One-fourth of colorectal neoplasias are missed during screening colonoscopies; these can develop into colorectal cancer (CRC). Deep learning systems allow for real-time computer-aided detection ...(CADe) of polyps with high accuracy. We performed a multicenter, randomized trial to assess the safety and efficacy of a CADe system in detection of colorectal neoplasias during real-time colonoscopy.
We analyzed data from 685 subjects (61.32 ± 10.2 years old; 337 men) undergoing screening colonoscopies for CRC, post-polypectomy surveillance, or workup due to positive results from a fecal immunochemical test or signs or symptoms of CRC, at 3 centers in Italy from September through November 2019. Patients were randomly assigned (1:1) to groups who underwent high-definition colonoscopies with the CADe system or without (controls). The CADe system included an artificial intelligence–based medical device (GI-Genius, Medtronic) trained to process colonoscopy images and superimpose them, in real time, on the endoscopy display a green box over suspected lesions. A minimum withdrawal time of 6 minutes was required. Lesions were collected and histopathology findings were used as the reference standard. The primary outcome was adenoma detection rate (ADR, the percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, non-neoplastic resection rate, and withdrawal time.
The ADR was significantly higher in the CADe group (54.8%) than in the control group (40.4%) (relative risk RR, 1.30; 95% confidence interval CI, 1.14–1.45). Adenomas detected per colonoscopy were significantly higher in the CADe group (mean, 1.07 ±1.54) than in the control group (mean 0.71 ± 1.20) (incidence rate ratio, 1.46; 95% CI, 1.15–1.86). Adenomas 5 mm or smaller were detected in a significantly higher proportion of subjects in the CADe group (33.7%) than in the control group (26.5%; RR, 1.26; 95% CI, 1.01–1.52), as were adenomas of 6 to 9 mm (detected in 10.6% of subjects in the CADe group vs 5.8% in the control group; RR, 1.78; 95% CI, 1.09–2.86), regardless of morphology or location. There was no significant difference between groups in withdrawal time (417 ± 101 seconds for the CADe group vs 435 ± 149 for controls; P = .1) or proportion of subjects with resection of non-neoplastic lesions (26.0% in the CADe group vs 28.7% of controls; RR, 1.00; 95% CI, 0.90–1.12).
In a multicenter, randomized trial, we found that including CADe in real-time colonoscopy significantly increases ADR and adenomas detected per colonoscopy without increasing withdrawal time. ClinicalTrials.gov no: 04079478
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False positive (FP) results by computer-aided detection (CADe) hamper the efficiency of colonoscopy by extending examination time. Our aim was to develop a classification of the causes and clinical ...relevance of CADe FPs, and to assess the relative distribution of FPs in a real-life setting.
In a post-hoc analysis of a randomized trial comparing colonoscopy with and without CADe (NCT: 04079478), we extracted 40 CADe colonoscopy videos. Using a modified Delphi process, 4 expert endoscopists identified the main domains for the reasons and clinical relevance of FPs. Then, 2 expert endoscopists manually examined each FP and classified it according to the proposed domains. The analysis was limited to the withdrawal phase.
The 2 main domains for the causes of CADe FPs were identified as artifacts due to either the mucosal wall or bowel content, and clinical relevance was defined as the time spent on FPs and the FP rate per minute. The mean number of FPs per colonoscopy was 27.3 ± 13.1, of which 24 ± 12 (88%) and 3.2 ± 2.6 (12%) were due to artifacts in the bowel wall and bowel content, respectively. Of the 27.3 FPs per colonoscopy, 1.6 (5.7%) required additional exploration time of 4.8 ± 6.2 seconds per FP (ie, 0.7% of the mean withdrawal time). In detail, 15 (24.2%), 33 (53.2%), and 14 (22.6%) FPs were classified as being of mild, moderate, or severe clinical relevance. The rate of FPs per minute of withdrawal time was 2.4 ± 1.2, and was higher for FPs due to artifacts from the bowel wall than for those from bowel content (2.4 ± 0.6 vs 0.3 ± 0.2, P < .001).
FPs by CADe are primarily due to artifacts from the bowel wall. Despite a high frequency, FPs result in a negligible 1% increase in the total withdrawal time because most of them are immediately discarded by the endoscopist.
Background and Aims The natural history of refractory benign esophageal strictures (RBES) is unclear, and surgery or percutaneous endoscopic gastrostomy (PEG) may be the only viable long-term ...options. The aim of the present study was to assess the long-term outcomes of patients with RBES. Methods Clinical data of consecutive patients with RBES treated in the previous 15 years in 2 tertiary-care referral academic centers with specialized interest in esophageal stricture management were retrospectively analyzed. RBES was defined as the persistence and/or recurrence of dysphagia despite at least 5 dilation sessions and/or cycles with dilation to at least 14 mm. Information regarding the use of dilation or stents and the dysphagia-free period between subsequent interventions and adverse events was collected. Clinical success was defined as no need for endoscopic interventions for at least 6 months; unfavorable outcomes were defined as the need for endoscopic treatment at the end of follow-up, surgery, or percutaneous endoscopic gastrostomy (PEG). Predictors of unfavorable outcomes were assessed by multivariate analysis. A linear mixed-effect model was used to measure dysphagia-free period changes over time. Results Overall, 70 patients with RBES (46 male; mean age 60 years) were followed for a mean of 43.9 months (range 3.7-157 months). Caustic, postradiotherapy, surgical, mixed, and postinflammatory etiology accounted for 10%, 14.3%, 31.4%, 40%, and 4.3% of causes, respectively. All patients underwent sequential sessions of pneumatic or bougie dilation, with a median of 15.5 dilation sessions per patient. Self-expandable metal stents (SEMSs) and biodegradable stents were placed in 18 (25.7%) and 14 (20%) patients, respectively. RBES resolution was achieved in only 22 of 70 (31.4%) patients. Two deaths (3%) were related to RBES. The success rate was lower in those who also were treated with endoprosthetics (odds ratio OR 3.7; 95% confidence interval CI, 1.01-18.0). The mean dysphagia-free period was 3.3 months (95% CI, 2.4-4.1) for patients treated with dilation and 2.4 months (95% CI, 1.2-3.6) for those treated with stents ( P = .062). Over time, the total dysphagia-free period increased at a rate of 4.1 days (95% CI, 1.7-6.4) per dilation. There was no difference in the rate of change across groups defined by sex ( P = .976), age ( P = .633), or endoscopic treatment ( P = .267). Conclusions Our multicenter series showed a disappointing long-term outcome for RBES, with only 1 of 3 achieving clinical resolution. The dysphagia-free period was relatively short, affecting the quality of life. Endoprosthetics did not appear to affect the natural history of RBES.
In this paper, we describe Remote Monitoring Validation Engineering System (ReMoVES), a newly-developed platform for motion rehabilitation through serious games and biophysical sensors. The main ...features of the system are highlighted as follows: motion tracking capabilities through Microsoft Kinect V2 and Leap Motion are disclosed and compared with other solutions; the emotional state of the patient is evaluated with heart rate measurements and electrodermal activity monitored by Microsoft Band 2 during the execution of the functional exercises planned by the therapist. The ReMoVES platform is conceived for home-based rehabilitation after the hospitalisation period, and the system will deploy machine learning techniques to provide an automated evaluation of the patient performance during the training. The algorithms should deliver effective reports to the therapist about the training performance while the patient exercises on their own. The game features that will be described in this manuscript represent the input for the training set, while the feedback provided by the therapist is the output. To face this supervised learning problem, we are describing the most significant features to be used as key indicators of the patient’s performance along with the evaluation of their accuracy in discriminating between good or bad patient actions.
Background Endoscopic submucosal dissection (ESD) was recently developed to allow en bloc resection of early neoplasia of the GI tract, including colorectal neoplasia. The endoscopic technique is ...technically demanding and not yet standardized, and new devices are needed. Objective This study aimed to evaluate the efficacy and safety of a new device that combines the functions of injection and cutting. Design Prospective, pilot, single-arm study. Methods Consecutive patients with rectal laterally spreading tumors (LSTs) 3 cm or larger unsuitable for en bloc resection were enrolled. ESD was performed with a new device that allows cutting and coagulation as well as a needleless, tissue-selective mucosal and submucosal elevation through an axial water-jet channel. Main Outcome Measurement The primary endpoint of the study was the en bloc resection rate achieved with ESD in a Western hospital setting. Results Overall, ESD was attempted in 40 consecutive patients (27 male, mean age 65.3 years) with rectal LSTs larger than 3 cm (72.5% LSTs, nongranular type, 5% depressed type, 22.5% protruding type). The mean lesion size was 46.8 ± 10.9 mm (range 33-80 mm). The mean procedure time was 86.1 ± 35.5 minutes (range 40-190 minutes). The en bloc resection rate was 90% (36/40). In the remaining patients, resection was completed with a piecemeal approach. The rate of curative resection (R0) was 32 of 40 LSTs (80%). Two patients with submucosal invasion were referred for surgery. Perforation occurred in 1 patient (2.5%), which was managed conservatively. Postoperative bleeding occurred in 2 patients (5%) and was treated by endoscopic hemostasis. Limitations Single-center study with a relatively small number of patients. Conclusions ESD is a safe and effective method to provide en bloc and curative resection of large rectal LSTs. The operating time and adverse event rate were comparable to those of previously published data from Japanese experts.
Background and Objectives: EUS-guided biliary drainage (BD) through hepaticogastrostomy (HGS) is an option in case of ERCP failure. Available data suggest that this procedure may be challenging with ...possible severe adverse events (AEs) mainly due to stent migration. The aim of our pilot study was to prospectively assess the technical and clinical outcomes of EUS-HGS using a new dedicated partially covered self-expandable metal stent with anti-migratory systems. Methods: This is a single-center prospective study enrolling patients with malignant biliary obstruction undergoing EUS-HGS after failed ERCP, between June 2020 and March 2021. The primary endpoint was the technical success rate. Evaluation of specific stent-related technical features as compared with commonly used self-expandable metal stent, clinical success rate, and procedure-related AEs was also assessed. Results: Twenty-two patients (15%-68.2%, female; mean age, 66.0 ± 10.0) were enrolled in the study analysis. Different causes of ERCP failure were infiltration of papilla by neoplastic tissue (4, 18.2%), unreachable papilla for duodenal stricture (9, 40.9%), surgically altered anatomy with Roux-en-Y reconstruction (4, 18.2%), and incomplete BD after transpapillary stent placement (5, 22.7%). Technical success was achieved in all patients, in a mean procedural time of 43.3 ± 26.8 min. Technical features were graded as high or medium in all cases. The clinical success rate was 91% (20/22, mean follow-up: 10.8 ± 3.1 months). There were no cases of stent misplacement or stent migration. Three (13.6%) cases of a hepatic abscess requiring percutaneous drainage and systemic antibiotics were reported, with no impact on clinical success and following oncologic treatments. No deaths occurred. Conclusion: EUS-HGS with a new dedicated stent with anti-migratory systems is feasible and effective, preventing stent migration, and misplacement. Although the persistent procedural challenges, dedicated devices may contribute to outcomes improvement and procedure diffusion.
The study aimed to evaluate the effectiveness and safety of self-expanding metal stents (SEMS) in the management of post-surgical esophageal leaks.
Retrospective data of consecutive patients with a ...post-surgical esophageal leak treated by means of a metal stent between January 2008 and December 2014 at the Humanitas Research Hospital (Milan, Italy) were extracted from a prospectively maintained register of SEMS used for benign indications, such as post-surgical benign esophageal strictures and/or leaks. The primary outcome of the study was to assess the rate of successful leak closure and to identify the variables associated with its achievement. As a secondary outcome, we evaluated the overall safety of SEMS placement and the efficacy and safety for different types of SEMS in this specific setting of patients. Leak resolution was documented with endoscopic and/or imaging studies. In the case of leak persistence, further attempts of esophageal stenting were carried out at the discretion of both endoscopists and surgeons.
A total of 49 patients were included in the study (men 41 of 49, 83.7%, mean age 62.4 ± 11.9). One patient was excluded from analysis, because of death 1 day after stent insertion due to worsening of pre-existing mediastinitis. A total number of 82 stents were placed (mean number of stents per patient: 1.7) in 49 patients: 35 patients (71.4%) received a partially covered SEMS (PCSEMS) as the first stent positioned, while the remaining 14 (28.6%) received a fully covered SEMS (FCSEMS); but 1 patient (2%) died following stent insertion; therefore, data regarding therapeutic success were available for 48 patients. Stents were left in place for a mean period of 21.9 ± 15.2 days. Leak closure after the first stent placement was achieved in 22 of 48 (45.8%) patients. Of the 26 patients with failure of index stent placement, 18 patients underwent further stenting attempts (69.2%), and secondary closure of leak was achieved in 7 (38.9%) of these 18 patients. Thus, the overall success rate was 60.5% (29 of 48). On the basis of stent type, the success rate was 57.1% (8 of 14) for FCSEMS and 64.7% (22 of 34) for PCSEMS. Logistic regression analysis did not find any significant association between successful leak closure and analyzed variables. Overall mortality was 13.0%. Complication rate was 38.8% (19 of 49 patients).
The use of SEMS is an effective and safe option for post-surgical esophageal leaks, with no evidence of any significant influence of stent type on outcome.
AIM：To assess the efficacy and safety of a balanced approach using midazolam in combination with propofol,administered by nonanesthesiologists,in a large series of diagnostic ...colonoscopies.METHODS：Consecutive patients undergoing diagnostic colonoscopy were sedated with a single dose of midazolam（0.05 mg/kg）and lowdose propofol（starter bolus of 0.5 mg/kg and repeated boluses of 10 to 20 mg）.Induction time and deepest level of sedation,adverse and serious adverse events,as well as recovery times,were prospectively assessed.Cecal intubation and adenoma detection rates were also collected.RESULTS：Overall,1593 eligible patients were included.The median dose of propofol administered was 70 mg（range：40120 mg）,and the median dose of midazolam was 2.3 mg（range：24 mg）.Median induction time of sedation was 3 min（range：14 min）,and median recovery time was 23 min（range：1040 min）.A moderate level of sedation was achieved in 1561（98%） patients,whilst a deep sedation occurred in 32（2%） cases.Transient oxygen desaturation requiring further oxygen supplementation occurred in 8（0.46%;95% CI：0.2%0.8%）patients.No serious adverse event was observed.Cecal intubation and adenoma detection rates were 93.5%and 23.4%（27.8%for male and 18.5%for female,subjects）,respectively.CONCLUSION：A balanced sedation protocol provided a minimalization of the dose of propofol needed to target a moderate sedation for colonoscopy,resulting in a high safety profile for nonanesthesiologist propofol sedation.
Background:
The endoscopic submucosal dissection (ESD) is a technically demanding and time-consuming procedure, with an increased risk of adverse events compared to standard endoscopic resection ...techniques. The main difficulties are related to the instability of the operating field and to the loss of traction. We aimed to evaluate in a pilot trial a new endoscopic platform tissue retractor system (TRS); ORISE, Boston scientific Co., Marlborough, MA, USA, designed to stabilize the intraluminal space, and to provide tissue retraction and counter traction.
Method:
We prospectively enrolled all consecutive patients who underwent an ESD for sigmoid/rectal lesions. The primary outcome was the rate of technical feasibility. Further technical aspects such as en-bloc and R0 resection rate, number of graspers used, circumferential incision time, TRS assemblage time, submucosal dissection time, and submucosal dissection speed were provided. Clinical outcomes (recurrence rate and adverse events) were recorded as well.
Results:
In all, 10 patients (M/F 4/6, age: 70.4 ± 11.0 years old) were enrolled. Eight out of 10 lesions were located in the rectum. Average lesion size was 31.2 ± 2.7 mm, and mean lesion area was 1628.88 ± 205.3 mm2. The two sigmoid lesions were removed through standard ESD, because the platform assemblage failed after several attempts. All rectal lesions were removed in an en-bloc fashion. R0 resection was achieved in 7/8 (87.5%) patients in an average procedure time of 60.5 ± 23.3 min. None of the patients developed neither intraprocedural nor postprocedural adverse events.
Conclusion:
TRS-assisted ESD is a feasible option when used in the rectum, with promising result in terms of efficacy and safety outcomes. Nevertheless, our pilot study underlines few technical limitations of the present platform that need to be overcome before the system could be widely and routinely used.
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