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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Main Recommendations
ESGE recommends offering stone extraction to all patients with common bile duct stones, symptomatic or not, who are fit enough to tolerate the intervention.
Strong ...recommendation, low quality evidence.
ESGE recommends liver function tests and abdominal ultrasonography as the initial diagnostic steps for suspected common bile duct stones. Combining these tests defines the probability of having common bile duct stones.
Strong recommendation, moderate quality evidence.
ESGE recommends endoscopic ultrasonography or magnetic resonance cholangiopancreatography to diagnose common bile duct stones in patients with persistent clinical suspicion but insufficient evidence of stones on abdominal ultrasonography.
Strong recommendation, moderate quality evidence.
ESGE recommends the following timing for biliary drainage, preferably endoscopic, in patients with acute cholangitis, classified according to the 2018 revision of the Tokyo Guidelines:
– severe, as soon as possible and within 12 hours for patients with septic shock
– moderate, within 48 – 72 hours
– mild, elective.
Strong recommendation, low quality evidence.
ESGE recommends endoscopic placement of a temporary biliary plastic stent in patients with irretrievable biliary stones that warrant biliary drainage.
Strong recommendation, moderate quality of evidence.
ESGE recommends limited sphincterotomy combined with endoscopic papillary large-balloon dilation as the first-line approach to remove difficult common bile duct stones.
Strong recommendation, high quality evidence.
ESGE recommends the use of cholangioscopy-assisted intraluminal lithotripsy (electrohydraulic or laser) as an effective and safe treatment of difficult bile duct stones.
Strong recommendation, moderate quality evidence.
ESGE recommends performing a laparoscopic cholecystectomy within 2 weeks from ERCP for patients treated for choledocholithiasis to reduce the conversion rate and the risk of recurrent biliary events.
Strong recommendation, moderate quality evidence.
Background and Aims In high-risk surgical patients, the treatment of choice of acute cholecystitis is percutaneous transhepatic gallbladder drainage (PTGBD). Recently, a novel endoscopic device ...containing a lumen-apposing metal stent with an electrocautery (ECE-LAMS) on the tip has been developed. Methods High-risk surgical patients with acute cholecystitis who underwent EUS-guided gallbladder drainage (EUS-GBD) with the novel device were retrospectively retrieved from 7 tertiary care referral centers. Main endpoints were technical and clinical success rates, rate of procedural adverse events, and short- and long-term adverse events. Results Seventy-five patients (mean age, 75 ± 11 years; 36 men) underwent EUS-GBD. The procedure was technically and clinically successful in 98.7% and 95.9% of cases, respectively. Three patients without resolution of cholecystitis died, and 2 patients had procedure-related adverse events: 1 perforation requiring surgery and 1 major bleeding resolved conservatively. The mean follow-up for the entire cohort was 201 ± 226 days. Seven patients (9.6%) died within the first 30 days; 50 patients (71.4%) were alive at the last date of follow-up. Short- and long-term adverse events occurred in 6 patients: 3 had recurrent cholecystitis, 2 had migration of the stent, and 1 developed Bouveret syndrome, all managed nonsurgically. Overall, 8 adverse events (10.7%) occurred in the entire cohort of patients. Conclusions The novel ECE-LAMS for high-risk surgical patients with acute cholecystitis is safe, with a high technical and clinical success rate. Future multicenter studies comparing EUS-GBD versus PTGBD are warranted to determine which procedure is safer and clinically more effective for patients with high surgical risk acute cholecystitis.
The role and timing of endoscopy in the setting of acute biliary pancreatitis(ABP) is still being debated. Despite numerous randomized trials have been published,there is an obvious lack of consensus ...on the indications and timing of endoscopic retrograde cholangiopancreatography(ERCP) in ABP in metaanalyses and nationwide guidelines. The present editorial has been written to clarify the role of endoscopy in ABP. In clinical practice the decision to perform an ERCP is often based on biochemical and radiological criteria despite they already have been shown to be unreliable predictors of common bile duct stone presence. Endoscopic ultrasonography(EUS) is not currently a worldwide standard diagnostic procedure early in the course of acute biliary pancreatitis,but it has been shown to be accurate,safe and cost effective in diagnosing biliary obstructions compared with magnetic resonance cholangiopancreatography and ERCP and therefore in preventing unnecessary ERCP and its related complications. Early EUS in ABP allows,if appropriate,immediate endoscopic treatment and significant spare of unnecessary operative procedures thus reducing possible related complications.
In this Special Issue of
entitled "Recent Advances in Biliopancreatic Endoscopy" in the Section "Gastroenterology & Hepatology", nine articles pave new insights into the advances in the world of ...biliopancreatic endoscopy ....
Malignant gastric outlet obstruction (MGOO) is a clinical condition characterized by the mechanical obstruction of the pylorus or the duodenum due to tumor compression/infiltration, with consequent ...reduction or impossibility of an adequate oral intake. MGOO is mainly secondary to advanced pancreatic or gastric cancers, and significantly impacts on patients' survival and quality of life. Patients suffering from this condition often present with intractable vomiting and severe malnutrition, which further compromise therapeutic chances. Currently, palliative strategies are based primarily on surgical gastrojejunostomy and endoscopic enteral stenting with self-expanding metal stents. Several studies have shown that surgical approach has the advantage of a more durable relief of symptoms and the need of fewer re-interventions, at the cost of higher procedure-related risks and longer hospital stay. On the other hand, enteral stenting provides rapid clinical improvement, but have the limit of higher stent dysfunction rate due to tumor ingrowth and a subsequent need of frequent re-interventions. Recently, a third way has come from interventional endoscopic ultrasound, through the development of endoscopic ultrasound-guided gastroenterostomy technique with lumen-apposing metal stent. This new technique may ideally encompass the minimal invasiveness of an endoscopic procedure and the long-lasting effect of the surgical gastrojejunostomy, and brought encouraging results so far, even if prospective comparative trial are still lacking. In this Review, we described technical aspects and clinical outcomes of the above-cited therapeutic approaches, and discussed the open questions about the current management of MGOO.
Background and Aims Flexible endoscopic septum division (FESD) is a rapidly evolving technique for the treatment of Zenker's diverticulum (ZD). The aim was to perform a systematic review and ...meta-analysis of the literature focusing on FESD for ZD, including an in-depth evaluation of its efficacy, safety, and limitations. Methods A comprehensive literature search was completed to identify papers that examined the efficacy and safety of FESD for ZD. Demographic, clinical, and technical information was retrieved. Main outcomes were extracted, pooled, and analyzed. Heterogeneity among studies was assessed using the I2 statistic. A random effect model was used as the pooling method in cases of high heterogeneity; otherwise the fixed effect model was applied. Meta-regression was also performed. Main outcomes such as rates of success, adverse events, and recurrences were evaluated. Results Twenty studies with a total of 813 patients were selected. The pooled success, adverse events, and recurrence rates were 91% (95% confidence interval CI, 86%–95%; I2 = 69.5%), 11.3% (95% CI, 8%–16%; I2 = 64%), and 11% (95% CI, 8%–15%; I2 = 38.4%), respectively. Substantial heterogeneity across studies was found. However, for success rates, excluding 3 studies reduced heterogeneity to non-significant rates I2 = 25.6%; P = .154. Adverse event rates decreased with larger samples (coefficient, −0.0123; 95% CI, −0.03 to −0.003; P = .017), whereas recurrence rates increased (coefficient, 0.006; 95% CI, −0.0010 to 0.0125; P = .093). Year of publication was negatively associated with success rate, whereas the opposite pattern was found for recurrence rates. Conclusions FESD is a feasible, safe, and effective treatment for symptomatic ZD, with low adverse event and recurrence rates.
Stent misdeployment (SM) has hindered the dissemination of EUS-guided gastroenterostomy (EUS-GE) for gastric outlet obstruction (GOO) management. We aimed to provide a classification system for SM ...during EUS-GE and study clinical outcomes and management accordingly.
This is a retrospective study involving 16 tertiary care centers (8 in the United States, 8 in Europe) from March 2015 to December 2020. Patients who developed SM during EUS-GE for GOO were included. We propose classifying SM into 4 types. The primary outcome was rate and severity of SM (per American Society for Gastrointestinal Endoscopy lexicon), whereas secondary outcomes were clinical outcomes and management of dislodgement according to the SM classification type, in addition to salvage management of GOO after SM.
From 467 EUS-GEs performed for GOO during the study period, SM occurred in 46 patients (9.85%). Most SMs (73.2%) occurred during the first 13 EUS-GE cases by the performing operators. SM was graded as mild (n = 28, 60.9%), moderate (n = 11, 23.9%), severe (n = 6, 13.0%), or fatal (n = 1, 2.2%), with 5 patients (10.9%) requiring surgical intervention. Type I SM was the most common (n = 29, 63.1%), followed by type II (n = 14, 30.4%), type IV (n = 2, 4.3%), and type III (n = 1, 2.2%). Type I SM was more frequently rated as mild compared with type II SM (75.9% vs 42.9%, P = .04) despite an equivalent rate of surgical repair (10.3% vs 7.1%, P = .7). Overall, 4 patients (8.7%) required an intensive care unit stay (median, 2.5 days). The median length of stay was 4 days after SM.
Although SM is not infrequent during EUS-GE, most are type I, mild/moderate in severity, and can be managed endoscopically with a surgical intervention rate of approximately 11%.
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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.
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