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1.
Lancet Oncol ; 25(4): 488-500, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38547893

RESUMO

BACKGROUND: Pancreatic ductal adenocarcinoma is characterised by low immunogenicity and an immunosuppressive tumour microenvironment. LOAd703, an oncolytic adenovirus with transgenes encoding TMZ-CD40L and 4-1BBL, lyses cancer cells selectively, activates cytotoxic T cells, and induces tumour regression in preclinical models. The aim of this study was to evaluate the safety and feasibility of combining LOAd703 with chemotherapy for advanced pancreatic ductal adenocarcinoma. METHODS: LOKON001 was a non-randomised, phase 1/2 study conducted at the Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA, and consisted of two arms conducted sequentially; the results of arm 1 are presented here. In arm 1, patients 18 years or older with previously treated or treatment-naive unresectable or metastatic pancreatic ductal adenocarcinoma were treated with standard 28-day cycles of intravenous nab-paclitaxel 125 mg/m2 plus gemcitabine 1000 mg/m2 (up to 12 cycles) and intratumoural injections of LOAd703 every 2 weeks. Patients were assigned using Bayesian optimal interval design to receive 500 µL of LOAd703 at 5 × 1010 (dose 1), 1 × 1011 (dose 2), or 5 × 1011 (dose 3) viral particles per injection, injected endoscopically or percutaneously into the pancreatic tumour or a metastasis for six injections. The primary endpoints were safety and treatment-emergent immune response in patients who received at least one dose of LOAd703, and antitumour activity was a secondary endpoint. This study was registered with ClinicalTrials.gov, NCT02705196, arm 2 is ongoing and open to new participants. FINDINGS: Between Dec 2, 2016, and Oct 17, 2019, 23 patients were assessed for eligibility, leading to 22 patients being enrolled. One patient withdrew consent, resulting in 21 patients (13 [62%] men and eight [38%] women) assigned to a dose group (three to dose 1, four to dose 2, and 14 to dose 3). 21 patients were evaluable for safety. Median follow-up time was 6 months (IQR 4-10), and data cutoff was Jan 5, 2023. The most common treatment-emergent adverse events overall were anaemia (96 [8%] of 1237 events), lymphopenia (86 [7%] events), hyperglycaemia (70 [6%] events), leukopenia (63 [5%] events), hypertension (62 [5%] events), and hypoalbuminaemia (61 [5%] events). The most common adverse events attributed to LOAd703 were fever (14 [67%] of 21 patients), fatigue (eight [38%]), chills (seven [33%]), and elevated liver enzymes (alanine aminotransferase in five [24%], alkaline phosphatase in four [19%], and aspartate aminotransferase in four [19%]), all of which were grade 1-2, except for a transient grade 3 aminotransferase elevation occurring at dose 3. A maximum tolerated dose was not reached, thereby establishing dose 3 as the highest-evaluated safe dose when combined with nab-paclitaxel plus gemcitabine. Proportions of CD8+ effector memory cells and adenovirus-specific T cells increased after LOAd703 injections in 15 (94%) of 16 patients for whom T-cell assays could be performed. Eight (44%, 95% CI 25-66) of 18 patients evaluable for activity had an objective response. INTERPRETATION: Combining LOAd703 with nab-paclitaxel plus gemcitabine in patients with advanced pancreatic ductal adenocarcinoma was feasible and safe. To build upon this novel chemoimmunotherapeutic approach, arm 2 of LOKON001, which combines LOAd703, nab-paclitaxel plus gemcitabine, and atezolizumab, is ongoing. FUNDING: Lokon Pharma, the Swedish Cancer Society, and the Swedish Research Council.


Assuntos
Adenocarcinoma , Anemia , Vírus Oncolíticos , Neoplasias Pancreáticas , Trombocitopenia , Masculino , Humanos , Feminino , Gencitabina , Vírus Oncolíticos/genética , Teorema de Bayes , Neoplasias Pancreáticas/terapia , Neoplasias Pancreáticas/tratamento farmacológico , Paclitaxel , Anemia/induzido quimicamente , Trombocitopenia/induzido quimicamente , Adenocarcinoma/terapia , Adenocarcinoma/tratamento farmacológico , Albuminas , Terapia Genética/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Microambiente Tumoral
2.
Gastrointest Endosc ; 2024 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-39078360

RESUMO

This clinical practice guideline from the American Society for Gastrointestinal Endoscopy provides an evidence-based approach for the role of therapeutic EUS in the management of biliary tract disorders. This guideline was developed using the Grading of Recommendations Assessment, Development and Evaluation framework and addresses the following: 1: The role of EUS-guided biliary drainage (EUS-BD) versus percutaneous transhepatic biliary drainage (PTBD) in resolving biliary obstruction in patients after failed ERCP. 2: The role of EUS-guided hepaticogastrostomy versus EUS-guided choledochoduodenostomy in resolving distal malignant biliary obstruction after failed ERCP. 3: The role of EUS-directed transgastric ERCP (EDGE) versus laparoscopic-assisted ERCP and enteroscopy-assisted ERCP (E-ERCP) in resolving biliary obstruction in patients with Roux-en-Y gastric bypass (RYGB) anatomy. 4: The role of EUS-BD versus E-ERCP and PTBD in resolving biliary obstruction in patients with surgically altered anatomy other than RYGB. 5: The role of EUS-guided gallbladder drainage (EUS-GBD) versus percutaneous gallbladder drainage and endoscopic transpapillary transcystic gallbladder drainage in resolving acute cholecystitis in patients who are not candidates for cholecystectomy.

3.
Gastrointest Endosc ; 2024 Aug 08.
Artigo em Inglês | MEDLINE | ID: mdl-39115496

RESUMO

This clinical practice guideline from the American Society for Gastrointestinal Endoscopy (ASGE) provides an evidence-based approach for the role of endoscopy in the management of chronic pancreatitis (CP). This document was developed using the Grading of Recommendations Assessment, Development and Evaluation framework. The guideline addresses effectiveness of endoscopic therapies for the management of pain in CP, including celiac plexus block, endoscopic management of pancreatic duct (PD) stones and strictures, and adverse events such as benign biliary strictures (BBSs) and pseudocysts. In patients with painful CP and an obstructed PD, the ASGE suggests surgical evaluation in patients without contraindication to surgery before initiation of endoscopic management. In patients who have contraindications to surgery or who prefer a less-invasive approach, the ASGE suggests an endoscopic approach as the initial treatment over surgery, if complete ductal clearance is likely. When a decision is made to proceed with a celiac plexus block, the ASGE suggests an EUS-guided approach over a percutaneous approach. The ASGE suggests indications for when to consider ERCP alone or with pancreatoscopy and extracorporeal shock wave lithotripsy alone or followed by ERCP for treating obstructing PD stones based on size, location, and radiopacity. For the initial management of PD strictures, the ASGE suggests using a single plastic stent of the largest caliber that is feasible. For symptomatic BBSs caused by CP, the ASGE suggests the use of covered metal stents over multiple plastic stents. For symptomatic pseudocysts, the ASGE suggests endoscopic therapy over surgery. This document clearly outlines the process, analyses, and decision processes used to reach the final recommendations and represents the official ASGE recommendations on the above topics.

4.
Gastrointest Endosc ; 98(3): 381-391, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37061137

RESUMO

BACKGROUND AND AIMS: Endoscopic suturing enables full closure of large defects after endoscopic submucosal dissection (ESD). However, its use is limited by the need for a double-channel endoscope. A novel closure system, the OverStitch Sx (Apollo Endosurgery, Austin, Tex, USA), compatible with any single-channel endoscope, was introduced to address these shortcomings. The aim of this study was to assess the safety and feasibility of OverStitch Sx for the closure of large defects after ESD. METHODS: This is a prospective single-center feasibility study of patients who underwent closure of large defects after ESD using the OverStitch Sx system. Main outcomes of the study are technical and clinical success, same-day discharge rate, and adverse event rate. RESULTS: Thirty-three patients were enrolled. The mean diameter of included lesions was 5.38 ± 2.52 cm. The defect occupied ≥50% of the lumen circumference in 70% of the cases. En-bloc resection, R0 resection, and curative resection were achieved in 97%, 87.5%, and 78.8% of patients, respectively. Technical success and clinical success were seen in 93.9% and 90.9% of the cases, respectively. Same-day hospital discharge was achieved in 77.4% of patients. Total adverse event rate was 35.7%, including delayed bleeding in 1 patient after rectal ESD that was managed conservatively, self-resolving rectal pain in 7 patients, rectal stricture requiring dilation in 1 patient, and temporary dysphagia in 1 patient. No immediate or delayed perforation was reported. CONCLUSIONS: OverStitch Sx enabled safe and effective closure of large defects after ESD. Future trials are needed to determine its superiority over OverStitch for the closure of defects in challenging locations. (Clinical trial registration number: NCT04361227.).


Assuntos
Ressecção Endoscópica de Mucosa , Humanos , Ressecção Endoscópica de Mucosa/efeitos adversos , Estudos Prospectivos , Reto , Resultado do Tratamento , Estudos Retrospectivos
5.
Pancreatology ; 22(8): 1187-1194, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36402715

RESUMO

OBJECTIVES: The impact of fatty pancreas on pancreatic parenchymal changes is unclear. The aim of this study is to assess parenchymal alterations over time in patients with fatty pancreas (FP). METHODS: This is a retrospective study (2014-2021) of patients with FP identified on endoscopic ultrasound (EUS). Subjects with follow up imaging studies including Computed Tomography (CT) scan, Magnetic Resonance Imaging (MRI), and EUS at least two years after the initial EUS were included. RESULTS: A total of 39 patients with a mean age of 51.21 ± 12.34 years were included. Mean initial weight was 80.17 ± 17.75 kg. Diabetes, hepatic steatosis, and EPI were present in 15%, 46% and 33% of the patients at baseline, respectively. In 25 patients with available follow up EUS over 2.4 ± 0.76 years, 16% progressed to chronic pancreatitis (CP) and 24% had progressive parenchymal changes without meeting the criteria for CP. One patient progressed from focal to diffuse FP, while one patient had resolution of FP. In multivariate analysis, progressive parenchymal changes on EUS were associated with an increase in weight over time (p-value 0.04), independent of the effects of gender, alcohol, or tobacco. CONCLUSION: Progressive parenchymal changes were noted in 44%. Our result suggests that FP is a dynamic process with the possibility of progression or regression over time.


Assuntos
Pancreatopatias , Pancreatite Crônica , Humanos , Adulto , Pessoa de Meia-Idade , Seguimentos , Estudos Retrospectivos , Pancreatopatias/diagnóstico por imagem , Pâncreas/diagnóstico por imagem , Endossonografia
6.
Dig Dis Sci ; 65(4): 1144-1154, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31385097

RESUMO

BACKGROUND: While Roux-en-Y gastric bypass (RYGB) is one of the most effective and durable treatment options for obesity and its comorbidities, it is complicated by long-term weight regain in over 20% of patients. AIMS: We sought to determine the metabolite signatures of serum samples of patients with weight regain (RYGB-WR) after RYGB and features distinguishing these patients from patients with sustained weight loss (RYGB-SWL). METHODS: We prospectively analyzed serum samples from 21 RYGB-WR patients, 14 RYGB-SWL patients, and 11 unoperated controls. The main outcome measure was their serum metabolite profile. RESULTS: Weight regain after RYGB was associated with a unique serum metabolomic fingerprint. Most of the statistically different metabolites were involved in amino acid metabolism, one-carbon metabolism, and related nucleotide metabolism. A principal component analysis identified groups of metabolites that correlate with weight regain. Specifically, weight regain was associated with lower serum levels of metabolites related to the serine, glycine and threonine pathway, phenylalanine metabolism, tricyclic acid cycle, alanine and glutamate metabolism, and higher levels of other amino acids. CONCLUSIONS: Weight regain after RYGB is associated with unique serum metabolite signatures. Metabolite profiling may eventually help us to identify markers that could differentiate the patients who will regain weight versus those who will likely sustain weight loss.


Assuntos
Derivação Gástrica/tendências , Metabolômica/tendências , Obesidade/metabolismo , Obesidade/cirurgia , Aumento de Peso/fisiologia , Redução de Peso/fisiologia , Adulto , Idoso , Feminino , Derivação Gástrica/métodos , Humanos , Masculino , Metabolômica/métodos , Pessoa de Meia-Idade , Projetos Piloto , Estudos Prospectivos
7.
Gastroenterology ; 155(5): 1483-1494.e7, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30056094

RESUMO

BACKGROUND & AIMS: It is unclear whether participation in competency-based fellowship programs for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) results in high-quality care in independent practice. We measured quality indicator (QI) adherence during the first year of independent practice among physicians who completed endoscopic training with a systematic assessment of competence. METHODS: We performed a prospective multicenter cohort study of invited participants from 62 training programs. In phase 1, 24 advanced endoscopy trainees (AETs), from 20 programs, were assessed using a validated competence assessment tool. We used a comprehensive data collection and reporting system to create learning curves using cumulative sum analysis that were shared with AETs and trainers quarterly. In phase 2, participating AETs entered data into a database pertaining to every EUS and ERCP examination during their first year of independent practice, anchored by key QIs. RESULTS: By the end of training, most AETs had achieved overall technical competence (EUS 91.7%, ERCP 73.9%) and cognitive competence (EUS 91.7%, ERCP 94.1%). In phase 2 of the study, 22 AETs (91.6%) participated and completed a median of 136 EUS examinations per AET and 116 ERCP examinations per AET. Most AETs met the performance thresholds for QIs in EUS (including 94.4% diagnostic rate of adequate samples and 83.8% diagnostic yield of malignancy in pancreatic masses) and ERCP (94.9% overall cannulation rate). CONCLUSIONS: In this prospective multicenter study, we found that although competence cannot be confirmed for all AETs at the end of training, most meet QI thresholds for EUS and ERCP at the end of their first year of independent practice. This finding affirms the effectiveness of training programs. Clinicaltrials.gov ID NCT02509416.


Assuntos
Colangiopancreatografia Retrógrada Endoscópica , Competência Clínica , Endossonografia , Colangiopancreatografia Retrógrada Endoscópica/normas , Endossonografia/normas , Humanos , Curva de Aprendizado , Estudos Prospectivos , Indicadores de Qualidade em Assistência à Saúde
10.
Gastrointest Endosc ; 89(6): 1160-1168.e9, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30738985

RESUMO

BACKGROUND AND AIMS: Minimum EUS and ERCP volumes that should be offered per trainee in "high quality" advanced endoscopy training programs (AETPs) are not established. We aimed to define the number of procedures required by an "average" advanced endoscopy trainee (AET) to achieve competence in technical and cognitive EUS and ERCP tasks to help structure AETPs. METHODS: American Society for Gastrointestinal Endoscopy (ASGE)-recognized AETPs were invited to participate; AETs were graded on every fifth EUS and ERCP examination using a validated tool. Grading for each skill was done using a 4-point scoring system, and learning curves using cumulative sum analysis for overall, technical, and cognitive components of EUS and ERCP were shared with AETs and trainers quarterly. Generalized linear mixed-effects models with a random intercept for each AET were used to generate aggregate learning curves, allowing us to use data from all AETs to estimate the average learning experience for trainees. RESULTS: Among 62 invited AETPs, 37 AETs from 32 AETPs participated. Most AETs reported hands-on EUS (52%, median 20 cases) and ERCP (68%, median 50 cases) experience before starting an AETP. The median number of EUS and ERCPs performed per AET was 400 (range, 200-750) and 361 (range, 250-650), respectively. Overall, 2616 examinations were graded (EUS, 1277; ERCP-biliary, 1143; pancreatic, 196). Most graded EUS examinations were performed for pancreatobiliary indications (69.9%) and ERCP examinations for ASGE biliary grade of difficulty 1 (72.1%). The average AET achieved competence in core EUS and ERCP skills at approximately 225 and 250 cases, respectively. However, overall technical competence was achieved for grade 2 ERCP at about 300 cases. CONCLUSION: The thresholds provided for an average AET to achieve competence in EUS and ERCP may be used by the ASGE and AETPs in establishing the minimal standards for case volume exposure for AETs during their training. (Clinical trial registration number: NCT02509416.).


Assuntos
Colangiopancreatografia Retrógrada Endoscópica , Competência Clínica , Educação de Pós-Graduação em Medicina/normas , Endoscopia do Sistema Digestório/educação , Endossonografia , Bolsas de Estudo/normas , Gastroenterologia/educação , Curva de Aprendizado , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico , Humanos , Estudos Prospectivos , Esfinterotomia Endoscópica/educação
11.
Gastrointest Endosc ; 85(1): 243-247, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27468858

RESUMO

BACKGROUND AND AIMS: Transjugular intrahepatic portosystemic shunting involves the creation of a low-resistance channel between the portal vein (PV) and the hepatic vein (HV), and is routinely performed under angiography. The aims were to evaluate (1) safety and technical feasibility; (2) procedural duration; and (3) subjective workload assessment of EUS-guided intrahepatic portosystemic shunt (EIPS). METHODS: Five Yorkshire pigs were used in the study. The HV or inferior vena cava (IVC) was identified using a linear-array echoendoscope and accessed with a 19-G FNA needle preloaded with a digital pressure wire. Mean pressure was recorded. The needle was advanced into the PV, where pressure measurements were again taken, and ultimately exchanged over a guidewire. A lumen-apposing metal stent was deployed under EUS and fluoroscopic guidance, with distal and proximal ends positioned inside the PV and HV (IVC), respectively. Dilation was performed, and pressure measurements repeated. The National Aeronautics and Space Administration (NASA) Task Load Index (TLI) was scored. Animals survived 2 weeks before necropsy. RESULTS: EIPS was successful in 5 out of 5 pigs. Mean time required for EUS identification, needle access, pressure measurement, and stent placement was 43 (31-55) minutes. NASA TLI scores revealed moderate workload. Mean baseline pressure measurements were PV 7.0 (5-9) and HV/IVC 5.0 (3-7) mm Hg and PV 6.3 (5-7) and HV/IVC 6.0 (4-7) mm Hg after. All animals survived 2 weeks. No bleeding was seen on necropsy. CONCLUSIONS: This study demonstrates the technical feasibility of EIPS using LAMS, with direct portal pressure measurement, in a survival model. In addition, the procedure was performed quickly with moderate technical demand.


Assuntos
Derivação Portossistêmica Cirúrgica/métodos , Ultrassonografia de Intervenção , Animais , Endossonografia , Estudos de Viabilidade , Veias Hepáticas/fisiologia , Duração da Cirurgia , Pressão na Veia Porta , Derivação Portossistêmica Cirúrgica/efeitos adversos , Stents , Suínos , Ultrassonografia de Intervenção/efeitos adversos , Carga de Trabalho/psicologia
12.
Scand J Gastroenterol ; 52(6-7): 784-787, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28355953

RESUMO

BACKGROUND: There are very few available data on the novel SharkCore™ needles for EUS-FNB. AIM: Comparison of the performance of the SharkCore™ needles with the standard EUS-FNA needles for the diagnosis of solid upper GI masses. PATIENTS AND METHODS: Single-center, retrospective cohort study in an academic tertiary referral hospital. Patients were matched 1:1 for the site of the lesion and the presence or absence of rapid on-site evaluation (ROSE). RESULTS: A total of 102 patients were included. There was no statistically significant difference in the mean number of passes (3.3 ± 1.3 versus 3.4 ± 1.5; p = .89). Similar results were observed at the subgroup with ROSE (4.3 ± 1.3 versus 3.7 ± 1.5; p = .26). More histological specimens were obtained with the SharkCore™ needles compared to standard needles (59 versus 5%; p < .001). Diagnostic test characteristics were not significantly different (sensitivity: 91.5 versus 85.7; specificity: 100 versus 100%; accuracy: 92.2 versus 85.4% for SharkCore™ versus standard needles, p > .05 in all cases). At multivariable analysis, there was no statistically significant difference in the mean number of passes in all patients (p = .23) and in the ROSE subgroup (p = .66). However, the SharkCore™ needle obtained significantly more histological material than the standard needle (odds ratio 66; 95% confidence interval: 11.8, 375.8, p < .001). There was no significant difference in complication rates (p = .5). LIMITATIONS: Retrospective study, single-center. CONCLUSION: The SharkCore needles were similar to standard FNA needles in terms of the number of passes to reach diagnosis, but obtained significantly more histological specimen.


Assuntos
Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico/instrumentação , Agulhas/classificação , Neoplasias/patologia , Trato Gastrointestinal Superior/patologia , Idoso , Diagnóstico Diferencial , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Neoplasias/diagnóstico , Análise de Regressão , Estudos Retrospectivos , Sensibilidade e Especificidade , Centros de Atenção Terciária
13.
Surg Endosc ; 31(10): 4010-4015, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28229238

RESUMO

BACKGROUND: Preclinical simulator training has the potential to decrease endoscopic procedure time and patient discomfort. This study aims to characterize the learning curve of endoscopic novices in a part-task simulator and propose a threshold score for advancement to initial clinical cases. METHODS: Twenty novices with no prior endoscopic experience underwent repeated endoscopic simulator sessions using the part-task simulator. Simulator scores were collected; their inverse was averaged and fit to an exponential curve. The incremental improvement after each session was calculated. Plateau was defined as the session after which incremental improvement in simulator score model was less than 5%. Additionally, all participants filled out questionnaires regarding simulator experience after sessions 1, 5, 10, 15, and 20. A visual analog scale and NASA task load index were used to assess levels of comfort and demand. RESULTS: Twenty novices underwent 400 simulator sessions. Mean simulator scores at sessions 1, 5, 10, 15, and 20 were 78.5 ± 5.95, 176.5 ± 17.7, 275.55 ± 23.56, 347 ± 26.49, and 441.11 ± 38.14. The best fit exponential model was [time/score] = 26.1 × [session #]-0.615; r 2 = 0.99. This corresponded to an incremental improvement in score of 35% after the first session, 22% after the second, 16% after the third and so on. Incremental improvement dropped below 5% after the 12th session corresponding to the predicted score of 265. Simulator training was related to higher comfort maneuvering an endoscope and increased readiness for supervised clinical endoscopy, both plateauing between sessions 10 and 15. Mental demand, physical demand, and frustration levels decreased with increased simulator training. CONCLUSION: Preclinical training using an endoscopic part-task simulator appears to increase comfort level and decrease mental and physical demand associated with endoscopy. Based on a rigorous model, we recommend that novices complete a minimum of 12 training sessions and obtain a simulator score of at least 265 to be best prepared for clinical endoscopy.


Assuntos
Competência Clínica/normas , Endoscopia/educação , Treinamento por Simulação , Adulto , Simulação por Computador , Avaliação Educacional , Endoscopia/normas , Feminino , Humanos , Curva de Aprendizado , Masculino , Treinamento por Simulação/normas , Análise e Desempenho de Tarefas
14.
Endoscopy ; 48(11): 1023-1028, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27576179

RESUMO

Background and aim: Endoscopic closure of fistulas is desirable but remains a challenge, especially for gastrogastric fistulas. The aim of this study was to assess the success rate for the closure of gastrointestinal fistulas using an endoscopic suturing device. Patients and methods: Electronic records at three medical centers were reviewed to identify patients who underwent sutured fistula closure as recorded on a central database. Demographic details, clinical variables, and details of the endoscopic procedure were recorded. Results: A total of 56 patients (mean age 54 ± 12.7 years) underwent fistula closure. Gastrogastric fistulas were most common (n = 29; 51.8 %). Sixteen patients (28.6 %) had undergone previous failed attempts at closure. Immediate success was universal (n = 56; 100 %). Thirteen patients had persistent closure without any need for further therapies, while 17 underwent additional endoscopic procedures, with successful closure in 4 /17. Only one patient had abdominal pain requiring hospital admission. Conclusion: Sutured closure of fistulas in a single session is safe and can be expected, even in what are known to be challenging cases. Sequential closure for recurrences is sometimes successful in the longer term.


Assuntos
Fístula Cutânea/cirurgia , Endoscopia Gastrointestinal/métodos , Fístula Gástrica/cirurgia , Fístula Intestinal/cirurgia , Técnicas de Sutura , Adulto , Idoso , Fístula Cutânea/diagnóstico por imagem , Intervalo Livre de Doença , Endoscopia Gastrointestinal/efeitos adversos , Feminino , Seguimentos , Fístula Gástrica/diagnóstico por imagem , Humanos , Fístula Intestinal/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Recidiva , Reoperação , Estudos Retrospectivos , Técnicas de Sutura/efeitos adversos
15.
Gastrointest Endosc ; 80(3): 495-502, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-24679655

RESUMO

BACKGROUND: The lack of countertraction in endoscopic submucosal dissection (ESD) results in increased technical demand and procedure time. Although the suture-pulley method for countertraction has been reported, its effectiveness compared with the traditional ESD technique remains unclear. OBJECTIVE: To objectively analyze efficacy of countertraction using the suture-pulley method for ESD. DESIGN: Prospective ex vivo animal study. SETTING: Animal laboratory. INTERVENTIONS: Twenty simulated gastric lesions were created in porcine stomachs by using a standard circular template 30 mm in diameter. In the control arm (n = 10), ESD was performed by using the standard technique. In the suture-pulley arm (N = 10), a circumferential incision was made, and an endoscopic suturing device was used to place the suture pulley. MAIN OUTCOME MEASUREMENTS: The primary outcome of this study was total procedure time. RESULTS: The median total procedure time with the suture-pulley method was significantly shorter than the traditional ESD technique (median, 25% to 75%, interquartile range [IQR]: 531 seconds [474.3-549.3 seconds] vs 845 seconds [656.3-1547.5 seconds], P < .001). The median time (IQR) for suture-pulley placement was 160.5 seconds (150.0-168.8 seconds). Although there was a significantly longer procedure time for proximal versus middle/lower stomach lesions with traditional ESD (median, 1601 seconds; IQR, 1547.5-1708.8 seconds vs median, 663 seconds; IQR, 627.5-681.8 seconds; P = .01), there was no significant difference in procedure time for lesions of various locations when using the suture-pulley method. Compared with traditional ESD, the suture-pulley method was less demanding in all categories evaluated by the NASA Task Load Index. LIMITATIONS: Ex vivo study. CONCLUSIONS: The suture-pulley method facilitates direct visualization of the submucosal layer during ESD and significantly reduces procedure time and technical difficulty. In addition, the benefit of the suture-pulley method was seen for both simple and more complicated ESDs.


Assuntos
Dissecação/métodos , Mucosa Gástrica/cirurgia , Gastroscopia/métodos , Duração da Cirurgia , Estômago/cirurgia , Suturas , Animais , Modelos Anatômicos , Modelos Animais , Estudos Prospectivos , Técnicas de Sutura , Suínos
17.
VideoGIE ; 8(7): 260-262, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37456216

RESUMO

Video 1Closure of a refractory gastrocutaneous fistula with endoscopically guided percutaneous suturing with the use of miniature biopsy forceps.

18.
Clin Endosc ; 56(6): 754-760, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37157961

RESUMO

BACKGROUND/AIMS: Endoscopic vacuum therapy (EVT) can heal a variety of defects within the gastrointestinal (GI) tract via applying negative pressure, which reduces the defect size, aspirates the infected fluid, and promotes granulation tissue. Here we present our experience with EVT as it relates to both spontaneous and iatrogenic upper GI tract perforations, leaks, and fistulas. METHODS: This retrospective study was conducted at four large hospital centers. All patients who underwent EVT between June 2018 and March 2021 were included. Data on multiple variables were collected, including demographics, defect size and location, number and intervals of EVT exchanges, technical success, and hospital length of stay. Student t-test and the chi-squared test were used to analyze the data. RESULTS: Twenty patients underwent EVT. The most common defect cause was spontaneous esophageal perforation (50%). The most common defect location was the distal esophagus (55%). The success rate was 80%. Seven patients were treated with EVT as the primary closure method. The mean number of exchanges was five with a mean interval of 4.3 days between exchanges. The mean length of hospital stay was 55.8 days. CONCLUSION: EVT is a safe and effective initial management option for esophageal leaks and perforations.

20.
VideoGIE ; 7(8): 278-279, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-36034069

RESUMO

Video 1The peroral endoscopic tunneling-silastic bandectomy technique to remove a silastic band causing a vertical banded gastroplasty stenosis. This method is a viable alternative to surgical removal of foreign bodies outside the gastrointestinal lumen.

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