Prospective multicenter study to identify optimal target population for motorized spiral enteroscopy.

Motorized spiral enteroscopy (MSE) enhances small bowel exploration, but the optimal target population for this technique is unknown. We aimed to identify the target population for MSE by evaluating its efficacy and safety, as well as detecting predictors of efficacy. A prospective multicenter observational study was conducted at 9 tertiary hospitals in Spain, enrolling patients between June 2020-2022. Analyzed data included demographics, indications for the procedure, exploration time, depth of maximum insertion (DMI), technical success, diagnostic yield, interventional yield, and adverse events (AE) up to 14 days from enteroscopy. Patients with prior gastrointestinal surgery, unsuccessful balloon enteroscopy and small bowel strictures were analyzed. A total of 326 enteroscopies (66.6% oral route) were performed in 294 patients (55.1% males, 65 years ± 21). Prior abdominal surgery was present in 50% of procedures (13.5% gastrointestinal surgery). Lower DMI (162 vs 275 cm, p = 0.037) and diagnostic yield (47.7 vs 67.5%, p = 0.016) were observed in patients with prior gastrointestinal surgery. MSE showed 92.2% technical success and 56.9% diagnostic yield after unsuccessful balloon enteroscopy (n = 51). In suspected small bowel strictures (n = 49), the finding was confirmed in 23 procedures (46.9%). The total AE rate was 10.7% (1.8% classified as major events) with no differences related to prior gastrointestinal/abdominal surgery, unsuccessful enteroscopy, or suspected small bowel strictures. The study demonstrates that MSE has a lower diagnostic yield and DMI in patients with prior gastrointestinal surgery but is feasible after unsuccessful balloon-enteroscopy and in suspected small bowel strictures without safety concerns.

The evolving role of device-assisted enteroscopy: The state of the art as of August 2023.

Device-assisted enteroscopy (DAE), balloon-assisted enteroscopy (BAE) in particular, has become a routine endoscopic procedure which has revolutionized our approach to small-bowel disease. Evidence demonstrating the efficacy and safety of BAE spans over 22-years of experience, making it an established pillar of minimally invasive care. The robust evidence for BAE's safety and efficacy has now been incorporated into international clinical guidelines, technical reviews, benchmarking performance measures and curricula. The more recently introduced motorized spiral enteroscopy (MSE) which had replaced the previous manual version, abruptly ended its 7-year stint in clinical practice, when it was withdrawn and recalled from the market by its manufacturing company in July 2023, due to several associated serious adverse events (including fatalities). This article, written by the original developer of double-balloon enteroscopy (DBE) and other recognized international experts and pioneers in this field, focuses mainly on the technical aspects, evolving indications, and equipment-related technological advances. Despite the very recent withdrawal of MSE from clinical practice, for completeness, this technology and its technique is still briefly covered here, albeit importantly, along with a short description of reported, associated, serious adverse events which have contributed to its withdrawal/recall from the market and clinical practice.

Motorized Spiral Enteroscopy Is Effective in Patients with Prior Abdominal Surgery.

BACKGROUND: Motorized Spiral Enteroscopy (MSE) reduces procedure time and increases insertion depth into the small bowel; however, there is scarce evidence on factors affecting MSE efficacy. AIMS: To evaluate diagnostic yield and adverse events of MSE including patients with prior major abdominal surgery. METHODS: A prospective observational study was conducted on patients undergoing MSE from June 2019 to December 2021. Demographic characteristics, procedure time, depth of maximum insertion (DMI), technical success, diagnostic yield, and adverse events were collected. RESULTS: Seventy-four anterograde (54.4%) and 62 retrograde (45.6%) enteroscopies were performed in 117 patients (64 males, median age 67 years). Fifty patients (42.7%) had prior major abdominal surgery. Technical success was 91.9% for anterograde and 90.3% for retrograde route. Diagnostic yield was 71.6% and 61.3%, respectively. The median DMI was 415 cm (264-585) for anterograde and 120 cm (37-225) for retrograde enteroscopy. In patients with prior major abdominal surgery, MSE showed significantly longer small bowel insertion time (38 vs 29 min, p = 0.004), with similar diagnostic yield (61 vs 71.4%, p = 0.201) and DMI (315 vs 204 cm, p = 0.226). The overall adverse event rate was 10.3% (SAE 1.5%), with no differences related to prior abdominal surgery (p = 0.598). Patients with prior surgeries directly involving the gastrointestinal tract showed lower DMI (189 vs 374 cm, p = 0.019) with equal exploration time (37.5 vs 38 min, p = 0.642) compared to those with other abdominal surgeries. CONCLUSIONS: MSE is effective and safe in patients with major abdominal surgery, although longer procedure times were observed. A lower depth of insertion was detected in patients with gastrointestinal surgery.

Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022.

MR1: ESGE recommends small-bowel capsule endoscopy as the first-line examination, before consideration of other endoscopic and radiological diagnostic tests for suspected small-bowel bleeding, given the excellent safety profile of capsule endoscopy, its patient tolerability, and its potential to visualize the entire small-bowel mucosa.Strong recommendation, moderate quality evidence. MR2: ESGE recommends small-bowel capsule endoscopy in patients with overt suspected small-bowel bleeding as soon as possible after the bleeding episode, ideally within 48 hours, to maximize the diagnostic and subsequent therapeutic yield.Strong recommendation, high quality evidence. MR3: ESGE does not recommend routine second-look endoscopy prior to small-bowel capsule endoscopy in patients with suspected small-bowel bleeding or iron-deficiency anemia.Strong recommendation, low quality evidence. MR4: ESGE recommends conservative management in those patients with suspected small-bowel bleeding and high quality negative small-bowel capsule endoscopy.Strong recommendation, moderate quality evidence. MR5: ESGE recommends device-assisted enteroscopy to confirm and possibly treat lesions identified by small-bowel capsule endoscopy.Strong recommendation, high quality evidence. MR6: ESGE recommends the performance of small-bowel capsule endoscopy as a first-line examination in patients with iron-deficiency anemia when small bowel evaluation is indicated.Strong recommendation, high quality evidence. MR7: ESGE recommends small-bowel capsule endoscopy in patients with suspected Crohn's disease and negative ileocolonoscopy findings as the initial diagnostic modality for investigating the small bowel, in the absence of obstructive symptoms or known bowel stenosis.Strong recommendation, high quality evidence. MR8: ESGE recommends, in patients with unremarkable or nondiagnostic findings from dedicated small-bowel cross-sectional imaging, small-bowel capsule endoscopy as a subsequent investigation if deemed likely to influence patient management.Strong recommendation, low quality evidence. MR9: ESGE recommends, in patients with established Crohn's disease, the use of a patency capsule before small-bowel capsule endoscopy to decrease the capsule retention rate.Strong recommendation, moderate quality evidence. MR10: ESGE recommends device-assisted enteroscopy (DAE) as an alternative to surgery for foreign bodies retained in the small bowel requiring retrieval in patients without acute intestinal obstruction.Strong recommendation, moderate quality evidence. MR11: ESGE recommends DAE-endoscopic retrograde cholangiopancreatography (DAE-ERCP) as a first-line endoscopic approach to treat pancreaticobiliary diseases in patients with surgically altered anatomy (except for Billroth II patients).Strong recommendation, moderate quality evidence.

Predictive factors for inadequate bowel cleansing in colon capsule endoscopy.

BACKGROUND AND AIMS: Achieving adequate bowel cleansing is of utmost importance for the efficiency of colon capsule endoscopy (CCE). However, information about predictive factors is lacking. The aim of this study was to assess the predictive factors of poor bowel cleansing in the CCE setting. METHODS: In this observational study, 126 patients who underwent CCE at two tertiary care hospitals were included between June 2017 and January 2020. Participants prepared for bowel cleansing with a 1-day clear liquid diet, a 4-L split-dose polyethylene glycol regimen and boosters with sodium phosphate, sodium amidotrizoate and meglumine amidotrizoate. Domperidone tablets and bisacodyl suppositories were administered when needed. Overall and per-segment bowel cleansing was evaluated using a CCE cleansing score. Simple and multiple logistic regression analysis were carried out to assess poor bowel cleansing and excretion rate predictors. RESULTS: Overall bowel cleansing was optimal in 53 patients (50.5%). Optimal per-segment bowel cleansing was achieved as follows: cecum (86 patients; 74.8%), transverse colon (91 patients; 81.3%), distal colon (81 patients; 75%) and rectum (64 patients; 66.7%). In the univariate analysis, elderly (OR, 1.03; 95% CI (1.01-1.076)) and constipation (OR, 3.82; 95% CI (1.50-9.71)) were associated with poor bowel cleansing. In the logistic regression analysis, constipation (OR, 3.77; 95% CI (1.43-10.0)) was associated with poor bowel cleansing. No variables were significantly associated with the CCE device excretion rate. CONCLUSION: Our results suggest that constipation is the most powerful predictor of poor bowel cleansing in the CCE setting. Tailored cleansing protocols should be recommended for these patients.

Endoscopic evaluation of surgically altered bowel in inflammatory bowel disease: a consensus guideline from the Global Interventional Inflammatory Bowel Disease Group.

The majority of patients with Crohn's disease and a proportion of patients with ulcerative colitis will ultimately require surgical treatment despite advances in diagnosis, therapy, and endoscopic interventions. The surgical procedures that are most commonly done include bowel resection with anastomosis, strictureplasty, faecal diversion, and ileal pouch. These surgical treatment modalities result in substantial alterations in bowel anatomy. In patients with inflammatory bowel disease, endoscopy plays a key role in the assessment of disease activity, disease recurrence, treatment response, dysplasia surveillance, and delivery of endoscopic therapy. Endoscopic evaluation and management of surgically altered bowel can be challenging. This consensus guideline delineates anatomical landmarks and endoscopic assessment of these landmarks in diseased and surgically altered bowel.

Oral ingestion versus endoscopic delivery of endoscopic capsule in patients with previous gastrointestinal surgery (ORENCES study): A Spanish multicentre observational study.

BACKGROUND: Small Bowel Capsule Endoscopy is the first-choice technique for investigating the majority of small bowel diseases. Its most common complications are related to incomplete examinations and capsule retention. There is no consensus on how patients with previous gastrointestinal surgery should receive the capsule. OBJECTIVE: The primary endpoint was to compare the rate of complete small-bowel examinations (completion rate) between oral ingestion and endoscopic delivery of the capsule. The secondary endpoint was to compare diagnostic yield and adverse events in the two groups. METHODS: A retrospective observational study was conducted in nine hospitals in Spain. Demographic data, previous surgery, indication for capsule endoscopy, intestinal transit time, diagnosis, completion rate (percentage of capsules reaching the caecum), diagnostic yield (percentage of results compatible with indication for the exam) and adverse events were collected. RESULTS: From January 2009 to May 2019 fifty-seven patients were included (39 male, mean age 66±15 years). The most common indications for the exam were "overt" (50.9%) and "occult" (35.1%) small bowel bleeding. Previous Billroth II gastrectomy and Roux-en-Y gastric bypass were present in 52.6% and 17.5% of patients respectively. The capsule was swallowed in 34 patients and placed endoscopically in 23 patients. No significant differences were observed between the oral ingestion and endoscopic delivery groups in terms of completion rate (82.4% vs. 78.3%; p=0.742), diagnostic yield (41.2% vs. 52.2%; p=0.432) or small bowel transit time (301 vs. 377min, p=0.118). No capsule retention occurred. Only one severe adverse event (anastomotic perforation) was observed in the endoscopic delivery group. CONCLUSIONS: In our case series, there were no significant differences between oral ingestion and endoscopic delivery in terms of completion rate, diagnostic yield or safety. Being less invasive, oral ingestion of the capsule should be the first-choice method in patients with previous gastrointestinal surgery.

Colon capsule endoscopy versus CT colonography in FIT-positive colorectal cancer screening subjects: a prospective randomised trial-the VICOCA study.

BACKGROUND: Colon capsule endoscopy (CCE) and CT colonography (CTC) are minimally invasive techniques for colorectal cancer (CRC) screening. Our objective is to compare CCE and CTC for the identification of patients with colorectal neoplasia among participants in a CRC screening programme with positive faecal immunochemical test (FIT). Primary outcome was to compare the performance of CCE and CTC in detecting patients with neoplastic lesions. METHODS: The VICOCA study is a prospective, single-centre, randomised trial conducted from March 2014 to May 2016; 662 individuals were invited and 349 were randomised to CCE or CTC before colonoscopy. Endoscopists were blinded to the results of CCE and CTC. RESULTS: Three hundred forty-nine individuals were included: 173 in the CCE group and 176 in the CTC group. Two hundred ninety individuals agreed to participate: 147 in the CCE group and 143 in the CTC group. In the intention-to-screen analysis, sensitivity, specificity and positive and negative predictive values for the identification of individuals with colorectal neoplasia were 98.1%, 76.6%, 93.7% and 92.0% in the CCE group and 64.9%, 95.7%, 96.8% and 57.7% in the CTC group. In terms of detecting significant neoplastic lesions, the sensitivity of CCE and CTC was 96.1% and 79.3%, respectively. Detection rate for advanced colorectal neoplasm was higher in the CCE group than in the CTC group (100% and 93.1%, respectively; RR = 1.07; p = 0.08). Both CCE and CTC identified all patients with cancer. CCE detected more patients with any lesion than CTC (98.6% and 81.0%, respectively; RR = 1.22; p = 0.002). CONCLUSION: Although both techniques seem to be similar in detecting patients with advanced colorectal neoplasms, CCE is more sensitive for the detection of any neoplastic lesion. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02081742 . Registered: September 16, 2013.

Evaluation of long-term adherence to oesophagogastroduodenoscopy quality indicators. / Evaluación del cumplimiento a largo plazo de los indicadores de calidad en la esofagogastroduodenoscopia.

INTRODUCTION: In a previous study we demonstrated that a simple training programme improved quality indicators of Oesophagogastroduodenoscopy (OGD) achieving the recommended benchmarks. However, the long-term effect of this intervention is unknown. The aim of this study was to assess the quality of OGDs performed 3 years after of having completed a training programme. MATERIAL AND METHODS: A comparative study of 2 cohorts was designed as follows: Group A included OGDs performed in 2016 promptly after a training programme and Group B with OGDs performed from January to March 2019, this group was also divided into 2 subgroups: subgroup B1 of Endoscopists who had participated in the previous training programme and subgroup B2 of Endoscopists who had not. The intra-procedure quality indicators proposed by ASGE-ACG were used. RESULTS: A total of 1236 OGDs were analysed, 600 from Group A and 636 from Group B (439 subgroup B1 and 197 subgroup B2). The number of complete examinations was lower in Group B (566 [94.3%] vs. 551 [86.6%]; p<0.001). A significant decrease was observed in nearly all quality indicators and they did not reach the recommended benchmarks: retroflexion in the stomach (96% vs. 81%; p<0.001); Seattle biopsy protocol (86% vs. 50%; p=0.03), description of the upper GI bleeding lesion (100% vs. 62%; p<0.01), sufficient intestinal biopsy specimens (at least 4) in suspected coeliac disease (92.5% vs. 18%; p<0.001), photo documentation of the lesion (94% vs. 90%; p<0.05). Regarding the overall assessment of the procedure (including correct performance and adequate photo documentation), a significant decrease was also observed (90.5% vs. 62%; p<0.001). There were no differences between subgroups B1 and B2. CONCLUSIONS: The improvement observed in 2016 after a training programme did not prevail after 3 years. In order to keep the quality of OGDs above the recommended benchmarks, it is necessary to implement continuous training programmes.

Are we experiencing a technological revolution? The novel motorized PowerSpiral enteroscope (PSE): a case of total oral enteroscopy.

The novel motorized spiral rnteroscope (PowerSpiral®, Olympus) (PSE) has been recently commercialized with promising results in relation to insertion depth and time of exploration. We herewith report our first case of a total small bowel exploration with PSE.

Is endoscopic treatment of small bowel strictures effective and safe in patients with Crohn's disease?

INTRODUCTION: there is very little scientific evidence about the efficacy of endoscopic balloon dilation (EBD) performed with balloon-assisted enteroscopy (BAE) for the treatment of small bowel strictures (SBS) in Crohn's disease (CD). OBJECTIVE: to evaluate the efficacy and safety of EBD using BAE in patients with CD and SBS. METHODS: a retrospective observational study was performed in a tertiary care medical center in patients with CD and SBS, evaluated by CT enterography or MRI enterography. RESULTS: from 2009 to 2019, 205 endoscopic dilations were performed in 80 patients with CD. 17 (21.25 %) had only SBS and 70.6 % were male with a median age of 42.2 (±14.4) years. The mean follow-up was 37.8 ±28.7 months. A total of 39 dilations were performed, 94.1 % were native and less than 5cm long, all strictures were ulcerated. The overall technical success was 82.4 % and clinical success was 88.2 %. During follow-up, 23.5 % of patients required surgery and 29.4 % were re-dilated. The long-term efficacy was 76.5 % and no severe adverse events (AE) were observed. No factors were identified to predict the need for surgery after dilation. CONCLUSIONS: SBS can be safely and effectively treated with EBD using BAE, thus reducing the need for surgery in the long term.

Association between a regular arrangement of collecting venules and absence of Helicobacter pylori infection in a European population.

BACKGROUND AND AIMS: Helicobacter pylori is the major cause of gastritis and gastritis-associated diseases. Detection of a regular arrangement of collecting venules (RAC) in the lesser gastric curvature correlates with negative H pylori status with a sensitivity and negative predictive value (NPV) higher than 90% in Asian countries. The aim of the study was to evaluate the value of RAC as a diagnostic method of H pylori infection in a European population. METHODS: A prospective study with high-definition endoscopes without magnification was performed by 3 endoscopists. The presence of starfish-like minute points regularly distributed throughout the lesser curvature of the gastric body was considered RAC positive (RAC+). Gastric biopsies were performed during the procedure for H pylori diagnosis. RESULTS: One hundred forty patients were included from February 2017 to May 2018. The prevalence of H pylori infection was 31% and 47 of 140 patients (34%) were RAC+; 13 of 23 patients in whom H pylori was eradicated were RAC+. The mean age of RAC+ patients was lower (44.4 vs 52.4 years, P = .004) and they had less- significant endoscopic findings (9; 19.1% vs 38; 80.9%; P = .017). Gender, use of nonsteroidal anti-inflammatory drugs, antithrombotic or anticoagulants treatments, and a history of H pylori eradication did not show differences in the RAC pattern. The absence of RAC was associated with H pylori infection in 47.3% (44/93) of cases. In contrast, all RAC+ patients were free of H pylori infection, with sensitivity and NPV of 100% for the exclusion of H pylori infection. CONCLUSION: The presence of RAC+ in the lesser curvature evaluated with high-definition endoscopy can accurately identify patients without H pylori.

Comparison of Capsule Endoscopy and Magnetic Resonance Enterography for the Assessment of Small Bowel Lesions in Crohn's Disease.

Background and Aims: Diagnostic yield of Small Bowel Capsule Endoscopy (SBCE) for the assessment of small bowel (SB) lesions is higher than radiologic imaging techniques. However, magnetic resonance enterography (MRE) data are scarce and inconclusive. Colon Capsule Endoscopy (CCE) is a new capsule modality. The primary aim of our study was to compare MRE and capsule endoscopy (CE) for the assessment of Crohn's disease (CD). The secondary objectives were to compare the diagnostic accuracy of both CE modalities and changes in Montreal classification after each examination. Methods: We included 47 patients with established (n = 32) or suspected CD (n = 15). MRE was performed first to rule out strictures. In patients with a suspected stricture by MRE, an Agile Patency Capsule was performed. SB disease activity was measured by MaRIA score (MRE) and Lewis Index (CE). Results: SB lesions were found in 36 of47 patients with CE and in 21 of47 patients with MRE (76.6% vs 44.7%, P = 0.001). Jejunal inflammation was detected by CE in 31.9% of patients and by MRE in 6.4% of patients (15/47 vs 3/47; P = 0.03); lesions in ileum were detected in 57.4% of patients by CE, and in 21.3% of patients by MRE (27/ 47 vs 10/ 47; P = 0.04). Finally, in terminal ileum, CE showed lesions in 68.1% (32/47) of patients, whereas MRE detected lesions in 38.3% (18/ 47 patients), (P = 0.001). The original Montreal classification was changed in 53.1% of patients (25/ 47) based on CE findings and in 12.7% of patients (6/47) based on MRE findings (P < 0.05). Conclusions: In our cohort CE was significantly superior to MRE for detecting SB lesions, mainly superficial and proximal lesions. CE is useful for a appropriate patients' classification according to Montreal classification.

Development and validation of a scoring index to predict the presence of lesions in capsule endoscopy in patients with suspected Crohn's disease of the small bowel: a Spanish multicenter study.

BACKGROUND: Capsule endoscopy (CE) is the first-line investigation in cases of suspected Crohn's disease (CD) of the small bowel, but the factors associated with a higher diagnostic yield remain unclear. OBJECTIVE: Our aim is to develop and validate a scoring index to assess the risk of the patients in this setting on the basis of biomarkers. PATIENTS AND METHODS: Data on fecal calprotectin, C-reactive protein, and other biomarkers from a population of 124 patients with suspected CD of the small bowel studied by CE and included in a PhD study were used to build a scoring index. This was first used on this population (internal validation process) and after that on a different set of patients from a multicenter study (external validation process). RESULTS: An index was designed in which every biomarker is assigned a score. Three risk groups have been established (low, intermediate, and high). In the internal validation analysis (124 individuals), patients had a 10, 46.5, and 81% probability of showing inflammatory lesions in CE in the low-risk, intermediate-risk, and high-risk groups, respectively. In the external validation analysis, including 410 patients from 12 Spanish hospitals, this probability was 15.8, 49.7, and 80.6% for the low-risk, intermediate-risk, and high-risk groups, respectively. CONCLUSION: Results from the internal validation process show that the scoring index is coherent, and results from the external validation process confirm its reliability. This index can be a useful tool for selecting patients before CE studies in cases of suspected CD of the small bowel.

Clinical guidelines for endoscopic mucosal resection of non-pedunculated colorectal lesions. / Guía clínica para la resección mucosa endoscópica de lesiones colorrectales no pediculadas.

This document summarizes the contents of the Clinical Guidelines for the Endoscopic Mucosal Resection of Non-Pedunculated Colorectal Lesions that was developed by the working group of the Spanish Society of Digestive Endoscopy (GSEED of Endoscopic Resection). This document presents recommendations for the endoscopic management of superficial colorectal neoplastic lesions.

Clinical guidelines for endoscopic mucosal resection of non-pedunculated colorectal lesions.

This document summarizes the contents of the Clinical Guidelines for the Endoscopic Mucosal Resection of Non-Pedunculated Colorectal Lesions that was developed by the working group of the Spanish Society of Digestive Endoscopy (GSEED of Endoscopic Resection). This document presents recommendations for the endoscopic management of superficial colorectal neoplastic lesions.