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BACKGROUND & AIMS: Thermal treatment of the defect margin after endoscopic mucosal resection (EMR) of large nonpedunculated colorectal lesions reduces the recurrence rate. Both snare tip soft coagulation (STSC) and argon plasma coagulation (APC) have been used for thermal margin treatment, but there are few data directly comparing STSC with APC for this indication. METHODS: We performed a randomized 3-arm trial in 9 US centers comparing STSC with APC with no margin treatment (control) of defects after EMR of colorectal nonpedunculated lesions ≥15 mm. The primary end point was the presence of residual lesion at first follow-up. RESULTS: There were 384 patients and 414 lesions randomized, and 308 patients (80.2%) with 328 lesions completed ≥1 follow-up. The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% with control subjects (no margin treatment). The odds of residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (P = .001 and P = .01, respectively). The difference in odds was not significant between STSC and APC. STSC took less time to apply than APC (median, 3.35 vs 4.08 minutes; P = .019). Adverse event rates were low, with no difference between arms. CONCLUSIONS: In a randomized trial STSC and APC were each superior to no thermal margin treatment after EMR. STSC was faster to apply than APC. Because STSC also results in lower cost and plastic waste than APC (APC requires an additional device), our study supports STSC as the preferred thermal margin treatment after colorectal EMR. (Clinicaltrials.gov, Number NCT03654209.).
Assuntos
Pólipos do Colo , Neoplasias Colorretais , Ressecção Endoscópica de Mucosa , Humanos , Pólipos do Colo/patologia , Colonoscopia/métodos , Coagulação com Plasma de Argônio , Neoplasias Colorretais/cirurgia , Neoplasias Colorretais/etiologia , Ressecção Endoscópica de Mucosa/métodosRESUMO
BACKGROUND AND AIMS: Endoscopic mucosal resection (EMR) is established as the primary approach for large/complex dysplastic lesions. However, submucosal fibrosis caused by previous attempts at removal, biopsy, inflammation, or tattoo can cause a benign "negative lift sign" and create difficulty for EMR. Here, we present the use of distal-cap assisted EMR (EMR-DC) specifically for the use of resecting dysplastic colon lesions when submucosal fibrosis is present in IBD patients. METHODS: 16 IBD patients were retrospectively evaluated from two high volume centers. The patient demographics, lesion pathology and classification, outcomes including time and success of resection, SAEs within 30 days of the procedure, and efficacy were measured. RESULTS: 75% of patients treated with EMR-DC achieved complete resection with 0 serious adverse events within 30 days of the procedure. CONCLUSION: EMR-DC represents an attractive option for the resection of adherent dysplastic lesions in chronic IBD which is effective, safe, and inexpensive.
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BACKGROUND AND AIMS: The application of endoscopic suturing has revolutionized defect closures. Conventional over-the-scope suturing necessitates removal of the scope, placement of the device, and reinsertion. A single channel, single sequence, through-the-scope suturing device has been developed to improve this process. This study aims to describe the efficacy, feasibility, and safety of a through-the-scope suturing device for gastrointestinal defect closure. METHODS: This was a retrospective multicenter study involving 9 centers of consecutive adult patients who underwent suturing using the X-Tack Endoscopic HeliX Tacking System (Apollo Endosurgery). The primary outcomes were technical success and long-term clinical success. Secondary outcomes included adverse events, recurrence, and reintervention rates. RESULTS: In all, 56 patients (mean age 53.8, 33 women) were included. Suturing indications included fistula repair (n=22), leak repair (n=7), polypectomy defect closure (n=12), peroral endoscopic myotomy (POEM) site closure (n=7), perforation repair (n=6), and ulcers (n=2). Patients were followed at a mean duration of 74 days. Overall technical and long-term clinical success rates were 92.9% and 75%, respectively. Both technical and clinical success rates were 100% for polypectomies, POEM-site closures, and ulcers. Success rates were lower for the repair of fistulas (95.5% technical, 54.5% clinical), leaks (57.1%, 28.6%), and perforations (100%, 66.7%). No immediate adverse events were noted. CONCLUSION: This novel, through-the-scope endoscopic suturing system, is a safe and feasible method to repair defects that are ≤3 cm. The efficacy of this device may be better suited for superficial defects as opposed to full-thickness defects. Larger defects will need more sutures and probably a double closure technique to provide a reinforcement layer.
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BACKGROUND AND AIMS: EUS-guided pancreatic cyst chemoablation is safe and effective for appropriately selected patients; however, the proper frequency of radiographic surveillance after successful chemoablation is unknown. Here we report the long-term follow-up of two randomized, prospective, ChARM clinical trials. Additionally, the performance of a post-ablation reduced radiographic surveillance protocol was evaluated using clinical and economic outcomes and patient experience metrics. METHODS: Patients who successfully completed one of the two ChARM randomized control trials were evaluated for durability of response and clinical outcomes. Patients were eligible if two years or more of follow-up were available and complete. We calculated economic outcomes using Medicare allowable costs applicable to EUS, MRI, and outpatient clinic visits. We modeled costs of a patient followed by the ChARM Post-treatment Reduced Radiographic Surveillance Protocol compared with a similar patient followed under Fukuoka or ACG guidelines over 5 years. Additionally, patients under long-term surveillance in our clinic were interviewed via a 4 question Likert scale questionnaire. RESULTS: 52 patients were eligible and included in the study. At the most recent follow-up of the 52 patients, 36 (69.2%) achieved complete response, an additional 11 (21.2%) showed partial response, and only 5 (9.6%) with nonresponse. All patients were successfully reduced to annual or less surveillance without recurrence or the development of cyst associated malignancy. When compared with Fukukoa or ACG guidelines, a patient treated and followed under the ChARM Post-Treatment Reduced Radiographic Surveillance Protocol incurred a Medicare allowable cost of $7,200.00 versus $19,437.44 and $12,526.52 if untreated and followed under Fukukoa or ACG guidelines, respectively. The patient experience questionnaire was returned completed by 49 participants. CONCLUSIONS: The ChARM Post-Treatment Reduced Radiographic Surveillance Protocol safely allows a reduction in radiographic surveillance. A reduction in cost associated with cyst management under the ChARM protocol was shown when compared to management following Fukukoa or ACG guidelines. According to the questionnaire, most patients reported a moderate level of logistical and emotional burden associated with MRI surveillance, and a majority were in favor of reducing the frequency of radiographic surveillance if it can be done without a marked increase in oncologic risk.
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BACKGROUND & AIMS: Serrated polyps are important colorectal cancer precursors and are most commonly located in the proximal colon, where post-polypectomy bleeding rates are higher. There is limited clinical trial evidence to guide best practices for resection of large serrated polyps (LSPs). METHODS: In a multicenter trial, patients with large (≥20 mm) non-pedunculated polyps undergoing endoscopic mucosal resection (EMR) were randomized to clipping of the resection base or no clipping. This analysis is stratified by histologic subtype of study polyp(s), categorized as serrated [sessile serrated lesions (SSLs) or hyperplastic polyps (HPs)] or adenomatous, comparing clip vs control groups. The primary outcome was severe post-procedure bleeding within 30 days of colonoscopy. RESULTS: A total of 179 participants with 199 LSPs (191 SSLs and 8 HPs) and 730 participants with 771 adenomatous polyps were included in the study. Overall, 5 patients with LSPs (2.8%) experienced post-procedure bleeding compared with 42 (5.8%) of those with adenomas. There was no difference in post-procedure bleeding rates between patients in the clip vs control group among those with LSPs (2.3% vs 3.3%, respectively, difference 1.0%; P = NS). However, among those with adenomatous polyps, clipping was associated with a lower risk of post-procedure bleeding (3.9% vs 7.6%, difference 3.7%; P = .03) and overall serious adverse events (5.5% vs 10.6%, difference 5.1%; P = .01). CONCLUSION: The post-procedure bleeding risk for LSPs removed via EMR is low, and there is no discernable benefit of prophylactic clipping of the resection base in this group. This study indicates that the benefit of endoscopic clipping following EMR may be specific for >2 cm adenomatous polyps located in the proximal colon. CLINICALTRIALS: gov, Number: NCT01936948.
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Adenoma , Pólipos Adenomatosos , Pólipos do Colo , Neoplasias Colorretais , Ressecção Endoscópica de Mucosa , Adenoma/patologia , Pólipos Adenomatosos/patologia , Pólipos Adenomatosos/cirurgia , Pólipos do Colo/patologia , Colonoscopia/métodos , Neoplasias Colorretais/patologia , Ressecção Endoscópica de Mucosa/efeitos adversos , Ressecção Endoscópica de Mucosa/métodos , Humanos , Hemorragia Pós-Operatória/epidemiologia , Hemorragia Pós-Operatória/etiologia , Hemorragia Pós-Operatória/prevenção & controleRESUMO
Pancreatic cancer has known precursor lesions with potential to develop into malignancy over time. At least 20% of pancreatic cancer evolves from mucinous cystic neoplasms and intraductal papillary mucinous neoplasms, which are often discovered incidentally.1,2 Current guidelines for the management of mucinous cystic neoplasms and intraductal papillary mucinous neoplasms include long-term surveillance, which is expensive and nontherapeutic, or surgical resection, which is associated with major risk and may not be an option for patients with significant concomitant illness.3.
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Carcinoma Ductal Pancreático , Cisto Pancreático , Neoplasias Pancreáticas , Carcinoma Ductal Pancreático/patologia , Carcinoma Ductal Pancreático/cirurgia , Seguimentos , Humanos , Cisto Pancreático/diagnóstico por imagem , Cisto Pancreático/patologia , Cisto Pancreático/cirurgia , Neoplasias Pancreáticas/patologiaRESUMO
BACKGROUND AND AIMS: EMR is the mainstay of therapy for large colorectal polyps. Local recurrence after EMR is common and can be reduced using margin ablation. Our aim was to evaluate recurrence rates when using hybrid argon plasma coagulation (h-APC) ablation after EMR. METHODS: Adult patients (aged 18-89 years) undergoing EMR of nonpedunculated colorectal polyps ≥20 mm were enrolled in a prospective multicenter study. h-APC was used to ablate all defect margins and also the resection surface in selected cases. The primary study outcome was recurrence rates found during the first follow-up colonoscopy. Secondary outcomes were technical success and adverse event rates. RESULTS: EMR with h-APC ablation was used in 101 polyps (84 patients, 46.4% women). EMR with h-APC ablation was technically successful in all cases (median EMR time, 15 minutes; median h-APC ablation time, 4 minutes). Median polyp size was 30 mm (range, 20-60). Resected polyps were either adenomas (68/101 [67.3%]), sessile serrated lesions (27/101 [27%]), or adenocarcinomas (6/101 [6%]). The post-EMR recurrence rate was 2.2% (2/91) (95% confidence interval, .27-7.71). All 6 patients with cancer (intramucosal cancer, 4; T1sm cancer, 2) were found to have complete eradication of the primary tumor after EMR with h-APC, and none had lymph node metastasis. Four serious adverse events occurred in 3 patients (2 delayed bleeding [2.4%], 1 abdominal pain [1.2%], and 1 microperforation [1.2%]. All serious adverse events resolved with either endoscopic or antibiotic treatment only. CONCLUSIONS: EMR with h-APC showed a high technical success rate, low adverse event rate, and very low post-EMR recurrence rates. (Clinical trial registration number: NCT04015765.).
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Pólipos do Colo , Neoplasias Colorretais , Ressecção Endoscópica de Mucosa , Adulto , Humanos , Feminino , Masculino , Pólipos do Colo/patologia , Coagulação com Plasma de Argônio , Estudos Prospectivos , Colonoscopia , Antibacterianos , Neoplasias Colorretais/cirurgia , Neoplasias Colorretais/etiologia , Ressecção Endoscópica de Mucosa/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Endoscopic mucosal resection (EMR) of large, sessile colon polyps often results in incomplete resection with subsequent recurrence. The aim of this prospective pilot study was to evaluate the efficacy and safety of a novel technique, hybrid argon plasma coagulation-assisted EMR (hAPC-EMR), to remove large, sessile polyps. METHODS: 40 eligible patients underwent hAPC-EMR for the removal of one or more nonpedunculated colon polyps ≥â20âmm. Participants were contacted 30 days post-procedure to assess for adverse events and were recommended to return for a surveillance colonoscopy at 6 months to assess for local recurrence. RESULTS: At the time writing, 32 patients with 35 polyps (median size 27 mm; interquartile range 14.5âmm) resected by hAPC-EMR had undergone the 6-month follow-up colonoscopy. Recurrence rate was 0â% (95â% confidence interval [CI] 0-0) at follow-up.âPost-polypectomy bleeding was experienced by three patients (7.5â%; 95â%CI 0.00-0.15), and no patients developed post-polypectomy syndrome. CONCLUSION: These preliminary results showed 0â% local recurrence rate at 6 months and demonstrated the safety profile of hAPC-EMR. A large, randomized, controlled trial is required to confirm these results.
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Pólipos do Colo , Ressecção Endoscópica de Mucosa , Coagulação com Plasma de Argônio/efeitos adversos , Colo , Pólipos do Colo/cirurgia , Colonoscopia/efeitos adversos , Colonoscopia/métodos , Ressecção Endoscópica de Mucosa/efeitos adversos , Ressecção Endoscópica de Mucosa/métodos , Humanos , Projetos Piloto , Estudos ProspectivosRESUMO
BACKGROUND & AIMS: There is debate over the type of electrosurgical setting that should be used for polyp resection. Some endoscopists use a type of blended current (yellow), whereas others prefer coagulation (blue). We performed a single-blinded, randomized trial to determine whether type of electrosurgical setting affects risk of adverse events or recurrence. METHODS: Patients undergoing endoscopic mucosal resection of nonpedunculated colorectal polyps 20 mm or larger (n = 928) were randomly assigned, in a 2 × 2 design, to groups that received clip closure or no clip closure of the resection defect (primary intervention) and then to either a blended current (Endocut Q) or coagulation current (forced coagulation) (Erbe Inc) (secondary intervention and focus of the study). The study was performed at multiple centers, from April 2013 through October 2017. Patients were evaluated 30 days after the procedure (n = 919), and 675 patients underwent a surveillance colonoscopy at a median of 6 months after the procedure. The primary outcome was any severe adverse event in a per patient analysis. Secondary outcomes were complete resection and recurrence at first surveillance colonoscopy in a per polyp analysis. RESULTS: Serious adverse events occurred in 7.2% of patients in the Endocut group and 7.9% of patients in the forced coagulation group, with no significant differences in the occurrence of types of events. There were no significant differences between groups in proportions of polyps that were completely removed (96% in the Endocut group vs 95% in the forced coagulation group) or the proportion of polyps found to have recurred at surveillance colonoscopy (17% and 17%, respectively). Procedural characteristics were comparable, except that 17% of patients in the Endocut group had immediate bleeding that required an intervention, compared with 11% in the forced coagulation group (P = .006). CONCLUSIONS: In a randomized trial to compare 2 commonly used electrosurgical settings for the resection of large colorectal polyps (Endocut vs forced coagulation), we found no difference in risk of serious adverse events, complete resection rate, or polyp recurrence. Electrosurgical settings can therefore be selected based on endoscopist expertise and preference. Clinicaltrials.gov ID NCT01936948.
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Pólipos do Colo/cirurgia , Eletrocirurgia/efeitos adversos , Ressecção Endoscópica de Mucosa/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Idoso , Colo/diagnóstico por imagem , Colo/patologia , Colo/cirurgia , Pólipos do Colo/diagnóstico , Pólipos do Colo/patologia , Colonoscopia , Eletrocirurgia/instrumentação , Eletrocirurgia/métodos , Ressecção Endoscópica de Mucosa/instrumentação , Ressecção Endoscópica de Mucosa/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Recidiva , Resultado do TratamentoRESUMO
BACKGROUND AND STUDY AIM : Delayed bleeding is a common adverse event following endoscopic mucosal resection (EMR) of large colorectal polyps. Prophylactic clip closure of the mucosal defect after EMR of nonpedunculated polyps larger than 20 mm reduces the incidence of severe delayed bleeding, especially in proximal polyps. This study aimed to evaluate factors associated with complete prophylactic clip closure of the mucosal defect after EMR of large polyps. METHODS : This is a post hoc analysis of the CLIP study (NCT01936948). All patients randomized to the clip group were included. Main outcome was complete clip closure of the mucosal resection defect. The defect was considered completely closed when no remaining mucosal defect was visible and clips were less than 1 cm apart. Factors associated with complete closure were evaluated in multivariable analysis. RESULTS : In total, 458 patients (age 65, 58â% men) with 494 large polyps were included. Complete clip closure of the resection defect was achieved for 338 polyps (68.4â%); closure was not complete for 156 (31.6â%). Factors associated with complete closure in adjusted analysis were smaller polyp size (odds ratio 1.06 for every millimeter decrease [95â% confidence interval 1.02-1.08]), good access (OR 3.58 [1.94-9.59]), complete submucosal lifting (OR 2.28 [1.36-3.90]), en bloc resection (OR 5.75 [1.48-22.39]), and serrated histology (OR 2.74 [1.35-5.56]). CONCLUSIONS : Complete clip closure was not achieved for almost one in three resected large nonpedunculated polyps. While stable access and en bloc resection facilitate clip closure, most factors associated with clip closure are not modifiable. This highlights the need for alternative closure options and measures to prevent bleeding.
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Pólipos do Colo , Ressecção Endoscópica de Mucosa , Idoso , Pólipos do Colo/cirurgia , Colonoscopia , Ressecção Endoscópica de Mucosa/efeitos adversos , Feminino , Humanos , Masculino , Instrumentos CirúrgicosRESUMO
BACKGROUND & AIMS: Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. METHODS: We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, postprocedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. RESULTS: A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure bleeding occurred in 3.5% of patients in the clip group and 7.1% in the control group (absolute risk difference [ARD] 3.6%; 95% confidence interval [CI] 0.7%-6.5%). Among 615 patients (66.9%) with a proximal large polyp, the risk of bleeding in the clip group was 3.3% and in the control group was 9.6% (ARD 6.3%; 95% CI 2.5%-10.1%); among patients with a distal large polyp, the risks were 4.0% in the clip group and 1.4% in the control group (ARD -2.6%; 95% CI -6.3% to -1.1%). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8% of patients in the clip group and 9.5% of patients in the control group (ARD 4.6%; 95% CI 1.3%-8.0%). CONCLUSIONS: In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon. ClinicalTrials.gov no: NCT01936948.
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Colectomia/efeitos adversos , Pólipos do Colo/cirurgia , Colonoscopia/efeitos adversos , Técnicas Hemostáticas/instrumentação , Hemorragia Pós-Operatória/prevenção & controle , Instrumentos Cirúrgicos , Idoso , Colectomia/métodos , Pólipos do Colo/patologia , Desenho de Equipamento , Feminino , Técnicas Hemostáticas/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , América do Norte , Hemorragia Pós-Operatória/etiologia , Fatores de Risco , Espanha , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION: Inflammatory bowel disease (IBD) patients are at greater risk of developing colorectal cancer (CRC). Detection of precursor dysplasia is important for cancer prevention. Recent guidelines recommend dye chromoendoscopy (DCE) as the preferred method for dysplasia detection. Universal adoption of DCE is time-consuming and may limit endoscopy access. The benefit of universal application of the guidelines is unclear. We compared high-definition white-light colonoscopy (HD-WLC) with DCE for dysplasia detection in IBD patients. METHODS: We conducted a retrospective case-control study of adult IBD patients undergoing dysplasia surveillance between September 1, 2015, and February 1, 2020. DCE cases were matched to HD-WLC in a 1:1 ratio for gender, IBD diagnosis, and age. DCE patients were considered high risk for colorectal cancer by the referring provider. RESULTS: A total of 187 subjects were enrolled. Majority were males, were Caucasian, and had longstanding IBD (primarily ulcerative colitis). Baseline characteristics were similar between the two groups, except for history of surgery, duration of IBD, and history of dysplasia. There was no significant difference in dysplasia detection between DCE and HD-WLC (10.2% vs 6.7%, p = 0.39). More polyps were detected in the DCE arm compared with the HD-WLC group (1.35 vs 0.80, p = 0.018), but adenoma detection rate was not statistically different between the two groups (10.2% vs 9.0%, p = 0.31). Mean withdrawal time was longer in the DCE group (24.6 min vs 15.4, p < 0.001). CONCLUSIONS: There were no differences in dysplasia detection using DCE compared with HD-WLC, although withdrawal times were longer with DCE.
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Colite Ulcerativa , Neoplasias Colorretais , Doenças Inflamatórias Intestinais , Adulto , Estudos de Casos e Controles , Colonoscopia , Neoplasias Colorretais/diagnóstico , Feminino , Humanos , Doenças Inflamatórias Intestinais/diagnóstico , Masculino , Estudos RetrospectivosRESUMO
PURPOSE OF REVIEW: Pancreatic cystic lesions represent a growing public health dilemma, particularly as our population ages and cross-sectional imaging becomes more sensitive. Mucinous cysts carry a clinically significant risk of developing pancreatic cancer, which carries an extremely poor prognosis. Determining which cysts will develop cancer may be challenging, and surgical resection of the pancreas carries significant morbidity. The goal of this paper is to review the rationale for cyst ablation and discuss prior and current research on cyst ablation techniques and efficacy. Indications, contraindications, and factors related to optimal patient selection are outlined. RECENT FINDINGS: Endoscopic ultrasound-guided chemoablation of pancreatic cysts has been performed in neoplastic cysts, with varying levels of efficacy. Safety concerns arose due to the risk of pancreatitis in alcohol-based treatments; however, the most recent data using a non-alcohol chemoablation cocktail suggests that ablation is effective without the need for alcohol, resulting in a significantly more favorable adverse event profile. Endoscopic ultrasound-guided chemoablation of neoplastic pancreatic cysts is a promising, minimally invasive approach for treatment of cysts, with recent significant advances in safety and efficacy, suggesting that it should play a role in the treatment algorithm.
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Técnicas de Ablação/métodos , Antineoplásicos/administração & dosagem , Endossonografia , Cisto Pancreático/diagnóstico por imagem , Cisto Pancreático/tratamento farmacológico , Neoplasias Pancreáticas/tratamento farmacológico , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico , Humanos , Cisto Pancreático/terapia , Neoplasias Pancreáticas/diagnóstico por imagem , Neoplasias Pancreáticas/terapia , Ultrassonografia de IntervençãoRESUMO
BACKGROUND & AIMS: Endoscopic ultrasound (EUS)-guided chemoablation with ethanol lavage followed by infusion of paclitaxel is effective for the treatment of mucinous pancreatic cysts. However, complications arise in 3%-10% of patients, presumably linked to the inflammatory effects of ethanol. We aimed to determine whether alcohol is required for effective pancreatic cyst ablation, if removing alcohol from the ablation process would improve complication rates, and whether a multi-agent chemotherapeutic cocktail could increase the rate of complete cyst resolution compared with findings reported from previous trials using alcohol followed by paclitaxel alone. METHODS: Between November 2011 and December 2016, we conducted a single-center, prospective, double-blind trial of 39 patients with mucinous-type pancreatic cysts. Patients were randomly assigned to 1 of 2 groups that underwent EUS-guided pancreatic cyst lavage with either 80% ethanol (control) or normal saline (alcohol-free group). Cysts in both groups were then infused with an admixture of paclitaxel and gemcitabine. Primary outcomes were the rates of complete ablation 12 months after the procedure, and rates of serious and minor adverse events within 30 days of the procedure. RESULTS: At 12 months, 67% of patients who underwent alcohol-free EUS-guided cyst chemoablation had complete ablation of cysts compared with 61% of patients in the control group. Serious adverse events occurred in 6% of patients in the control group vs none of the patients in the alcohol-free group. Minor adverse events occurred in 22% of patients in the control group and none of the patients in the alcohol-free group. The overall rate of complete ablation was 64%. CONCLUSIONS: In this prospective, randomized, controlled trial, we found that alcohol is not required for effective EUS-guided pancreatic cyst ablation, and when alcohol is removed from the ablation process, there is a significant reduction in associated adverse events. A multi-agent chemotherapeutic ablation admixture did not appear to significantly improve rates of complete ablation compared with the current standard of alcohol lavage followed by paclitaxel alone. ClinicalTrials.gov ID: NCT01475331.
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Técnicas de Ablação , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Desoxicitidina/análogos & derivados , Etanol/administração & dosagem , Neoplasias Císticas, Mucinosas e Serosas/cirurgia , Paclitaxel/administração & dosagem , Cisto Pancreático/cirurgia , Neoplasias Pancreáticas/cirurgia , Técnicas de Ablação/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Desoxicitidina/administração & dosagem , Desoxicitidina/efeitos adversos , Método Duplo-Cego , Quimioterapia Combinada , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico , Endossonografia , Etanol/efeitos adversos , Feminino , Humanos , Imageamento por Ressonância Magnética , Masculino , Neoplasias Císticas, Mucinosas e Serosas/diagnóstico por imagem , Neoplasias Císticas, Mucinosas e Serosas/patologia , Paclitaxel/efeitos adversos , Cisto Pancreático/diagnóstico por imagem , Cisto Pancreático/patologia , Neoplasias Pancreáticas/diagnóstico por imagem , Neoplasias Pancreáticas/patologia , Pennsylvania , Complicações Pós-Operatórias/prevenção & controle , Estudos Prospectivos , Fatores de Risco , Irrigação Terapêutica , Fatores de Tempo , Resultado do Tratamento , GencitabinaRESUMO
BACKGROUND: Endoscopic mucosal resection comprises the first-line treatment for large cecal polyps. With up to 14% of unresectable colonic polyps harboring malignancy, the management of endoscopically unresectable cecal polyps remains an oncologic right hemicolectomy, which can be associated with substantial postoperative morbidity. OBJECTIVE: This study compares the outcomes of patients with cecal polyps who underwent either endoscopic mucosal resection, a cecectomy, or a right hemicolectomy. DATA SOURCES: Patients undergoing either endoscopic mucosal resection, partial cecectomy, or right hemicolectomy from 2008 to 2017 at a single tertiary care institution were selected. STUDY SELECTION: This was a retrospective cohort study. MAIN OUTCOME MEASURES: The primary outcomes measured were the rate of malignancy, complication rate, estimated blood loss, and hospital length of stay between surgical cohorts. RESULTS: One hundred twenty-nine patients with cecal polyps were identified, of which 52 were referred for surgery. Nineteen underwent partial cecectomy and 33 (27.3%) underwent right hemicolectomy. Two patients undergoing cecectomy required conversion to hemicolectomy because the resected specimen did not contain the polyp. The 2 surgical cohorts did not differ significantly regarding age, sex, or ASA classification. Procedural complication rates were higher among those undergoing hemicolectomy compared with those undergoing cecectomy (37.1% versus 5.9%, p = 0.02). Estimated blood loss (50 vs 10 mL, p = 0.02), operative duration (98 vs 76 minutes, p = 0.009), and length of stay (4 vs 2 days, p < 0.001) were higher in patients undergoing hemicolectomy than in those undergoing cecectomy. No invasive malignancies were identified on final pathology within the cecectomy cohort. LIMITATIONS: Single-institution data and retrospective design were limitations of this study. CONCLUSIONS: In tertiary centers, the majority of large cecal polyps are benign and can be addressed by using endoscopic mucosal resection. When involvement of the appendiceal orifice or ileocecal valve precludes endoscopic treatment, surgical resection is the standard of care. In the subset of cases not involving the ileocecal valve and without preoperative evidence of malignancy, partial cecectomy spares the ileocecal valve and can offer reduced postoperative morbidity compared with a formal right hemicolectomy. See Video Abstract at http://links.lww.com/DCR/A674.
Assuntos
Colectomia/métodos , Pólipos do Colo/cirurgia , Ressecção Endoscópica de Mucosa/métodos , Valva Ileocecal/cirurgia , Idoso , Ceco/patologia , Ceco/cirurgia , Estudos de Coortes , Colectomia/efeitos adversos , Ressecção Endoscópica de Mucosa/efeitos adversos , Feminino , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Tratamentos com Preservação do Órgão/métodos , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND AND AIMS: Referrals for endoscopic management of large non-pedunculated (NP) colorectal polyps have increased as new techniques have emerged. The outcomes for referred large NP polyps based on the polyp morphology were investigated METHODS: A retrospective review of patients referred for large (≥20 mm) NP polyp management from January 2010 through June 2014 was completed. Polyp morphology was classified as either a NP polyp with depression (M1) or NP polyp with no depression (M0). Differences in treatment, histology, adverse events, outcomes at follow-up including residual disease, and need for surgical treatment were determined by morphology for all NP polyps ≥20 mm in size. RESULTS: One-hundred and sixty-nine M1 and 136 M0 polyps ≥20 mm were removed endoscopically during the review period. Mean size was 31.9 ± 11.0 mm in M1, and 26.8 ± 9.5 mm in M0 group (p < 0.0001). En bloc resection was possible in 18.3 % of M1 and 30.9 % of M0 lesions (p = 0.011) with endoscopic submucosal dissection used in 13 and 2.2 % of polyps, respectively (p < 0.0001). Residual polyp was found in 26.5 % (27/102) of M1 and 13.6 % (12/88) of M0 patients at surveillance colonoscopy (p = 0.029). On multivariate analysis, piecemeal resection and M1 morphology showed significant association with residual polyp (OR 4.23, 95 % CI 1.23-14.59, p = 0.022, and OR 2.15, 95 % CI 1.004-4.62, p = 0.049, respectively). CONCLUSION: Effective endoscopic management of large NP colorectal polyps, especially polyps without depression (M0), can be accomplished in the great majority of patients. Polyp morphology, particularly the presence or absence of depression, is a useful tool which influenced treatment, histology, and outcomes.
Assuntos
Adenocarcinoma in Situ/cirurgia , Adenocarcinoma/cirurgia , Adenoma/cirurgia , Pólipos do Colo/cirurgia , Neoplasias Colorretais/cirurgia , Ressecção Endoscópica de Mucosa/métodos , Adenocarcinoma/patologia , Adenocarcinoma in Situ/patologia , Adenoma/patologia , Idoso , Pólipos do Colo/patologia , Colonoscopia , Neoplasias Colorretais/patologia , Feminino , Humanos , Pólipos Intestinais/patologia , Pólipos Intestinais/cirurgia , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Neoplasia Residual , Reto/patologia , Reto/cirurgia , Estudos Retrospectivos , Carga TumoralAssuntos
Anticorpos Monoclonais Humanizados , Clonidina/análogos & derivados , Influenza Humana/tratamento farmacológico , Transtornos de Enxaqueca/tratamento farmacológico , Oxazinas , Piridinas , Síndrome de Abstinência a Substâncias/tratamento farmacológico , Tiepinas , Triazinas , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/efeitos adversos , Anticorpos Monoclonais Humanizados/farmacocinética , Anticorpos Monoclonais Humanizados/uso terapêutico , Clonidina/administração & dosagem , Clonidina/efeitos adversos , Clonidina/farmacocinética , Clonidina/uso terapêutico , Dibenzotiepinas , Interações Medicamentosas , Humanos , Morfolinas , Oxazinas/administração & dosagem , Oxazinas/efeitos adversos , Oxazinas/farmacocinética , Oxazinas/uso terapêutico , Piridinas/administração & dosagem , Piridinas/efeitos adversos , Piridinas/farmacocinética , Piridinas/uso terapêutico , Piridonas , Tiepinas/administração & dosagem , Tiepinas/efeitos adversos , Tiepinas/farmacocinética , Tiepinas/uso terapêutico , Triazinas/administração & dosagem , Triazinas/efeitos adversos , Triazinas/farmacocinética , Triazinas/uso terapêuticoRESUMO
Endoscopic ultrasound (EUS) has rapidly evolved from a diagnostic to a therapeutic tool with applications for various pancreaticobiliary diseases. As part of this evolution, EUS-guided chemoablation for neoplastic pancreatic cysts is developing as a minimally invasive treatment option for appropriately selected mucinous cysts, which can spare patients major resective surgery and may reduce progression to pancreatic cancer. Chemotherapeutic cyst ablation has demonstrated encouraging complete resolution rates, while an alcohol-free chemoablation protocol has demonstrated a significant decrease in adverse events without a compromise to complete ablation rates when compared with previous alcohol-based protocols. Most pancreatic cysts are small, low risk, and best managed by surveillance per accepted guidelines. Cysts with features suggestive of overt malignancy are best discussed by a multidisciplinary committee, and surgery is considered if appropriate. However, for patients in the middle ground with cysts that are structurally suitable for chemoablation, alcohol-free chemoablation has been shown to allow effective, safe, and durable results especially for those who are not ideal operative candidates. EUS-guided alcohol-free chemoablation is promising and continues to evolve; however, as a relatively novel treatment option it has areas of uncertainty that will require further investigation and development.