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BACKGROUND AND AIMS: Nonanesthesiologist-administered propofol (NAAP) is increasingly accepted, but data are limited on drug administration using target-controlled infusion (TCI) in clinical practice. TCI adjusts the drug infusion based on patient-specific parameters, maintaining a constant drug dose to reduce the risk of adverse events (AEs) because of drug overdosing and to enhance patient comfort. The aims of this study were to assess the rate of AEs and to evaluate patient satisfaction with NAAP using TCI in a retrospective cohort of 18,302 procedures. METHODS: Low-risk patients (American Society of Anesthesiologists score I and II) undergoing outpatient GI endoscopic procedures, including EGDs and colonoscopies, were sequentially enrolled at IRCCS San Raffaele Hospital (Milan, Italy) between May 2019 and November 2021. RESULTS: Data from 7162 EGDs and 11,140 colonoscopies were analyzed. Mean patient age was 59.1 ± 14.8 years, and mean body mass index was 24.9 ± 3.7 kg/m2. The male-to-female ratio was equal at 8798 (48.1%):9486 (51.9%). AEs occurred in 240 procedures (1.3%) out of the total cohort, with no differences between EGDs and colonoscopies (100 [1.4%] and 140 [1.2%], respectively; P = .418). Most patients (15,875 [98.9%]) indicated they would likely repeat the procedure with the same sedation protocol. Age (odds ratio, 1.02; 95% confidence interval, 1.01-1.03; P < .008) was the only independent factor associated with overall AEs. CONCLUSIONS: NAAP using TCI is an effective and safe sedation method for routine endoscopy. The proper propofol dosage based on individual patients and the presence of trained operators are crucial for NAAP sedation management.
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Anestésicos Intravenosos , Colonoscopia , Endoscopia Gastrointestinal , Satisfação do Paciente , Propofol , Humanos , Propofol/administração & dosagem , Propofol/efeitos adversos , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Retrospectivos , Idoso , Colonoscopia/métodos , Endoscopia Gastrointestinal/métodos , Anestésicos Intravenosos/administração & dosagem , Anestésicos Intravenosos/efeitos adversos , Adulto , Infusões Intravenosas , Hipnóticos e Sedativos/administração & dosagem , Hipnóticos e Sedativos/efeitos adversosRESUMO
BACKGROUND AND AIMS: Patients with sigmoid-type achalasia can be challenging to treat with per-oral endoscopic myotomy (POEM). A short myotomy improves technical success, however outcomes have not previously been evaluated METHODS: This was a multicenter, international, retrospective study of patients who underwent POEM with short (≤ 4 cm) or standard esophageal myotomy. Outcomes included clinical and technical success, procedural adverse events, and reflux rates. RESULTS: A total of 109 patients with sigmoid achalasia (sigmoid = 74, advanced sigmoid = 35) underwent POEM across 13 centers (Short myotomy = 59, standard = 50). Technical success was 100% across both groups. Patients who underwent short myotomy had a significantly shorter mean procedure time (57.7 ± 27.8 vs 83.1 ± 44.7 minutes, p = 0.0005). A total of 6 AEs were recorded in 6 patients (5.5%; 4 mild, 2 moderate); AE rate was not significantly different between short and standard groups. Ninety-eight patients had follow-up data (median = 3.6 months [IQR, 1-14]) months). Clinical success was 94% (short = 93%; standard = 95%, p = 0.70) and did not differ based on achalasia subtype or sigmoid achalasia severity. Twenty-one (22%) patients reported post-POEM reflux and 44% (16/36) had objective evidence of pathologic reflux. Rates of pathologic reflux were significantly increased in the standard vs short group (OR 18.0 [95% CI: 2.0 - 159.0]; p = 0.009). CONCLUSIONS: POEM with short myotomy is effective and safe for the short-term treatment of sigmoid and advanced sigmoid achalasia. Short myotomy may lead to less reflux than standard myotomy.
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BACKGROUND AND AIMS: Fully covered self-expandable metal stents (FCSEMSs) are widely used in benign upper gastrointestinal (GI) conditions, but stent migration remains a limitation. An over-the-scope clip (OTSC) device (Ovesco Endoscopy) for stent anchoring has been recently developed. The aim of this study was to evaluate the effect of OTSC fixation on SEMS migration rate. METHODS: A retrospective review of consecutive patients who underwent FCSEMS placement for benign upper GI conditions between 1/2011 and 10/2022 at 16 centers. The primary outcome was rate of stent migration. The secondary outcomes were clinical success and adverse events. RESULTS: A total of 311 (no fixation 122, OTSC 94, endoscopic suturing 95) patients underwent 316 stenting procedures. Compared to the no fixation (NF) group (n=49, 39%), the rate of stent migration was significantly lower in the OTSC (SF) (n=16, 17%, p=0.001) and endoscopic suturing (ES) group (n=23, 24%, p=0.01). The rate of stent migration was not different between the SF and ES groups (p=0.2). On multivariate analysis, SF (OR 0.34, CI 0.17-0.70, p<0.01) and ES (OR 0.46, CI 0.23-0.91, p=0.02) were independently associated with decreased risk of stent migration. Compared to the NF group (n=64, 52%), there was a higher rate of clinical success in the SF (n=64, 68%; p=0.03) and ES group (n=66, 69%; p = 0.02). There was no significant difference in the rate of adverse events between the three groups. CONCLUSION: Stent fixation using OTSC is safe and effective at preventing stent migration and may also result in improved clinical response.
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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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Peroral endoscopic myotomy (POEM) is an established treatment for achalasia, yet there is still a lack of technical standardization. No clear definition of 'long', 'standard', or 'short' POEM exists to date. We conducted a systematic review with meta-analysis to analyze current POEM length standards. We included studies reporting technical details of POEM, in which no definite or comparative myotomy length was intentionally adopted (standard myotomy). The primary outcome was the pooled mean total myotomy length. Sub-group analyses were performed to explore heterogeneity across studies. From the initial 7172 records, 31 studies with 3023 patients were included. Pooled mean of total myotomy length was 10.39 cm (95% CI 10.06-10.71; I2 99.3%). Pooled mean of esophageal and gastric myotomy length, provided by 17 studies, was 7.11 cm (95% CI 6.51-7.71; I2 99.8%) and 2.81 cm (95% CI 2.41-3-22; I2 99.8%), respectively. On subgroup analysis for achalasia subtypes, pooled mean length in non-spastic achalasia (type I and II) was 10.17 cm (95% CI 9.91-10.43; I2 94.2%), while in type III it was 14.02 cm (95% CI 10.59-17.44; I2 98.9%). Pooled mean myotomy length for studies conducted between 2014-2020 was 10.53 cm (95% CI, 10.22-10.84; I2 99.1%) and 9.74 cm (95% CI, 7.95-11.54; I2 99.7%) in 2021-2022. Myotomy length during a 'standard' POEM is 10.4 cm, remaining over 10 cm in non-spastic achalasia. The high heterogeneity across studies confirms that the POEM technique needs further standardization. We found no significant time trend towards adopting short POEM, despite recent evidence supporting its use.
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OBJECTIVES: We compared the efficacy and safety of transoral incisionless fundoplication (TIF) with the EsophyX2.0 and MUSE systems for treatment of gastroesophageal reflux disease (GERD). METHODS: TIF outcomes from prospective protocols (Esophy2.0X: 2007-2012; MUSE: 2015-2019) were retrospectively compared regarding technical success, moderate/severe adverse events, morpho-functional findings up to 1 year, and clinical outcomes up to 3 years. Inclusion criteria were: (i) at least 6-month symptomatic GERD, full/partial response to proton pump inhibitors (PPI), esophagitis, and nonerosive reflux disease/hypersensitive esophagus (both protocols); (ii) hiatal hernia <3 cm (Esophy2.0X) and ≤2.5 cm (MUSE); and (iii) Barrett's esophagus <3 cm (MUSE). RESULTS: In the 50 EsophyX2.0 and 46 MUSE procedures, technical success and adverse event rates were similar, but MUSE-related adverse events (4.4%) were life-threatening. At 12 months, hiatal hernia recurred more frequently after EsophyX2.0 (P = 0.008). At 6 months, significantly fewer total and acid refluxes were reported after both TIF, but not more significantly at 1 year. Symptoms improved after both TIF up to 1 year (P < 0.0001), but to a greater extent in MUSE patients up to 3 years (P < 0.0001 vs. P < 0.01 for EsophyX2.0). The rates of 3-year off-PPI therapy patients were 73.5% in the MUSE and 53.3% in the EsophyX2.0 series (P = 0.069). CONCLUSION: Although no conclusion could be drawn from this limited study, the MUSE technique seemed more effective in the long term in patients with hiatal hernia; however, there were more severe adverse events than with EsophyX2.0.
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BACKGROUND: Endoscopic submucosal dissection (ESD) represents the method of choice for removal of large colorectal neoplasms with suspected submucosal invasion. Presence and degree of submucosal fibrosis increases ESD duration and technical complexity, reduces the rate of curative resection and reduces safety profile. The aim of the study was to identify pre-procedural predictive factors of submucosal fibrosis in naïve colorectal neoplasms and to assess the impact of fibrosis on technical and clinical ESD outcomes. METHODS: All consecutive ESD performed between 2014 and 2021 were retrieved from a prospectively collected database. For each patient, pre-procedural, procedural, and post-procedural data were recorded. Logistic regression was used to identify pre-procedural predictive factors for submucosal fibrosis. The study was approved by Institutional Reviewer Board and registered on ClinicalTrials.gov (NCT04780256). RESULTS: One hundred-74 neoplasms (46.6% rectum, 21.8% left colon, 31.6% right colon; size 34.9 ± 17.5 mm) from 169 patients (55.0% male; 69.5 ± 10.4-year-old) were included. 106 (60.9%) neoplasms were granular type laterally spreading tumor (LST-G), 42 (24.1%) non-granular (LST-NG), and 26 (14.9%) sessile; invasive pit pattern was observed in 90 (51.7%) lesions. No fibrosis (F0) mild (F1) and severe (F2) were observed in 62 (35.6%), 92 (52.9%), and 20 (11.5%), respectively. Left colonic localization [OR 3.23 (1.1-9.31)], LST-NG morphology [OR 5.84 (2.03-16.77)] and invasive pit pattern [OR 7.11 (3.11-16.23)] were independently correlated to submucosal fibrosis. Lower curative resection rate (59.8% vs. 93.5%, P < 0.001) was observed in case of fibrosis; the incidence of adverse events was higher in case of severe fibrosis (35.5%) compared to no (3.2%) and mild fibrosis (3.3%; P < 0.001). Procedure time was significantly impacted by presence and degree of fibrosis (P < 0.001). CONCLUSIONS: Left colonic localization, LST-NG morphology, and invasive pit pattern are independent predictors of fibrosis, affecting technical and clinical ESD outcomes. Pre-procedural stratification is pivotal to estimate procedure time, required operator's experience and advanced dissection techniques. Cecinato P et al. Left colonic localization, non-granular morphology, and pit pattern independently predict submucosal fibrosis of colorectal neoplasms before endoscopic submucosal dissection. Surg Endosc. 2023.
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Neoplasias Colorretais , Ressecção Endoscópica de Mucosa , Fibrose Oral Submucosa , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Ressecção Endoscópica de Mucosa/métodos , Fibrose Oral Submucosa/etiologia , Fibrose Oral Submucosa/patologia , Neoplasias Colorretais/cirurgia , Neoplasias Colorretais/patologia , Fibrose , Mucosa Intestinal/cirurgia , Mucosa Intestinal/patologia , Estudos Retrospectivos , Resultado do Tratamento , Colonoscopia/métodosRESUMO
BACKGROUND: Management of anastomotic leaks after Ivor-Lewis esophagectomy remains a challenge. Although intracavitary endoscopic vacuum therapy (EVT) has shown great efficacy for large dehiscences, the optimal management of smaller leaks has not been standardized. This study aims to compare EVT versus self-expandable metal stent (SEMS) in the treatment of leaks < 30 mm in size, due to the lack of current data on this topic. METHODS: Patients undergoing EVT (cases) or SEMS (controls) between May 2017 and July 2022 for anastomotic leaks < 3 cm following oncologic Ivor-Lewis esophagectomy were enrolled. Controls were matched in a 1:1 ratio based on age (± 3 years), BMI (± 3 kg/m2) and leak size (± 4 mm). RESULTS: Cases (n = 22) and controls (n = 22) showed no difference in baseline characteristics and leak size, as per matching at enrollment. No differences were detected between the two groups in terms of time from surgery to endoscopic treatment (p = 0.11) or total number of procedures per patient (p = 0.05). Remarkably, the two groups showed comparable results in terms of leaks resolution (90.9% vs. 72.7%, p = 0.11). The number of procedures per patient was not significant between the two cohorts (p = 0.05). The most frequent complication in the SEMS group was migration (15.3% of procedures). CONCLUSION: EVT and SEMS seem to have similar efficacy outcomes in the treatment of anastomotic defects < 30 mm after Ivor-Lewis esophagectomy. However, larger studies are needed to corroborate these findings.
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Neoplasias Esofágicas , Tratamento de Ferimentos com Pressão Negativa , Stents Metálicos Autoexpansíveis , Humanos , Fístula Anastomótica/etiologia , Fístula Anastomótica/cirurgia , Esofagectomia/efeitos adversos , Esofagectomia/métodos , Estudos de Casos e Controles , Tratamento de Ferimentos com Pressão Negativa/efeitos adversos , Estudos Retrospectivos , Resultado do Tratamento , Stents Metálicos Autoexpansíveis/efeitos adversos , Anastomose Cirúrgica/efeitos adversos , Neoplasias Esofágicas/cirurgia , Neoplasias Esofágicas/complicaçõesRESUMO
BACKGROUND: Early-onset colorectal cancer (eoCRC), defined as a colorectal cancer (CRC) in patients younger than 50 years old, shows an increasing incidence worldwide in the latest years. The role of exogenous factors associated with CRC has been largely overlooked in eoCRC. Here, we conducted a case-control study to evaluate the diet and the lifestyle habits in an Italian population of patients with eoCRC, compared to age-matched healthy controls (HCs). METHODS: We enrolled 118 subjects (47 cases, 71 controls) in a third-level academic hospital. We analyzed epidemiological features (age, sex, body mass index), lifestyle behaviors (smoking habits, physical activity, type of diet, use of dietary supplements), and eating habits (semiquantitative food-frequency questionnaire) in eoCRCs and HCs, covering the previous 5 years. RESULTS: In our cohort, positive family history of CRC was significantly associated with the development of eoCRC (p = 0.004). Fresh meat (p = 0.003), processed meat (p < 0.001), dairy products (p = 0.013), and smoking (p = 0.0001) were significantly associated with eoCRC compared to controls. Other variables did not differ significantly between the two groups. CONCLUSION: Fresh and processed meat, dairy products, and smoking could be considered significant risk factors for eoCRC, although further confirmation by international multicenter studies is desirable. Diet and smoking could be the main areas of future interventions for eoCRC primary prevention.
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Neoplasias Colorretais , Humanos , Pessoa de Meia-Idade , Estudos de Casos e Controles , Neoplasias Colorretais/epidemiologia , Neoplasias Colorretais/etiologia , Estilo de Vida , Dieta/efeitos adversos , Fatores de Risco , HábitosRESUMO
BACKGROUND: Transoral incisionless fundoplication (TIF) with Medigus Ultrasonic Surgical Endostapler (MUSE) is a new intervention for treatment of gastro-esophageal reflux disease (GERD). We aimed at assessing the clinical, functional, and endoscopic effects of TIF by MUSE. METHODS: Forty-six patients underwent TIF. Proton pump inhibitor (PPI) consumption, GERD-health-related quality of life (HRQL) and reflux symptom index (RSI) questionnaires, upper gastrointestinal (GI) endoscopy, esophageal 24-h pH-impedance recording, and high-resolution manometry (HRM) were done before TIF and scheduled 6 and 12 months later (HRM only at 6-month). PPI consumption and symptoms were then assessed yearly. Data up to 3 years are reported in this study (PP- and ITT-analysis). RESULTS: TIF was successfully performed in 45/46 patients; in one patient esophageal intubation was impossible. Perforation occurred in two cases. One patient required surgery within 6 months. Clinical follow-up was available for 42 patients at 6 months and 1 year, 35 patients at 2 years, and 31 patients at 3 years. At 1, 2, and 3 years, PPI consumption was stopped, respectively, in 64.3%, 62.9%, and 74.2% of cases (ITT-analysis: 58.7%, 56.4%, and 65.7%). GERD-HRQL and RSI scores decreased at least 50%, respectively, in 71.5% and 76.2%, 71.4% and 68.6%, and 67.7% of cases (ITT-analysis: 65.2% and 69.6%, 64.1% and 61.5%, and 60%). A significant improvement of both scores was observed up to 3 years. 6-month and 1-year functional follow-up were possible in 31 and 20 patients. HRM showed significant increase of the median lower esophageal sphincter length and rate of peristaltic waves. Esophageal pH-impedance recording found significantly fewer acid, proximal and total refluxes, and percentage of esophageal pH < 4 total time at 6 months, but not at 1 year. CONCLUSION: TIF by MUSE significantly improved symptoms and PPIs consumption up to 3 years. However, esophagitis still persisted in one-third of cases at 1 year and functional improvement at 6 months was not confirmed at 1 year. Severe complications requiring surgery occurred in two cases. CLINICALTRIALS: GOV: ID: NCT03669874.
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Esofagite Péptica , Refluxo Gastroesofágico , Alprostadil/uso terapêutico , Esofagite Péptica/tratamento farmacológico , Fundoplicatura/efeitos adversos , Refluxo Gastroesofágico/tratamento farmacológico , Humanos , Inibidores da Bomba de Prótons/uso terapêutico , Qualidade de Vida , Resultado do Tratamento , UltrassomRESUMO
BACKGROUND: Endoscopic vacuum therapy (EVT) represents an effective endoscopic technique for the treatment of post-esophagectomy leaks and can be used after failure of primary treatment. We aimed to investigate endoscopic data and success rate of EVT for post-esophagectomy anastomotic leaks, after failed redo surgery or previous endoscopic treatment. METHODS: We retrospectively recruited 12 patients from January 2018 to October 2020. Success was defined as dehiscence closure at radiological and/or endoscopic evaluation. Ethical Committee of our institution approved the study. RESULTS: Twelve patients (66.7% male, mean age 65.08 ± 16.7 years) affected by esophago-gastric (n = 10) or esophago-jejunal (n = 2) anastomosis dehiscences after oncologic surgery were treated with EVT, after failure of previous redo-surgical (n = 3, 25%) or endoscopic management (n = 9, 75%). Technical success rate was 100% (60/60 procedures) and dehiscence closure was achieved in three quarters of patients (9/12, 75%). Regarding complications, one case of sponge dislocation (1/60 = 1.7%) and another case of delayed stricture after post-EVT stent placement (1/60 = 1.7%) were recorded, during a mean follow up of 182.3 days. CONCLUSIONS: EVT is a promising option in the treatment of the most complicated anastomotic dehiscences. Its use could be also considered after failure of previous endoscopic or surgical management.