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BACKGROUND: The standard salvage technique used for difficult bile duct cannulation is precut sphincterotomy, whereas endoscopic ultrasound-guided rendezvous technique (EUS-RV) is a relatively newer method. Prospective comparative data between these 2 techniques as salvage for biliary access in patients with benign biliary disease and difficult bile duct cannulation is lacking. OBJECTIVE: To compare EUS-RV and precut sphincterotomy as salvage technique for difficult bile duct cannulation in benign biliary obstruction. DESIGN: Participant-masked, parallel-group, superiority, randomized controlled trial. (Clinical Trials Registry of India: CTRI/2020/07/026613). SETTING: Tertiary care academic institute from July 2020 to May 2021. PARTICIPANTS: All patients with benign biliary disease and difficult bile duct cannulation requiring salvage strategy. INTERVENTION: Patients were randomly assigned by computer-generated randomized blocks sequence in 1:1 fashion to either EUS-RV or precut sphincterotomy. Patients with failure in EUS-RV were crossed over to precut sphincterotomy and vice versa. MEASUREMENTS: The primary outcome measure was technical success. The other outcome measures included procedure time, radiation dose, and adverse events. RESULTS: In total, 100 patients were randomly assigned to EUS-RV (n = 50) and precut sphincterotomy (n = 50). The technical success rate (92% vs. 90%; P = 1.00; relative risk, 1.02 [95% CI, 0.90 to 1.16]), median procedure time (10.1 vs. 9.75 minutes), and overall complication rate (12% vs. 10%; relative risk, 1.20 [CI, 0.39 to 3.68]) were similar between the 2 groups. Five patients (10%) in the EUS-RV group and 5 patients (10%) in the precut sphincterotomy group had developed post-endoscopic retrograde cholangiopancreatography pancreatitis. All failed cases in either salvage group could be successfully cannulated when crossed over to the other group. LIMITATION: Single center study done by experts. CONCLUSION: Endoscopic ultrasound-guided rendezvous technique and precut sphincterotomy have similar success rates as salvage techniques in the technically challenging cohort of difficult bile duct cannulation for benign biliary disease, with acceptable complications rates. PRIMARY FUNDING SOURCE: None.
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Endosonografía , Esfinterotomía Endoscópica , Humanos , Masculino , Femenino , Esfinterotomía Endoscópica/métodos , Esfinterotomía Endoscópica/efectos adversos , Persona de Mediana Edad , Endosonografía/métodos , Terapia Recuperativa/métodos , Ultrasonografía Intervencional/métodos , Cateterismo/métodos , Adulto , Colangiopancreatografia Retrógrada Endoscópica/métodos , Anciano , Estudios ProspectivosRESUMEN
BACKGROUND: Computer-aided diagnosis (CADx) allows prediction of polyp histology during colonoscopy, which may reduce unnecessary removal of nonneoplastic polyps. However, the potential benefits and harms of CADx are still unclear. PURPOSE: To quantify the benefit and harm of using CADx in colonoscopy for the optical diagnosis of small (≤5-mm) rectosigmoid polyps. DATA SOURCES: Medline, Embase, and Scopus were searched for articles published before 22 December 2023. STUDY SELECTION: Histologically verified diagnostic accuracy studies that evaluated the real-time performance of physicians in predicting neoplastic change of small rectosigmoid polyps without or with CADx assistance during colonoscopy. DATA EXTRACTION: The clinical benefit and harm were estimated on the basis of accuracy values of the endoscopist before and after CADx assistance. The certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework. The outcome measure for benefit was the proportion of polyps predicted to be nonneoplastic that would avoid removal with the use of CADx. The outcome measure for harm was the proportion of neoplastic polyps that would be not resected and left in situ due to an incorrect diagnosis with the use of CADx. Histology served as the reference standard for both outcomes. DATA SYNTHESIS: Ten studies, including 3620 patients with 4103 small rectosigmoid polyps, were analyzed. The studies that assessed the performance of CADx alone (9 studies; 3237 polyps) showed a sensitivity of 87.3% (95% CI, 79.2% to 92.5%) and specificity of 88.9% (CI, 81.7% to 93.5%) in predicting neoplastic change. In the studies that compared histology prediction performance before versus after CADx assistance (4 studies; 2503 polyps), there was no difference in the proportion of polyps predicted to be nonneoplastic that would avoid removal (55.4% vs. 58.4%; risk ratio [RR], 1.06 [CI, 0.96 to 1.17]; moderate-certainty evidence) or in the proportion of neoplastic polyps that would be erroneously left in situ (8.2% vs. 7.5%; RR, 0.95 [CI, 0.69 to 1.33]; moderate-certainty evidence). LIMITATION: The application of optical diagnosis was only simulated, potentially altering the decision-making process of the operator. CONCLUSION: Computer-aided diagnosis provided no incremental benefit or harm in the management of small rectosigmoid polyps during colonoscopy. PRIMARY FUNDING SOURCE: European Commission. (PROSPERO: CRD42023402197).
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Pólipos del Colon , Colonoscopía , Diagnóstico por Computador , Humanos , Pólipos del Colon/patología , Pólipos del Colon/diagnóstico por imagen , Neoplasias Colorrectales/patología , Neoplasias Colorrectales/diagnósticoRESUMEN
BACKGROUND: Although both nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids are used for analgesia in acute pancreatitis (AP), the analgesic of choice is not known. We compared buprenorphine, an opioid, and diclofenac, an NSAID, for analgesia in AP. METHODS: In a double-blind randomized controlled trial, AP patients were randomized to receive intravenous diclofenac or intravenous buprenorphine. Fentanyl was used as rescue analgesia, delivered through a patient-controlled analgesia pump. Primary outcome was the difference in the dose of rescue fentanyl required. Secondary outcomes were the number of effective and ineffective demands of rescue fentanyl, pain-free interval, reduction in visual analogue scale (VAS) score, adverse events, and organ failure development. RESULTS: Twenty-four patients were randomized to diclofenac and 24 to buprenorphine. The 2 groups were matched at baseline. The total amount of rescue fentanyl required was significantly lower in the buprenorphine group:130 µg, interquartile range (IQR), 80-255 vs 520 µg, IQR, 380-1065 (P < .001). The number of total demands was 32 (IQR, 21-69) in the diclofenac arm vs 8 (IQR, 4-15) in the buprenorphine arm (P < .001). The buprenorphine group had more prolonged pain-free interval (20 vs 4 hours; P < .001), with greater reduction in the VAS score at 24, 48, and 72 hours compared with the diclofenac group. These findings were confirmed in the subgroup of moderately severe/severe pancreatitis. Adverse events profile was similar in the 2 groups. CONCLUSIONS: Compared with diclofenac, buprenorphine appears to be more effective and equally safe for pain management in AP patients, even in the subcohort of moderately severe or severe pancreatitis (Trial Registration number: CTRI/2020/07/026914).
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Buprenorfina , Pancreatitis , Humanos , Diclofenaco/efectos adversos , Buprenorfina/efectos adversos , Manejo del Dolor , Enfermedad Aguda , Pancreatitis/complicaciones , Pancreatitis/tratamiento farmacológico , Pancreatitis/inducido químicamente , Antiinflamatorios no Esteroideos/efectos adversos , Analgésicos Opioides/uso terapéutico , Dolor/etiología , Dolor/inducido químicamente , Fentanilo/efectos adversos , Método Doble CiegoRESUMEN
BACKGROUND & AIMS: Sleeve gastrectomy (SG) is one of the most commonly performed bariatric procedures worldwide. Gastroesophageal reflux disease (GERD) is a major concern in patients undergoing SG and is a risk factor for Barrett's esophagus (BE). We conducted a systematic review and meta-analysis to assess the incidence of and analyze predictive factors for post-SG BE. METHODS: A comprehensive literature search was conducted in April 2024, for studies reporting on incidence of BE, erosive esophagitis (EE), and hiatal hernia (HH) post-SG. Primary outcomes were post-SG pooled rates of de novo BE, EE, GERD symptoms, proton pump inhibitor use, and HH. Meta-regression analysis was performed to assess if patient and post-SG factors influenced the rates of post-SG BE. RESULTS: Nineteen studies with 2046 patients (79% females) were included. Mean age was 42.2 years (standard deviation, 11.1) and follow-up ranged from 2 to 11.4 years. The pooled rate of de novo BE post-SG was 5.6% (confidence interval, 3.5-8.8). Significantly higher pooled rates of EE (risk ratio [RR], 3.37], HH (RR, 2.09), GER/GERD symptoms (RR, 3.32), and proton pump inhibitor use (RR, 3.65) were found among patients post-SG. GER/GERD symptoms post-SG positively influenced the pooled BE rates, whereas age, sex, body mass index, post-SG EE, and HH did not. CONCLUSIONS: Our analysis shows that SG results in a significantly increased risk of de novo BE and higher rates of EE, proton pump inhibitor use, and HH. Our findings suggest that clinicians should routinely screen patients with SG for BE and future surveillance intervals should be followed as per societal guidelines.
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BACKGROUND AND AIMS: Limited evidence exists regarding the impact of glucagon-like peptide-1 receptor agonists (GLP-1RAs) on upper endoscopy. Therefore, a meta-analysis was conducted to comprehensively review the available evidence on this subject. METHODS: A systematic bibliographic search was carried out until May 2024. Pooled estimates were analyzed using a random-effects model, with results presented as odds ratio (OR) and 95% confidence interval (CI). The primary outcome assessed was the rate of retained gastric content (RGC), while secondary outcomes included rates of aborted and repeated procedures, adverse event rate, and rates of aspiration. RESULTS: This analysis included 13 studies involving a total of 84,065 patients. Patients receiving GLP-1RA therapy exhibited significantly higher rates of RGC (OR, 5.56; 95% CI, 3.35 to 9.23), a trend that was consistent among patients with diabetes (OR, 2.60; 95% CI, 2.23 to 3.02). Adjusted analysis, accounting for variables such as sex, age, body mass index, diabetes, and other therapies, confirmed the elevated rates of RGC in the GLP-1RA user group (adjusted OR, 4.20; 95% CI, 3.42 to 5.15). Furthermore, rates of aborted and repeated procedures were higher in the GLP-1RA user group (OR, 5.13; 95% CI, 3.01 to 8.75; and OR, 2.19; 95% CI, 1.43 to 3.35; respectively). However, no significant differences were found in AE and aspiration rates between the 2 groups (OR, 4.04; 95% CI, 0.63 to 26.03; and OR, 1.75; 95% CI, 0.64 to 4.77; respectively). CONCLUSION: Use of GLP-1RAs is associated with increased retention of gastric contents and more frequent aborted procedures during upper endoscopy. However, the adverse event and aspiration rates do not seem different; therefore, adjusting fasting time instead of routinely withholding GLP-1RAs could be reasonable in these patients.
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BACKGROUND & AIMS: Both computer-aided detection (CADe)-assisted and Endocuff-assisted colonoscopy have been found to increase adenoma detection. We investigated the performance of the combination of the 2 tools compared with CADe-assisted colonoscopy alone to detect colorectal neoplasias during colonoscopy in a multicenter randomized trial. METHODS: Men and women undergoing colonoscopy for colorectal cancer screening, polyp surveillance, or clincial indications at 6 centers in Italy and Switzerland were enrolled. Patients were assigned (1:1) to colonoscopy with the combinations of CADe (GI-Genius; Medtronic) and a mucosal exposure device (Endocuff Vision [ECV]; Olympus) or to CADe-assisted colonoscopy alone (control group). All detected lesions were removed and sent to histopathology for diagnosis. The primary outcome was adenoma detection rate (percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, advanced adenomas and serrated lesions detection rate, the rate of unnecessary polypectomies (polyp resection without histologically proven adenomas), and withdrawal time. RESULTS: From July 1, 2021 to May 31, 2022, there were 1316 subjects randomized and eligible for analysis; 660 to the ECV group, 656 to the control group). The adenoma detection rate was significantly higher in the ECV group (49.6%) than in the control group (44.0%) (relative risk, 1.12; 95% CI, 1.00-1.26; P = .04). Adenomas detected per colonoscopy were significantly higher in the ECV group (mean ± SD, 0.94 ± 0.54) than in the control group (0.74 ± 0.21) (incidence rate ratio, 1.26; 95% CI, 1.04-1.54; P = .02). The 2 groups did not differ in term of detection of advanced adenomas and serrated lesions. There was no significant difference between groups in mean ± SD withdrawal time (9.01 ± 2.48 seconds for the ECV group vs 8.96 ± 2.24 seconds for controls; P = .69) or proportion of subjects undergoing unnecessary polypectomies (relative risk, 0.89; 95% CI, 0.69-1.14; P = .38). CONCLUSIONS: The combination of CADe and ECV during colonoscopy increases adenoma detection rate and adenomas detected per colonoscopy without increasing withdrawal time compared with CADe alone. CLINICALTRIALS: gov, Number: NCT04676308.
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Adenoma , Neoplasias Colorrectales , Masculino , Humanos , Femenino , Colonoscopía , Adenoma/diagnóstico por imagen , Adenoma/patología , Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/patología , Membrana Mucosa , ComputadoresRESUMEN
BACKGROUND & AIMS: Computer-aided diagnosis (CADx) assists endoscopists in differentiating between neoplastic and non-neoplastic polyps during colonoscopy. This study aimed to evaluate the impact of polyp location (proximal vs. distal colon) on the diagnostic performance of CADx for ≤5 mm polyps. METHODS: We searched for studies evaluating the performance of real-time CADx alone (ie, independently of endoscopist judgement) for predicting the histology of colorectal polyps ≤5 mm. The primary endpoints were CADx sensitivity and specificity in the proximal and distal colon. Secondary outcomes were the negative predictive value (NPV), positive predictive value (PPV), and the accuracy of the CADx alone. Distal colon was limited to the rectum and sigmoid. RESULTS: We included 11 studies for analysis with a total of 7782 polyps ≤5 mm. CADx specificity was significantly lower in the proximal colon compared with the distal colon (62% vs 85%; risk ratio (RR), 0.74; 95% confidence interval [CI], 0.72-0.84). Conversely, sensitivity was similar (89% vs 87%); RR, 1.00; 95% CI, 0.97-1.03). The NPV (64% vs 93%; RR, 0.71; 95% CI, 0.64-0.79) and accuracy (81% vs 86%; RR, 0.95; 95% CI, 0.91-0.99) were significantly lower in the proximal than distal colon, whereas PPV was higher in the proximal colon (87% vs 76%; RR, 1.11; 95% CI, 1.06-1.17). CONCLUSION: The diagnostic performance of CADx for polyps in the proximal colon is inadequate, exhibiting significantly lower specificity compared with its performance for distal polyps. Although current CADx systems are suitable for use in the distal colon, they should not be employed for proximal polyps until more performant systems are developed specifically for these lesions.
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BACKGROUND AND AIMS: The SpyGlass (Boston Scientific, Marlborough, Mass, USA) single-operator cholangioscopy (SOC) system is generally considered to be safe but adds additional risks to those associated with standard ERCP. METHODS: We evaluated adverse events (AEs) associated with the SpyGlass system reported in the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database between January 2016 and August 2023. RESULTS: From the database, 2311 device problems (SpyGlass DS, 1301; SpyGlass DS II, 1010) were reported. An optical problem was the most reported issue (SpyGlass DS, 83; SpyGlass DS II, 457). Patient-related events were found in 62 of 1743 reports (3.5%): 33 with the SpyGlass DS and 29 with the SpyGlass DS II. The most common AEs were bleeding/hemorrhage followed by perforation; infection, fever, or sepsis; and pancreatitis. CONCLUSIONS: Our findings add to the existing literature and provide a fuller picture of potential problems associated with the SpyGlass SOC.
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Bases de Datos Factuales , Endoscopía del Sistema Digestivo , Humanos , Endoscopía del Sistema Digestivo/efectos adversos , Endoscopía del Sistema Digestivo/métodos , Endoscopía del Sistema Digestivo/instrumentación , Estados Unidos , Pancreatitis/etiología , Sepsis/etiología , Falla de Equipo , Colangiopancreatografia Retrógrada Endoscópica/efectos adversos , Colangiopancreatografia Retrógrada Endoscópica/métodos , Perforación Intestinal/etiología , United States Food and Drug Administration , Hemorragia/etiología , Hemorragia Gastrointestinal/etiologíaRESUMEN
BACKGROUND: This study aimed to evaluate the effectiveness of ChatGPT (Chat Generative Pretrained Transformer) in answering patients' questions about colorectal cancer (CRC) screening, with the ultimate goal of enhancing patients' awareness and adherence to national screening programs. METHODS: 15 questions on CRC screening were posed to ChatGPT4. The answers were rated by 20 gastroenterology experts and 20 nonexperts in three domains (accuracy, completeness, and comprehensibility), and by 100 patients in three dichotomic domains (completeness, comprehensibility, and trustability). RESULTS: According to expert rating, the mean (SD) accuracy score was 4.8 (1.1), on a scale ranging from 1 to 6. The mean (SD) scores for completeness and comprehensibility were 2.1 (0.7) and 2.8 (0.4), respectively, on scales ranging from 1 to 3.âOverall, the mean (SD) accuracy (4.8 [1.1] vs. 5.6 [0.7]; Pâ<â0.001) and completeness scores (2.1 [0.7] vs. 2.7 [0.4]; Pâ<â0.001) were significantly lower for the experts than for the nonexperts, while comprehensibility was comparable among the two groups (2.8 [0.4] vs. 2.8 [0.3]; Pâ=â0.55). Patients rated all questions as complete, comprehensible, and trustable in between 97â% and 100â% of cases. CONCLUSIONS: ChatGPT shows good performance, with the potential to enhance awareness about CRC and improve screening outcomes. Generative language systems may be further improved after proper training in accordance with scientific evidence and current guidelines.
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BACKGROUND: There is limited evidence on the comparative diagnostic performance of endoscopic tissue sampling techniques for subepithelial lesions. We performed a systematic review with network meta-analysis to compare these techniques. METHODS: A systematic literature review was conducted for randomized controlled trials (RCTs) comparing the sample adequacy and diagnostic accuracy of bite-on-bite biopsy, mucosal incision-assisted biopsy (MIAB), endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), and EUS-guided fine-needle biopsy (FNB). Results were expressed as relative risk (RR) and 95%CI. RESULTS: Eight RCTs were identified. EUS-FNB was significantly superior to EUS-FNA in terms of sample adequacy (RR 1.20 [95%CI 1.05-1.45]), whereas none of the other techniques significantly outperformed EUS-FNA. Additionally, bite-on-bite biopsy was significantly inferior to EUS-FNB (RR 0.55 [95%CI 0.33-0.98]). Overall, EUS-FNB appeared to be the best technique (surface under cumulative ranking [SUCRA] score 0.90) followed by MIAB (SUCRA 0.83), whereas bite-on-bite biopsy showed the poorest performance. When considering lesions <20 mm, MIAB, but not EUS-FNB, showed significantly higher accuracy rates compared with EUS-FNA (RR 1.68 [95%CI 1.02-2.88]). Overall, MIAB ranked as the best intervention for lesions <20 mm (SUCRA score 0.86 for adequacy and 0.91 for accuracy), with EUS-FNB only slightly superior to EUS-FNA. When rapid on-site cytological evaluation (ROSE) was available, no difference between EUS-FNB, EUS-FNA, and MIAB was observed. CONCLUSION: EUS-FNB and MIAB appeared to provide better performance, whereas bite-on-bite sampling was significantly inferior to the other techniques. MIAB seemed to be the best option for smaller lesions, whereas EUS-FNA remained competitive when ROSE was available.
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Neoplasias Pancreáticas , Herida Quirúrgica , Tracto Gastrointestinal Superior , Humanos , Metaanálisis en Red , Biopsia por Aspiración con Aguja Fina Guiada por Ultrasonido Endoscópico/métodos , Endoscopía , Tracto Gastrointestinal Superior/patología , Neoplasias Pancreáticas/patologíaRESUMEN
INTRODUCTION: Endoluminal radiofrequency ablation (RFA) is a palliative treatment for patients suffering from malignant biliary obstruction. We aimed to conduct a meta-analysis to evaluate the impact of RFA on stent patency, patient survival, and adverse events. METHODS: Major databases were searched through November 2023 for patients who underwent stenting with or without RFA for extra-hepatic malignant biliary obstruction. A random effects model was employed for analysis and results conveyed using relative risk ratio with 95% confidence interval. RESULTS: Nine RCTs involving 750 subjects (n=374 RFA plus stent vs. n=376 stent only) with malignant biliary obstruction were included. Meta-analysis revealed similar risks of stent patency at 3 months (RR = 1.01; 95% CI [0.92 - 1.11], I2=4% for RFA plus stenting vs. stent only). Meta-analysis showed improved survival at 6 months (RR = 0.84; 95% CI [0.73 - 0.96], I2=21%, P=0.01 for RFA plus stenting vs. stent only). Subgroup analysis comparing plastic vs uncovered metal stents showed that stent patency was unaffected at 3 months (RR = 1.06; 95% CI [0.91 - 1.23]; I2=17%). Subgroup analysis showed that patients with cholangiocarcinoma experienced an overall survival benefit with RFA plus stenting vs. stent only (P<0.001), however, stent patency remained unaffected (P=0.08). An increased incidence of cholecystitis was noted with RFA plus stent vs. stent only (5.1%; 95% CI [3.1% - 7.8%] vs 0.3%; 95% CI [0.01% - 1.5%], respectively). CONCLUSION: Combining endoluminal RFA and stenting may improve overall survival in patients with malignant biliary obstruction. RFA did not impact stent patency significantly.
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BACKGROUND: The gender gap in the authorship of scientific research may affect career advancement. Our aim was to assess the potential gender gap in gastrointestinal (GI) journals. METHODS: A systematic review was performed of the GI literature and ongoing research in the period 2020-2022. A total 10 GI journals and ongoing research on clinicaltrials.gov were selected for review. The gender gap in first and senior authorship was evaluated for each article and ongoing research project. Associations between the gender gap and possible predictors were measured and results are presented as odds ratios (ORs) with 95%CI. RESULTS: The number of first female authors (FFAs) and senior female authors (SFAs) in published articles were 1408/4207 (33.5%) and 911/4207 (21.7%), respectively. There were 781/2654 (29.4%) female principal investigators (PI)s for the ongoing research. On comparison of non-endoscopic vs. endoscopic topics, the latter were associated with the gender gap (hepatology, OR 2.15 [95%CI 1.83-2.55]; inflammatory bowel disease, OR 2.12 [95%CI 1.60-2.45]; upper and lower GI, OR 1.31 [95%CI 1.18-1.73]); as well as the type of article (original article vs. editorial, OR 1.92 [95%CI 1.58-2.33]). The type of research was also associated with the gender gap (clinical vs. preclinical studies, OR 0.88 [95%CI 0.66-0.91]). CONCLUSION: Our results demonstrated a correlation between the gender gap and the design and topic of the research. Future strategies for improving equity in career development in GI endoscopy should focus on closing the gender gap in equity of authorship.
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Autoria , Gastroenterología , Publicaciones Periódicas como Asunto , Humanos , Gastroenterología/estadística & datos numéricos , Femenino , Masculino , Publicaciones Periódicas como Asunto/estadística & datos numéricos , Estados Unidos , Europa (Continente) , Sexismo , Médicos Mujeres/estadística & datos numéricos , Factores Sexuales , Investigación BiomédicaRESUMEN
INTRODUCTION: Endoscopic ultrasound (EUS)-guided drainage of symptomatic pancreatic fluid collections (PFCs) using the Hot-Axios device has recently been associated with a significant risk of bleeding. This adverse event (AE) seems to occur less frequently with the use of a different device, the Spaxus stent. The aim of the current study was to compare the rates of bleeding between the two stents. METHODS: Patients admitted for treatment of PFCs by EUS plus lumen-apposing metal stent in 18 endoscopy referral centers between 10 July 2019 and 28 February 2022 were identified and their outcomes compared using a propensity-matching analysis. RESULTS: 363 patients were evaluated. After a 1-to-1 propensity score match, 264 patients were selected (132 per group). The technical and clinical success rates were comparable between the two groups. Significantly more bleeding requiring transfusion and/or intervention occurred in the Hot-Axios group than in the Spaxus group (6.8% vs. 1.5%; Pâ=â0.03); stent type was a significant predictor of bleeding in both univariate and multivariate regression analyses (Pâ=â0.03 and 0.04, respectively). Bleeding necessitating arterial embolization did not however differ significantly between the two groups (3.0% vs. 0%; Pâ=â0.12). In addition, the Hot-Axios was associated with a significantly higher rate of overall AEs compared with the Spaxus stent (9.8% vs. 3.0%; Pâ=â0.04). CONCLUSION: Our study showed that, in patients with PFCs, bleeding requiring transfusion and/or intervention occurred significantly more frequently with use of the Hot-Axios stent than with the Spaxus stent, although this was not the case for bleeding requiring embolization.
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Páncreas , Enfermedades Pancreáticas , Humanos , Estudios Retrospectivos , Stents/efectos adversos , Endosonografía/efectos adversos , Drenaje/efectos adversos , Hemorragia/etiología , Endoscopía Gastrointestinal , Resultado del TratamientoRESUMEN
OBJECTIVE: Bowel cleansing is a key element for a quality colonoscopy. Despite recent advances, not all predictors of successful cleansing are fully known. This post hoc analysis of an RCT aims to explore gender differences in bowel cleansing quality. METHODS: The "OVER" trial was a multicenter phase-4 RCT including 478 patients randomized 1:1 to receive split-dose 1L polyethylene glycol plus ascorbate (PEG+ASC) or 4L-PEG. In this post hoc analysis, multivariable logistic regression models were designed to assess predictors of cleansing success (CS) and adenoma detection rate (ADR) by gender. RESULTS: Of the 478 randomized patients, 50.2% were males and 49.8% females.Overall, CS was comparable between females and males (87.1% vs 88.4, P = 0.6), whereas CS in the right (95.7% vs 90.9, P = 0.049) and transverse colon (98.6% vs 93.9, P=0.011) was significantly higher in females.At multivariable regression analysis for CS outpatient setting (OR = 5.558) and higher withdrawal time (OR = 1.294) were independently associated with CS in females, whereas screening/surveillance indication (OR = 6.776) was independently associated with CS in males.At multivariable regression analysis for ADR, running time <5 hours (OR = 3.014) and higher withdrawal time (OR = 1.250) were independently associated with ADR in females, whereas older age (OR = 1.040) and higher withdrawal time (OR = 1.093) were independently associated with ADR in males. CONCLUSIONS: This study showed different results in bowel preparation quality and different predictors of CS and ADR by gender. These findings suggest the need for further research to explore gender-specific approaches for bowel preparation.
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BACKGROUND: There is increasing evidence that cold endoscopic mucosal resection (c-EMR) can effectively treat large colorectal polyps. We aim to appraise the current literature and evaluate outcomes following c-EMR for nonpedunculated colonic polyps ≥20 mm. METHODS: Major databases were searched. Primary outcomes included recurrence rate and adverse events. Meta-analysis was performed using a random-effects model. RESULTS: Nine articles were included in the final analysis, which included 817 patients and 1077 colorectal polyps. Average polyp size was 28.8 (±5.1) mm. The pooled recurrence rate of polyps of any histology at 4 to 6 months was 21.0% (95% CI: 9.0%-32.0%, P <0.001, I2 =97.3, P <0.001). Subgroup analysis showed that recurrence was 10% for proximal lesions (95% CI: 0.0%-20.0%, P =0.054, I2 =93.7%, P =0.054) and 9% for distal lesions (95% CI: 2.0%-21.0%, P =0.114, I2 =95.8%, P =0.114). Furthermore, subgroup analysis showed that recurrence was 12% for adenoma (95% CI: 4.0%-19.0%, P =0.003, I2 =98.0%, P =0.003), and 3% for sessile serrated polyps (95% CI: 1.0%-5.0%, P =0.002, I2 =34.4%, P =0.002). Post-polypectomy bleeding occurred in 1% (n=8/817) of patients, whereas abdominal pain occurred in 0.2% (n=2/817) of patients. CONCLUSIONS: C-EMR for nonpedunculated colorectal polyps ≥20 mm shows an excellent safety profile with a very low rate of delayed bleeding as well as significantly less recurrence for sessile serrated polyps than adenomas.
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Pólipos del Colon , Resección Endoscópica de la Mucosa , Humanos , Resección Endoscópica de la Mucosa/métodos , Pólipos del Colon/cirugía , Pólipos del Colon/patología , Recurrencia Local de Neoplasia , Resultado del Tratamiento , Colonoscopía/métodos , Neoplasias Colorrectales/cirugía , Neoplasias Colorrectales/patologíaRESUMEN
BACKGROUND AND OBJECTIVES: Endoscopic ultrasound-guided biliary drainage (EUS-BD) is a viable alternative in cases with failed ERCP transpapillary drainage (ERCP-TPD). This systematic review and meta-analysis aimed to compare the efficacy and safety of EUS-BD and ERCP-TPD for primary biliary drainage in patients with distal malignant biliary obstruction (DMBO). METHODS: We searched Embase, PubMed, and Medline databases for studies comparing EUS-BD and ERCP-TPD in DMBO, from inception until September 2023. The primary endpoint was clinical success and secondary endpoints included technical success, procedure duration, and adverse events. RESULTS: Eight studies (815 patients, 56.1% male) were included in this analysis. Indications for biliary drainage were pancreatic carcinoma (75.1%), followed by cholangiocarcinoma (10.1%). Clinical success was comparable between EUS-BD and ERCP-TPD groups (OR 1.34; 95% CI, 0.75-2.40; P=0.32). Technical success was similar between the 2 groups (OR 2.09; 95% CI, 0.83-5.25; P=0.12). There was a trend toward fewer adverse events in the EUS-BD group (OR 0.65; 95% CI, 0.40-1.07; P=0.09), with significantly lower odds of post-procedure pancreatitis (OR 0.17; 95% CI, 0.06-0.50; P=0.001). CONCLUSION: EUS-BD is comparable to ERCP for primary biliary drainage in DMBO patients with shorter procedural time and a significantly reduced risk of post-procedure pancreatitis.
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INTRODUCTION: Endoscopic removal techniques for colorectal polyps include cold snare polypectomy (CSP) and hot snare polypectomy (HSP). Although HSP is recommended for pedunculated polyps (PPs) larger than 10 mm, data regarding use of CSP for PPs <10 mm continues to emerge. We aimed to investigate outcomes of these techniques in small (<10 mm) pedunculated colorectal polyps. METHODS: Multiple databases were searched till June 2022 to identify studies involving the removal of small PPs with CSP and HSP. Random effects model was used to calculate outcomes and 95% CI. Primary outcome was the pooled rate of successful en-bloc resection. Secondary outcomes were immediate and delayed bleeding with CSP and HSP as well as prophylactic and post resection clip placement. RESULTS: Six studies including 1025 patients (1111 polyps with a mean size 4 to 8.5 mm) were analyzed. 116 and 995 polyps were removed with HSP and CSP, respectively. The overall pooled rate of successful en-bloc resection with CSP was 99.7% (CI 99.1-99.9; I2 0%). Pooled immediate and delayed bleeding after CSP was 49.8% (CI 46.8-52.91; I2 98%) and 0% (CI 0.00-0.00; I2 0%), respectively. Delayed bleeding was higher with HSP, relative risk 0.05 (CI 0.01-0.43; I2 0%), P =0.006, whereas immediate bleeding was higher with CSP, relative risk 7.89 (CI 4.36-14.29; I2 0%), P <0.00001. Pooled rates of prophylactic clip placement and post-procedure clip placement (to control immediate bleeding) were 55.3% and 47.2%, respectively. Finally, right colon polyp location significantly correlated with frequency of immediate bleeding. CONCLUSION: Our analysis shows that CSP is safe and effective for resection of small PPs.
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Pólipos del Colon , Colonoscopía , Humanos , Pólipos del Colon/cirugía , Pólipos del Colon/patología , Colonoscopía/métodos , Colonoscopía/efectos adversos , Resultado del Tratamiento , Hemorragia Posoperatoria/prevención & control , Hemorragia Posoperatoria/etiologíaRESUMEN
BACKGROUND: Clips are endoscopic mechanical devices with tensile and closure strength that can approximate tissue and provide hemostasis through a tamponade effect. Clips are ubiquitously used in endoscopic practice, and numerous studies have validated the clinical efficacy of clips, with recent guidelines recommending them as a first-line intervention for recurrent and persistent nonvariceal gastrointestinal bleeding. However, the safety profile for these devices has yet to be delineated, thus, we aim to investigate this feature by examining the adverse events reported to the Food and Drug Administration. METHODS: Postmarketing surveillance data from the Food and Drug Administration Manufacturer And User Facility Device Experience database were analyzed from January 2012 to January 2021. The Manufacturer And User Facility Device Experience database is a reporting software and does not independently verify the details of complications. RESULTS: Two thousand five hundred forty reports were issued, of which 287 were patient adverse events and 2766 were device problems. Activation, separation, and positioning issues were most common. No consequences or clinically significant impact on patients were seen in 1968 reports. Foreign bodies were seen in 97 cases, hemorrhage in 57 cases, tissue damage in 42 cases, embedded clips in tissues/plaques in 16 cases, perforation in 15 cases, lacerations in 6 cases, and infection in 3 cases. CONCLUSIONS: While the most commonly reported device problems involved activation, separation, and positioning, most patients were clinically unaffected. Moreover, perforation and infection were exceedingly rare, further highlighting the safety profile of endoscopic clips.
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Endoscopía , Hemorragia Gastrointestinal , Humanos , Estados Unidos , Hemorragia Gastrointestinal/epidemiología , Hemorragia Gastrointestinal/etiología , Resultado del Tratamiento , Instrumentos Quirúrgicos/efectos adversos , Bases de Datos FactualesRESUMEN
BACKGROUND: The effectiveness of prophylactic pancreatic duct stenting (PPDS) in preventing post-ampullectomy pancreatitis (PAP) at the time of endoscopic ampullectomy (EA) has been reported, however, results are conflicting. We conducted a systematic review and meta-analysis looking at the use of PPDS in reducing PAP as well as overall post-ampullectomy complications. METHODS: Multiple databases were searched through May 2023 for studies reporting on EA. Meta-analysis was performed to determine pooled proportions and relative risk (RR) with 95% confidence intervals (CI) of PAP, with and without PPDS. Pooled rates of adverse events including perforation, delayed bleeding, cholangitis, and procedure related mortality were assessed. Random effects model was used for our meta-analysis and heterogeneity was assessed using the I2 statistics. RESULTS: Thirty-four studies (14 case series, 18 cohort studies and 2 randomized controlled trials) with 1868 patients were included. The overall pooled rate of PAP was 12.3% (CI 10.3-14.5). We found no statistically significant difference in rates of PAP among patients with PPDS, 11.9% (CI 8.9-15.7) and without PPDS, 16.6% (CI 13.4-20.4), RR 0.8 (CI 0.51-1.28), p = 0.4. In terms of severe PAP, we found no difference between the two groups. The overall pooled rates of successful en-bloc and piecemeal resection were 74.8% (CI 67.3-81.1) and 25.1% (CI 19-32.4). Additionally, pooled rates of ampullary stenosis, post procedural bleeding, perforation, cholangitis, and procedure related mortality were 3.6%, 11.1%, 4.2%, 3.5%, and 1.3%, respectively. CONCLUSIONS: Our analysis shows that PPDS at the time of EA does not offer a significant protective effect against PAP. While the incidence of PAP was higher among the no PPDS group, it is plausible that this is more likely due to variation among studies in terms of lesion size, length/size of pancreatic stent used and etiology of ampullary lesions. Future well-designed randomized controlled trials are needed to validate our findings.
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Ampolla Hepatopancreática , Conductos Pancreáticos , Pancreatitis , Complicaciones Posoperatorias , Stents , Humanos , Ampolla Hepatopancreática/cirugía , Conductos Pancreáticos/cirugía , Pancreatitis/prevención & control , Pancreatitis/etiología , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiologíaRESUMEN
Stag Beetle Knife (SB Knife) is increasingly being utilized for Zenker's Diverticulectomy (ZD). Our study assessed the effectiveness and safety of the SB Knife for the management of ZD. Ovid EBM reviews, Ovid Embase, Ovid Medline, ClinicalTrials.gov, Scopus, and Web of Science were searched to identify studies that utilized SB knife for ZD. Pooled proportions (PP) were calculated using the random-effects model. Heterogeneity was evaluated using I2 statistics. A total of 7 studies with 268 patients were included in the final analysis. Dysphagia and regurgitation were the most common clinical symptoms. The mean size of the ZD was 2.8 ± 0.7 cm and 28 (of 148) patients had undergone previous treatments. The PP of technical success was 98% (95% CI: 92.3-99.5; I20) with a mean procedure duration of 26.2 ± 8.3 minutes. The PP of clinical response at first follow-up and relapse after index procedure was 87.9% (95% CI: 81.6-92.3; I219) and 13.5% (95% CI: 9.6-18.6; I22), respectively. At final follow-up, the PP of clinical remission was 96.2% (95% CI: 91-98.4; I230.6) while the PP of procedure failure was 3.6% (95% CI: 1.6-8.1; I20). No severe adverse events (AEs) were noted while using the SB Knife. However, the PP of intraprocedural and postprocedural AEs was 13.2% (95% CI: 9.6-17.8; I20) and 9.3% (95% CI: 5.7-14.9; I2 < 20.9), respectively. SB Knife is highly safe and effective for Zenker's Diverticulectomy with a failure rate of only 3.6%.