Molecular testing for personalized therapy is underutilized in patients with borderline resectable and locally advanced pancreatic cancer - real world data from the NORPACT-2 study.

Background: International guidelines currently recommend the use of molecular testing in patients with advanced pancreatic cancer. The rate of actionable molecular alterations is low. The utility of molecular testing in patients with borderline resectable (BRPC) or locally advanced (LAPC) pancreatic cancer in real world clinical practice is unclear.Methods: 188 consecutive patients included in a prospective, population-based study (NORPACT-2) in patients with BRPC and LAPC (2018-2020) were reviewed. Molecular testing was performed at the discretion of the treating oncologist and was not recommended as a routine investigation by the national guidelines. All patients were considered fit to undergo primary chemotherapy and potential surgical resection. The frequency and the results of molecular testing (microsatellite instability (MSI) and/or KRAS status) were assessed.Results: Thirty patients (16%) underwent molecular testing. MSI tumour was detected in one (3.6%) of 28 tested patients. The patient received immunotherapy and subsequently underwent surgical resection. Histological assessment of the resected specimen revealed a complete response. KRAS wild type was detected in one (14.3%) of seven tested patient. Patients who initiated FOLFIRINOX as the primary chemotherapy regimen (p = 0.022), or were being treated at one of the eight hospital trusts (p = 0.001) were more likely to undergo molecular testing.Conclusions: Molecular testing was rarely performed in patients with BRPC or LAPC. Routine molecular testing for all patients with BRPC and LAPC should be considered to increase identification of targetable mutations and improve outcomes.

Upper gastrointestinal endoscopy in the surgically altered patient.

As management of upper gastrointestinal malignancies improves, and with popularization of bariatric surgery, endoscopists are likely to meet patients with altered upper gastrointestinal anatomy. Short-term, the surgery can cause complications like bleeding, leaks, and fistulas, and longer-term problems such as intestinal or biliary anastomotic strictures or biliary stones can arise, all necessitating endoscopy. In addition, the usual upper gastrointestinal pathologies can also still occur. These patients pose unique challenges. To proceed, understanding the new layout of the upper gastrointestinal tract is essential. The endoscopist, armed with a clear plan for navigation, can readily diagnose and manage most commonly occurring conditions, such as marginal ulcers and proximal anastomotic strictures with standard endoscopic instruments. With complex reconstructions involving long segments of small bowel, such as Roux-en-Y gastric bypass, utilization of balloon-assisted enteroscopy may be necessary, mandating modification of procedures such as endoscopic retrograde cholangiopancreatography. Successful endoscopic management of patients with altered anatomy will require prior planning and preparation to ensure the appropriate equipment, setting, and skill set is provided.

Clinicopathologic characteristics and treatment outcomes of pancreatic cancer patients at a tertiary referral hospital in Kenya.

The global incidence of pancreatic cancer (PC) continues to steadily increase whereas its prognosis remains poor. Previous studies have suggested worse outcomes among individuals of African descent. The characteristics of patients with PC in Kenya, and their contemporary management and survival outcomes remain largely unknown. This study aimed to describe the clinical and pathologic characteristics, management, and outcomes of patients diagnosed with PC at Kenyatta National Hospital (KNH), a tertiary referral hospital in Kenya. Records of 242 patients diagnosed with PC at KNH between 1st January 2014 and 30th September 2021 were assessed in this retrospective cohort study. Data on their clinical, histopathologic, and treatment characteristics was presented as mean (± standard deviation) and/or median (interquartile range) for continuous variables and frequency (percentage) for categorical variables. Kaplan-Meier and Cox proportional hazard ratios were used for survival analysis. PC occurred in a young population, the median age being 58.5 years (inter-quartile range 35-88). The majority of tumours (54%) were metastatic at diagnosis, while 28% and 14% were stage III and stage I/II, respectively. Surgical resections with curative intent were performed on 7% overall and 44% of stage I/II cases. The majority of patients with stage I/II disease (52.9%) received chemotherapy whereas the majority with stage III and IV disease received the best supportive care only (62.7% and 64.9%, respectively). Patients who underwent surgical resection (HR for mortality 0.20, 95% CI 0.05-0.83, p = 0.021) and chemotherapy (HR for mortality 0.15, 95% CI 0.08-0.29, p < 0.001) had significantly improved survival, reflecting a more favourable stage of the disease more amenable to aggressive therapies. The median survival time was 3 months and the 1-year survival rate was 32%.

Push-PEG or Pull-PEG: Does the Technique Matter? A Prospective Study Comparing Outcomes After Gastrostomy Placement.

BACKGROUND: Push-PEG (percutaneous endoscopic gastrostomy) with T-fastener fixation (PEG-T) allows one-step insertion of a balloon tube or button, and avoids contamination of the stoma by oral bacteria. However, PEG-T is a technically more demanding procedure with a significant learning curve. The aim of the present study was to compare outcomes after PEG-T and pull-PEG in a setting where both procedures were well established. MATERIALS AND METHODS: The study is a prospective cohort study including all patients between 0 and 18 year undergoing PEG-T and pull-PEG between 2017 and 2020 at a combined local and tertiary referral center. Complications and parent reported outcomes were recorded during hospital stay, after 14 days and 3 months postoperatively. RESULTS: 82 (93%) of eligible PEG-T and 37 (86%) pull-PEG patients were included. The groups were not significantly different with regard to age or weight. Malignant disorders and heart conditions were more frequent in the pull-PEG group, whilst neurodevelopmental disorders were more frequent in the PEG-T group (p < 0.001). 54% in both groups had a complication within 2 weeks. Late complications (between 2 weeks and 3 months postoperatively) occurred in 63% PEG-T vs 62% pull-PEG patients (p = 0.896). More parents in the pull-PEG group (49%) reported that the gastrostomy tube restricted their child's activity, compared to PEG-T (24%) (p = 0.01). At 3 months follow-up, more pull-PEG patients (43%) reported discomfort from the gastrostomy compared to PEG-T (21%) (p = 0.03). CONCLUSION: Overall complication rates were approximately similar, but pull-PEG was associated with more discomfort and restriction of activity. LEVELS OF EVIDENCE: Treatment study level II.

Per-oral cholangioscopy in patients with primary sclerosing cholangitis: a 12-month follow-up study.

Background and study aims Patients with primary sclerosing cholangitis (PSC) have a 9% to 20% lifetime incidence of cholangiocarcinoma (CCA). Per-oral cholangioscopy (POCS) added to endoscopic retrograde cholangiography (ERC) could potentially improve detection of CCA occurrence. We prospectively assessed POCS identification of 12-month CCA incidence in PSC patients undergoing ERC. Patients and methods Consecutive patients with PSC, an indication for ERC, and no prior liver transplantation were enrolled. During the index procedure, POCS preceded planned therapeutic maneuvers. The primary endpoint was ability for POCS visualization with POCS-guided biopsy to identify CCA during 12-month follow-up. Secondary endpoints included ability of ERC/cytology to identify CCA, repeat ERC, liver transplantation, and serious adverse events (SAEs). Results Of 42 patients enrolled, 36 with successful cholangioscope advancement were analyzed. Patients had a mean age 43.5±15.6 years and 61% were male. Three patients diagnosed with CCA had POCS visualization impressions of benign/suspicious/suspicious, and respective POCS-guided biopsy findings of suspicious/positive/suspicious for malignancy at the index procedure. The three CCA cases had ERC visualization impressions of benign/benign/suspicious, and respective cytology findings of atypical/atypical/suspicious for malignancy. No additional patients were diagnosed with CCA during median 11.5-month follow-up. Twenty-three repeat ERCs (5 including POCS) were performed in 14 patients. Five patients had liver transplantation, one after CCA diagnosis and four after benign cytology at the index procedure. Three patients (7.1%) had post-ERC pancreatitis. No SAEs were POCS-related. Conclusions In PSC patients, POCS visualization/biopsy and ERC/cytology each identified three cases of CCA. Some patients had a repeat procedure and none experienced POCS-related SAEs.

Performance and safety of diagnostic EUS FNA/FNB and therapeutic ERCP in patients with borderline resectable and locally advanced pancreatic cancer - results from a population-based, prospective cohort study.

Objective: Endoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS FNA/FNB) and potential endoscopic retrograde cholangiopancreatography (ERCP) for biliary decompression are indicated in patients with pancreatic cancer before initation of primary chemotherapy. This study aims to investigate the performance and safety of these two procedures in patients with borderline resectable (BRPC) or locally advanced pancreatic cancer (LAPC). Methods: Endoscopy and pathology reports, and hospital records of consecutive patients with a radiological diagnosis of BRPC/LAPC included in a population based, protocol-driven study (NORPACT-2) were reviewed. Results: Of 251 patients, 223 (88.9%) underwent EUS-FNA/FNB, and 133 (53%) underwent ERCP. Repeated EUS attempts were performed in 33 (14.8%), eight (3.6%), and four (1.8%) patients. FNA was performed in 155 procedures, FNB in 30, and combined EUS-FNA/FNB in 83. Diagnostic accuracy was 86.1% for first EUS-FNA/FNB. The cumulative diagnostic accuracy for all attempts was 96%. False positive rate for malignancy was 0.9%. Of a total of 149 ERCP procedures, 122 (81.9%) were successful, and 27 (18.1%) were unsuccessful. Success rate of first ERCP attempt was 80.5% (107/133). Sixteen patients (12%) underwent a second attempt with a success rate of 93.8% (15 of 16). Combined EUS and ERCP was performed in 41 patients. Complications occurred in eight procedures (3%) after EUS-FNA/FNB, 23 procedures (15.3%) after ERCP, and four (9.8%) patients after combined EUS-FNA/FNB and ERCP. Conclusion: EUS-FNA/FNB and ERCP with biliary stenting in patients with BRPC/LAPC demonstrated acceptable performance and safety. Repeat procedures were performed with high success rates. Same session EUS-FNA/FNB and ERCP for biliary decompression is safe.

Resection rates and intention-to-treat outcomes in borderline and locally advanced pancreatic cancer: real-world data from a population-based, prospective cohort study (NORPACT-2).

BACKGROUND: Systemic chemotherapy is the initial treatment strategy for borderline resectable and locally advanced pancreatic cancer to facilitate curative resection. The aim of this study was to investigate the resection rates and overall survival in patients with borderline resectable pancreatic cancer and locally advanced pancreatic cancer. METHODS: Consecutive patients with borderline resectable pancreatic cancer/locally advanced pancreatic cancer discussed by Oslo University Hospital multidisciplinary team between 2018 and 2020, serving a population of 3.1 million within a geographically defined area in south-eastern Norway, were included in this prospective Norwegian Pancreatic Cancer Trial-2 study, according to intention-to-treat principles. The total number of patients with pancreatic cancer was sought from the Cancer Registry of Norway. RESULTS: A total of 1178 patients were diagnosed with pancreatic cancer, of whom 618 were referred to Oslo University Hospital. After multidisciplinary team evaluation, 230 patients were considered to have borderline resectable pancreatic cancer/locally advanced pancreatic cancer. The final study group consisted of 188 patients (borderline resectable pancreatic cancer n = 96, locally advanced pancreatic cancer n = 92) who were fit to receive primary chemotherapy. Resection rates were 46.9% (45 of 96) for borderline resectable pancreatic cancer and 13% (12 of 92) for locally advanced pancreatic cancer (P <0.001). Median overall survival was 14.6 months (borderline resectable pancreatic cancer 16.4 months; locally advanced pancreatic cancer 13.7 months, (P = 0.2)). Adjusted for immortal time bias, median overall survival for patients undergoing resection versus only chemotherapy was 24.4 months versus 10.1 months (P <0.001) for borderline resectable pancreatic cancer and 28.4 months versus 12.6 months for locally advanced pancreatic cancer (P = 0.001). CONCLUSION: Resection rates and survival in patients with borderline resectable pancreatic cancer and locally advanced pancreatic cancer treated at a high-volume centre in a universal healthcare system compare well with those treated at international expert centres.Registration number: NCT04423731 (http://www.clinicaltrials.gov).

Primær skleroserende kolangitt.

Primary sclerosing cholangitis is a severe liver disease and a leading cause of liver transplantation in Scandinavia. This clinical review article examines recently revised recommendations on diagnosis, follow-up and treatment of patients with this disease. Treatment of symptoms, assessment of fibrosis and monitoring for the development of cancer in the liver and bowel are central.

A pilot study of implementation of endoscopic sleeve gastroplasty (ESG) in Norway.

BACKGROUND AND AIM: Bariatric surgery is the most effective treatment for obesity but is invasive and associated with serious complications. Endoscopic sleeve gastroplasty (ESG) is a less invasive weight loss procedure to reduce the stomach volume by full-thickness sutures. ESG has been adopted in many countries, but implementation at Scandinavian centres has not yet been documented. We performed a clinical pilot trial at a Norwegian centre with the primary objective to assess the feasibility of the ESG procedure. PATIENTS AND METHODS: We included the first 10 patients treated with ESG at a Norwegian centre in a single-arm pilot study. The eligibility criteria were either a body mass index (BMI) of 40-49.9 kg/m2, BMI 35-39.9 kg/m2 and at least one obesity-related comorbidity, or BMI 30-34.9 kg/m2 and type 2 diabetes. Patient follow-up resembled the scheme used for bariatric surgery at the center, including dietary plans and outpatient visits. RESULTS: All procedures were technically successful except for one patient who had adhesions between the stomach and anterior abdominal wall, related to a prior hernia repair, resulting in less-than-intended stomach volume reduction. Mean total body weight loss (TBWL) after 26 and 52 weeks was 12.2% (95% CI 8.1-16.2) and 9.1% (95% CI 3.3 - 15.0). One patient experienced a minor suture-induced diaphragmatic injury, which was successfully managed conservatively. CONCLUSIONS: This first Scandinavian clinical trial of ESG, documenting the implementation of the procedure at a Norwegian center, demonstrated acceptable feasibility and safety, with large variations in individual weight loss during the 52-week follow-up period.

Effects of faecal microbiota transplantation on the small intestinal mucosa in systemic sclerosis.

OBJECTIVES: In SSc, gastrointestinal tract (GIT) involvement is a major concern, with no disease-modifying and limited symptomatic therapies available. Faecal microbiota transplantation (FMT) represents a new therapeutic option for GIT-affliction in SSc, showing clinical promise in a recent controlled pilot trial. Here, we aim to investigate effects of FMT on duodenal biopsies collected from SSc patients by immunohistochemistry and transcriptome profiling. METHODS: We analysed duodenal biopsies obtained pre-intervention (week 0) and post-intervention (weeks 2 and 16) from nine SSc patients receiving an intestinal infusion of FMT (n = 5) or placebo (n = 4). The analysis included immunohistochemistry (IHC) with a selected immune function and fibrosis markers, and whole biopsy transcriptome profiling. RESULTS: In patients receiving FMT, the number of podoplanin- and CD64-expressing cells in the mucosa were lower at week 2 compared with baseline. This decline in podoplanin- (r = 0.94) and CD64-positive (r = 0.89) cells correlated with improved patient-reported lower GIT symptoms. Whole biopsy transcriptome profiling from week 2 showed significant enrichment of pathways critical for cellular and endoplasmic reticulum stress responses, microvillus and secretory vesicles, vascular and sodium-dependent transport, and circadian rhythm. At week 16, we found enrichment of pathways mandatory for binding activity of immunoglobulin receptors, T cell receptor complexes, and chemokine receptors, as well as response to zinc-ions. We found that 25 genes, including Matrix metalloproteinase-1 were upregulated at both week 2 and week 16. CONCLUSION: Combining selective IHC and unbiased gene expression analyses, this exploratory study highlights the potential for disease-relevant organ effects of FMT in SSc patients with GIT involvement. TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT03444220.

Clinical Variables as Indicative Factors for Endoscopy in Adolescents with Esophageal Atresia.

INTRODUCTION: Gastro-esophageal reflux disease (GERD) occurs frequently in patients operated for esophageal atresia (EA). Longstanding esophagitis may lead to dysphagia, strictures, columnar metaplasia, and dysplasia with an increased risk of adenocarcinoma. Are clinical factors and non-invasive assessments reliable indicators for follow-up with endoscopy? MATERIAL AND METHOD: A follow-up study with inclusion of EA adolescents in Norway born between 1996 and 2002 was conducted. Clinical assessment with pH monitoring, endoscopy with biopsies, along with interviews and questionnaires regarding gastroesophageal reflux disease (GERD) and dysphagia were performed. RESULTS: We examined 68 EA adolescents. 62% reported GERD by interview, 22% by questionnaire. 85% reported dysphagia by interview, 71% by questionnaire. 24-hour pH monitoring detected pathological reflux index (RI) (>7%) in 7/59 (12%). By endoscopy with biopsy 62 (92%) had histologic esophagitis, of whom 3 (4%) had severe esophagitis. Gastric metaplasia was diagnosed in twelve (18%) adolescents, intestinal metaplasia in only one (1.5%). None had dysplasia or carcinoma. Dysphagia and GERD were statistically correlated to esophagitis and metaplasia, but none of the questionnaires or interviews alone were good screening instruments with high combined sensitivity and specificity. A compound variable made by simply taking the mean of rescaled RI and dysphagia by interview showed to be the best predictor of metaplasia (85% sensitivity, 67% specificity). CONCLUSION: The questionnaires and interviews used in the present study were not good screening instruments alone. However, combining dysphagia score by interview and RI may be helpful in assessing which patients need endoscopy with biopsy at each individual follow-up examination. LEVEL OF EVIDENCE: Level II prognostic study.

International cross-sectional survey on endoscopic retrograde cholangiopancreatography training by the World Endoscopy Organization.

OBJECTIVES: Endoscopic retrograde cholangiopancreatography (ERCP) has revolutionized the treatment of many pancreaticobiliary conditions. However, little is known about the global practices, training programs, and credentialing of the procedure. The aim of the current study is to address the above questions. METHODS: This was an international cross-sectional survey conducted between October 2020 and May 2021. Participating countries were requested to complete an online survey on ERCP services and training. RESULTS: Eighty-nine countries responded to the survey. There were significant increases in the proportion of ERCP services provided by the government (P < 0.0001), number of endoscopists per million of population (P < 0.0001), and number of institutions per million of population (P < 0.0001) from low to high human development index (HDI). Eighteen percent of the countries offer the procedure as part of a standard training program, 68.5% do not follow a standardized training curriculum. Risk factors for higher incidence and mortality from pancreatic cancers include higher HDI category, smaller population, a larger number of endoscopists proficient in ERCP, and lower number of institutions providing ERCP training. Countries with very high HDI have four times higher incidence and mortality from pancreatic cancers as compared to those with low HDI. CONCLUSIONS: There is still an ongoing need for improving ERCP training in low to very high HDI countries. A structured training program is still lacking in many parts of the world. With increasing incidence and mortality of pancreatic cancers, particularly in high HDI countries, there is a need for further increasing facilities for ERCP training.

Tailored surgery in chronic pancreatitis after implementation of a multidisciplinary team assessment; a prospective observational study.

INTRODUCTION: Optimal management of chronic pancreatitis involves several specialties. Selection of patients for surgery may benefit from evaluation by a multidisciplinary team (MDT), similar to cancer care. The aim of this study was to evaluate outcomes in patients selected for surgery after MDT decision. METHODS: A prospective, observational study of consecutive patients operated for pain due to chronic pancreatitis after implementation of a MDT. The main outcome was Quality of life (QoL) assessed by EORTC-QLQ C30 and pain relief in patients followed >3 months. Complications were registered and predictive factors for pain relief analyzed. RESULTS: Of 269 patients evaluated by the MDT, 60 (22%) underwent surgery. Postoperative surgical complications occurred in five patients (8.3%) and reoperation within 30 days in two. There was no 90-days mortality. Complete or partial pain relief was achieved in 44 of 50 patients followed >3 months (88%). Preoperative duration of pain predicted lower probability of success. Postoperative improvement in QoL was most prominent for pain, appetite and nausea. CONCLUSIONS: After MDT evaluation, one in five patients was selected for surgery. Pain relief was obtained in a majority of patients with improved QoL. A tailored approach through a MDT seems warranted and efficient.

How to perform EUS-guided biliary drainage.

EUS-guided biliary drainage (EUS-BD) has recently gained widespread acceptance as a minimally invasive alternative method for biliary drainage. Even in experienced endoscopy centers, ERCP may fail due to inaccessibility of the papillary region, altered anatomy (particularly postsurgical alterations), papillary obstruction, or neoplastic gastric outlet obstruction. Biliary cannulation fails at first attempt in 5%-10% of cases even in the absence of these factors. In such cases, alternative options for biliary drainage must be provided since biliary obstruction is responsible for poor quality of life and even reduced survival, particularly due to septic cholangitis. The standard of care in many centers remains percutaneous transhepatic biliary drainage (PTBD). However, despite the high technical success rate with experienced operators, the percutaneous approach is more invasive and associated with poor quality of life. PTBD may result in long-term external catheters for biliary drainage and carry the risk of serious adverse events (SAEs) in up to 10% of patients, including bile leaks, hemorrhage, and sepsis. PTBD following a failed ERCP also requires scheduling a second procedure, resulting in prolonged hospital stay and additional costs. EUS-BD may overcome many of these limitations and offer some distinct advantages in accessing the biliary tree. Current data suggest that EUS-BD is safe and effective when performed by experts, although SAEs have been also reported. Despite the high number of clinical reports and case series, high-quality comparative studies are still lacking. The purpose of this article is to report on the current status of this procedure and to discuss the tools and techniques for EUS-BD in different clinical scenarios.

Comparison between Enteroscopy-, Laparoscopy- and Endoscopic Ultrasound-Assisted Endoscopic Retrograde Cholangio-Pancreatography in Patients with Surgically Altered Anatomy: A Systematic Review and Meta-Analysis.

BACKGROUND AND AIMS: Endoscopic retrograde cholangiopancreatography (ERCP), in surgically altered anatomy (SAA), can be challenging and the optimal technique selection remains debatable. Most common foregut interventions resulting to this burden consist of Billroth II gastrectomy, Whipple surgery and Roux-en-Y anastomoses, including gastric by-pass. This systematic review, with meta-analysis, aimed to compare the rates of successful enteroscope-assisted (EA)-, endosonography-directed transgastric- (EDGE), and laparoscopy-assisted (LA)-ERCP. METHODS: A systematic research (Medline) was performed for relative studies, through January 2022. The primary outcome was technical success, defined as approaching the ampulla site. Secondary outcomes included the desired duct cannulation, successful therapeutic manipulations, and complication rates. We performed meta-analyses of pooled data, and subgroup analysis considering the EA-ERCP subtypes (spiral-, double and single balloon-enteroscope). Pooled rates are reported as percentages with 95% Confidence Intervals (95%CIs). RESULTS: Seventy-six studies were included (3569 procedures). Regarding primary outcome, EA-ERCP was the least effective [87.3% (95%CI: 85.3-89.4); I2: 91.0%], whereas EDGE and LA-ERCP succeeded in 97.9% (95%CI: 96.4-99.4; I2: 0%) and 99.1% (95%CI: 98.6-99.7; I2: 0%), respectively. Similarly, duct cannulation and therapeutic success rates were 74.7% (95%CI: 71.3-78.0; I2: 86.9%) and 69.1% (95%CI: 65.3-72.9; I2: 91.8%) after EA-ERCP, 98% (95%CI: 96.5-99.6; I2: 0%) and 97.9% (95%CI: 96.3-99.4) after EDGE, and 98.6% (95%CI: 97.9-99.2; I2: 0%) and 98.5% (95%CI: 97.8-99.2; I2: 0%) after LA-ERCP, respectively. The noticed high heterogeneity in EA-ERCP results probably reflects the larger number of included studies, the different enteroscopy modalities and the variety of surgical interventions. Comparisons revealed the superiority of LA-ERCP and EDGE over EA-ERCP (p ≤ 0.001) for all success-related outcomes, though LA-ERCP and EDGE were comparable (p ≥ 0.43). ERCP with spiral-enteroscope was inferior to balloon-enteroscope, while the type of the balloon-enteroscope did not affect the results. Most adverse events were recorded after LA-ERCP [15.1% (95%CI: 9.40-20.8); I2: 87.1%], and EDGE [13.1% (95%CI: 7.50-18.8); I2: 48.2%], significantly differing from EA-ERCP [5.7% (95%CI: 4.50-6.80); p ≤ 0.04; I2: 64.2%]. CONCLUSIONS: LA-ERCP and EDGE were associated with higher technical, cannulation, and therapeutic success compared to EA-ERCP, though accompanied with more adverse events.

Impact of artificial intelligence on colorectal polyp detection for early-career endoscopists: an international comparative study.

BACKGROUND: Artificial intelligence (AI) for polyp detection is being introduced to colonoscopy, but there is uncertainty how this affects endoscopists' ability to detect polyps and neoplasms. We performed a video-based study to address whether AI improved the endoscopists' performance to detect polyps. METHODS: We established a dataset of 200 colonoscopy videos (length 5 s; 100 without polyps and 100 with one polyp). About 33 early-career endoscopists (50-400 colonoscopies performed) from 10 European countries classified each video as either 'polyp present' or 'polyp not present'. The video assessment was performed twice with a four-week interval. The first assessment was performed without any AI tool, whereas the second was performed with an AI tool for polyp detection. The primary endpoint was early-career endoscopists' sensitivity to detect polyps. Gold standard for presence and histology of polyps were confirmed by two expert endoscopists and pathologists, respectively. McNemar's test was used for statistical significance. RESULTS: There were 86 neoplastic and 14 non-neoplastic polyps (mean size 5.6 mm) in the 100 videos with polyps. Early-career endoscopists' sensitivity to detect polyps increased from 86.3% (95% confidence interval [CI]: 85.1-87.5%) to 91.7% (95%CI: 90.7-92.6%) with the AI aid (p < .0001). Their sensitivity to detect neoplastic polyps increased from 85.4% (95% CI: 84.0-86.7%) to 92.1% (95%CI: 91.1-93.1%) with the AI aid (p < .0001). CONCLUSION: The polyp detection AI tool helped early-career endoscopists to increase their sensitivity to identify all polyps and neoplastic polyps during colonoscopy.

Motorized spiral enteroscopy: results of an international multicenter prospective observational clinical study in patients with normal and altered gastrointestinal anatomy.

BACKGROUND : Motorized spiral enteroscopy (MSE) has been shown to be safe and effective for deep enteroscopy in studies performed at expert centers with limited numbers of patients without previous abdominal surgery. This study aimed to investigate the safety, efficacy, and learning curve associated with MSE in a real-life scenario, with the inclusion of patients after abdominal surgery and with altered anatomy. METHODS : Patients with indications for deep enteroscopy were enrolled in a prospective observational multicenter study. The primary objective was the serious adverse event (SAE) rate; secondary objectives were the diagnostic and therapeutic yield, procedural success, time, and insertion depth. Data analysis was subdivided into training and core (post-training) study phases at centers with different levels of MSE experience. RESULTS : 298 patients (120 women; median age 68, range 19-92) were enrolled. In the post-training phase, 21.5 % (n = 54) had previous abdominal surgery, 10.0 % (n = 25) had surgically altered anatomy. Overall, SAEs occurred in 2.3 % (7/298; 95 %CI 0.9 %-4.8 %). The SAE rate was 2.0 % (5/251) in the core group and 4.3 % (2/47) in the training group, and was not increased after abdominal surgery (1.9 %). Total enteroscopy was achieved in half of the patients (n = 42) undergoing planned total enteroscopy. In 295/337 procedures (87.5 %), the anatomical region of interest could be reached. CONCLUSIONS : This prospective multicenter study showed that MSE was feasible and safe in a large cohort of patients in a real-life setting, after a short learning curve. MSE was shown to be feasible in postsurgical patients, including those with altered anatomy, without an increase in the SAE rate.