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1.
Ann Surg ; 2024 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-39225420

RESUMO

OBJECTIVE: To compare outcomes of laparoscopic transgastric necrosectomy (LTN) and direct endoscopic necrosectomy (DEN) in the management of retrogastric walled-off necrosis. SUMMARY OF BACKGROUND DATA: Surgical and endoscopic transgastric approaches are used to manage retrogastric pancreatic necrosis. Studies comparing these treatment modalities are lacking but would influence contemporary practice patterns. METHODS: LTN or DEN treated patients at Stanford University Hospital between 2011 and 2023 were identified. Cohort data included demographics, core pancreatitis care benchmarks, and clinical outcomes (total debridement time, new-onset endocrine and exocrine pancreatic insufficiency) as well as re-intervention, 30-day readmission, complication, and mortality rates. Long-term follow-up was also compared between intervention arms. Multivariable linear regression was used to assess the interaction between admission APACHE-II score and intervention on length of stay (LOS). RESULTS: 106 patients (62% LTN, 38% DEN) were identified. Demographic and core pancreatitis benchmark data were similar between cohorts. 30-day readmission, complication, and mortality rates for surgical and endoscopic approaches were also similar: 23% vs. 25% (P = 0.98), 42% vs. 40% (P = 0.97), and 3% vs. 3% (P > 0.99). Median LTN total debridement time (minutes) was 131 vs. 134 for DEN, however, complete debridement was achieved with only 1 LTN compared to 3 DENs (P<0.01). While not statistically significant, LOS and unplanned intervention rates were less for LTN (8 vs. 10 days, P = 0.41 and 6% vs. 15%, P = 0.24). Multivariable analysis revealed a significant interaction between APACHE-II scores and LOS for LTN compared to DEN, which translated into a length of stay reduction for higher APACHE-II scoring patients (P = 0.02). CONCLUSIONS: LTN is a safe and efficient treatment modality for walled-off necrosis, and compared to DEN, can reduce the LOS in high APACHE-II score patients. While additional comparative research between the two intervention types is needed, this study supports a role for a surgical approach in the management of retrogastric pancreatic necrosis.

2.
Gastroenterology ; 164(5): 736-751, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36706842

RESUMO

Gastric cancer (GC) is a leading cause of global mortality but also a cancer whose footprint is highly unequal. This review aims to define global disease epidemiology, critically appraise strategies of prevention and disease attenuation, and assess how these strategies could be applied to improve outcomes from GC in a world of variable risk and disease burden. Strategies of primary prevention focus on improving the detection and eradication of the main environmental risk factor, Helicobacter pylori. In certain countries of high incidence, endoscopic or radiographic screening of the asymptomatic general population has been adopted as a means of secondary prevention. By contrast, identification and targeted surveillance of individuals with precancerous lesions (such as intestinal metaplasia) is being increasingly embraced in nations of low incidence. This review also highlights existing knowledge gaps in GC prevention as well as the role of emerging technologies for early detection and risk stratification.


Assuntos
Infecções por Helicobacter , Helicobacter pylori , Lesões Pré-Cancerosas , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/diagnóstico , Neoplasias Gástricas/epidemiologia , Neoplasias Gástricas/prevenção & controle , Infecções por Helicobacter/complicações , Infecções por Helicobacter/diagnóstico , Infecções por Helicobacter/epidemiologia , Lesões Pré-Cancerosas/diagnóstico , Lesões Pré-Cancerosas/epidemiologia , Lesões Pré-Cancerosas/patologia , Endoscopia/efeitos adversos , Incidência , Metaplasia/patologia , Mucosa Gástrica/patologia , Fatores de Risco
3.
Artigo em Inglês | MEDLINE | ID: mdl-39214390

RESUMO

BACKGROUND & AIMS: There is significant variability in the immediate post-operative and long-term management of patients undergoing per-oral endoscopic myotomy (POEM), largely stemming from the lack of high-quality evidence. We aimed to establish a consensus on several important questions on the after care of post-POEM patients through a modified Delphi process. METHODS: A steering committee developed an initial questionnaire consisting of 5 domains (33 statements): post-POEM admission/discharge, indication for immediate post-POEM esophagram, peri-procedural medications and diet resumption, clinic follow-up recommendations, and post-POEM reflux surveillance and management. A total of 34 experts participated in the 2 rounds of the Delphi process, with quantitative and qualitative data analyzed for each round to achieve consensus. RESULTS: A total of 23 statements achieved a high degree of consensus. Overall, the expert panel agreed on the following: (1) same-day discharge after POEM can be considered in select patients; (2) a single dose of prophylactic antibiotics may be as effective as a short course; (3) a modified diet can be advanced as tolerated; and (4) all patients should be followed in clinic and undergo objective testing for surveillance and management of reflux. Consensus could not be achieved on the indication of post-POEM esophagram to evaluate for leak. CONCLUSIONS: The results of this Delphi process established expert agreement on several important issues and provides practical guidance on key aspects in the care of patients following POEM.

4.
Gastrointest Endosc ; 2024 Sep 30.
Artigo em Inglês | MEDLINE | ID: mdl-39357660

RESUMO

BACKGROUND AND AIMS: Covered self-expanding metal stents (C-SEMS) are used for malignant hilar biliary obstruction (MHBO) management. Despite increasing evidence, comprehensive evaluation of the efficacy and safety of C-SEMS in MHBO management is lacking. METHODS: PubMed, EMBASE, and the Cochrane Library were screened up to March 31, 2024 for studies including MHBO treated by a C-SEMS. Studies meeting predefined inclusion criteria, including adult MHBO patients treated with C-SEMS placement, reporting technical success, clinical success, and adverse event rates, were selected. Data synthesis and statistical analysis were performed using the random effects model, with heterogeneity and publication bias assessment. RESULTS: From 401 articles, seven studies were included. Pooled technical and clinical success rate of C-SEMS was 96.7% (95% CI 92.6-98.6%, I2=0%) and 91.6% (95% CI 86.1-95.0%, I2=0%). Overall adverse events were reported in 16.6% (95% CI 11.2-23.9%, I2=24%) of cases which included cholangitis (7.4%), pancreatitis (5.9%), liver abscess (5.9%), and cholecystitis (2.8%). Stent migration and recurrent biliary obstruction were observed in 8.9% and 49.6% of cases, respectively, with a median time to recurrent biliary obstruction of 142 days. Reintervention was successful in 92.5% of cases (95% CI 83.1-96.9%, I2=0%) CONCLUSION: Our meta-analysis revealed high technical and clinical success rates of C-SEMS in MHBO. Adverse events, notably cholangitis, cholecystitis, and pancreatitis were <10%. RBO and stent migration was mitigated by C-SEMS removal and successful reintervention. Our findings highlight the efficacy and safety of C-SEMS in managing MHBO, warranting further research to optimize treatment strategies.

5.
Gastrointest Endosc ; 99(1): 83-90.e1, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-37481003

RESUMO

BACKGROUND AND AIMS: Complete closure after endoscopic resection of large nonpedunculated colorectal lesions (LNPCLs) can reduce delayed bleeding but is challenging with conventional through-the-scope (TTS) clips alone. The novel dual-action tissue (DAT) clip has clip arms that open and close independently of each other, facilitating tissue approximation. We aimed to evaluate the rate of complete closure and delayed bleeding with the DAT clip after endoscopic resection of LNPCLs. METHODS: This was a multicenter prospective cohort study of all patients who underwent defect closure with the DAT clip after EMR or endoscopic submucosal dissection (ESD) of LNPCLs ≥20 mm from July 2022 to May 2023. Delayed bleeding was defined as a bleeding event requiring hospitalization, blood transfusion, or any intervention within 30 days after the procedure. Complete closure was defined as apposition of mucosal defect margins without visible submucosal areas <3 mm along the closure line. RESULTS: One hundred seven patients (median age, 64 years; 42.5% women) underwent EMR (n = 63) or ESD (n = 44) of LNPCLs (median size, 40 mm; 74.8% right-sided colon) followed by defect closure. Complete closure was achieved in 96.3% (n = 103) with a mean of 1.4 ± .6 DAT clips and 2.9 ± 1.8 TTS clips. Delayed bleeding occurred in 1 patient (.9%) without requiring additional interventions. CONCLUSIONS: The use of the DAT clip in conjunction with TTS clips achieved high complete defect closure after endoscopic resection of large LNPCLs and was associated with a .9% delayed bleeding rate. Future comparative trials and formal cost-analyses are needed to validate these findings. (Clinical trial registration number: NCT05852457.).


Assuntos
Neoplasias Colorretais , Ressecção Endoscópica de Mucosa , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Estudos Prospectivos , Hemorragia , Ressecção Endoscópica de Mucosa/efeitos adversos , Ressecção Endoscópica de Mucosa/métodos , Instrumentos Cirúrgicos , Mucosa Intestinal/cirurgia , Mucosa Intestinal/patologia , Neoplasias Colorretais/cirurgia , Neoplasias Colorretais/patologia , Resultado do Tratamento , Estudos Retrospectivos
6.
Gastrointest Endosc ; 100(2): 240-246, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38431104

RESUMO

BACKGROUND AND AIMS: Direct endoscopic necrosectomy (DEN) is a recommended strategy for treatment of walled-off necrosis (WON). DEN uses a variety of devices including the EndoRotor (Interscope, Inc, Northbridge, Mass, USA) debridement catheter. Recently, a 5.1-mm EndoRotor with an increased chamber size and rate of tissue removal was introduced. The aim of this study was to assess the efficacy and safety of this device. METHODS: A multicenter cohort study was conducted at 8 institutions including patients who underwent DEN with the 5.1-mm EndoRotor. The primary outcome was the number of DEN sessions needed for WON resolution. Secondary outcomes were the average percentage of reduction in solid WON debris and decrease in WON area per session, total time spent performing EndoRotor therapy for WON resolution, and adverse events (AEs). RESULTS: Sixty-four procedures in 41 patients were included. For patients in which the 5.1-mm EndoRotor catheter was the sole therapeutic modality, an average of 1.6 DEN sessions resulted in WON resolution with an average cumulative time of 85.5 minutes. Of the 21 procedures with data regarding percentage of solid debris, the average reduction was 85% ± 23% per session. Of the 19 procedures with data regarding WON area, the mean area significantly decreased from 97.6 ± 72.0 cm2 to 27.1 ± 35.5 cm2 (P < .001) per session. AEs included 2 intraprocedural dislodgements of lumen-apposing metal stents managed endoscopically and 3 perforations, none of which was related to the EndoRotor. Bleeding was reported in 7 cases, in which none required embolic or surgical therapy and 2 required blood transfusions. CONCLUSIONS: This is the first multicenter retrospective study to investigate the efficacy and safety of the 5.1-mm EndoRotor catheter for WON. Results from this study showed an average of 1.6 DEN sessions were needed to achieve WON resolution with an 85% single-session reduction in solid debris and a 70% single-session decrease in WON area with minimal AEs.


Assuntos
Catéteres , Desbridamento , Pancreatite Necrosante Aguda , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Desbridamento/métodos , Pancreatite Necrosante Aguda/cirurgia , Pancreatite Necrosante Aguda/terapia , Idoso , Adulto , Resultado do Tratamento , Estudos Retrospectivos , Estudos de Coortes
7.
Gastrointest Endosc ; 99(6): 924-930, 2024 06.
Artigo em Inglês | MEDLINE | ID: mdl-38184116

RESUMO

BACKGROUND AND AIMS: Opioid-induced esophageal dysfunction (OIED) often presents as spastic esophageal disorders (SEDs) and esophagogastric junction outflow obstruction (EGJOO). The aim of this study was to evaluate and compare clinical outcomes of peroral endoscopic myotomy (POEM) for SEDs and EGJOO among opioid users and nonusers. METHODS: This propensity score (PS) matching study included consecutive opioid users and nonusers who underwent POEM for SEDs and EGJOO between January 2018 and September 2022. The following covariates were used for the PS calculation: age, sex, duration of symptoms, Eckardt score, type of motility disorder, and length of myotomy during POEM. Clinical response was defined as a post-POEM Eckardt score ≤3. RESULTS: A total of 277 consecutive patients underwent POEM during the study period. PS matching resulted in the selection of 64 pairs of patients strictly matched 1:1 (n = 128) with no statistically significant differences in demographic, baseline, or procedural characteristics or in the parameters considered for the PS between the 2 groups. Clinical response to POEM was significantly lower among opioid users (51 of 64 [79.7%]) versus nonusers (60 of 64 [93.8%]) (P = .03) at a median follow-up of 18 months. Among opioid users, higher opioid dose (>60 morphine milligram equivalents per day) was associated with a higher likelihood of failure to respond to POEM (odds ratio, 4.59; 95% confidence interval, 1.31-3.98; P = .02). CONCLUSIONS: Clinical response to POEM for SEDs and EGJOO is significantly lower among opioid users versus nonusers. There was a dose-relationship between opioids and response to POEM, with higher daily opioid usage associated with a higher likelihood of treatment failure.


Assuntos
Transtornos da Motilidade Esofágica , Miotomia , Pontuação de Propensão , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Transtornos da Motilidade Esofágica/cirurgia , Miotomia/métodos , Miotomia/efeitos adversos , Analgésicos Opioides/uso terapêutico , Cirurgia Endoscópica por Orifício Natural/métodos , Cirurgia Endoscópica por Orifício Natural/efeitos adversos , Idoso , Estudos Retrospectivos , Resultado do Tratamento , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Esofagoscopia/métodos
8.
Surg Endosc ; 38(4): 2280-2287, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38467861

RESUMO

BACKGROUND: Endoscopic submucosal dissection (ESD) is the standard treatment for early malignant stomach lesions. However, this procedure is technically demanding and carries a high complication risk. The level of difficulty in performing ESD is influenced by the location of the lesion. In our study, we aimed to investigate and analyze the effectiveness of robot-assisted ESD for lesions situated in challenging locations within the stomach. METHODS: We developed a gastric simulator that could be used to implement various gastric ESD locations. An EndoGel (Sunarrow, Tokyo, Japan) was attached to the simulator for the dissection procedures. Robot-assisted or conventional ESD was performed at challenging or easy locations by two ESD-trainee endoscopists. RESULTS: The procedure time was remarkably shorter for robotic ESD than conventional dissection at challenging locations (6.2 vs. 10.2 min, P < 0.05), mainly due to faster dissection (220.3 vs. 101.9 mm2/min, P < 0.05). The blind dissection rate was significantly lower with robotic ESD than with the conventional method (17.6 vs. 35.2%, P < 0.05) at challenging locations. CONCLUSION: The procedure time was significantly shortened when robot-assisted gastric ESD procedures were performed at challenging locations. Therefore, our robotic device provides simple, effective, and safe multidirectional traction for endoscopic submucosal dissection at challenging locations, thereby reducing difficulty of the procedure.


Assuntos
Ressecção Endoscópica de Mucosa , Robótica , Neoplasias Gástricas , Humanos , Mucosa Gástrica/cirurgia , Mucosa Gástrica/patologia , Ressecção Endoscópica de Mucosa/métodos , Neoplasias Gástricas/cirurgia , Neoplasias Gástricas/patologia , Resultado do Tratamento
9.
J Clin Gastroenterol ; 57(2): 159-164, 2023 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-35180150

RESUMO

BACKGROUND: Question prompt lists (QPLs) are structured sets of disease-specific questions that enhance patient-physician communication by encouraging patients to ask questions during consultations. AIM: The aim of this study was to develop a preliminary achalasia-specific QPL created by esophageal experts. METHODS: The QPL content was derived through a modified Delphi method consisting of 2 rounds. In round 1, experts provided 5 answers to the prompts "What general questions should patients ask when given a new diagnosis of achalasia" and "What questions do I not hear patients asking, but given my expertise, I believe they should be asking?" In round 2, experts rated questions on a 5-point Likert scale. Questions considered "essential" or "important" were accepted into the QPL. Feedback regarding the QPL was obtained in a pilot study wherein patients received the QPL before their consultation and completed surveys afterwards. RESULTS: Nineteen esophageal experts participated in both rounds. Of 148 questions from round 1, 124 (83.8%) were accepted into the QPL. These were further reduced to 56 questions to minimize redundancy. Questions were categorized into 6 themes: "What is achalasia," "Risks with achalasia," "Symptom management in achalasia," "Treatment of achalasia," "Risk of reflux after treatment," and "Follow-up after treatment." Nineteen patients participated in the pilot, most of whom agreed that the QPL was helpful (84.2%) and recommended its wider use (84.2%). CONCLUSIONS: This is the first QPL developed specifically for adults with achalasia. Although well-received in a small pilot, follow-up studies will incorporate additional patient feedback to further refine the QPL content and assess its usability, acceptability, and feasibility.


Assuntos
Acalasia Esofágica , Humanos , Adulto , Acalasia Esofágica/diagnóstico , Acalasia Esofágica/terapia , Projetos Piloto , Técnica Delphi , Participação do Paciente , Comunicação , Inquéritos e Questionários , Relações Médico-Paciente
10.
Gastroenterology ; 161(6): 2030-2040.e1, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34689964

RESUMO

The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update was to review the available evidence and provide expert advice regarding surveillance using endoscopy and other relevant modalities after removal of dysplastic lesions and early gastrointestinal cancers with endoscopic submucosal dissection deemed to be pathologically curative. This Clinical Practice Update was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the Clinical Practice Updates Committee and external peer review through standard procedures of Gastroenterology. This expert commentary incorporates important as well as recently published studies in this field, and it reflects the experiences of the authors, who are advanced endoscopists with high-level expertise in performing endoscopic submucosal dissection to treat dysplasia and early cancers in the luminal gastrointestinal tract.


Assuntos
Diagnóstico por Imagem/normas , Detecção Precoce de Câncer/normas , Ressecção Endoscópica de Mucosa/normas , Endoscopia Gastrointestinal/normas , Gastroenterologia/normas , Neoplasias Gastrointestinais/cirurgia , Biópsia/normas , Tomada de Decisão Clínica , Consenso , Ressecção Endoscópica de Mucosa/efeitos adversos , Neoplasias Gastrointestinais/diagnóstico por imagem , Neoplasias Gastrointestinais/patologia , Humanos , Margens de Excisão , Estadiamento de Neoplasias , Valor Preditivo dos Testes , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
11.
Clin Gastroenterol Hepatol ; 20(4): 950-952.e3, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-33434656

RESUMO

Early identification of gastric precancerous lesions, including atrophic gastritis (AG) and intestinal metaplasia (IM), may improve gastric cancer detection and prevention. Because AG and IM are generally asymptomatic, many of the estimated 15 million Americans who carry these lesions remain undiagnosed.1 AG and IM are associated with either active or prior Helicobacter pylori (Hp) infection. Hp infection leads to perturbations in the serum concentration of gastric hormones pepsinogen I (PGI), pepsinogen II, the pepsinogen I/II ratio (PGR), gastrin-17 (G-17), and Hp IgG.2,3 In East Asia and other regions with high burden of Hp infection and gastric cancer, these biomarkers have been used as screening tools for AG and IM.4 However, there exists limited data on the sensitivity and discrimination of these serologic markers in low-Hp-prevalence populations, such as the United States.


Assuntos
Helicobacter pylori , Lesões Pré-Cancerosas , Gastrinas , Humanos , Pepsinogênio A , Lesões Pré-Cancerosas/diagnóstico , Lesões Pré-Cancerosas/patologia , Estômago/patologia , Estados Unidos/epidemiologia
12.
Clin Gastroenterol Hepatol ; 20(10): 2218-2228.e2, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-34624563

RESUMO

BACKGROUND & AIMS: Gastric cancer (GC) remains a leading cause of mortality among certain racial, ethnic, and immigrant groups in the United States (US). The majority of GCs are diagnosed at advanced stages, and overall survival remains poor. There exist no structured national strategies for GC prevention in the US. METHODS: On March 5-6, 2020 a summit of researchers, policy makers, public funders, and advocacy leaders was convened at Stanford University to address this critical healthcare disparity. After this summit, a writing group was formed to critically evaluate the effectiveness, potential benefits, and potential harms of methods of primary and secondary prevention through structured literature review. This article represents a consensus statement prepared by the writing group. RESULTS: The burden of GC is highly inequitably distributed in the US and disproportionately falls on Asian, African American, Hispanic, and American Indian/Alaskan Native populations. In randomized controlled trials, strategies of Helicobacter pylori testing and treatment have been demonstrated to reduce GC-specific mortality. In well-conducted observational and ecologic studies, strategies of endoscopic screening have been associated with reduced GC-specific mortality. Notably however, all randomized controlled trial data (for primary prevention) and the majority of observational data (for secondary prevention) are derived from non-US sources. CONCLUSIONS: There exist substantial, high-quality data supporting GC prevention derived from international studies. There is an urgent need for cancer prevention trials focused on high-risk immigrant and minority populations in the US. The authors offer recommendations on how strategies of primary and secondary prevention can be applied to the heterogeneous US population.


Assuntos
Infecções por Helicobacter , Helicobacter pylori , Neoplasias Gástricas , Etnicidade , Disparidades em Assistência à Saúde , Infecções por Helicobacter/epidemiologia , Hispânico ou Latino , Humanos , Prevenção Secundária , Neoplasias Gástricas/epidemiologia , Neoplasias Gástricas/prevenção & controle , Estados Unidos/epidemiologia
13.
Cancer Causes Control ; 33(2): 183-191, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34797436

RESUMO

PURPOSE: Gastric cancers are classified as diffuse-type (DTGC) or intestinal-type (ITGC). DTGCs have distinct clinical and histopathologic features, and carry a worse overall prognosis compared to ITGCs. Atrophic gastritis (AG) and intestinal metaplasia (IM) are known precursors to ITGC. It is unknown if AG and IM increase risk for DTGC. METHODS: We performed a systematic review to identify studies reporting on the association of AG/IM and DTGC. We extracted the odds ratio (OR) of the association from studies, and performed pool analysis. Subgroup analysis was performed on studies reporting histologic severity (using operative link systems) to assess if histologic severity of AG/IM was associated with higher risk. RESULTS: We identified six case-control and eight cohort studies for inclusion. Both AG (pooled OR = 1.9, 95% CI 1.5 to 2.4, p < 0.001) and IM (pooled OR = 2.3, 95% CI 1.9 to 2.9, p < 0.001) demonstrated an association with DTGC. High AG severity was associated with increased risk for DTGC compared to low AG severity (OR = 1.7, 95% CI 1.2 to 2.3, p = 0.002). Similarly, high IM severity was associated with increased risk compared to low IM severity (OR = 1.9, 95% CI 1.3 to 2.7, p = 0.001). CONCLUSION: Both AG and IM are associated with DTGC. Increasing histologic severity of both AG and IM increases risk for DTGC. There may exist a common pathway between ITGC and some DTGCs mediated through mucosal precursor lesions. These data may inform future strategies of cancer risk attenuation and control.


Assuntos
Gastrite Atrófica , Infecções por Helicobacter , Helicobacter pylori , Lesões Pré-Cancerosas , Neoplasias Gástricas , Mucosa Gástrica , Gastrite Atrófica/epidemiologia , Humanos , Metaplasia , Lesões Pré-Cancerosas/diagnóstico , Lesões Pré-Cancerosas/epidemiologia , Fatores de Risco , Neoplasias Gástricas/diagnóstico , Neoplasias Gástricas/epidemiologia , Neoplasias Gástricas/etiologia
14.
Gastrointest Endosc ; 95(3): 471-479, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34562471

RESUMO

BACKGROUND AND AIMS: Direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis (WOPN) lacks dedicated instruments and requires repetitive and cumbersome procedures. This study evaluated the safety and efficacy of a new powered endoscopic debridement (PED) system designed to simultaneously resect and remove solid debris within WOPN. METHODS: This was a single-arm, prospective, multicenter, international device trial conducted from November 2018 to August 2019 at 10 sites. Patients with WOPN ≥6 cm and ≤22 cm and with >30% solid debris were enrolled. The primary endpoint was safety through 21 days after the last DEN procedure. Efficacy outcomes included clearance of necrosis, procedural time, adequacy of debridement, number of procedures until resolution, hospital stay duration, and quality of life. RESULTS: Thirty patients (mean age, 55 years; 60% men) underwent DEN with no device-related adverse events. Of 30 patients, 15 (50%) achieved complete debridement in 1 session and 20 (67%) achieved complete debridement within 2 or fewer sessions. A median of 1.5 interventions (range, 1-7) were required. Median hospital stay was 10 days (interquartile range, 22). There was an overall reduction of 91% in percent necrosis within WOPN from baseline to follow-up and 85% in collection volume. Baseline WOPN volume was positively correlated with the total number of interventions (ρ = .363, P = .049). CONCLUSIONS: The new PED system seems to be a safe and effective treatment tool for WOPN, resulting in fewer interventions and lower hospital duration when compared with published data on using conventional instruments. Randomized controlled trials comparing the PED system with conventional DEN are needed. (Clinical trial registration number: NCT03694210.).


Assuntos
Pancreatite Necrosante Aguda , Drenagem/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Necrose/cirurgia , Pâncreas/cirurgia , Pancreatite Necrosante Aguda/cirurgia , Estudos Prospectivos , Qualidade de Vida , Estudos Retrospectivos , Stents , Resultado do Tratamento
15.
Clin Gastroenterol Hepatol ; 19(1): 24-40, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32950747

RESUMO

The evolution of endoscopic ultrasound (EUS) from a diagnostic to a therapeutic procedure has resulted in a paradigm shift toward endoscopic management of disease states that previously required percutaneous or surgical approaches. The past few years have seen additional techniques and devices that have enabled endoscopists to expand its diagnostic and therapeutic capabilities. Some of these techniques initially were reported more than a decade ago; however, with further device development and refinement in techniques there is potential for expanding the application of these techniques and new technologies to a broader group of interventional gastroenterologists. Lack of formalized training, devices, and prospective data regarding their use in addition to a scarcity of guidelines on implementation of these technologies into clinical practice are contributing factors impeding the growth of the field of interventional EUS. In April 2019, the American Gastroenterological Association's Center for Gastrointestinal Innovation and Technology conducted its annual Tech Summit and a key session focused on interventional EUS. This article is a White Paper generated from the conference, discusses the published literature pertaining to the topic of interventional EUS, and outlines a proposed framework for the implementation of interventional EUS techniques into clinical practice. Three primary areas of interventional EUS are addressed: (1) EUS-guided access; (2) EUS-guided tumor ablation; and (3) endohepatology. There was general agreement among participants on several key components. The introduction of these novel interventions requires better tools, more data on safety/outcomes, and improved training for endoscopists. Participants also agreed that widespread implementation and use of these techniques will require support from Gastrointestinal Societies and other key stakeholders including payers. Continued work by the Gastrointestinal Societies and manufacturers to provide training programs, appropriate equipment/work environments, and policies that motivate endoscopists to adopt new techniques is essential for growing the field of interventional EUS.


Assuntos
Endossonografia , Gastroenterologia , Endoscopia , Humanos , Estudos Prospectivos , Ultrassonografia de Intervenção
16.
Gastrointest Endosc ; 93(3): 740-749, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-32739483

RESUMO

BACKGROUND AND AIMS: Loop formation can impede endoscope advancement, destabilize the tip, and cause pain. Strategies to mitigate looping include torque-based reduction maneuvers, variable stiffness shafts, and abdominal splinting. In some cases, these strategies are insufficient, and there is need for novel instruments. Loop formation is of particular concern in colonoscopy, but it can also impact performance of other endoscopic procedures such as enteroscopy and altered-anatomy ERCP. In this case series we demonstrate the utility of a novel rigidizing overtube (Pathfinder; Neptune Medical, Burlingame, Calif, USA) in colonoscopy and other endoscopic procedures where loop management is critical. METHODS: We describe our initial experience with the Pathfinder overtube in 29 patients. The overtube is 85 cm long and can accommodate a pediatric colonoscope. In its native state, the overtube is extremely flexible. Once the overtube is advanced to the desired location, application of a vacuum to the device causes the device to become 15 times stiffer. The endoscope can then be advanced through the overtube without loop formation in the region that the overtube traverses. RESULTS: The overtube was used in 29 patients to assist with difficult procedures. Patients were predominantly men (n = 18; 62.1%), with a median age of 66 years (interquartile range, 57-72). One patient received an upper endoscopy (3.4%), 24 received colonoscopy (82.8%), and 4 received enteroscopy (13.8%). The overtube was used in 12 procedures for incomplete colonoscopy (41.4%), 6 for depth (20.7%), and 11 for stability (37.9%). Colonoscopy was performed in the setting of screening (n = 3), surveillance given polyp history (n = 7), referrals for polyp removal (n = 10), workup of iron deficiency anemia (n = 2), and incomplete colonoscopy (n = 1). The lower endoscopy cases had a median cecal intubation time of 5 minutes (interquartile range, 4.25-7). Enteroscopy was performed in 4 patients: In one patient the distal 60 cm of the ileum was examined with a pediatric colonoscope to exclude ileitis, in another the overtube was used to stabilize a 6-mm endoscope to traverse a tight Crohn's ileocolonic stricture, in a third patient altered-anatomy ERCP was performed using an enteroscope through the overtube to reach a hepaticojejunostomy, and in the final patient upper enteroscopy was performed and the mid-jejunum was reached. We present 4 cases that demonstrate the use of the overtube. There were no adverse events. CONCLUSIONS: Initial experience with a novel rigidizing overtube suggests that this tool can be useful in colonoscopy and other endoscopic procedures affected by looping.


Assuntos
Ceco , Colonoscopia , Idoso , Criança , Colonoscópios , Endoscopia Gastrointestinal , Desenho de Equipamento , Humanos , Masculino , Programas de Rastreamento
17.
Gastrointest Endosc ; 93(4): 797-804.e1, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32987004

RESUMO

BACKGROUND AND AIMS: The optimal method of gallbladder drainage (GBD) for acute cholecystitis in nonsurgical candidates is uncertain. The aim of the current study was to conduct a network meta-analysis comparing the 3 methods of GBD (percutaneous [PT], endoscopic transpapillary [ETP], and EUS-guided). METHODS: A comprehensive literature search for all comparative studies assessing the efficacy of either 2 or all modalities used for treatment of acute cholecystitis in patients at high risk for cholecystectomy was performed. Primary outcomes of technical and clinical success and postprocedure adverse events were assessed. Secondary outcomes were reintervention, unplanned readmissions, recurrent cholecystitis, and mortality. RESULTS: Ten studies were identified, comprising 1267 patients (472 EUS-GBD, 493 PT-GBD, and 302 ETP-GBD). In the network ranking estimate, PT-GBD and EUS-GBD had the highest likelihood of technical success (EUS-GBD vs PT-GBD vs ETP-GBD: 2.00 vs 1.02 vs 2.98) and clinical success (EUS-GBD vs PT-GBD vs ETP-GBD: 1.48 vs 1.55 vs 2.98). EUS-GBD had the lowest risk of recurrent cholecystitis (EUS-GBD vs PT-GBD vs ETP-GBD: 1.089 vs 2.02 vs 2.891). PT-GBD had the highest risk of reintervention (EUS-GBD vs PT-GBD vs ETP-GBD: 1.81 vs 2.99 vs 1.199) and unplanned readmissions (EUS-GBD vs PT-GBD vs ETP-GBD: 1.582 vs 2.944 vs 1.474), whereas ETP-GBD was associated with the lowest rates of mortality (EUS-GBD vs PT-GBD vs ETP-GBD: 2.62 vs 2.09 vs 1.29). CONCLUSIONS: The 3 modalities of GBD have their respective advantages and disadvantages. Selection of technique will depend on available expertise. In centers with expertise in endoscopic GBD, the techniques are preferred over PT-GBD with improved outcomes. (Clinical trial registration number: CRD42020181972.).


Assuntos
Colecistite Aguda , Vesícula Biliar , Colecistite Aguda/cirurgia , Drenagem , Endossonografia , Vesícula Biliar/diagnóstico por imagem , Humanos , Metanálise em Rede
18.
Surg Endosc ; 35(2): 792-801, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-32157405

RESUMO

INTRODUCTION: Many centers have reported excellent short-term efficacy of per-oral endoscopic myotomy (POEM) for the treatment of achalasia. However, long-term data are limited and there are few studies comparing the efficacy of POEM versus Heller Myotomy (HM). AIMS: To compare the long-term clinical efficacy of POEM versus HM. METHODS: Using a retrospective, parallel cohort design, all cases of POEM or HM for achalasia between 2010 and 2015 were assessed. Clinical failure was defined as (a) Eckardt Score > 3 for at least 4 weeks, (b) achalasia-related hospitalization, or (c) repeat intervention. All index manometries were classified via Chicago Classification v3. Pre-procedural clinical, manometric, radiographic data, and procedural data were reviewed. RESULTS: 98 patients were identified (55 POEM, 43 Heller) with mean follow-up of 3.94 years, and 5.44 years, respectively. 83.7% of HM patients underwent associated anti-reflux wrap (Toupet or Dor). Baseline clinical, demographic, radiographic, and manometric data were similar between the groups. There was no statistical difference in overall long-term success (POEM 72.7%, HM 65.1% p = 0.417, although higher rates of success were seen in Type III Achalasia in POEM vs Heller (53.3% vs 44.4%, p < 0.05). Type III Achalasia was the only variable associated with failure on a univariate COX analysis and no covariants were identified on a multivariate Cox regression. There was no statistical difference in GERD symptoms, esophagitis, or major procedural complications. CONCLUSION: POEM and HM have similar long-term (4-year) efficacy with similar adverse event and reflux rates. POEM was associated with greater efficacy in Type III Achalasia.


Assuntos
Endoscopia/métodos , Acalasia Esofágica/cirurgia , Miotomia de Heller/métodos , Laparoscopia/métodos , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
19.
J Appl Clin Med Phys ; 22(9): 345-359, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34346559

RESUMO

BACKGROUND: High-intensity focused ultrasound (HIFU) has been in clinical use for a variety of solid tumors and cancers. Accurate and reliable calibration is in a great need for clinical applications. An extracorporeal clinical HIFU system applied for the investigational device exemption (IDE) to the Food and Drug Administration (FDA) so that evaluation of its characteristics, performance, and safety was required. METHODS: The acoustic pressure and power output was characterized by a fiber optic probe and a radiation force balance, respectively, with the electrical power up to 2000 W. An in situ acoustic energy was established as the clinical protocol at the electrical power up to 500 W. Temperature elevation inside the tissue sample was measured by a thermocouple array. Generated lesion volume at different in situ acoustic energies and pathological examination of the lesions was evaluated ex vivo. RESULTS: Acoustic pressure mapping showed the insignificant presence of side/grating lobes and pre- or post-focal peaks (≤-12 dB). Although distorted acoustic pressure waveform was found in the free field, the nonlinearity was reduced significantly after the beam propagating through tissue samples (i.e., the second harmonic of -11.8 dB at 500 W). Temperature elevation was <10°C at a distance of 10 mm away from a 20-mm target, which suggests the well-controlled HIFU energy deposition and no damage to the surrounding tissue. An acoustic energy in the range of 750-1250 J resulted in discrete lesions with an interval space of 5 mm between the treatment spots. Histology confirmed that the lesions represented a region of permanently damaged cells by heat fixation, without causing cell lysis by either cavitation or boiling. CONCLUSIONS: Our characterization and ex vivo evaluation protocol met the IDE requirement. The in-situ acoustic energy model will be used in clinical trials to deliver almost consistent energy to the various targets.


Assuntos
Ablação por Ultrassom Focalizado de Alta Intensidade , Acústica , Calibragem , Fenômenos Mecânicos , Estados Unidos
20.
Gastrointest Endosc ; 92(2): 241-251, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32470427

RESUMO

The American Society for Gastrointestinal Endoscopy's GIE Editorial Board reviewed original endoscopy-related articles published during 2019 in Gastrointestinal Endoscopy and 10 other leading medical and gastroenterology journals. Votes from each individual member were tallied to identify a consensus list of 10 topic areas of major advances in GI endoscopy. Individual board members summarized important findings published in these 10 areas of disinfection, artificial intelligence, bariatric endoscopy, adenoma detection, polypectomy, novel imaging, Barrett's esophagus, third space endoscopy, interventional EUS, and training. This document summarizes these "top 10" endoscopic advances of 2019.


Assuntos
Adenoma , Esôfago de Barrett , Gastroenterologia , Inteligência Artificial , Endoscopia Gastrointestinal , Humanos
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