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1.
Am J Gastroenterol ; 119(8): 1600-1606, 2024 Aug 01.
Artículo en Inglés | MEDLINE | ID: mdl-38421004

RESUMEN

INTRODUCTION: Colorectal cancer (CRC) screening is now recommended at the age of 45 years in the United States. However, information regarding the adenomas detection rate (ADR) and sessile serrated lesions (SSLs) in 45- to 49-year-old individuals is limited. In addition, the impact of lowering the screening age to 45 years on the ADR and the detection rate of SSLs is not well elucidated. This systematic review and meta-analysis aims to report the overall ADR and SSL detection rate in 45- to 49-year-old individuals undergoing colonoscopy. METHODS: We searched MEDLINE, EMBASE, SCOPUS, Web of Science, ClinicalTrials.gov , and the Cochrane database from inception through October 2022 to identify studies reporting on ADR and SSL detection rates in 45- to 49-year-old individuals undergoing colonoscopies for all indications. This approach acknowledges the possibility of including individuals undergoing diagnostic colonoscopies or those with increased risk factors for CRC. We also conducted a separate analysis examining ADR in average-risk individuals undergoing screening colonoscopy. The pooled rates with their corresponding 95% confidence intervals (CIs) were generated using the fixed-effects model. I2 was used to adjudicate heterogeneity. RESULTS: Sixteen studies met the inclusion criteria. All studies were retrospective except one; 3 had data from national/local registries. There were 41,709 adenomas detected across 150,436 colonoscopies. The pooled overall ADR was 23.1% (95% CI 19.7%-27.0%, I2 = 98.6%). The pooled ADR in individuals with average risk of CRC from 7 studies was 28.2% (95% CI 24.6%-32.0%, I2 = 96.5%). The pooled overall SSL detection rate from 6 studies was 6.3% (95% CI 3.8%-10.5%, I2 = 97%). The included studies were heterogeneous because of differences in the inclusion and exclusion criteria and patient population. DISCUSSION: In 45- to 49-year-old individuals undergoing a colonoscopy for any indication, the ADR and SSL detection rates were 23.1% and 6.3%, respectively. We conclude that these outcomes in 45- to 49-year-olds are comparable with individuals aged 50-54 years.


Asunto(s)
Adenoma , Pólipos del Colon , Colonoscopía , Neoplasias Colorrectales , Detección Precoz del Cáncer , Humanos , Colonoscopía/estadística & datos numéricos , Adenoma/diagnóstico , Adenoma/patología , Adenoma/epidemiología , Persona de Mediana Edad , Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/patología , Neoplasias Colorrectales/epidemiología , Detección Precoz del Cáncer/métodos , Pólipos del Colon/patología , Pólipos del Colon/diagnóstico , Pólipos del Colon/epidemiología
2.
Inflamm Res ; 73(2): 183-198, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38153524

RESUMEN

BACKGROUND AND OBJECTIVE: One sphingosine-1-phosphate (S1P) receptor modulator is approved (ozanimod) and another (etrasimod) is under investigation for the induction and maintenance of remission of ulcerative colitis (UC). We aim to evaluate the efficacy and safety of S1P modulators in patients with active UC. METHODS: We conducted a systematic review and meta-analysis synthesizing randomized controlled trials (RCTs), which were retrieved by systematically searching: PubMed, Web of Science, SCOPUS, and Cochrane through May 13th, 2023. We used the fixed-effect model to pool dichotomous data using risk ratio (RR) with a 95% confidence interval (CI). RESULTS: Five RCTs with a total of 1990 patients were included. S1P receptor modulators were significantly associated with increased clinical response during both the induction (RR 1.71 with 95% CI [1.50, 1.94], P = 0.00001) and maintenance phases (RR 1.89 with 95% CI [1.33, 2.69], P = 0.0004); clinical remission rates during both induction (RR 2.76 with 95% CI [1.88, 4.05], P = 0.00001) and maintenance phases (RR 3.34 with 95% CI [1.41, 7.94], P = 0.006); endoscopic improvement during both induction (RR 2.15 with 95% CI [1.71, 2.70], P = 0.00001) and maintenance phases (RR 2.41 with 95% CI [1.15, 5.05], P = 0.02); and histologic remission during both induction (RR 2.60 with 95% CI [1.89, 3.57] [1.17, 2.10], P = 0.00001) and maintenance phases (RR 2.52 with 95% CI [1.89, 3.37], P = 0.00001). Finally, there was no difference regarding safety outcomes as compared to placebo in both the induction and maintenance phases. CONCLUSION: S1P receptor modulators are effective in inducing and maintaining remission in patients with moderate to severe UC.


Asunto(s)
Colitis Ulcerosa , Lisofosfolípidos , Moduladores de los Receptores de fosfatos y esfingosina 1 , Esfingosina/análogos & derivados , Humanos , Colitis Ulcerosa/tratamiento farmacológico , Moduladores de los Receptores de fosfatos y esfingosina 1/uso terapéutico , Receptores de Esfingosina-1-Fosfato/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto
3.
J Clin Gastroenterol ; 58(4): 402-406, 2024 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-37267458

RESUMEN

BACKGROUND: Topical hemostatic powder is a mineral powder that forms an adherent barrier and coagulates active bleeding in the gastrointestinal (GI) tract. Hemospray is the first hemostatic powder approved by the Food and Drug Administration (FDA) in the United States. Hemospray has been increasingly used to manage GI bleeding. However, data on the adverse events of hemostatic powders are lacking. Therefore, we aim to report and analyze adverse events associated with Hemospray using the FDA's "Manufacturer and User Facility Device Experience" database. METHODS: We analyzed the postmarketing surveillance data from the FDA's Manufacturer and User Facility Device Experience database for Hemospray, initially known as TC-325, from June 2018 through April 2022. Results of the search were classified into device-related technical issues, patient-related adverse events and health care staff-related adverse events. RESULTS: Five hundred two medical device reporting claims were identified from June 2018 through April 2022. Seven duplicate claims were identified, and some claims included more than one event type. Therefore, there were 558 device-related problems, 28 patient-related adverse events, and 2 adverse events in health care staff members. The most common device-related problems were activation failure or failure to fire (n = 385, 70.0%) and obstruction of carbon dioxide flow (n = 121, 21.7). The most common patient-related adverse events included tissue injury or bleeding (n = 21) and perforation (n = 5). CONCLUSION: Although Hemospray is a valuable tool in the armamentarium for endoscopists in managing GI bleeding, endoscopists must be mindful of deice-related problems and potential patient-related adverse events.


Asunto(s)
Hemostáticos , Minerales , Humanos , Estados Unidos , United States Food and Drug Administration , Polvos , Hemostáticos/efectos adversos , Bases de Datos Factuales
4.
J Clin Gastroenterol ; 58(6): 554-563, 2024 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-38687161

RESUMEN

Limited objective data exist on the comparison of post-endoscopic retrograde cholangiopancreatography (ERCP) complications in patients with cirrhosis based on the severity of the disease. We evaluated the effectiveness of the Child-Turcotte-Pugh (CTP) score system in anticipating the risk of post-ERCP complications in patients with cirrhosis. The PubMed, Scopus, Embase, and Cochrane databases were searched from inception through September 2022 to identify studies comparing post-ERCP complications in patients with cirrhosis based on CTP score. Odds ratios (ORs) and their associated 95% CIs were pooled using a random-effect model to calculate effect size. The reference group for analysis was the CTP class C patient group. Seven studies comprising 821 patients who underwent 1068 ERCP procedures were included. The CTP class C patient population exhibited a higher risk of overall post-ERCP adverse events compared with those with class A or B (OR: 2.87, 95% CI: 1.77-4.65, P = 0.00 and OR: 2.02, 95% CI: 1.17-3.51, P = 0.01, respectively). Moreover, CTP class B patients had a significantly higher complication rate than CTP class A patients (OR: 1.62, 95% CI: 1.04-2.53, P = 0.03). However, no statistically significant differences were found in the occurrence of specific types of complications, including bleeding, pancreatitis, cholangitis, perforation, or mortality across the three CTP groups. We demonstrated that the CTP classification system is a reliable predictor of ERCP complications in patients with cirrhosis. Consequently, caution should be exercised when performing ERCP in patients classified as CTP class C.


Asunto(s)
Colangiopancreatografia Retrógrada Endoscópica , Cirrosis Hepática , Índice de Severidad de la Enfermedad , Humanos , Cirrosis Hepática/complicaciones , Colangiopancreatografia Retrógrada Endoscópica/efectos adversos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiología , Medición de Riesgo/métodos
5.
J Clin Gastroenterol ; 2024 Jul 16.
Artículo en Inglés | MEDLINE | ID: mdl-39008570

RESUMEN

GOALS: This systematic review aims to evaluate the risk factors, clinical features, and outcomes of bowel perforation caused by stent migration after endoscopic retrograde cholangiopancreatography (ERCP). BACKGROUND: Distal migration of biliary stents can occur after ERCP. Upon migration, most stents pass through the intestine without adverse events; however, bowel perforation has been reported. STUDY: A comprehensive literature search of PubMed, EMBASE, and Cochrane databases was conducted through October 2023 for articles that reported bowel perforation because of stent migration. Cases of incomplete stent migration and proximal stent migration were excluded. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines to identify full-length articles in English reporting. RESULTS: Of 2041 articles retrieved on the initial search, 92 met the inclusion criteria. A total of 132 cases of bowel perforation occurred due to stent migration after ERCP (56.1% female; average age: 66 y). The median time from initial ERCP to perforation was 44.5 days (IQR 12.5-125.5). Most cases of perforation occurred in the small bowel (64.4%) compared with the colon (34.8%). Stents were mostly plastic (87.1%) with a median diameter of 10 Fr (IQR 8.5-10) and median length of 10.3 cm (IQR 715). Surgical management was pursued in 52.3% and endoscopic management in 42.4%. Bowel resection was required for 25.8% of patients. The overall mortality rate was 17.4%. CONCLUSION: In summary, this study demonstrates that bowel perforation after ERCP stent migration primarily occurs within 44.5 days and most frequently with a 10 Fr plastic biliary stent. The overall mortality rate was 17.4%. It is important for endoscopists to be mindful of this rare but serious adverse event.

6.
J Clin Gastroenterol ; 2024 Sep 04.
Artículo en Inglés | MEDLINE | ID: mdl-39312519

RESUMEN

OBJECTIVE: Gastric antral vascular ectasia (GAVE) is characterized by vascular ectasias accounting for 4% of nonvariceal upper gastrointestinal bleeds, which can range from occult bleeds to severe acute upper gastrointestinal bleeding. In turn, GAVE can lead to severe morbidity and recurrent hospitalization. Current endoscopic treatments for GAVE include argon plasma coagulation (APC), endoscopic band ligation (EBL), and radiofrequency ablation. With this significant burden in mind, a systematic review and network meta-analysis were conducted to compare the efficacy and safety of various modalities in the treatment of GAVE. METHODS: All studies that involved adults and children with endoscopic characteristics of GAVE undergoing treatment with APC, EBL, radiofrequency ablation, or a combination of 2 treatment modalities were included. RESULTS: There was no statistical difference in the rate of adverse events and the number of red blood cell transfusions across all 3 groups (APC, EBL, and APC + EBL). However, statistical differences were noted for outcomes of bleeding recurrence, length of hospitalization, and change in hemoglobin status. EBL exhibited a significant decrease in bleeding recurrence when compared with APC. Moreover, shorter hospitalization stays were seen in APC + EBL and EBL groups compared with APC, and a beneficial change in hemoglobin status was also more often seen in APC + EBL and EBL groups compared with APC. CONCLUSIONS: Based on this study, EBL was found to have superior efficacy when compared with APC for the treatment of GAVE; however, there was no significant difference in rates of adverse events between APC, EBL, and combination therapy.

7.
Am J Ther ; 2024 Aug 30.
Artículo en Inglés | MEDLINE | ID: mdl-39212744

RESUMEN

BACKGROUND: Targeting interleukin-23 (IL-23) represents a significant therapeutic avenue for treating ulcerative colitis (UC). STUDY QUESTION: What are the effectiveness and safety of selective inhibitors targeting IL-23p19 and IL-12/23p40 in individuals with moderate-to-severe UC? DATA SOURCES: MEDLINE, Embase, Scopus, and Cochrane databases. STUDY DESIGN: A systematic search of MEDLINE, Embase, Scopus, and Cochrane databases till January 15, 2024, to identify randomized controlled trials comparing IL-23p19 and IL-12/23p40 inhibitors against placebo or active comparators in UC patients. The primary outcome was clinical remission, with secondary outcomes including clinical response, endoscopic remission, and safety profiles during induction and maintenance phases. Using a fixed-effect model, we pooled dichotomous data with risk ratio (RR) and 95% confidence interval (CI) for analysis. RESULTS: In 5 trials involving 1120 patients with moderate to severe UC, targeting IL-23 showed significant superiority in inducing clinical remission [RR: 2.08, 95% CI, (1.66-2.61)], endoscopic remission [RR: 1.73, 95% CI, (1.39-2.16)], and histologic remission [RR: 1.88, 95% CI, (1.34-2.64)]. Additionally, individuals treated with IL-12/23p40 or IL-23p19 antagonists maintained clinical remission [RR: 1.85, 95% CI, (1.53-2.23)], endoscopic remission [RR: 2.03, 95% CI, (1.60-2.57)], and histologic remission [RR: 1.66, 95% CI, (1.11-2.48)]. Targeting IL-23 was linked with a reduced risk of any adverse events (AE) during both induction [RR: 0.94, 95% CI, (0.86-1.02)] and maintenance phases [RR: 0.93, 95% CI, (0.86-0.99)], any serious AE during the induction phase [RR: 0.53, 95% CI, (0.36-0.78)], and withdrawal due to AEs compared to patients receiving placebo during induction [RR: 0.24, 95% CI (0.14, 0.43)]. CONCLUSION: Targeting IL-23 demonstrates efficacy and safety for inducing and maintaining clinical and endoscopic remission in moderate-to-severe UC patients.

8.
Colorectal Dis ; 2024 Sep 13.
Artículo en Inglés | MEDLINE | ID: mdl-39272218

RESUMEN

AIMS: Anal cancer, despite its rarity, is a matter of serious concern in the United States, with an uptrend in recent years and marked racial disparities in mortality rates. The aim of this work was to investigate anal cancer mortality trends and sex race disparities in the United States from 1999 to 2020. METHOD: This is a retrospective study using data from the CDC WONDER database (1999-2020). We investigated deaths attributed to anal cancer, identified by the ICD-10 code C21.1, and excluded individuals aged 14 years and under. The Mann-Kendall trend test was used to investigate temporal trends and a t-test was used to compare continuous variables. RESULTS: Both male and female age-adjusted mortality attributed to anal cancer increased significantly during the study period across all subgroups, including race (Black and White), US Census region (Northeast, Midwest, South and West) and age (15-64 and ≥65 years) (p < 0.001 for all comparisons). For each subgroup, women demonstrated significantly higher rates of mortality than men, except in the Black population, where Black men had higher rates than Black women (0.40 vs. 0.29, p < 0.001). Additionally, Black men had significantly higher mean mortality rates than White men (0.40 vs. 0.27, p < 0.001). The highest rates of anal cancer mortality were among geriatric individuals, especially women aged ≥65 years, at 1.18 per 100 000. CONCLUSION: The rise in anal cancer mortality and racial and sex disparities present a significant challenge for healthcare providers and policy makers. Further studies are required to devise evidence-based strategies to effectively tackle this challenge.

9.
Surg Endosc ; 38(10): 5528-5540, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-39271515

RESUMEN

BACKGROUND: Transoral incisionless fundoplication (TIF) is safe and effective in select patients with hiatal hernias ≤ 2 cm with refractory gastroesophageal reflux disease (GERD). For patients with hiatal hernias > 2 cm, concomitant hiatal hernia (HH) repair with TIF (cTIF) is offered as an alternative to conventional anti-reflux surgery (ARS). Yet, data on this approach is limited. Through a comprehensive systematic review, we aim to evaluate the efficacy and safety of cTIF for managing refractory GERD in patients with hernias > 2 cm. STUDY DESIGN: We conducted a systematic review of studies evaluating cTIF outcomes from PubMed, EMBASE, SCOPUS, and Cochrane databases up to February 14, 2024. Primary outcomes included complete cessation of proton pump inhibitors (PPIs). Secondary outcomes included objective GERD assessment, adverse events, and treatment-related side effects. Pooled analysis was employed wherever feasible. RESULTS: Seven observational studies (306 patients) met the inclusion criteria. Five were retrospective cohort studies and two were prospective observational studies. The median rate of discontinuation of PPIs was 73.8% (range 56.4-94.4%). Significant improvements were observed in disease-specific, validated GERD questionnaires. The median rate for complications was 4.4% (range 0-7.9%), and the 30-day readmission rate had a median of 3.3% (range 0-5.3%). The incidence of dysphagia was 11 out of 164 patients, with a median of 5.3% (range 0-8.3%), while the incidence of gas bloating was 15 out of 127 patients, with a median of 6.9% (range 0-13.8%). CONCLUSION: Current data on cTIF suggests a promising alternative to ARS with comparable short-term efficacy and safety profile for managing refractory GERD with a low side effect profile. However, longer-term data and comparative efficacy studies are needed.


Asunto(s)
Fundoplicación , Reflujo Gastroesofágico , Hernia Hiatal , Herniorrafia , Humanos , Fundoplicación/métodos , Reflujo Gastroesofágico/complicaciones , Reflujo Gastroesofágico/cirugía , Hernia Hiatal/cirugía , Hernia Hiatal/complicaciones , Herniorrafia/métodos , Cirugía Endoscópica por Orificios Naturales/métodos , Resultado del Tratamiento
10.
Dig Dis Sci ; 2024 Jun 26.
Artículo en Inglés | MEDLINE | ID: mdl-38926222

RESUMEN

BACKGROUND AND AIM: Luminal strictures, common in inflammatory bowel disease (IBD), especially Crohn's disease (CD), are typically treated with endoscopic balloon dilatation (EBD). The newer endoscopic stricturotomy (ESt) approach shows promise, but data is limited. This systematic review and meta-analysis assess the effectiveness and safety of ESt in IBD-related strictures. METHODS: A comprehensive literature search was conducted until November 2023 for studies assessing ESt efficacy and safety in IBD. Primary outcomes were clinical and technical success, with secondary endpoints covering adverse events, subsequent stricture surgery, additional endoscopic treatments (ESt or EBD), medication escalation, disease-related emergency department visits, and hospitalization post-ESt. Technical success was defined as passing the scope through the stricture, and clinical success was defined as symptom improvement. Single-arm meta-analysis (CMA version 3) calculated the event rate per patient with a 95% confidence interval (CI). Heterogeneity was evaluated using I2. RESULTS: Nine studies were included, involving 640 ESt procedures on 287 IBD patients (169 CD, 118 ulcerative colitis). Of these, 53.3% were men, with a mean age of 43.3 ± 14.3 years and a mean stricture length of 1.68 ± 0.84 cm. The technical success rate was 96.4% (95% CI 92.5-98.3, p-value < 0.0001), and the clinical success rate was 62% (95% CI 52.2-70.9, p-value = 0.017, I2 = 34.670). The bleeding rate was 10.5% per patient, and the perforation rate was 3.5%. After an average follow-up of 0.95 ± 1.1 years, 16.4% required surgery for strictures post-ESt, while 44.2% needed additional endoscopic treatment. The medication escalation rate after ESt was 14.7%. The disease-related emergency department visit rate was 14.7%, and the disease-related hospitalization rate post-procedure was 21.3%. CONCLUSION: Our analysis shows that ESt is safe and effective for managing IBD-related strictures, making it a valuable addition to the armamentarium of endoscopists. Formal training efforts should focus on ensuring its widespread adoption.

11.
Surg Endosc ; 38(8): 4186-4197, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38987483

RESUMEN

BACKGROUND AND AIMS: Biliary drainage is vital in managing malignant biliary obstruction (MBO). Suprapapillary stenting has emerged as a viable alternative to transpapillary stenting and is performed using inside plastic (iPS) or metal stents (iMS). This meta-analysis aims to evaluate the outcomes of suprapapillary stent placement for MBO. METHODS: The Embase, PubMed, and Web of Science databases were systematically searched to include all studies published before September 31, 2023, that reported on the outcomes of suprapapillary stents placed for MBO. Using the random-effect model, the pooled, weight-adjusted event rate estimate for the clinical outcomes was calculated with 95% confidence intervals (CIs). RESULTS: Twenty-eight studies were included, with a total of 1401 patients. The pooled clinical success rate was 98.9%. A subgroup analysis yielded non-significant differences between the iPS and iMS groups (99.3% vs. 98.6%, respectively; P = 0.44). The pooled incidence rate of adverse events (AE) with suprapapillary stents was 9.5%. In a subgroup analysis, the incidence of AEs with iPS was 10.7% compared to 9% in the iMS group without a statistical difference (P = 0.32). The most common adverse event was cholangitis (2.2%), followed by pancreatitis (1.1%), cholecystitis (0.5%), and bleeding (0.12%). CONCLUSION: When technically feasible, suprapapillary stenting for MBO is a viable endoscopic option with a high clinical success rate and acceptable adverse event rates. Both iPS and iMS exhibit similar efficacy.


Asunto(s)
Colestasis , Plásticos , Stents , Humanos , Colestasis/cirugía , Colestasis/etiología , Stents/efectos adversos , Metales , Neoplasias de los Conductos Biliares/complicaciones , Neoplasias de los Conductos Biliares/cirugía , Drenaje/métodos , Drenaje/instrumentación , Resultado del Tratamiento
12.
Dig Dis Sci ; 69(4): 1380-1388, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38436866

RESUMEN

BACKGROUND AND AIMS: Screening colonoscopy has significantly contributed to the reduction of the incidence of colorectal cancer (CRC) and its associated mortality, with adenoma detection rate (ADR) as the quality marker. To increase the ADR, various solutions have been proposed including the utilization of Artificial Intelligence (AI) and employing second observers during colonoscopies. In the interest of AI improving ADR independently, without a second observer, and the operational similarity between AI and second observer, this network meta-analysis aims at evaluating the effectiveness of AI, second observer, and a single observer in improving ADR. METHODS: We searched the Medline, Embase, Cochrane, Web of Science Core Collection, Korean Citation Index, SciELO, Global Index Medicus, and Cochrane. A direct head-to-head comparator analysis and network meta-analysis were performed using the random-effects model. The odds ratio (OR) was calculated with a 95% confidence interval (CI) and p-value < 0.05 was considered statistically significant. RESULTS: We analyzed 26 studies, involving 22,560 subjects. In the direct comparative analysis, AI demonstrated higher ADR (OR: 0.668, 95% CI 0.595-0.749, p < 0.001) than single observer. Dual observer demonstrated a higher ADR (OR: 0.771, 95% CI 0.688-0.865, p < 0.001) than single operator. In network meta-analysis, results were consistent on the network meta-analysis, maintaining consistency. No statistical difference was noted when comparing AI to second observer. (RR 1.1 (0.9-1.2, p = 0.3). Results were consistent when evaluating only RCTs. Net ranking provided higher score to AI followed by second observer followed by single observer. CONCLUSION: Artificial Intelligence and second-observer colonoscopy showed superior success in Adenoma Detection Rate when compared to single-observer colonoscopy. Although not statistically significant, net ranking model favors the superiority of AI to the second observer.


Asunto(s)
Adenoma , Neoplasias Colorrectales , Humanos , Inteligencia Artificial , Colonoscopía/métodos , Adenoma/diagnóstico , Metaanálisis en Red , Oportunidad Relativa , Neoplasias Colorrectales/diagnóstico
13.
Dig Dis Sci ; 69(8): 2765-2774, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38811504

RESUMEN

INTRODUCTION: Esophageal Stents are used to maintain esophageal lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignancies and the occlusion of concomitant esophageal fistulas. While data on the efficacy and safety of esophageal stents exist, comprehensive evaluation of adverse events is limited. The aim of this study is to investigate the reported adverse events and device failures associated with esophageal self-expandable metal stents (SEMS) using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: Post-marketing surveillance data for the esophageal SEMSs were analyzed using the FDA's MAUDE database from January 2014 to December 10, 2023. The outcomes of interest were patient-related adverse events and device failures. Statistical analysis was performed using Microsoft Excel 2010 and SPSS. Pooled numbers and percentages were calculated for each adverse event. Continuous variables underwent analysis using a two-tailed student t test, and significance was set to p ≤ 0.05. RESULTS: During the study period, 548 MAUDE reports revealed 873 device failures and 186 patient-related adverse events. The most common device issues were stent activation, positioning, or separation problems (4 n = 403; 46.2%), followed by device detachment or migration (n = 109, 12.5%), and material problems (n = 93, 10.7%). Patient complications included dysphagia/odynophagia (10%), perforation, pain, and bleeding (each 7.6%). The most common device failures in over-the-wire (OTW) stents and through-the-scope (TTS) stents were activation, positioning, or separation problems (TTS: n = 183, 52.6% vs OTW: n = 220, 41.9%). Compared to OTW stents, TTS stents had higher migration and breakage (13.5% vs. 11.8%, p = 0.24), and (9.2% vs. 6.7%, p = 0.08) respectively, while OTW stents had more challenges with stent advancement or removal (5.1% vs. 0.3%, p < 0.001 and 4.6% vs 3.4%, p = 0.19, respectively) and material problems (14.7% vs. 4.6%, p < 0.001). Activation, positioning, and separation problems were the most frequent device failures in fully covered (FC) and partially covered (PC) stents (FC: n = 62, 32.8%, PC: n = 168, 43.5%). FC stents had higher migration rates (20.6% vs 9.8%, p < 0.001), while PC stents exhibited more material problems (17.4% vs. 5.8%, p < 0.001) and difficulties with advancing the stents (6.7% vs. 0%, p < 0.001). CONCLUSION: Our examination showed a prevalence of reported device complications associated with stent activation, positioning, and separation problems. Dysphagia or odynophagia emerged as the most frequently reported patient complication. Furthermore, our analysis, provides insights into TTS vs. OTW and FC vs. PC esophageal SEMSs, enabling endoscopists and manufacturers to better understand adverse events and potentially optimize device design for future iterations.


Asunto(s)
Bases de Datos Factuales , Vigilancia de Productos Comercializados , Falla de Prótesis , Stents Metálicos Autoexpandibles , United States Food and Drug Administration , Humanos , Stents Metálicos Autoexpandibles/efectos adversos , Estados Unidos/epidemiología , Estenosis Esofágica/etiología , Estenosis Esofágica/terapia
14.
Dig Dis Sci ; 69(6): 2018-2025, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38580887

RESUMEN

INTRODUCTION: Pancreatic duct stents (PDS) are widely used for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, there is a paucity of data regarding the adverse events associated with PDS placement. This study aims to investigate the reported adverse events and device failures related to PDS, utilizing the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the U.S. Food and Drug Administration (FDA). METHODS: Post-marketing surveillance data from January 2013 to December 8, 2023, were extracted from the FDA's MAUDE database to analyze the reports pertaining to the use of commonly used PDS. The primary outcomes of interest were device issues and patient-related adverse events. Statistical analysis was performed using Microsoft Excel 2010, with the calculation of pooled numbers and percentages for each device and patient adverse event. RESULTS: A total of 579 device issues and 194 patient-related adverse events were identified. Device issues were primarily attributed to stent deformation (n = 72; 12.4%), followed by migration of the device into the pancreatic duct or expulsion out of the duct (n = 60; 10.4%), and stent fracture/breakage (n = 55; 9.4%). Among the patient-reported adverse events, inflammation was the most common (n = 26; 13.4%), followed by reports of stents becoming embedded in tissue (n = 21; 10.8%) and stent occlusion/obstruction (n = 16; 8.2%). The most prevalent device failures associated with Advanix stents were material deformation, with perforation (n = 3, 30%) being the most frequently reported adverse event. Concerning Geenen stents, migration or expulsion of the device (n = 34, 16.9%) constituted the most common device-related adverse events, while inflammation (n = 20, 16.7%) was the most frequently reported patient-related issue. For Zimmon stents, migration or expulsion of the device (n = 22, 8.8%) were the most frequently reported device-related problems, whereas perforation (n = 7, 10.9%) and bleeding (n = 7, 10.9%) were the most frequent patient-related adverse events. CONCLUSION: Our findings highlight important device and patient adverse events that endoscopists and referring providers should be aware of before considering pancreatic stent placement.


Asunto(s)
Bases de Datos Factuales , Conductos Pancreáticos , Vigilancia de Productos Comercializados , Falla de Prótesis , Stents , United States Food and Drug Administration , Humanos , Estados Unidos/epidemiología , Stents/efectos adversos , Conductos Pancreáticos/cirugía , Colangiopancreatografia Retrógrada Endoscópica/efectos adversos , Colangiopancreatografia Retrógrada Endoscópica/instrumentación , Pancreatitis/etiología , Pancreatitis/epidemiología , Pancreatitis/prevención & control , Falla de Equipo/estadística & datos numéricos , Migración de Cuerpo Extraño/etiología , Migración de Cuerpo Extraño/epidemiología , Migración de Cuerpo Extraño/prevención & control
15.
J Clin Gastroenterol ; 57(8): 760-773, 2023 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-36787428

RESUMEN

BACKGROUND AND OBJECTIVE: Endoscopic polypectomy is an excellent tool for colon cancer prevention. With the innovation of novel resection techniques, the best method is still being investigated. Hence, we aim to evaluate the efficacy and safety of cold snare polypectomy (CSP) versus hot snare polypectomy (HSP) for colorectal polyp resection. METHODS: A systematic review and meta-analysis synthesizing evidence from randomized controlled trials retrieved from PubMed, EMBASE, WOS, SCOPUS, and CENTRAL until July 16, 2022. We pooled dichotomous outcomes using risk ratio (RR) with the corresponding CI. This review's protocol was prospectively registered in PROSPERO with ID: CRD42022347496. RESULTS: We included 18 randomized controlled trials with a total of 4317 patients and 7509 polyps. Pooled RR favored HSP regarding the complete resection rate (RR: 0.96 with 95% CI: 0.95, 1, P = 0.03) and local recurrence incidence (RR: 5.74 with 95% CI: 1.27, 25.8, P = 0.02). Pooled RR favored CSP regarding the colonoscopy time (mean difference: -6.50 with 95% CI: -7.55, -5.44, P = 0.00001) and polypectomy time (mean difference: -57.36 with 95% CI: -81.74, -32.98, P = 0.00001). There was no difference regarding the incidence of immediate bleeding ( P = 0.06) and perforation ( P = 0.39); however, HSP was associated with more incidence of delayed bleeding ( P = 0.01), abdominal pain ( P = 0.007), and postresection syndrome ( P = 0.02). DISCUSSION: HSP is associated with a higher complete resection and lower recurrence rates; however, HSP is also associated with a higher incidence of adverse events. Therefore, improving the complete resection rate with CSP still warrants more innovation, giving the technique safety and shorter procedure duration.


Asunto(s)
Neoplasias del Colon , Pólipos del Colon , Neoplasias Colorrectales , Humanos , Colonoscopía/métodos , Pólipos del Colon/cirugía , Pólipos del Colon/etiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Neoplasias Colorrectales/etiología
16.
J Clin Gastroenterol ; 2023 Aug 07.
Artículo en Inglés | MEDLINE | ID: mdl-37548451

RESUMEN

INTRODUCTION: There is an increasing interest in cold snare endoscopic mucosal resection (CS-EMR), and studies have shown its safety and efficacy for colonic polyps. This meta-analysis aims to assess the safety and efficacy of CS-EMR for the removal of duodenal adenomas. METHODS: We conducted a comprehensive literature search of several databases, from inception through February 2023, for studies that addressed outcomes of CS-EMR for nonampullary duodenal adenomas. We used the random-effects model for the statistical analysis. The weighted pooled rates were used to summarize the technical success, polyp recurrence, bleeding, and perforation events. Cochran Q test and I2 statistics adjudicated heterogeneity. RESULTS: Six studies were included in the analysis. In all, 178 duodenal polyps were resected using CS-EMR. The pooled rates were 95.8% (95% CI 89.1-98.5%, I2=21.5%) for technical success and 21.2% (95% CI 8.5-43.6%, I2=78%) for polyp recurrence. With regards to CS-EMR safety, the pooled rates were 4.2% (95% CI 1.6-10.5%, I2=12%) for immediate bleeding, 3.4% (95% CI 1.5-7.6%, I2=0%) for delayed bleeding, 2.8% (95% CI 1.1-6.7%, I2=0%) for perforation, and 2% (95% CL 0.5-7.5%, I2=0%) for post-polypectomy syndrome. Rates were not significantly different for large adenomas. Three studies reported data on CS-EMR and conventional EMR. Compared with conventional EMR, CS-EMR had lower odds of delayed bleeding, OR 0.11 (CI 0.02-0.62, P value 0.012, I2=0%). CONCLUSION: Our findings suggest that CS-EMR is a safe and effective strategy for the resection of nonampullary duodenal adenomas, with an acceptable recurrence rate. Data from larger randomized controlled studies are needed to validate our findings.

17.
Dig Dis Sci ; 68(6): 2493-2500, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-37119378

RESUMEN

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is a highly effective endo bariatric procedure. Data on outcomes of ESG in patients with diabetes mellitus (DM) compared to non-diabetics are limited. AIMS: We aim to assess differences in clinical outcomes of ESG in DM patients in North America. METHODS: We used the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program database from 2016 to 2021 to identify all DM patients who underwent ESG as the primary procedure for weight loss. A 1:1 propensity score matched cohort of non-DM patients served as controls. Patient characteristics, clinical outcomes, and complications were compared and analyzed. Adult patients with Class I obesity and above were included. RESULTS: After matching, 310 DM and non-DM patients that underwent ESG were compared. The median % BMI decrease (3.3% vs. 3.1%, P = 0.62) and median total body weight loss (%TBWL) (4.3% vs. 4%, P = 0.75) in 30 days were similar in the DM compared to non-DM cohorts. A similar proportion of patients with major adverse events (AEs) were present after ESG in the DM (1.6% vs. 1.3%, P = 0.74) compared to the non-DM cohort. The DM cohort had more patients with 30-day readmissions (3.2% vs. 1.9%, P = 0.08) than the non-DM cohort. %TBWL was similar in patients with HbA1c < 9% compared to ≥ 9%, (4.3% each, P = 0.33) with comparable AEs. CONCLUSION: ESG is a safe procedure in DM patients, without an increase in AEs, and it shows similar short-term weight loss compared to non-DM patients.


Asunto(s)
Diabetes Mellitus , Gastroplastia , Obesidad Mórbida , Adulto , Humanos , Gastroplastia/efectos adversos , Gastroplastia/métodos , Resultado del Tratamiento , Endoscopía/métodos , Diabetes Mellitus/cirugía , Pérdida de Peso , Obesidad Mórbida/cirugía
18.
Dig Dis Sci ; 68(10): 3921-3934, 2023 10.
Artículo en Inglés | MEDLINE | ID: mdl-37634184

RESUMEN

INTRODUCTION: Peptic ulcers with adherent clots are associated with a high-risk of rebleeding and mortality. However, the optimal management of bleeding ulcers with adherent clots remains unclear. We conducted this systematic review and meta-analysis to compare endoscopic therapy and conservative therapy to manage bleeding ulcers with adherent clots. METHODS: We systematically searched PubMed, Embase, and Web of Science databases through October 2022 to include all studies comparing the endoscopic and conservative therapeutic approaches for bleeding ulcers with adherent clots. Our primary outcome was rebleeding (overall and 30-day). The secondary outcomes were mortality (overall and 30-day), need for surgery, and length of hospital stay (LOS). The random-effects model was used to calculate the pooled odds ratios (OR) and mean differences (MD) with the corresponding confidence intervals (CI) for proportional and continuous variables, respectively. RESULTS: Eleven studies (9 RCTs) with 833 patients (431 received endoscopic therapy vs. 402 received conservative therapy) were included. Overall, endoscopic therapy was associated with lower overall rebleeding (OR 0.41, 95% CI 0.22-0.79, P = 0.007), 30-day rebleeding (OR 0.43, 95% CI 0.21-0.89, P = 0.002), overall mortality (OR 0.47, 95% CI 0.23-0.95, P = 0.04), 30-day mortality (OR 0.43, 95% CI 0.21-0.89, P = 0.002), need for surgery (OR 0.44, 95% CI 0.21-0.95, P = 0.04), and LOS (MD - 3.17 days, 95% CI - 4.14, - 2.19, P < 0.00001). However, subgroup analysis of randomized controlled trials (RCTs) showed no significant difference in overall mortality (OR 0.78, 95% CI 0.24-2.52, P = 0.68) between the two strategies, with numerically lower but statistically non-significant rates of overall rebleeding (7.2% vs. 18.5%, respectively; OR 0.42, 95% CI 0.17-1.05, P = 0.06), statistically lower rate of need for surgery (OR 0.28, 95% CI 0.08-0.96, P = 0.04) with endoscopic therapy compared to conservative therapy. CONCLUSIONS: Our meta-analysis demonstrates that endoscopic therapy was overall associated with lower rates of rebleeding (overall and 30-day), mortality (overall and 30-day), need for surgery, and LOS, compared to conservative therapy for the management of bleeding ulcers with adherent clots. However, subgroup analysis of RCTs showed that endoscopic therapy was associated with numerically lower but statistically non-significant rates of overall rebleeding and a statistically lower rate of need for surgery compared to conservative therapy with similar overall mortality rates. Combined treatment with thermal therapy and injection therapy was the most effective treatment modality in reducing rebleeding risk. Further large-scale RCTs are needed to validate our findings.


Asunto(s)
Hemostasis Endoscópica , Úlcera Péptica , Trombosis , Humanos , Úlcera Péptica Hemorrágica/tratamiento farmacológico , Úlcera , Tratamiento Conservador , Inhibidores de la Bomba de Protones/uso terapéutico , Recurrencia Local de Neoplasia/terapia , Úlcera Péptica/complicaciones , Trombosis/tratamiento farmacológico , Recurrencia
19.
Mo Med ; 120(6): 451-458, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-38144924

RESUMEN

In this study, we found no significant acid-base changes after six weeks of ketogenic diet in patients with obesity with Chronic kidney disease) 2 or 3. A ketogenic diet was well tolerated overall with no gross changes to serum creatinine, anion gap, serum, or venous bicarbonate, or albumin. We were limited by a small sample size, and we did not confirm whether patients achieved a biochemical ketogenic state.


Asunto(s)
Acidosis , Dieta Cetogénica , Insuficiencia Renal Crónica , Humanos , Dieta Cetogénica/efectos adversos , Acidosis/tratamiento farmacológico , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/metabolismo , Equilibrio Ácido-Base , Obesidad/complicaciones , Obesidad/metabolismo
20.
Mo Med ; 119(6): 545-552, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36588649

RESUMEN

Chronic obstructive pulmonary disease (COPD) is not merely a lung disease as the name indicates. Patients with COPD experience associated complications with systemic inflammation, heart strain, muscle wasting, poor functional performance, and psychological issues. An assessment of these patients based only on lung function tests or functional capacity would be inadequate. Many studies have reported the significance and prognostic value of several laboratory tests. Troponin, C-reactive protein (CRP), hemoglobin, and carbon dioxide are older tests but compared with the newly developed tests, they are relatively inexpensive to measure and widely available. This article will review laboratory tests used for COPD and discuss their prognostic value. The laboratory tests that can identify high-risk patients will be discussed. We will explore the role of these tests in clinical practice.


Asunto(s)
Pulmón , Enfermedad Pulmonar Obstructiva Crónica , Humanos , Pronóstico , Pulmón/química , Pulmón/metabolismo , Biomarcadores , Enfermedad Pulmonar Obstructiva Crónica/diagnóstico , Proteína C-Reactiva/análisis , Proteína C-Reactiva/metabolismo
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