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.
EUS-guided biopsy sampling is the method of choice for obtaining pancreatic tissue. Next-generation sequencing (NGS) has been applied to EUS-guided biopsy sampling and may classify patients based on ...specific molecular profiles. Our study aimed to compare side-by-side the diagnostic yield achievable by genetic identification of somatic mutations detected with NGS versus histologic and cytologic typing in locally advanced pancreatic carcinoma (LAPC) in samples acquired under EUS guidance.
We conducted a prospective comparative pilot study at Humanitas Research Hospital. The study included 33 patients referred for LAPC who underwent EUS-guided tissue acquisition using a 22-gauge Franseen needle. Material was obtained for both pathologic diagnosis and DNA extraction and targeted NGS analysis with the AmpliSeq Comprehensive Panel v3 (Illumina Inc, San Diego, Calif, USA). Twenty-one genes were prioritized for somatic mutation detection.
The final diagnosis was pancreatic ductal adenocarcinoma (PDAC) in all patients (100%). A macroscopic core was obtained in 30 patients (91%). In 3 lesions no cores adequate for histologic analysis were obtained, but cytologic analysis revealed tumoral cells from PDAC. DNA was extracted from 32 of 33 samples (97%), most of which (27/32) carried at least 2 clearly pathogenic mutations in different genes. Detection of K-ras mutation allowed for molecular diagnosis of PDAC in most of the patients (30/32).
In our study we demonstrated that proper tissue specimens obtained under EUS guidance allowed DNA sample extraction and subsequent NGS analysis in 97% of cases. These results support the potential role of NGS as a complementary diagnostic test to be implemented in association with standard diagnostic modalities. (Clinical trial registration number: NCT03578939.)
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Electrocautery-tip lumen-apposing metal stents (EC-LAMSs) have extended the indications of therapeutic EUS. We aimed to retrospectively evaluate safety and technical and clinical success of a newly ...developed EC-LAMS, the Hot-Spaxus (Taewoong Medical Co, Gimpo, Korea), for various EUS-guided procedures.
We included and retrospectively analyzed consecutive patients at 8 tertiary care referral centers who had undergone EUS interventional procedures using the Hot-Spaxus between October 2018 and February 2021.
Of 58 included patients (male-to-female, 36:22; mean age, 63.5 ± 14.9 years), 29 had undergone pancreatic fluid collection drainage (50%), 22 (37.9%) biliary drainage for malignant distal obstruction, 3 (5.1%) gallbladder drainage for acute cholecystitis, 3 gastroenteroanastomoses, and 1 (1.7%) pelvic collection drainage. Technical success was achieved in 54 of 58 patients (93.1%) and clinical success in all 58. Adverse events occurred in 6 patients (11.1%): 2 early (3.7%), 1 late (1.8%), and 3 long term (5.6%). The outcomes were similar to those observed in a control group of patients treated with the Hot-Axios (Boston Scientific, Marlborough, Mass, USA), the other available EC-LAMS.
Our study showed that the novel EC-LAMS has high technical and clinical success rates for various interventional EUS indications. Future multicenter prospective studies will better clarify the role of this new EC-LAMS for different indications.
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Abstract
Background and study aims
The standard method for obtaining samples during endoscopic ultrasonography (EUS) is fine-needle aspiration (FNA), the accuracy of which can be affected by the ...presence of a cytopathologist in endoscopy room (rapid on-site evaluation ROSE). With the introduction of fine-needle biopsy (FNB), macroscopic on-site evaluation (MOSE) of a acquired specimen has been proposed. Only a few studies have evaluated the role of MOSE and in all except one, a 19G needle was used. Our primary aim was to evaluate the diagnostic yield and accuracy of MOSE with different needle sizes and the secondary aim was to identify factors influencing the yield of MOSE.
Patients and methods
Data from patients who underwent EUS-FNB for solid lesions, with MOSE evaluation of the specimen, were collected in six endoscopic referral centers.
Results
A total of 378 patients (145 F and 233 M) were enrolled. Needles sizes used during the procedures were 20G (42 %), 22G (45 %), and 25G (13 %). The median number of needle passes was two (IQR 2–3). The overall diagnostic yield of MOSE was of 90 % (confidence interval CI 86 %–92 %). On multivariable logistic regression analysis, variables independently associated with the diagnostic yield of MOSE were a larger needle diameter (20G vs. 25G, OR 11.64, 95 %CI 3.5–38.71; 22G vs. 25G, OR 6.20, 95 %CI 2.41–15.90) and three of more needle passes (OR 3.39, 95 %CI 1.38–8.31).
Conclusions
MOSE showed high diagnostic yield and accuracy. Its yield was further increased if performed with a large size FNB needles and more than two passes.
Abstract
Background and study aims
Chronic radiation proctitis (CRP) occurs in 5 % to 20 % of patients undergoing pelvic radiation therapy and frequently manifests with rectal bleeding. Endoscopic ...management of more severe and refractory cases can be challenging. Rectal band ligation (RBL) has been shown to be a feasible alternative to current available techniques, especially in extensive CRP. Our aim is to evaluate clinical and technical success of RBL.
Patients and methods
We enrolled all consecutive patients treated with RBL for severe or recurrent hemorrhagic CRP. Success was defined as endoscopic evidence of complete rectal healing and/or cessation of bleeding not requiring further treatment or blood transfusion.
Results
We enrolled 10 patients (7 males, mean age 75.6 years). Median length of the CRP from the anal verge was 4.5 cm and mean surface area involved was 89 %. Eight patients (80 %) were naïve to endoscopic treatment, while two had undergone argon plasma coagulation (APC). Median follow-up was 136.5 days. Success was achieved in 100 % of patients after a mean number of 1.8 RBL sessions. A mean number of 4.7 bands were released in the first session while a mean of 3.1 and 2 bands were placed in the second and third sessions, respectively. As for adverse events, only one patient reported mild tenesmus and pelvic pain after the procedure.
Conclusions
RBL is a safe and effective therapeutic modality for the treatment of hemorrhagic CRP. It could be considered a valid first-line option in case of extensive rectal involvement as well as a viable rescue treatment after failed APC.
Abstract
Background and study aims
Endoscopic retrograde cholangiopancreatography (ERCP) represents the gold standard for jaundice palliation in malignant biliary obstruction (MBO) patients. Biliary ...drainage using electrocautery lumen apposing metal stent (EC-LAMS) is currently a well-established procedure when ERCP fails. We aimed to assess the technical and clinical success of a new EC-LAMS as the first approach to the palliation of malignant jaundice due to MBO in patients unfit for surgery.
Patients and methods
Twenty-five consecutive patients undergoing endoscopic-guided biliary drainage with the new EC-LAMS were prospectively enrolled. Clinical success was defined as bilirubin level decrease > 15 % 24 hours after EC-LAMS placement.
Results
Mean age was 76.6 ± 11.56 years, and male patients were 10 (40 %). EC-LAMS placement was technically feasible in 24 patients (96 %) and clinical success rate was 100 %. Only one patient (4 %) experienced a misplacement rescued by an immediate second EC-LAMS placement. The mean duration of hospital stay was 4.66 ± 4.22 days. The median overall survival was 7 months (95 % CI 1–7).
Conclusions
In this preliminary study, the new EC-LAMS seems to allow a single-step palliative endoscopic therapy in patients affected by jaundice due to MBO, with high technical and clinical success and low adverse events. Further large prospective studies are warranted to validate these results.
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EUS-guided ileal-ascending colon anastomosis with water-filled technique for pallation of cecal colon cancer invading the ileo-cecal valve, after failed attempt to perform ileal stenting.
Abstract
Background and study aims
Little is known about outcomes of biliopancreatic endosonography (EUS) in patients with surgically altered upper gastrointestinal (gastrointestinal) anatomy. We ...aimed to assess the rate of procedural success and EUS-related adverse events (AEs), according to post-surgical anatomies.
Patients and methods
Retrospective study including patients with post-surgical altered upper gastrointestinal anatomy who underwent EUS for evaluation of the biliopancreatic region between January 2008 and June 2018 at eight European centers.
Results
Of 242 patients (162 males, mean age 66.4 ± 12.5), 86 had (35.5 %) Billroth II, 77 (31.8 %) pancreaticoduodenectomy, 23 (9.5 %) Billroth I, 19 (7.9 %) distal esophagectomy, 15 (6.2 %) total gastrectomy, 14 (5.8 %) sleeve gastrectomy, and eight (3.3 %) Roux-en-Y. Sleeve gastrectomy, Billroth I, and pancreaticoduodenectomy were associated with high rates of success (100 %, 95.7 %, and 92.2 %, respectively). Visualization of the head of the pancreas was significantly impacted by total gastrectomy, Billroth II, and Roux-en-Y (success rates 6.7 %, 53.7 %, and 57.1 %, respectively). Examination of the pancreatic body and tail was impaired in esophagectomy and total gastrectomy (82.4 % and 71.4 %, respectively). Technical success and diagnostic accuracy of EUS-guided tissue acquisition (EUS-TA) was 78.2 % and 71.3 % (95 % CI, 60.6–80.5), respectively. Four (1.6 %) AEs were observed: one mucosal tearing in a Billroth II patient, one cardiac arrest in a distal esophagectomy patient, one bleed after EUS-TA in a Billroth I patient, and one acute pancreatitis after EUS-TA in a sleeve gastrectomy patient.
Conclusions
The yield of bilio-pancreatic EUS is dependent on lesion location and surgery type. Before considering EUS in these patients, one must carefully consider whether the lesion may be approachable by EUS.
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