software was designed to shorten CE video reading. Our primary aim was to evaluate the diagnostic accuracy of EV in detecting significant small-bowel (SB) lesions. We also compared the reading times with EV mode and standard reading (SR). METHODS: 126 patients with suspected SB bleeding and/or suspected neoplasia were prospectively enrolled and underwent SB CE (MiroCam®1200, IntroMedic, Seoul, Korea). CE evaluation was performed in standard and EV mode. In case of discrepancies between SR and EV readings, a consensus was reached after reviewing the video segments and the findings were re-classified. RESULTS: The completion rate of SB CE in our cohort was 86.5% and no retention occurred. The per-patient analysis of sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of EV compared to SR were 86%, 86%, 90%, 81%, and 86%, respectively, before consensus. After consensus, they increased to 97%, 100%, 100%, 96%, and 98%, respectively. The median reading time with SR and EV was 71 min (range 26−340) and 13 min (range 3−85), respectively (p < 0.001). CONCLUSIONS: The new-generation EV shows high diagnostic accuracy and significantly reduces CE reading times.

Determinants of symptom burden related to bowel preparation for colonoscopy.

BACKGROUND: Symptoms developing during bowel preparation are major concerns among subjects who refuse the procedure. AIMS: We aimed to explore the determinants of symptoms occurring during preparation among patients undergoing elective colonoscopy. METHODS: This is a prospective multicenter study conducted in 10 Italian hospitals. A multidimensional approach collecting socio-demographic, clinical, psychological and occupational information before colonoscopy through validated instruments was used. Outcome was a four-category cumulative score based on symptoms occurring during preparation, according to the Mayo Clinic Bowel Prep Tolerability Questionnaire, weighted by intensity. Missing values were addressed through multiple imputation. Odds ratios (OR) and 95% confidence intervals (CI) were estimated through multivariate logistic regression models. RESULTS: 1137 subjects were enrolled. Severe symptoms were associated with female sex (OR=3.64, 95%CI 1.94-6.83), heavier working hours (OR=1.13, 95% CI=1.01-1.25), previous gastrointestinal symptoms (OR=7.81, 95% CI 2.36-25.8 for high score), somatic symptoms (OR=2.19, 95% CI=1.06-4.49 for multiple symptoms), day-before regimen (OR=2.71, 95%CI 1.28-5.73). On the other hand, age ≥60 years (OR=0.10, 95% CI 0.02-0.44) and good mood (p=0.042) were protective factors. A high-risk profile was identified, including women with low mood and somatic symptoms (OR=15.5, 95%CI 4.56-52.7). CONCLUSIONS: We identified previously unreported determinants of symptoms burdening bowel preparation and identified a particularly vulnerable phenotype. Symptoms during preparation especially impact heavier working activity.