Small-Bowel Capsule Endoscopy in Clinical Practice: Has Anything Changed Over 13 Years?

BACKGROUND: In Lombardia, one of the 20 Italian administrative Regions, small-bowel capsule endoscopy (SBCE) was introduced in 2001. In January 2011, the Regional Health Authorities established a reimbursement for outpatient SBCE. AIM: To prospectively record data on SBCE between 2011-2013 and compare them to similar data retrospectively collected from the same geographical area (covering the period 2001-2008) and published in 2008. METHODS: Consecutive SBCEs performed between January 2011 and December 2013 in Lombardia were prospectively collected. RESULTS: In 3 years, 3142 SBCEs were collected; the diagnostic yield (DY) and the overall complication rate were 48.4 and 0.9%, respectively. The main indication was suspected small-bowel bleeding (76.6% of patients); complete small-bowel inspection was achieved in 2796 (89.0%) patients. SBCE was performed as an outpatient procedure in 1945 patients (61.9%). A significant increase in the rate of patients undergoing SBCE for suspected small-bowel bleeding was observed from 2001-2008 to 2011-2013 (67.3 vs. 76.1%; p < 0.001). There was an increase in the number of complete small-bowel examinations (81.2 vs. 89.0%; p < 0.001) and of outpatient SBCEs (6.7 vs. 61.9%; p < 0.001). Conversely, both the retention rate (2.1 vs. 0.8%; p < 0.001) and the rate of patients undergoing SBCE for Crohn's disease (11.5 vs. 5.5%; p < 0.001) decreased significantly. The overall DY remained stable (50.6 vs. 48.4%; p = 0.089). CONCLUSION: Our study shows that, over 13 years, the SBCE safety profile and completion rate significantly improved over time; a change in the spectrum of clinical indications was also observed.

Utility of 3-dimensional image reconstruction in the diagnosis of small-bowel masses in capsule endoscopy (with video).

BACKGROUND: In small-bowel capsule endoscopy (SBCE), differentiating masses (ie, lesions of higher probability for neoplasia) requiring more aggressive intervention from bulges (essentially, false-positive findings) is a challenging task; recently, software that enables 3-dimensional (3D) reconstruction has become available. OBJECTIVE: To evaluate whether "coupling" 3D reconstructed video clips with the standard 2-dimensional (s2D) counterparts helps in distinguishing masses from bulges. DESIGN: Three expert and 3 novice SBCE readers, blind to others and in a random order, reviewed the s2D video clips and subsequently the s2D clips coupled with their 3D reconstruction (2D+3D). SETTING: Multicenter study in 3 community hospitals in Italy and a university hospital in Scotland. PATIENTS: Thirty-two deidentified 5-minute video clips, containing mucosal bulging (19) or masses (13). INTERVENTION: 3D reconstruction of s2D SBCE video clips. MAIN OUTCOME MEASURE: Differentiation of masses from bulges with s2D and 2D+3D video clips, estimated by the area under the receiver operating characteristic curve (AUC); interobserver agreement. RESULTS: AUC for experts and novices for s2D video clips was .74 and .5, respectively (P = .0053). AUC for experts and novices with 2D+3D was .70 (compared with s2D: P = .245) and .57 (compared s2D: P = .049), respectively. AUC for experts and novices with 2D+3D was similar (P = .1846). The interobserver agreement was good for both experts and novices with the s2D (k = .71 and .54, respectively) and the 2D+3D video clips (k = .58 in both groups). LIMITATIONS: Few, short video clips; fixed angle of 3D reconstruction. CONCLUSIONS: The adjunction of a 3D reconstruction to the s2D video reading platform does not improve the performance of expert SBCE readers, although it significantly increases the performance of novices in distinguishing masses from bulging.

Enteroscopy in diagnosis and treatment of small bowel bleeding: A Delphi expert consensus.

BACKGROUND: Enteroscopy plays an important role in the management of small bowel bleeding. However, current guidelines are not specifically designed for small bowel bleeding and recommendations from different international societies do not always align. Consequently, there is heterogeneity in the definitions of clinical entities, clinical practice policies, and adherence to guidelines among clinicians. This represents an obstacle to providing the best patient care and to obtain homogeneous data for clinical research. AIMS: The aims of the study were to establish a consensus on the definitions of bleeding entities and on the role of enteroscopy in the management of small bowel bleeding using a Delphi process. METHODS: A core group of eight experts in enteroscopy identified five main topics of small bowel bleeding management and drafted statements on each topic. An expert panel of nine gastroenterologists participated in three rounds of the Delphi process, together with the core group. RESULTS: A total of 33 statements were approved after three rounds of Delphi voting. CONCLUSION: This Delphi consensus proposes clear definitions and a unifying strategy to standardize the management of small bowel bleeding. Furthermore, it provides a useful guide in daily practice for both clinical and technical issues of enteroscopy.

Safety and clinical efficacy of the double switch from originator infliximab to biosimilars CT-P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicenter cohort study.

Data regarding double switching from originator infliximab (IFX) to IFX biosimilars in inflammatory bowel diseases (IBDs) are lacking. The purpose of this study was to evaluate the safety and efficacy of switching from originator IFX to CT-P13 and subsequently to SB2 (double switch) in patients with IBD. Patients undergoing IFX-double switch in eight Centers in Lombardy (Italy) from November 2018 to May 2019 were retrospectively analyzed. The IFX discontinuation rate, incidence and type of adverse events (AEs), and clinical remission rate were recorded. A comparison with a control group of patients with IBD single-switched from originator IFX to CT-P13 was performed, before and after an inverse probability of treatment weighting (IPTW)-based propensity score analysis. Fifty-two double-switched patients with IBD were enrolled. The 24- and 52-week proportions of patients continuing on IFX therapy following the second switch (CTP13 â†’ SB2) were 98% (95% confidence interval [CI] 94%-100%) and 90% (95% CI 81%-99%), respectively. Four patients experienced a total of five AEs, all graded 1-3 according to Common Terminology Criteria for Adverse Events (CTCAE). No infusion reactions were observed. The 24-week and follow-up end clinical remission rates following the second switch were 94% and 88%, respectively. No differences were observed in the safety and efficacy outcomes by comparing the double-switch group with a single-switch group of 66 patients with IBD; all these results were confirmed by IPTW-adjusted analysis. The study suggests both the safety and efficacy of the double switch from originator IFX to CT-P13 and SB2 in patients with IBD is maintained. This strategy may be associated with potential cost implications.

Development of a novel index to discriminate bulge from mass on small-bowel capsule endoscopy.

BACKGROUND: Submucosal malignant masses (SMMs) and innocent bulges look similar on small-bowel capsule endoscopy (SBCE). In a previous observational study, 4 criteria associated with innocent bulges were recognized. OBJECTIVE: To devise and validate an index based on these criteria (smooth, protruding lesion index on capsule endoscopy [SPICE]) to discriminate SMMs from innocent bulges. DESIGN: Single-center, prospective study. SETTING: General hospital in Busto Arsizio, Italy. PATIENTS: This study involved 25 of 424 consecutive SBCEs performed on as many patients having SBCE findings of smooth, round, protruding lesions. INTERVENTION: Patients' evaluation up to the final diagnosis. At study entry, a short video clip of the lesion was obtained and deidentified for blind SPICE calculation. MAIN OUTCOME MEASUREMENTS: SPICE accuracy, using the final diagnosis of each patient as the criterion standard. RESULTS: Six patients had SMMs (4 GI stromal tumors, 2 neuroendocrine tumors), and 19 had innocent bulges. SPICE scores ranged from 0 to 4; they discriminated SMMs from innocent bulges (P = .002). A SPICE value >2 had 83.3% sensitivity and 89.4% specificity, and the area under the curve was 0.90 (95% confidence interval, 0.72-0.98; P < .001) for the detection of SMMs. LIMITATIONS: Single-center study; small sample size; no invasive ascertainment in 36% of patients. CONCLUSION: SPICE is easy to calculate and useful for distinguishing SMMs from innocent bulges. An index >2 is predictive of SMM.

[Capsule endoscopy in Crohn's disease]. / La capsula endoscopica nella malattia di Crohn.

Capsule endoscopy appropriateness in Crohn's disease.The incidence of Crohn's disease is steadily growing in western countries and the diagnosis is still delayed from symptoms onset by several years. Up to one third of patients have exclusive disease location in the small bowel, the tract less accessible to conventional diagnostic visualization. In the last decade, astonishing improvements in radiologic and endoscopic imaging allowed to better diagnose small bowel Crohn's disease. In particular, capsule endoscopy is a high sensitive tool in diagnosing subtle inflammatory lesions of the mucosa, but retention risk and low specificity limit its use in this setting. The present review provides a critical evaluation of the published studies addressed to the diagnostic role of small bowel capsule endoscopy in established, suspect, operated Crohn's disease and unclassified inflammatory bowel disease: in an attempt to help the clinician to utilize capsule endoscopy properly in the different clinical scenarios associated to inflammatory bowel disease.

Erratum: Scoring systems in clinical small-bowel capsule endoscopy: all you need to know!

[This corrects the article DOI: 10.1055/a-1372-4051.].

Quality performance measures for small capsule endoscopy: Are the ESGE quality standards met?

Background and study aims The European Society of Gastrointestinal Endoscopy (ESGE) recently issued a quality performance measures document for small bowel capsule endoscopy (SBCE). The aim of this nationwide survey was to explore SBCE practice with ESGE quality measures as a benchmark. Patients and methods A dedicated per-center semi-quantitative questionnaire based on ESGE performance measures for SBCE was created by a group of SBCE experts. One-hundred-eighty-one centers were invited to participate and were asked to calculate performance measures for SBCE performed in 2018. Data were compared with 10 ESGE quality standards for both key and minor performance measures. Results Ninety-one centers (50.3 %) participated in the data collection. Overall in the last 5 years (2014-2018), 26,615 SBCEs were performed, 5917 of which were done in 2018. Eighty percent or more of the participating centers reached the minimum standard established by the ESGE Small Bowel Working Group (ESBWG) for four performance measures (indications for SBCE, complete small bowel evaluation, diagnostic yield and retention rate). Conversely, compliance with six minimum standards established by ESBWG concerning adequate bowel preparation, patient selection, timing of SBCE in overt bleeding, appropriate reporting, reading protocols and referral to device-assisted enteroscopy was met by only 15.5 %, 10.9 %, 31.1 %, 67.7 %, 53.4 %, and 32.2 % of centers, respectively. Conclusions The present survey shows significant variability across SBCE centers; only four (4/10: 40 %) SBCE procedural minimum standards were met by a relevant proportion of the centers ( ≥ 80 %). Our data should help in identifying target areas for quality improvement programs in SBCE.

Adherence to European Society of Gastrointestinal Endoscopy recommendations of endoscopists performing small bowel capsule endoscopy in Italy.

BACKGROUND: The European Society of Gastrointestinal Endoscopy (ESGE) has recently issued a technical review focused on small bowel capsule endoscopy (SBCE). AIM: To compare SBCE current practice in Italy to ESGE technical recommendations. MATERIAL AND METHODS: A dedicated per-centre semi-quantitative questionnaire was prepared by a group of SBCE experts. One-hundred-fifty Centres were invited to participate in the data collection concerning SBCEs performed between June 2016 and June 2017. Data were compared with ESGE recommendations. RESULTS: 120 Centres participated in the data collection. Current practices agreed with ESGE recommendations in 56.3% (9/16) of the issues evaluated. Differences between ESGE recommendations and current practice concerned the management of patients with pacemakers or cardiac implantable defibrillators (which was in agreement with ESGE recommendations in 31.7% and 15.8% of Centres, respectively), the SBCE setting (only 51% of SBCEs were performed as outpatients procedures), the assessment of capsule excretion (timing and modality were in agreement with ESGE recommendation in 20.0% of Centres), and in the involvement of trained nurses or fellows in training as pre-readers (7/120; 5.8%). CONCLUSIONS: Although SBCE is widely used and largely available in Italy, there are still some technical, practical and organizational issues that can be modified to bridge the gap between current practice and ESGE guideline recommendations.

Diagnosis of chronic anaemia in gastrointestinal disorders: A guideline by the Italian Association of Hospital Gastroenterologists and Endoscopists (AIGO) and the Italian Society of Paediatric Gastroenterology Hepatology and Nutrition (SIGENP).

Anaemia is a common pathologic condition, present in almost 5% of the adult population. Iron deficiency is the most common cause; other mechanisms can be involved, making anaemia a multi-factorial disorder in most cases. Anaemia being a frequent manifestation in the diseases of the gastrointestinal tract, patients are often referred to gastroenterologists. Furthermore, upper and lower endoscopy and enteroscopy are pivotal to the diagnostic roadmap of anaemia. In spite of its relevance in the daily clinical practice, there is a limited number of gastroenterological guidelines dedicated to the diagnosis of anaemia. For this reason, the Italian Association of Hospital Gastroenterologists and Endoscopists and the Italian Society of Paediatric Gastroenterology, Hepatology and Nutrition commissioned a panel of experts to prepare a specific guideline on anaemia and its diagnostic roadmap in the gastroenterological scenario. The panel also discussed about the potential involvement of gastroenterologists and endoscopists in the management of patients with anaemia, with particular attention to the correct use of investigations. The panel paid particular attention to practical issues with the aim to support gastroenterologists in their clinical practice when dealing with patients with anaemia.

Implications of small-bowel transit time in the detection rate of capsule endoscopy: A multivariable multicenter study of patients with obscure gastrointestinal bleeding.

AIM: To define the role of small-bowel transit time in the detection rate of significant small-bowel lesions. METHODS: Small-bowel capsule endoscopy records, prospectively collected from 30 participating centers in the Lombardy Registry from October 2011 to December 2013, were included in the study if the clinical indication was obscure gastrointestinal bleeding and the capsule reached the cecum. Based on capsule findings, we created two groups: P2 (significant findings) and P0-1 (normal/negligible findings). Groups were compared for age, gender, small-bowel transit time, type of instrument, modality of capsule performance (outpatients vs inpatients), bowel cleanliness, and center volume. RESULTS: We retrieved and scrutinized 1,433 out of 2,295 capsule endoscopy records (62.4%) fulfilling the inclusion criteria. Patients were 67 ± 15 years old, and 815 (57%) were males. In comparison with patients in the P0-1 group, those in the P2 group (n = 776, 54%) were older (P < 0.0001), had a longer small-bowel transit time (P = 0.0015), and were more frequently examined in low-volume centers (P < 0.001). Age and small-bowel transit time were correlated (P < 0.001), with age as the sole independent predictor on multivariable analysis. Findings of the P2 group were artero-venous malformations (54.5%), inflammatory (23.6%) and protruding (10.4%) lesions, and luminal blood (11.5%). CONCLUSION: In this selected, prospectively collected cohort of small-bowel capsule endoscopy performed for obscure gastrointestinal bleeding, a longer small-bowel transit time was associated with a higher detection rate of significant lesions, along with age and a low center volume, with age serving as an independent predictor.

First report of splenic rupture following deep enteroscopy.

Splenic rupture is a rare complication of diagnostic and therapeutic gastrointestinal endoscopy procedures. Herein, we report for the first time a case of splenic rupture following therapeutic retrograde double-balloon enteroscopy, which occurred in an 85-year-old man who was treated for recurrent mid-intestinal bleeding that resulted from ileal angioectasia. This patient promptly underwent an operation and eventually recovered.

Short article: Negative small-bowel cross-sectional imaging does not exclude capsule retention in high-risk patients.

BACKGROUND AND AIMS: Both Agile patency capsule (PC) and small-bowel cross-sectional imaging (SBCSI) techniques have been used to assess small-bowel patency in patients at high risk of capsule retention. The present study aimed to compare capsule retention rates in high-risk patients with negative PC or SBCSI. MATERIALS AND METHODS: Between January 2011 and December 2013, consecutive patients undergoing small-bowel capsule endoscopy (SBCE) in the Lombardia region were prospectively entered into a dedicated registry. They were classified as being at high or low risk of capsule retention by the local investigator according to predefined clinical criteria. High-risk patients underwent either PC or SBCSI depending on local expertise and availability; those who tested negative underwent SBCE. RESULTS: Out of 3117 patients (male/female: 1667/1450, mean age: 63.1±17.7), 2942 (94.4%) were classified as being at low risk and 175 (5.6%) were classified as being at high risk for capsule retention. Among 175 high-risk patients, 151 (86.3%) had negative PC and 24 (13.7%) had negative SBCSI: capsule retention occurred in two patients with negative SBCSI (8.3%) and in one patient (0.7%) with negative PC (P=0.049). The capsule retention rates in high-risk patients with negative PC and in low-risk patients (20/2942; 0.7%) were comparable (P=1.0). CONCLUSION: The capsule retention rate is similar in low-risk and negative PC high-risk patients. Conversely, high-risk patients with negative SBCSI have a significantly higher capsule retention rate. Our data suggest that in high-risk patients, negative SBCSI examination is not reassuring and, when SBCE is indicated, PC should be performed.

Small-bowel myeloid sarcoma: Report of a case with atypical presentation.

INTRODUCTION: Small-bowel myeloid sarcoma is rare. Acute bowel obstruction is its usual clinical presentation. PRESENTATION OF CASE: We report a case of small-bowel myeloid sarcoma that occurred in a 64-year-old woman who presented chronic secretory diarrhoea, hypokalaemia, and weight loss. Immature white blood cells in a peripheral smear and small-bowel capsule endoscopic features were the main diagnostic clues. The patient experienced capsule retention and developed acute bowel obstruction. Urgent laparotomy showed a stricturing ileal mass and pathology of the resected bowel specimen unveiled a CD34+, CD117+, and myeloperoxidase-positive myeloid sarcoma. The diarrhoea promptly resolved after surgery, and the patient is now undergoing chemotherapy. DISCUSSION: Secretory diarrhoea can be the first manifestation of small-bowel myeloid sarcoma. Capsule endoscopy may provide a diagnostic clue, but it can trigger an acute bowel obstruction. Differential diagnosis of the pathologic specimen may be difficult and a high suspicion index of is mandatory to perform immunophenotyping to determine the correct management. CONCLUSION: Chronic diarrhoea with alarm features can be the first manifestation of small-bowel myeloid sarcoma.

Can we improve the detection rate and interobserver agreement in capsule endoscopy?

BACKGROUND: Data about strategies for improving the diagnostic ability of capsule endoscopy readers are lacking. AIM: (1) To evaluate the detection rate and the interobserver agreement among readers with different experience; (2) to verify the impact of a specific training (hands-on training plus expert tutorial) on these parameters. METHODS: 17 readers reviewed 12 videos twice; between the two readings they underwent the training. The identified small bowel findings were described by a simplified version of Structured Terminology and classifies as clinically significant/non-significant. Findings identified by the readers were compared with those identified by three experts (Reference Standard). RESULTS: The Reference Standard identified 26 clinically significant findings. The mean detection rate of overall readers for significant findings was low (about 50%) and did not change after the training (46.2% and 46.4%, respectively). There was no difference in the detection rate among readers with different experience. The interobserver agreement with the Reference Standard in describing significant findings was moderate (k = 0.44; CI95%: 0.39-0.50) and did not change after the training (k = 0.44; CI95%: 0.38-0.49) or stratifying readers according to their experience. CONCLUSIONS: Both the interobserver agreement and the detection rate of significant findings are low, regardless of the readers' experience. Our training did not significantly increase the performance of readers with different experience.

Small bowel capsule endoscopy performance in octogenarians: a case-control study.

BACKGROUND AND STUDY AIMS: Capsule endoscopy is a high-sensitive tool for the investigation of suspected small bowel disorders, but its effectiveness in elderly patients is unknown. We sought to determine capsule endoscopy feasibility and diagnostic yield in octogenarians. PATIENTS AND METHODS: Records of patients ≥ 80 years old (Group A) were retrieved from a database of 827 consecutive capsule endoscopy performed on as many patients. Capsule endoscopy failures, complications, diagnostic yield, and findings were recorded and compared with those of patients younger than 80 (Group B), randomly extracted from the same database in a > 2:1 ratio. RESULTS: Group A consisted of 79 patients, 84 ± 6 years old and Group B of 188, 44 ± 11 years old (p < .0001). We visualized the entire small bowel in 59 (74.6%) patients of Group A and in 169 (89%) of Group B (odds ratio = 0.33, 95% confidence interval: 0.16-0.66, p = .0025), mainly for capsule failures in reaching the duodenum; this event occurred in 10 patients of Group A and in 3 of Group B (odds ratio = 9, 95% confidence interval: 2.4-33.4, p = .0004). The rate of adverse events and diagnostic yield did not differ between the two groups. Inflammatory and neoplastic lesions were more common in Group A (odds ratio = 2.60, 95% confidence interval: 1.07-6.28, p = .03 and odds ratio = 2.01, 95% confidence interval: 1.02-3.97, p = .04, respectively). CONCLUSIONS: In octogenarians, small bowel capsule endoscopy may be troublesome for capsule failure in reaching the duodenum. However, the diagnostic yield of small bowel capsule endoscopy and the rate of clinically significant lesions are high.

Cost estimation of small bowel capsule endoscopy based on "real world" data: inpatient or outpatient procedure?

BACKGROUND: Although capsule endoscopy is the cornerstone for the evaluation of the small bowel in patients with obscure GI bleeding data about costs are lacking. AIM: To evaluate, from a third party payer point of view, whether performing capsule endoscopy as an outpatient instead of an inpatient procedure can reduce costs. MATERIALS AND METHODS: The data source is a multicentre survey collecting data for 2921 patients; 1486 of them underwent capsule endoscopy for obscure GI bleeding or chronic unexplained iron-deficiency anaemia as inpatients (814 with positive, 211 with inconclusive and 461 with negative result). We estimated costs of inpatient procedures based on the diagnosis related groups (DRG) system, while those of outpatient procedures on reimbursement provided in five Italian regions. RESULTS: We estimated that the cost for each inpatient undergoing capsule endoscopy is about € 1775.90. Assuming that all these patients had undergone the same procedure as outpatients, € 175.00-741.00 per patient (depending on the reimbursement and/or on diagnosis related group codes applied) would have been saved. CONCLUSIONS: Our estimate suggests that, from the third party payer's perspective and using the diagnosis related group reimbursement system, shifting capsule endoscopy from inpatient to outpatient procedure, would be potentially cost saving at least for patients referred for obscure GI bleeding or chronic unexplained anaemia.