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BACKGROUND: First-line over-the-scope (OTS) clip treatment has shown higher efficacy than standard endoscopic therapy in acute nonvariceal upper gastrointestinal bleeding (NVUGIB) from different causes. We compared OTS clips with through-the-scope (TTS) clips as first-line mechanical treatment in the specific setting of peptic ulcer bleeding. METHODS: We conducted an international, multicenter randomized controlled trial on consecutive patients with suspected NVUGIB. Patients with Forrest Ia-IIb gastroduodenal peptic ulcer were randomized 1:1 to OTS clip or TTS clip treatment. The primary outcome was the rate of 30-day rebleeding after successful initial hemostasis. Secondary outcomes included the rates of successful initial hemostasis and overall clinical success, defined as the composite of successful initial hemostasis and no evidence of 30-day rebleeding. RESULTS: 251 patients were screened and 112 patients were randomized to OTS (n = 61) or TTS (n = 51) clip treatment. The 30-day rebleeding rates were 1.6% (1/61) and 3.9% (2/51) in patients treated with OTS clips and TTS clips, respectively (Kaplan-Meier log-rank, P = 0.46). Successful initial hemostasis rates were 98.4% (60/61) in the OTS clip group and 78.4% (40/51) in the TTS clip group (P = 0.001). Overall clinical success rates were 96.7% (59/61) with OTS clips and 74.5% (38/51) with TTS clips (P = 0.001). CONCLUSIONS: Low rates of 30-day rebleeding were observed after first-line endoscopic treatment of acute peptic ulcer bleeding with either OTS or TTS clips. However, OTS clips showed higher efficacy than TTS clips in achieving successful initial hemostasis and overall clinical success.
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Hemostase Endoscópica , Úlcera Péptica Hemorrágica , Recidiva , Instrumentos Cirúrgicos , Humanos , Úlcera Péptica Hemorrágica/terapia , Úlcera Péptica Hemorrágica/cirurgia , Masculino , Feminino , Hemostase Endoscópica/instrumentação , Hemostase Endoscópica/métodos , Pessoa de Meia-Idade , Idoso , Resultado do Tratamento , Idoso de 80 Anos ou mais , Úlcera Duodenal/complicações , Úlcera Gástrica/complicaçõesRESUMO
BACKGROUND: Endoscopic full-thickness resection (EFTR) is an effective and safe technique for nonlifting colorectal lesions. Technical issues or failures with the full-thickness resection device (FTRD) system are reported, but there are no detailed data. The aim of our study was to quantify and classify FTRD technical failures. METHODS: We performed a retrospective study involving 17 Italian centers with experience in advanced resection techniques and the required devices. Each center shared and classified all prospectively collected consecutive failures during colorectal EFTR using the FTRD from 2018 to 2022. The primary outcome was the technical failure rate and their classification; secondary outcomes included subsequent management, clinical success, and complications. RESULTS: Included lesions were mainly recurrent (52â%), with a mean (SD) dimension of 18.4 (7.5) mm. Among 750 EFTRs, failures occurred in 77 patients (35 women; mean [SD] age 69.4 [8.9] years). A classification was proposed: type I, snare noncutting (53â%); type II, clip misdeployment (31â%); and type III, cap misplacement (16â%). Among endoscopic treatments completed, rescue endoscopic mucosal resection was performed in 57 patients (74â%), allowing en bloc and R0 resection in 71â% and 64â%, respectively. The overall adverse event rate was 27.3â%. Pooled estimates for the rates of failure, complications, and rescue endoscopic therapy were similar for low and high volume centers (Pâ=â0.08, Pâ=â0.70, and Pâ=â0.71, respectively). CONCLUSIONS: Colorectal EFTR with the FTRD is a challenging technique with a non-negligible rate of technical failure and complications. Experience in rescue resection techniques and multidisciplinary management are mandatory in this setting.
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BACKGROUND AND AIMS: Patients undergoing colonoscopy are often in the workforce. Therefore, colonoscopy may affect patients' work productivity in terms of missed working days and/or reduced working efficiency. We aimed to investigate the impact of colonoscopy on work productivity and factors influencing this impact. METHODS: We conducted a prospective, observational, multicenter study in 10 Italian hospitals between 2016 and 2017. We collected information on individual characteristics, work productivity, symptoms, and conditions before, during, and after the procedure from patients undergoing colonoscopy for several indications using validated tools. Outcomes were interference of preparation with work, absenteeism, and impaired work performance after the procedure. We fitted multivariate logistic regression models to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for potential predictors of the outcomes. RESULTS: Among 1137 subjects in the study, 30.5% reported at least 1 outcome. Impaired work performance was associated with bowel preparation regimen (full dose on the day of colonoscopy vs split dose: OR, 4.04; 95% CI, 1.43-11.5), symptoms during bowel preparation (high symptom score: OR, 3.21; 95% CI, 1.15-8.95), and pain during the procedure (OR, 2.47; 95% CI, 1.40-4.35). Increasing number of working hours and less comfortable jobs were associated with absenteeism (P for trend = .06) and impairment of working performance (P for trend = .01) and GI symptoms both before and after colonoscopy. CONCLUSIONS: Occupational and individual characteristics of patients should be considered when scheduling colonoscopy because this procedure may impair work productivity in up to one-third of patients. Split-dose bowel preparation, performing a painless colonoscopy, and preventing the occurrence of GI symptoms may minimize the impact of colonoscopy on work productivity.
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Catárticos , Polietilenoglicóis , Colonoscopia/métodos , Humanos , Razão de Chances , Estudos ProspectivosRESUMO
BACKGROUND AND AIMS: Granular mixed laterally spreading tumors (GM-LSTs) have an intermediate level of risk for submucosal invasive cancer (SMICs) without clear signs of invasion (covert); the optimal resection method is uncertain. We aimed to determine the risk of covert SMIC in GM-LSTs based on clinical and endoscopic factors. METHODS: We collected data from 693 patients (50.6% male; median age, 69 years) with colorectal GM-LSTs, without signs of invasion, who underwent endoscopic resection (74.2%) or endoscopic submucosal dissection (25.2%) at 7 centers in Italy from 2016 through 2019. We performed multivariate and univariate analyses to identify demographic and endoscopic factors associated with risk of SMIC. We developed a multivariate model to calculate the number needed to treat (NNT) to detect 1 SMIC. RESULTS: Based on pathology analysis, 66 patients (9.5%) had covert SMIC. In multivariate analyses, increased risk of covert SMIC were independently associated with increasing lesion size (odds ratio per mm increase, 1.02, 95% CI, 1.01-1.03; P = .003) and rectal location (odds ratio, 3.08; 95% CI, 1.62-5.83; P = .004). A logistic regression model based on lesion size (with a cutoff of 40 mm) and rectal location identified patients with covert SMIC with 47.0% sensitivity, 82.6% specificity, and an area under the curve of 0.69. The NNT to identify 1 patient with a nonrectal SMIC smaller than 4 cm was 20; the NNT to identify 1 patient with a rectal SMIC of 4 cm or more was 5. CONCLUSIONS: In an analysis of data from 693 patients, we found the risk of covert SMIC in patients with GM-LSTs to be approximately 10%. GM-LSTs of 4 cm or more and a rectal location are high risk and should be treated by en-bloc resection. ClinicalTrials.gov, Number: NCT03836131.
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Neoplasias Colorretais , Ressecção Endoscópica de Mucosa , Idoso , Colonoscopia , Neoplasias Colorretais/epidemiologia , Endoscopia , Feminino , Humanos , Mucosa Intestinal , Masculino , Reto , Estudos RetrospectivosRESUMO
BACKGROUND: Several scientific societies have endorsed non-anesthesiologist sedation (NAS) during gastrointestinal endoscopy, considering it a safe procedure when administered by adequately trained personnel. This study aimed to evaluate the occurrence of adverse events after implementation of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) sedation training program. METHODS: From January 2017 to August 2018, data from all consecutive endoscopic procedures in adults (≥â18 years) performed at our endoscopy unit were collected using an electronic reporting system. RESULTS: All staff (physicians and nurses) completed the ESGE-ESGENA sedation course. In total, 12â 132 patients underwent endoscopic procedures, 10â755 (88.6â%) of which were performed in a non-anesthesiological setting. Of these, about 20â% used moderate sedation with midazolam + fentanyl and 80â% used deep sedation with additional propofol. No sentinel, 5 (0.05â%) moderate risk, and 18 (0.17â%) minor risk adverse events occurred, all during moderate or deep sedation, and all managed by endoscopy staff without the need for anesthesiologist assistance. CONCLUSIONS: After completing the ESGE-ESGENA sedation training program, the rate of adverse events was very low in our institution. The findings support implementation of the program in all digestive endoscopy units and inclusion in the curriculum for physicians and nurses to ensure safe endoscopic procedures.
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Gastroenterologia , Propofol , Adulto , Sedação Consciente/efeitos adversos , Endoscopia Gastrointestinal , Humanos , Midazolam , Propofol/efeitos adversosRESUMO
BACKGROUND: Although bowel preparation before colonoscopy and capsule endoscopy is widely evaluated and usually follows established guidelines, a standard preparation regime for peroral small bowel enteroscopy is yet to be defined.The aim of the present study was to compare small bowel preparation with polyethylene glycol (PEG) and "fasting only" (FO) before peroral single-balloon enteroscopy (SBE). STUDY: We compared small bowel preparation with PEG versus "FO" for peroral SBE in a randomized European multicenter trial. Patients' and procedural characteristics were documented and carefully analyzed. Primary endpoint was the oral intubation depth of the small bowel. A modified Boston preparation scale was used to assess bowel cleansing as a secondary endpoint. RESULTS: In total, 43 patients were enrolled in this study (FO group: n=25; PEG group: n=18). In both groups, patients' characteristics were comparable. The indications for oral enteroscopy were equally distributed in both groups (P=0.894). The oral intubation depth was significantly higher in the PEG versus the FO group (261±87 vs. 203±66 cm; P=0.019; mean±SD), while the quality of bowel preparation was equally sufficient in both groups [complete visualization of the mucosa (Boston preparation scale) 83% versus 76% (P=1.000)]. CONCLUSIONS: Small bowel preparation with PEG for SBE yields significantly deeper intubation as compared with "FO" preparation. As patient comfort and safety was similar in both groups, PEG preparation might be favored, especially if deep intubation of the small bowel is desired. For patients requiring visualization of the proximal jejunum, a FO preparation seems to be sufficient.
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Enteroscopia de Balão Único , Boston , Catárticos , Colonoscopia , Jejum , Humanos , PolietilenoglicóisAssuntos
Hemorragia Gastrointestinal , Hemangioma Cavernoso , Neoplasias do Jejuno , Humanos , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/terapia , Neoplasias do Jejuno/complicações , Neoplasias do Jejuno/cirurgia , Hemangioma Cavernoso/complicações , Hemangioma Cavernoso/cirurgia , Recidiva , Masculino , Hemostase Endoscópica/métodos , Idoso , FemininoRESUMO
Background and study aims The thulium laser system (TLS) is an emerging surgical tool. The 2-µm wavelength provides a confined coagulation depth (0.2â-â0.4âmm) to reduce the potential for inadvertent injuries. For the first time ever, we assessed TLS feasibility for endoscopic hemostasis ex vivo in pigs. In addition, we performed the first in vivo hemostatic treatments in humans. Patients and methods Tissue damage induced by TLS using different settings and optical fibers was compared to that from argon plasma coagulation (APC) in established ex vivo animal models. Three consecutive patients with complex nonvariceal upper gastrointestinal bleedings were treated and followed up. Results No deep submucosal injury was observed in animal models. The TLS showed a progressive penetration depth with increased power outputs and tissue exposures but very limited vertical tissue injury (0.1â-â2.0âmm) and lateral spreading damage (0.1â-â0.3âmm and 0.2â-â0.7âmm using the 365-µm and 550-µm fibers, respectively). In vivo, endoscopic hemostasis with TLS was always successful without complications. Conclusions The TLS has proven to be very precise and easy to use. This novel technique appears to be a promising tool for advanced interventional endoscopy.
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Hemorragia Gastrointestinal/terapia , Hemostase Endoscópica/métodos , Lasers de Estado Sólido/uso terapêutico , Neoplasias Peritoneais/complicações , Túlio , Idoso , Animais , Coagulação com Plasma de Argônio , Úlcera Duodenal/complicações , Endoscopia do Sistema Digestório , Estudos de Viabilidade , Ectasia Vascular Gástrica Antral/complicações , Ectasia Vascular Gástrica Antral/terapia , Mucosa Gástrica , Hemorragia Gastrointestinal/etiologia , Hemostase Endoscópica/efeitos adversos , Hemostase Endoscópica/instrumentação , Humanos , Terapia a Laser/instrumentação , Lasers de Estado Sólido/efeitos adversos , Masculino , Pessoa de Meia-Idade , Úlcera Péptica Hemorrágica/etiologia , Úlcera Péptica Hemorrágica/terapia , Neoplasias Peritoneais/patologia , SuínosRESUMO
BACKGROUND: Sedation, ranging from minimal, moderate and deep sedation to general anesthesia, improves patient comfort and procedure quality in gastrointestinal endoscopy (GIE). There are currently no comprehensive recommendations on sedation practice in diagnostic and therapeutic GIE. We aimed to investigate real-life sedation practice in elective GIE. METHODS: We performed a multicentric observational study across 14 Endoscopy Units in Italy. We recorded consecutive data on all diagnostic procedures performed with Anesthesiologist-directed care (ADC) and all therapeutic procedures performed with ADC or non-Anesthesiologist sedation (NAS) over a three-month period. RESULTS: Dedicated ADC is available five days/week in 28.6% (4/14), four days/week in 21.5% (3/14), three days/week in 35.7% (5/14), two days/week in 7.1% (1/14) and one day/week in 7.1% (1/14) of participating Centers. ADC use for elective diagnostic GIE varied from 18.2% to 75.1% of the total number of procedures performed with ADC among different Centers. ADC use for elective therapeutic GIE varied from 10.8% to 98.9% of the total number of elective therapeutic procedures performed among different Centers. CONCLUSIONS: Our study highlights the lack of standardization and consequent great variability in sedation practice for elective GIE, with ADC being potentially overused for diagnostic procedures and underused for complex therapeutic procedures. A collaborative effort involving Endoscopists, Anesthesiologist and Institutions is needed to optimize sedation practice in GIE.
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Video 1Endoscopic lithotripsy of a gallstone impacted in the lumen-apposing metal stent positioned for cholecysto-gastrostomy.
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INTRODUCTION: Bowel preparation is crucial for colonoscopy completeness and lesions detection. Today, several cleansing products are equally recommended by guidelines, irrespective of patients' characteristics. Identification of preparation-specific risk factors for inadequate bowel preparation may lead to a personalized prescription of cleansing products to refine patients' tolerance and improve endoscopic outcomes. METHODS: We prospectively enrolled consecutive outpatients referred for colonoscopy using either a high-volume [HV: 4 l polyethylene glycol (PEG)] or a low-volume (LV: 2 l PEG + bisacodyl) preparation. Day-before regimen or split-dose regimen was used for morning or afternoon colonoscopies, respectively. Univariate and multivariate analyses were conducted to identify risk factors related to inadequate bowel preparation, according to the Boston bowel preparation scale for HV and LV preparations. RESULTS: We enrolled 2040 patients, of which 1815 were included in the final analysis (average age 60.6 years, 50.2% men). Half of them (52%) used LV preparation. Adequate preparation was achieved by 87.6% without differences between the HV and LV groups (89.2% vs. 86.6%; P = 0.098). The use of day-before regimen and incomplete assumption of PEG were independent predictors of poor visibility for either HV or LV preparation. However, different specific risk factors for HV [diabetes: odds ratio (OR), 3.81; 95% confidence interval (CI), 1.91-7.58; low level of instruction: OR, 1.95; 95% CI, 1.11-3.44; and previous abdominal surgery: OR, 2.27; 95% CI, 1.20-4.30] and for LV (heart disease: OR, 2.06; 95% CI, 1.09-3.88; age > 65 years: OR, 1.51; 95% CI, 1.01-2.27) preparations were identified. CONCLUSION: Day-before preparation and incomplete assumption of the purgative agents affect bowel visibility irrespective of the preparation volume. LV should be preferred to HV preparations in patients with diabetes, low level of instruction, and previous abdominal surgery, whereas an HV preparation should be preferred in patients with heart disease and in older patients.
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Catárticos , Diabetes Mellitus , Masculino , Humanos , Idoso , Pessoa de Meia-Idade , Feminino , Catárticos/efeitos adversos , Bisacodil/efeitos adversos , Polietilenoglicóis/efeitos adversos , Colonoscopia/efeitos adversos , Fatores de RiscoRESUMO
INTRODUCTION: Preoperative gastric cancer (GC) staging is the most reliable prognostic factor that affects therapeutic strategies. Contrast-enhanced computed tomography (CECT) and radial endoscopic ultrasound (R-EUS) scans are the most commonly used staging tools for GC. The accuracy of linear EUS (L-EUS) in this setting is still controversial. The aim of this retrospective multicenter study was to evaluate the accuracy of L-EUS and CECT in preoperative GC staging, with regards to depth of tumor invasion (T staging) and nodal involvement (N staging). MATERIALS AND METHODS: 191 consecutive patients who underwent surgical resection for GC were retrospectively enrolled. Preoperative staging had been performed using both L-EUS and CECT, and the results were compared to postoperative staging by histopathologic analysis of surgical specimens. RESULTS: L-EUS diagnostic accuracy for depth of invasion of the GC was 100%, 60%, 74%, and 80% for T1, T2, T3, and T4, respectively. CECT accuracy for T staging was 78%, 55%, 45%, and 10% for T1, T2, T3, and T4, respectively. L-EUS diagnostic accuracy for N staging of GC was 85%, significantly higher than CECT accuracy (61%). CONCLUSIONS: Our data suggest that L-EUS has a higher accuracy than CECT in preoperative T and N staging of GC.
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Colangiopancreatografia Retrógrada Endoscópica/métodos , Duodeno/lesões , Endossonografia/efeitos adversos , Ruptura/terapia , Idoso de 80 Anos ou mais , Colangiopancreatografia Retrógrada Endoscópica/instrumentação , Duodeno/diagnóstico por imagem , Feminino , Humanos , Ruptura/diagnóstico por imagemAssuntos
Dissecação/métodos , Leiomioma/cirurgia , Neoplasias Gástricas/cirurgia , Idoso de 80 Anos ou mais , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico , Endoscopia Gastrointestinal , Feminino , Humanos , Leiomioma/complicações , Leiomioma/patologia , Melena/etiologia , Neoplasias Gástricas/complicações , Neoplasias Gástricas/patologiaRESUMO
BACKGROUND AND AIM: Very low-volume bowel preparation (BP) for colonoscopy with 1-liter polyethylene glycol plus ascorbate (1L-PEG-Asc) has displayed high tolerability and quality of bowel cleansing. Concerns have been raised regarding its safety. We aimed to evaluate the incidence of adverse events (AEs) following BP with 1L-PEG-Asc or 2L-PEG-Asc. PATIENTS AND METHODS: From January 2019 to September 2020, data from all consecutive adult outpatients who underwent colonoscopy in Our Unit were collected. AEs were assessed by reviewing the clinical and laboratory data of patients who attended the Emergency Department (ED) of Modena District Hospitals in the 7 days following the colonoscopy, and were classified as "BP-related" or "BP-unrelated". RESULTS: During the study, 4069 (68.03%) and 1912 (31.97%) patients underwent colonoscopy after taking 2L-PEG-Asc or 1L-PEG-Asc, respectively. Regarding AEs, 77 (1.29%) patients attended ED, 53 (53/4069, 1.30%) and 24 (24/1912, 1.25%) after taking 2L-PEG-Asc and 1L-PEG-Asc. BP-related AEs were observed in 5 (5/4069, 0.12%) and 4 (4/1912, 0.21%) patients, respectively. The most frequent BP-related AEs were tachyarrhythmias (6/5981, 0.10%). CONCLUSION: The incidence rate of clinically relevant BP-related AEs is extremely low. This strongly suggests that 1L-PEG-Asc colonoscopy BP is as safe as 2L-PEG-Asc BP in a real-life clinical setting of unselected patients.