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1.
Artigo em Inglês | MEDLINE | ID: mdl-38973521

RESUMO

BACKGROUND: Endoscopic submucosal dissection (ESD) is a minimally invasive resection technique that enables the en bloc resection of gastrointestinal lesions. Despite en bloc resection, pathological evaluation of lesions can reveal positive vertical or horizontal margins, which is referred to as R1 resection. Not all R1 lesions referred for surgical resection or endoscopic surveillance show evidence of residual tumor. We aimed to identify the predictors of residual neoplasia in patients with an R1 resection following ESD. PATIENTS AND METHODS: All lesions resected via ESD between June 2016 and September 2021 at a tertiary referral center were retrospectively identified. Lesions with an R1 resection and adequate follow-up were eligible for inclusion. Patient, lesion, and procedural characteristics were analyzed to identify predictors of residual neoplasia. RESULTS: Of 614 lesions, 163 (28%) had R1 resection. Of these, 56 lesions in 51 patients had complete follow-up and were included. Thirteen patients (25.5%) underwent surgical resection and the remainder underwent endoscopic surveillance. Seven (12.5%) patients had residual disease. All patients with residual disease had esophageal carcinoma. Positive deep and lateral margins, severe submucosal fibrosis, and moderate/poorly differentiated tumors were identified as significant predictors of residual neoplasia. CONCLUSION: Most R1 lesions (87.5%) resected by ESD did not have residual disease on follow-up. Those without identified risk factors for residual disease, such as esophageal carcinoma, severe submucosal fibrosis, or both histological margin positivity, may benefit from a strategy of close endoscopic surveillance rather than referral for surgical resection.

2.
Endoscopy ; 2024 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-38991535

RESUMO

BACKGROUND: A novel rigidizing overtube (ROT) was developed to facilitate endoscopic removal of complex gastrointestinal polyps. We aimed to prospectively evaluate the efficacy and safety of the device in the management of large gastrointestinal polyps. METHODS: A prospective, single-center study, conducted between May 2021 and April 2023, enrolled patients undergoing endoscopic resection of colon/duodenal polyps ≥25 mm. Primary outcomes were safety, technical success, and clinical success defined as the ability of ROT to facilitate endoscopic polyp removal without changing the initial resection method. RESULTS: 97 patients (98 polyps), with a mean polyp size of 33.2 mm (median 31.1), were evaluated. Technical and clinical success rates were 100% and 84%, respectively. Ileocecal valve location was the only predictor of clinical failure (P = 0.02). The mean time to reach the lesion was 7.2 minutes (95%CI 5-8), with overall resection and procedure times of 53.6 minutes (95%CI 48-61) and 88.9 minutes (95%CI 79-95), respectively. No device-related adverse events occurred. Lower technical (67%) and clinical (67%) success rates were seen for duodenal polyps (n = 6). CONCLUSION: The novel ROT was safe, with high technical and clinical success during resection of complex colon polyps. Future studies will determine timing of implementation during routine endoscopic resection.

3.
Am J Gastroenterol ; 2024 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-38912697

RESUMO

INTRODUCTION: Hybrid endoscopic submucosal dissection (H-ESD), which utilizes ESD knife along with snare-based resection, has been developed to overcome the technical complexity of conventional ESD (C-ESD). The aim of this study was to compare the therapeutic outcomes of H-ESD vs C-ESD for nonpedunculated colorectal lesions ≥20 mm in size. METHODS: We conducted a multicenter randomized controlled trial to compare H-ESD and C-ESD (Short-ESD trial). Patients with colorectal lesions between 20 and 50 mm in size were randomly assigned (1:1) to H-ESD or C-ESD. Primary outcome was procedure time/speed. Secondary outcomes were en bloc and complete (R0) resection rates and adverse event rates. RESULTS: A total of 89 patients (median age 63 years; 49.3% women) with the median polyp size of 30 mm underwent H-ESD (n = 40) and C-ESD (n = 49). The mean procedure time of H-ESD was significantly shorter than that of C-ESD (41.1 ± 16.3 vs 54.3 ± 28.2 minutes; P = 0.007). The en bloc and R0 resection rates trended lower in the H-ESD vs C-ESD groups (77.5% vs 87.8%; P = 0.26% and 72.5% vs 79.6%; P = 0.46) without reaching statistical significance. Adverse event rate was similar between H-ESD and C-ESD (10% vs 8.2%; P = 1.00). DISCUSSION: Both H-ESD and C-ESD were safe and effective for resection of large colorectal lesions. H-ESD was associated with a shorter procedure time. H-ESD may represent a viable alternative to C-ESD, with the main advantage being easy applicability of a snare-based technique for colorectal lesions. Future studies are needed to further define the most suitable lesions for H-ESD, as to optimize efficiency and safety without compromising resection outcomes. ClinicaTrials.gov NCT NCT05347446.

4.
Gastrointest Endosc ; 2024 Jun 13.
Artigo em Inglês | MEDLINE | ID: mdl-38879045

RESUMO

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) is a technically challenging resection technique for en-bloc removal of dysplastic and early cancerous gastrointestinal (GI) lesions. We conducted a single-arm retrospective study evaluating the safety and efficacy of a new through-the-needle injection-capable electrosurgical knife used in upper and lower ESD procedures performed at 6 US academic centers. METHODS: Data were retrospectively collected on consecutive cases in which the new ESD knife was used. The primary efficacy endpoint was successful ESD (en bloc resection with negative margins). Secondary efficacy endpoints included en-bloc resection rate, curative resection rate, median ESD time, and median dissection speed. The safety endpoint was device- or procedure-related serious adverse events (SAEs). RESULTS: ESD of 581 lesions in 579 patients were reviewed, including 187 (32.2%) upper GI and 394 (67.8%) lower GI lesions. Prior treatment was reported in 283 (48.9%) patients. Successful ESD was achieved in 477 (82.1% of 581) lesions ‒ lower for patients with versus without submucosal fibrosis (73.6% versus 87.0%, respectively, P < 0.001), but similar for those with versus without previous treatment (81.7% versus 82.3%, respectively, P = 0.848). Four hundred and forty-three (76.2% of 581) lesions met criteria for curative resection. Median ESD time was 1.0 (range 0.1-4.5) hour. Median dissection speed was 17.1 (IQR 5.3-29.8) cm2/hour. Related SAEs were reported in 15 (2.6%) patients, including delayed hemorrhage (1.9%), perforation (0.5%), or postpolypectomy syndrome (0.2%). CONCLUSION: A newly developed through-the-needle injection-capable ESD knife showed a good success rate and excellent safety at US centers. (ClinicalTrials.gov number, NCT04580940).

5.
Artigo em Inglês | MEDLINE | ID: mdl-38465439

RESUMO

BACKGROUND: Gastroesophageal reflux (GERD) is a concern after peroral endoscopic myotomy (POEM). Transoral incisionless fundoplication (TIF) has been recently described as a possible therapy for post-POEM GERD in case series. METHODS: We prospectively enrolled patients undergoing POEM who agreed to participate in objective post-procedure GERD evaluation. Patients with objective evidence of GERD and suitable anatomy were offered TIF vs. proton pump inhibitor (PPI) only. Patients who underwent TIF were compared to those on PPI-only therapy after follow-up. RESULTS: Of 21 enrolled POEM patients with objective testing, GERD was found in 11 (52%). Of those eligible for TIF, 4 (40%) opted to pursue TIF and were compared to those on PPI-only therapy (n = 6). Three months post-TIF, 75% of patients had discontinued or significantly decreased PPI. There were no adverse events. GERD health-related quality of life scores were low and comparable between TIF (3.75 ± 6.2) and those who remained on PPI-only therapy (4.1 ± 5). CONCLUSION: In this pilot, patient-driven prospective study, 75% of patients with post-POEM GERD undergoing TIF had stopped or significantly reduced PPI use. Post-POEM TIF is safe and effective and may be a viable alternative to PPI for POEM-related GERD; however, future studies should include a control arm and post-intervention pH monitoring.

6.
Gastrointest Endosc ; 100(2): 213-220, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38467200

RESUMO

BACKGROUND AND AIMS: Postoperative stricture is a serious common adverse event after extensive endoscopic submucosal dissection (ESD) in the esophagus. Self-assembling peptide (SAP) gel has been shown to promote tissue healing and re-epithelialization. The aim of this study was to evaluate the effect of the SAP gel for esophageal stricture prevention after ESD. METHODS: This was a multicenter prospective study of patients who underwent esophageal ESD followed by SAP gel application between March 2022 and December 2023. Patients were included if the ESD mucosal defect involved ≥50% of the circumference of the esophagus. High-risk cases were defined as mucosal defects ≥75% of the circumference. Stricture was defined as the inability to pass an endoscope ≥8.9 mm in diameter or a narrow-caliber lumen in a patient with symptoms. RESULTS: A total of 43 patients (median age, 71 years; 81.4% male) underwent ESD (median resected specimen size, 50 mm) during the study period. SAP gel (median, 3 mL) was successfully applied in all cases (median time, 4 minutes). In aggregate, stricture occurred in 20.9% (9 of 43) of the cases. Stricture developed in 30.8% of the high-risk cases: 80% (4 of 5) after circumferential ESD and 19% (4 of 21) in those with defects ≥75% but <100% of the circumference. All cases of stricture resolved with endoscopic treatment. Three cases (6.9%) of postoperative bleeding occurred and were adequately managed endoscopically. CONCLUSIONS: We show that SAP gel application was easy, quick, and associated with a relatively low stricture rate comparable to other prophylactic methods. Additional comparative studies are needed to corroborate these preliminary findings.


Assuntos
Ressecção Endoscópica de Mucosa , Neoplasias Esofágicas , Estenose Esofágica , Géis , Complicações Pós-Operatórias , Humanos , Ressecção Endoscópica de Mucosa/efeitos adversos , Ressecção Endoscópica de Mucosa/métodos , Masculino , Feminino , Estenose Esofágica/prevenção & controle , Estenose Esofágica/etiologia , Idoso , Estudos Prospectivos , Pessoa de Meia-Idade , Neoplasias Esofágicas/cirurgia , Complicações Pós-Operatórias/prevenção & controle , Peptídeos/administração & dosagem , Peptídeos/uso terapêutico , Idoso de 80 Anos ou mais , Esofagoscopia/métodos , Estados Unidos
7.
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
8.
VideoGIE ; 9(2): 65-68, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38357028

RESUMO

Video 1Demonstration of a successful peroral endoscopic myotomy using a novel disposable scope platform.

9.
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
10.
Gastrointest Endosc ; 99(2): 177-185, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37500019

RESUMO

BACKGROUND AND AIMS: Video analysis has emerged as a potential strategy for performance assessment and improvement. We aimed to develop a video-based skill assessment tool for peroral endoscopic myotomy (POEM). METHODS: POEM was deconstructed into basic procedural components through video analysis by an expert panel. A modified Delphi approach and 2 validation exercises were conducted to refine the POEM assessment tool (POEMAT). Twelve assessors used the final POEMAT version to grade 10 videos. Fully crossed generalizability (G) studies investigated the contributions of assessors, endoscopists' performance, and technical elements to reliability. G coefficients below .5 were considered unreliable, between .5 and .7 as modestly reliable, and above .7 as indicative of satisfactory reliability. RESULTS: After task deconstruction, discussions, and the modified Delphi process, the final POEMAT comprised 9 technical elements. G analysis showed low variance for endoscopist performance (.8%-24.9%) and high interrater variability (range, 63.2%-90.1%). The G score was moderately reliable (≥.60) for "submucosal tunneling" and "myotomy" and satisfactorily reliable (≥.70) for "active hemostasis" and "mucosal closure." CONCLUSIONS: We developed and established initial content and response process validity evidence for the POEMAT. Future steps include appraisal of the tool using a wider range of POEM videos to establish and improve the discriminative validity of this tool.


Assuntos
Procedimentos Cirúrgicos do Sistema Digestório , Acalasia Esofágica , Miotomia , Cirurgia Endoscópica por Orifício Natural , Humanos , Acalasia Esofágica/cirurgia , Reprodutibilidade dos Testes , Resultado do Tratamento , Esfíncter Esofágico Inferior
11.
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
12.
Endosc Int Open ; 11(8): E743-E751, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37941733

RESUMO

Background and study aims A novel electrosurgical generator unit (ESU), ConMed Beamer, was recently introduced to facilitate endoscopic submucosal dissection (ESD) by employing Automatic Cutting Effect (ACE) technology. Its use in submucosal endoscopy has yet to be investigated. The aim of this study was to evaluate the feasibility and safety of performing ESD and peroral endoscopic myotomy (POEM) using novel settings generated with ConMed Beamer ESU. Patients and methods This was a single-center prospective study of 59 consecutive patients undergoing ESD/POEM at a tertiary referral center. ESU settings were initially generated by testing in live animal models prior to first in-human study. The primary outcome was technical success. Secondary outcomes were procedure times, rate of en bloc/R0 resection, and rate of adverse events (AEs). Results A total of 44 patients (50 polyps) and 15 patients underwent ESD and POEM, respectively. En bloc resection, R0 resection, and curative resection rates were 90%, 77.1%, and 70.8%, respectively. Mean maximal length of the lesion was 3.07 cm ± 1.43 with an average dissection speed of 14.2 cm 2 /hr ± 11.1. Technical success was achieved in 100% of POEM patients. Mean time (minutes) to complete the POEM procedure was 50.1 min ± 12.4. Two major AEs occurred among all patients (3.4%). All intraprocedural bleeding events were controlled using the ConMed Beamer ESU. Conclusions ConMed Beamer ESU settings generated from this study were proven safe and effective in a prospective cohort of patients who underwent submucosal endoscopic procedures. This novel ESU can be added to the armamentarium of ESD capable generators.

13.
VideoGIE ; 8(6): 224-225, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37303706

RESUMO

Video 1Use of a novel dual-action traction device to facilitate endoscopic submucosal dissection.

14.
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
15.
Endoscopy ; 55(6): 571-577, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36323330

RESUMO

BACKGROUND: Complete closure of large mucosal defects following colorectal endoscopic submucosal dissection (ESD) with through-the-scope (TTS) clips is oftentimes not possible. We aimed to report our early experience of using a novel TTS suturing system for the closure of large mucosal defects after colorectal ESD. METHODS: We performed a retrospective multicenter cohort study of consecutive patients who underwent attempted prophylactic defect closure using the TTS suturing system after colorectal ESD. The primary outcome was technical success in achieving complete defect closure, defined as a < 5 mm residual mucosal defect in the closure line using TTS suturing, with or without adjuvant TTS clips. RESULTS: 82 patients with a median defect size of 30 (interquartile range 25-40) mm were included. Technical success was achieved in 92.7 % (n = 76): TTS suturing only in 44 patients (53.7 %) and a combination of TTS suturing to approximate the widest segment followed by complete closure with TTS clips in 32 (39.0 %). Incomplete/partial closure, failure of appropriate TTS suture deployment, and the need for over-the-scope salvage closure methods were observed in 7.3 % (n = 6). One intraprocedural bleed, one delayed bleed, and three intraprocedural perforations were observed. There were no adverse events related to placement of the TTS suture. CONCLUSION: The TTS suture system is an effective and safe tool for the closure of large mucosal defects after colorectal ESD and is an alternative when complete closure with TTS clips alone is not possible.


Assuntos
Neoplasias Colorretais , Ressecção Endoscópica de Mucosa , Humanos , Ressecção Endoscópica de Mucosa/métodos , Estudos de Coortes , Mucosa Intestinal/cirurgia , Neoplasias Colorretais/cirurgia , Suturas , Estudos Retrospectivos
16.
VideoGIE ; 7(11): 419-422, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36407047

RESUMO

Backgrounds and Aims: Defect closure post-EMR and endoscopic submucosal dissection (ESD) is recommended to decrease the risk of delayed bleeding and perforation. Current methods of tissue approximation and closure of mucosal defects have their limitations, including restricted maneuverability, need for scope withdrawal, or difficulty in apposing larger defects. Through-the-scope HeliX tacking system (Apollo Endosurgery, Austin, Tex, USA) is a novel tissue apposition device designed to mimic suture closure without the need to withdraw the endoscope or insert bulky devices on the tip of the endoscope. Previous reports demonstrate its effectiveness for closure of standard postresection defects, fistulae, and peroral endoscopic myotomy mucosectomy sites. However, reports on its feasibility and technique for very large defects are scarce. Methods: In this case series, we demonstrate a tissue approximation technique using a novel through-the-scope HeliX tacking system for a 10-cm ascending colon and a 5-cm gastric antrum postresection defects. A zig-zag running pattern and figure 8 suturing pattern were used for the colonic and gastric defect approximation, respectively. Results: Tissue approximation was easily and successfully achieved in both cases. Four and 2 sets of tacks were used in the colonic and gastric defect, respectively. Closure of these defects otherwise would have required a substantial number of clips, withdrawal/exchange of the endoscope to mount the suturing device, or difficulty in maneuvering the closure devices. There was no immediate or delayed adverse event postprocedure. Conclusions: Through-the-scope suturing using the HeliX tacking system is a unique tool that integrates the capabilities of current tissue apposition devices post EMR and ESD. Through-the-scope suturing is an ideal option especially for tissue approximation of large resection beds within the right side of the colon and areas with limited space for maneuverability.

18.
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.

19.
Gastrointest Endosc ; 96(3): 445-453, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35217020

RESUMO

BACKGROUND AND AIMS: The outcomes of endoscopic submucosal dissection (ESD) for T1b esophageal cancer (EC) and its recurrence rates remain unclear in the West. Using a multicenter cohort, we evaluated technical outcomes and recurrence rates of ESD in the treatment of pathologically staged T1b EC. METHODS: We included patients who underwent ESD of T1b EC at 7 academic tertiary referral centers in the United States (n = 6) and Brazil (n = 1). We analyzed demographic, procedural, and histopathologic characteristics and follow-up data. Time-to-event analysis was performed to evaluate recurrence rates. RESULTS: Sixty-six patients with pathologically staged T1b EC after ESD were included in the study. A preprocedure staging EUS was available in 54 patients and was Tis/T1a in 27 patients (50%) and T1b in 27 patients (50%). En-bloc resection rate was 92.4% (61/66) and R0 resection rate was 54.5% (36/66). Forty-nine of 66 patients (74.2%) did not undergo surgery immediately after resection and went on to surveillance. Ten patients had ESD resection within the curative criteria, and no recurrences were seen in a 13-month (range, 3-18.5) follow-up period in these patients. Ten of 39 patients (25.6%) with noncurative resections had residual/recurrent disease. Of the 10 patients with noncurative resection, local recurrence alone was seen in 5 patients (12.8%) and metastatic recurrence in 5 patients (12.8%). On univariate analysis, R1 resection had a higher risk of recurrent disease (hazard ratio, 6.25; 95% confidence interval, 1.29-30.36; P = .023). CONCLUSIONS: EUS staging of T1b EC has poor accuracy, and a staging ESD should be considered in these patients. ESD R0 resection rates were low in T1b EC, and R1 resection was associated with recurrent disease. Patients with noncurative ESD resection of T1b EC who cannot undergo surgery should be surveyed closely, because recurrent disease was seen in 25% of these patients.


Assuntos
Ressecção Endoscópica de Mucosa , Neoplasias Esofágicas , Brasil , Ressecção Endoscópica de Mucosa/métodos , Neoplasias Esofágicas/patologia , Neoplasias Esofágicas/cirurgia , Humanos , Recidiva Local de Neoplasia/epidemiologia , Neoplasia Residual , Estudos Retrospectivos , Resultado do Tratamento
20.
Endoscopy ; 54(5): 439-446, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-34450667

RESUMO

BACKGROUND: The difference in clinical outcomes after endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) for early Barrett's esophagus (BE) neoplasia remains unclear. We compared the recurrence/residual tissue rates, resection outcomes, and adverse events after ESD and EMR for early BE neoplasia. METHODS: We included patients who underwent EMR or ESD for BE-associated high grade dysplasia (HGD) or T1a esophageal adenocarcinoma (EAC) at eight academic hospitals. We compared demographic, procedural, and histologic characteristics, and follow-up data. A time-to-event analysis was performed to evaluate recurrence/residual disease and a Kaplan-Meier curve was used to compare the groups. RESULTS: 243 patients (150 EMR; 93 ESD) were included. EMR had lower en bloc (43 % vs. 89 %; P < 0.001) and R0 (56 % vs. 73 %; P = 0.01) rates than ESD. There was no difference in the rates of perforation (0.7 % vs. 0; P > 0.99), early bleeding (0.7 % vs. 1 %; P > 0.99), delayed bleeding (3.3 % vs. 2.1 %; P = 0.71), and stricture (10 % vs. 16 %; P = 0.16) between EMR and ESD. Patients with non-curative resections who underwent further therapy were excluded from the recurrence analysis. Recurrent/residual disease was 31.4 % [44/140] for EMR and 3.5 % [3/85] for ESD during a median (interquartile range) follow-up of 15.5 (6.75-30) and 8 (2-18) months, respectively. Recurrence-/residual disease-free survival was significantly higher in the ESD group. More patients required additional endoscopic resection procedures to treat recurrent/residual disease after EMR (EMR 24.2 % vs. ESD 3.5 %; P < 0.001). CONCLUSIONS: ESD is safe and results in more definitive treatment of early BE neoplasia, with significantly lower recurrence/residual disease rates and less need for repeat endoscopic treatments than with EMR.


Assuntos
Adenocarcinoma , Esôfago de Barrett , Ressecção Endoscópica de Mucosa , Neoplasias Esofágicas , Adenocarcinoma/patologia , Esôfago de Barrett/patologia , Esôfago de Barrett/cirurgia , Ressecção Endoscópica de Mucosa/efeitos adversos , Ressecção Endoscópica de Mucosa/métodos , Neoplasias Esofágicas/patologia , Humanos , Recidiva Local de Neoplasia/epidemiologia , Recidiva Local de Neoplasia/patologia , Neoplasia Residual/etiologia , Estudos Retrospectivos , Resultado do Tratamento
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