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1.
Gastrointest Endosc ; 97(3): 537-543.e2, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36228700

RESUMO

BACKGROUND AND AIMS: Performing a high-quality colonoscopy is critical for optimizing the adenoma detection rate (ADR). Colonoscopy withdrawal time (a surrogate measure) of ≥6 minutes is recommended; however, a threshold of a high-quality withdrawal and its impact on ADR are not known. METHODS: We examined withdrawal time (excluding polyp resection and bowel cleaning time) of subjects undergoing screening and/or surveillance colonoscopy in a prospective, multicenter, randomized controlled trial. We examined the relationship of withdrawal time in 1-minute increments on ADR and reported odds ratio (OR) with 95% confidence intervals. Linear regression analysis was performed to assess the maximal inspection time threshold that impacts the ADR. RESULTS: A total of 1142 subjects (age, 62.3 ± 8.9 years; 80.5% men) underwent screening (45.9%) or surveillance (53.6%) colonoscopy. The screening group had a median withdrawal time of 9.0 minutes (interquartile range [IQR], 3.3) with an ADR of 49.6%, whereas the surveillance group had a median withdrawal time of 9.3 minutes (IQR, 4.3) with an ADR of 63.9%. ADR correspondingly increased for a withdrawal time of 6 minutes to 13 minutes, beyond which ADR did not increase (50.4% vs 76.6%, P < .01). For every 1-minute increase in withdrawal time, there was 6% higher odds of detecting an additional subject with an adenoma (OR, 1.06; 95% confidence interval, 1.02-1.10; P = .004). CONCLUSIONS: Results from this multicenter, randomized controlled trial underscore the importance of a high-quality examination and efforts required to achieve this with an incremental yield in ADR based on withdrawal time. (Clinical trial registration number: NCT03952611.).


Assuntos
Adenoma , Pólipos do Colo , Neoplasias Colorretais , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Feminino , Estudos Prospectivos , Neoplasias Colorretais/diagnóstico , Fatores de Tempo , Adenoma/diagnóstico , Colonoscopia/métodos , Detecção Precoce de Câncer , Pólipos do Colo/diagnóstico
2.
Dis Esophagus ; 36(4)2023 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-36190182

RESUMO

There are limited data on the safety of same-day discharge (SDD) after peroral endoscopic myotomy (POEM). The aim of our study is to assess the frequency and relationship to POEM for emergency department (ED) visits and hospitalizations after SDD in these patients. We retrospectively identified consecutive patients between November 2019 and August 2021 who underwent POEM with SDD and at least 6 months follow-up. Criteria for SDD includes: (1) no serious procedure-related adverse event; (2) post-POEM esophagram without leak; (3) stable vital signs; (4) ability to take liquids orally; (5) pain controlled without IV analgesia; (6) adequate social support; (7) American Society of Anesthesiologists (ASA) class I-III. A causative relationship between POEM and ED visits and hospitalizations was assigned by consensus. Out of 185 POEMs performed, 78 (41.7%, 42M, mean 51±16 years) had SDD. Within 30 days of POEM, 8 ED visits occurred in 7/78 (9%) patients and 2 (25%) were considered related to POEM; hospitalization was required in 3 (38%). After 30 days, 11 ED visits occurred in 10/78 (12.8%) patients and 1 (9%) was considered related to POEM; hospitalization was required in 5 (45%). In this study of consecutive SDD patients after POEM, 3/19 (16%) ED visits and 2/8 (25%) hospitalizations within 6 months were considered related to the procedure. Therefore, eligible patients who follow and fulfill a strict protocol after POEM may be safely discharged the same day.


Assuntos
Acalasia Esofágica , Miotomia , Cirurgia Endoscópica por Orifício Natural , Humanos , Acalasia Esofágica/diagnóstico , Alta do Paciente , Estudos Retrospectivos , Resultado do Tratamento , Cirurgia Endoscópica por Orifício Natural/métodos , Dor , Miotomia/métodos , Esfíncter Esofágico Inferior
3.
Am J Gastroenterol ; 117(8): 1316-1319, 2022 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-35467562

RESUMO

INTRODUCTION: There are limited data correlating symptoms with reflux episodes during pH studies after peroral endoscopic myotomy. METHODS: Consecutive patients who underwent POEM followed up ≥6 months later by 48-hour ambulatory wireless pH testing off antisecretory therapy were identified. Reflux symptom association was defined as symptom association probability >95%. RESULTS: The most frequent symptoms of heartburn (47.2%), cough (45.1%), and chest pain (39.6%) were associated with a positive reflux symptom association (symptom association probability >95%) in 20.9%, 17.1%, and 19.4%, respectively. DISCUSSION: There is poor correlation between reported symptoms and esophageal acid exposure during pH testing after POEM.


Assuntos
Acalasia Esofágica , Esofagite Péptica , Refluxo Gastroesofágico , Miotomia , Cirurgia Endoscópica por Orifício Natural , Acalasia Esofágica/complicações , Acalasia Esofágica/cirurgia , Esofagoscopia , Refluxo Gastroesofágico/complicações , Refluxo Gastroesofágico/etiologia , Azia/etiologia , Humanos , Concentração de Íons de Hidrogênio , Resultado do Tratamento
4.
Gastrointest Endosc ; 95(5): 855-863, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-34979118

RESUMO

BACKGROUND AND AIMS: Outcomes after peroral endoscopic myotomy (POEM) are assessed clinically by the Eckardt score (ES) or objectively by high-resolution manometry (HRM) and functional lumen imaging probe (FLIP). This study compared HRM and FLIP to evaluate clinical response after POEM. METHODS: This was a single tertiary center retrospective study of consecutive patients who underwent POEM for treatment-naive achalasia and with ≥6 months of follow-up. Baseline and follow-up testing in all patients included ES, HRM, and FLIP of the esophagogastric junction (EGJ). A normal post-POEM (or normalized) EGJ distensibility index (EGJ-DI) >2.8 mm2/mm Hg, maximum EGJ diameter (MxEGJD) ≥14 mm, and integrated relaxation pressure (IRP) <15 mm Hg were compared with a clinical response, defined as ES ≤3. RESULTS: Eighty-seven patients (58% men, mean age 51 ± 17 years) were included. Overall clinical response by ES, IRP, MxEGJD, and EGJ-DI were 97.7%, 86.2%, 75.9%, and 92.0%, respectively. The sensitivity of a normal IRP (87.1% [95% confidence interval {CI}, 78.0-93.4]) was similar to the sensitivity of a normal MxEGJD (75.3% [95% CI, 64.7-84.0], P = .053) and normal EGJ-DI (91.8% [95% CI, 83.8%-96.6%], P = .39) after POEM to predict clinical response. However, the sensitivity of a normal post-POEM EGJ-DI was superior to a normal post-POEM MxEGJD (P = .001) to predict clinical response. There was no difference in the area under the curve of a normal MxEGJD or EGJ-DI to predict a normal IRP (P = .956) after POEM. CONCLUSIONS: Normal FLIP metrics ≥6 months after POEM for achalasia show good to excellent sensitivity but are equivalent to a normalized IRP by HRM to predict clinical response by ESs. FLIP may be used as an alternative to HRM to assess lower esophageal sphincter response to POEM in these patients. (Clinical trial registration number: NCT02770859.).


Assuntos
Acalasia Esofágica , Miotomia , Cirurgia Endoscópica por Orifício Natural , Adulto , Idoso , Acalasia Esofágica/cirurgia , Esfíncter Esofágico Inferior/cirurgia , Feminino , Humanos , Masculino , Manometria/métodos , Pessoa de Meia-Idade , Miotomia/métodos , Estudos Retrospectivos , Resultado do Tratamento
5.
Clin Gastroenterol Hepatol ; 20(9): 2023-2031.e6, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-34979245

RESUMO

BACKGROUND AND AIMS: Mucosal exposure devices including distal attachments such as the cuff and cap have shown variable results in improving adenoma detection rate (ADR) compared with high-definition white light colonoscopy (HDWLE). METHODS: We performed a prospective, multicenter randomized controlled trial in patients undergoing screening or surveillance colonoscopy comparing HDWLE to 2 different types of distal attachments: cuff (CF) (Endocuff Vision) or cap (CP) (Reveal). The primary outcome was ADR. Secondary outcomes included adenomas per colonoscopy, advanced adenoma and sessile serrated lesion detection rate, right-sided ADR, withdrawal time, and adverse events. Continuous variables were compared using Student's t test and categorical variables were compared using chi-square or Fisher's exact test using statistical software Stata version16. A P value <.05 was considered significant. RESULTS: A total of 1203 subjects were randomized to either HDWLE (n = 384; mean 62 years of age; 81.3% males), CF (n = 379; mean 62.7 years of age; 79.9% males) or CP (n = 379; mean age 62.1 years of age; 80.5% males). No significant differences were found among 3 groups for ADR (57.3%, 59.1%, and 55.7%; P = .6), adenomas per colonoscopy (1.4 ± 1.9, 1.6 ± 2.4, and 1.4 ± 2; P = .3), advanced adenoma (7.6%, 9.2%, and 8.2%; P = .7), sessile serrated lesion (6.8%, 6.3%, and 5.5%; P = .8), or right ADR (48.2%, 49.3%, and 46.2%; P = .7). The number of polyps per colonoscopy were significantly higher in the CF group compared with HDWLE and CP group (2.7 ± 3.4, 2.3 ± 2.5, and 2.2 ± 2.3; P = .013). In a multivariable model, after adjusting for age, sex, body mass index, withdrawal time, and Boston Bowel Preparation Scale score, there was no impact of device type on the primary outcome of ADR (P = .77). In screening patients, CF resulted in more neoplasms per colonoscopy (CF: 1.7 ± 2.6, HDWLE: 1.3 ± 1.7, and CP: 1.2 ± 1.8; P = .047) with a shorter withdrawal time. CONCLUSIONS: Results from this multicenter randomized controlled trial do not show any significant benefit of using either distal attachment devices (CF or CP) over HDWLE, at least in high-detector endoscopists. The Endocuff may have an advantage in the screening population. (ClinicalTrials.gov, Number: NCT03952611).


Assuntos
Adenoma , Pólipos do Colo , Neoplasias Colorretais , Idoso , Idoso de 80 Anos ou mais , Colonoscopia , Detecção Precoce de Câncer , Feminino , Humanos , Masculino , Programas de Rastreamento , Pessoa de Meia-Idade , Estudos Prospectivos
6.
Endosc Int Open ; 9(11): E1692-E1701, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34790532

RESUMO

Background and study aims The aim of this study was to evaluate whether timed barium esophagram within 24 hours post-per-oral endoscopic myotomy (POEM) (TBE-PP) could predict clinical outcomes. Patients and methods This was a single-center retrospective study of prospectively collected data on consecutive patients with ≥ 6-month follow-up who underwent POEM followed by TBE-PP. Esophageal contrast retention 2 minutes after TBE-PP was assessed as Grade 1 (< 10 %), 2 (10 %-49 %), 3 (50 %-89 %) or 4 (> 90 %). Eckardt score, esophagogastroduodenoscopy (EGD), high-resolution manometry (HRM) and function lumen imaging probe (FLIP) of the esophagogastric junction (EGJ) were obtained at baseline. These tests along with pH testing of antisecretory therapy were repeated 6 and 24 months after POEM. Clinical response by Eckardt score ≤ 3, EGJ-distensibility index (EGJ-DI) > 2.8 mm 2 /mm Hg, and integrated relaxation pressure (IRP) < 15 mm Hg and incidence of gastroesophageal reflux disease (GERD) were compared by transit time. Results Of 181 patients (58 % male, mean 53 ±â€Š17 yr), TBE-PP was classified as Grade 1 in 122 (67.4 %), Grade 2 in 41 (22.7 %), Grade 3 in 14 (7.7 %) and Grade 4 in 4 (2.2 %). At 6 months, overall clinical response by ES (91.7 %), IRP (86.6 %), EGJ-DI (95.7 %) and the diagnosis of GERD (68.6 %) was similar between Grade 1 and Grade 2-4 TBE-PP. At 24 months, Grade 1 had a higher frequency of a normal IRP compared to Grades 2-4 (95.7 % vs. 60 %, P  = 0.021) but overall response by ES (91.2 %), EGJ-DI (92.3 %) and the diagnosis of GERD (74.3 %) were similar. Conclusions Contrast emptying rate by esophagram after POEM has limited utility to predict clinical response or risk of post-procedure GERD.

7.
Scand J Gastroenterol ; 56(4): 505-507, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33599184

RESUMO

OBJECTIVES: Celiac disease (CD) is commonly found in women. Given the sex differences in diagnosed patients, we hypothesized sex differences in physicians obtaining biopsies for CD may exist. MATERIALS AND METHODS: We retrospectively reviewed duodenal biopsies for suspected CD excluding pre-existing CD patients. Appropriate biopsy practice was defined as ≥5 specimens per ACG guidelines. RESULTS: We included 125 patients (females, 92). There were 85 properly (68%) biopsied. Presence of a female endoscopist was associated with better adherence to biopsy guidelines (OR, 2.99, 95% CI, 1.19-7.54; p = .02) which remained significant after multivariable adjustment (adjusted OR, 2.7; p = .047). CONCLUSIONS: Physician sex-based differences in biopsy patterns may exist.


Assuntos
Doença Celíaca , Gastroenterologistas , Biópsia , Duodeno , Feminino , Humanos , Masculino , Estudos Retrospectivos
8.
Gastrointest Endosc ; 91(1): 115-120, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31299257

RESUMO

BACKGROUND AND AIMS: Devices for flattening colon folds can improve polyp detection at colonoscopy. However, there are few data on the endoscopic ring-fitted cap (EndoRings; EndoAid, Caesarea, Israel). We sought to compare adenoma detection with EndoRings with that of standard high-definition colonoscopy. METHODS: This was a single-center, randomized controlled trial of 562 patients (284 randomized to EndoRings and 278 to standard colonoscopy) at 2 outpatient endoscopy units in the Indiana University Hospital system. Adenoma detection was the primary outcome measured as adenoma detection rate (ADR) and adenomas per colonoscopy (APC). We also compared sessile serrated polyp detection rate, insertion times, withdrawal times, and ease of passage through the sigmoid colon. RESULTS: EndoRings was superior to standard colonoscopy in terms of APC (1.46 vs 1.06, P = .025), but there were no statistically significant differences in ADR or sessile serrated polyp detection rate. Mean withdrawal time (in patients with no polyps) was shorter and insertion time (all patients) was longer in the EndoRings arm by 1.8 minutes and 0.75 minutes, respectively. One provider had significantly higher detection with Endo-Rings and contributed substantially to the overall results. CONCLUSIONS: EndoRings can increase adenoma detection without a significant increase in procedure time, but the effect varies between operators. The use of EndoRings slows colonoscope insertion. (Clinical trial registration number: NCT03418662.).


Assuntos
Adenoma/diagnóstico por imagem , Neoplasias do Colo/diagnóstico por imagem , Pólipos do Colo/diagnóstico por imagem , Colonoscopia/instrumentação , Adenoma/patologia , Idoso , Neoplasias do Colo/patologia , Pólipos do Colo/patologia , Colonoscópios , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia
9.
Gastrointest Endosc ; 90(5): 835-840.e1, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31319060

RESUMO

BACKGROUND AND AIMS: Endocuff (Arc Medical Design, Leeds, UK) and Endocuff Vision (Arc Medical Design, Leeds, UK) are effective mucosal exposure devices for improving polyp detection during colonoscopy. AmplifEYE (Medivators Inc, Minneapolis, Minn, USA) is a device that appears similar to the Endocuff devices but has received minimal clinical testing. METHODS: We performed a randomized controlled clinical trial using a noninferiority design to compare Endocuff Vision with AmplifEYE. RESULTS: The primary endpoint of adenomas per colonoscopy was similar in AmplifEYE at 1.63 (standard deviation 2.83) versus 1.51 (2.29) with Endocuff Vision (P = .535). The 95% lower confidence limit was 0.88 for ratio of means, establishing noninferiority of AmplifEYE (P = .008). There was no difference between the arms for mean insertion time, and mean inspection time (withdrawal time minus polypectomy time and time for washing and suctioning) was shorter with AmplifEYE (6.8 minutes vs 6.9 minutes, P = .042). CONCLUSIONS: AmplifEYE is noninferior to Endocuff Vision for adenoma detection. The decision on which device to use can be based on cost. Additional comparisons of AmplifEYE with Endocuff by other investigators are warranted. (Clinical trial registration number: NCT03560128.).


Assuntos
Adenoma/diagnóstico por imagem , Neoplasias do Colo/diagnóstico por imagem , Colonoscopia/instrumentação , Idoso , Detecção Precoce de Câncer , Feminino , Humanos , Mucosa Intestinal/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia
10.
Gastrointest Endosc ; 90(1): 64-74.e3, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30684601

RESUMO

BACKGROUND AND AIMS: Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid antireflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent. METHODS: A phase III, multicenter, prospective, noninferiority, randomized controlled trial was conducted on patients with malignant dysphagia requiring SEMSs to be placed across the GEJ. Patients were randomized to receive SEMSs with no valve (SEMS-NV) or SEMS-V. Postdeployment dysphagia score at 2 weeks and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire score at 4 weeks were measured. Patients were followed for 24 weeks. RESULTS: Sixty patients were randomized (SEMS-NV: 30 patients, mean age 67 ± 13 years; SEMS-V: 30 patients, mean age 65 ± 12 years). Baseline dysphagia scores (SEMS-NV, 2.5 ± .8; SEMS-V, 2.5 ± .8) and GERD-HRQL scores (SEMS-NV, 11.1 ± 8.2; SEMS-V, 12.8 ± 8.3) were similar. All SEMSs were successfully deployed. A similar proportion of patients in both arms improved from advanced dysphagia to moderate to no dysphagia (SEMS-NV, 71%; SEMS-V, 74%; 95% confidence interval, 1.93 [-17.8 to 21.7]). The dysphagia scores were also similar across all follow-up time points. Mean GERD-HRQL scores improved by 7.4 ± 10.2 points in the SEMS-V arm and by 5.2 ± 8.3 in the SEMS-NV group (P = .96). The GERD-HRQL scores were similar across all follow-up time points. Aspiration pneumonia occurred in 3.3% in the SEMS-NV arm and 6.9% in the SEMS-V arm (P = .61). Migration rates were similar (SEMS-NV, 33%; SEMS-V, 48%; P = .29). Two SEMS-V spontaneously fractured. There was no perforation, food impaction, or stent-related death in either group. CONCLUSIONS: The SEMS-V was equally effective in relieving dysphagia as compared with the SEMS-NV. Presence of the valve did not increase the risks of adverse events. GERD symptom scores were similar between the 2 stents, implying either that the valve was not effective or that all patients on proton pump inhibitors could have masked the symptoms of GERD. Studies with objective evaluations such as fluoroscopy and/or pH/impedance are recommended. (Clinical trial registration number: NCT02159898.).


Assuntos
Adenocarcinoma/complicações , Transtornos de Deglutição/cirurgia , Neoplasias Esofágicas/complicações , Estenose Esofágica/cirurgia , Refluxo Gastroesofágico/epidemiologia , Pneumonia Aspirativa/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Desenho de Prótese , Stents Metálicos Autoexpansíveis , Idoso , Idoso de 80 Anos ou mais , Transtornos de Deglutição/etiologia , Endoscopia do Sistema Digestório , Estudos de Equivalência como Asunto , Estenose Esofágica/etiologia , Junção Esofagogástrica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cuidados Paliativos , Método Simples-Cego
11.
Endosc Int Open ; 6(9): E1085-E1092, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30211296

RESUMO

Background and aims The impact of the advent of an institutional endoscopic eradication therapy (EET) program on surgical practice for Barrett's esophagus (BE)-associated high grade dysplasia (HGD) or suspected T1a esophageal adenocarcinoma (EAC) is unknown. The aims of this study are to evaluate the different endoscopic modalities used during development of our EET program and factors associated with the use of EET or surgery for these patients after its development. Methods Patients who underwent primary endoscopic or surgical treatment for BE-HGD or early EAC at our hospital between January 1992 and December 2014 were retrospectively identified. They were categorized by their initial modality of treatment during the first year, and the impact over time for choice of therapy was assessed by multivariable logistic regression. Results We identified 386 patients and 80 patients who underwent EET and surgery, respectively. EET included single modality therapy in 254 (66 %) patients and multimodal therapy in 132 (34 %) patients. Multivariable logistic regression showed that, for each subsequent study year, EET was more likely to be performed in patients who were older ( P  = 0.0009), with shorter BE lengths ( P  < 0.0001), and with a pretreatment diagnosis of HGD ( P  = 0.0054) compared to surgical patients. The diagnosis of EAC did not increase the utilization of EET compared to surgery as time progressed ( P  = 0.8165). Conclusion The introduction of an EET program at our hospital increased the odds of utilizing EET versus surgery over time for initial treatment of patients who were older, had shorter BE lengths or the diagnosis of BE-HGD, but not in patients with EAC.

12.
Ann Thorac Surg ; 104(3): 1054-1061, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28619542

RESUMO

BACKGROUND: Level 1 programs have improved outcomes by expediting the multidisciplinary care of critically ill patients. We established a novel level 1 program for the management of esophageal emergencies. METHODS: After institutional review board approval, we performed a retrospective analysis of patients referred to our level 1 esophageal emergency program from April 2013 through November 2015. A historical comparison group of patients treated for the same diagnosis in the previous 2 years was used. RESULTS: Eighty patients were referred and transported an average distance of 56 miles (range, 1-163 miles). Median time from referral to arrival was 2.4 hours (range, 0.4-12.9 hours). Referrals included 6 (7%) patients with esophageal obstruction and 71 (89%) patients with suspected esophageal perforation. Of the patients with suspected esophageal perforation, causes included iatrogenic (n = 26), Boerhaave's syndrome (n = 32), and other (n = 13). Forty-six percent (n = 33) of patients were referred because of pneumomediastinum, but perforation could not be subsequently demonstrated. Initial management of patients with documented esophageal perforation included operative treatment (n = 25), endoscopic intervention (n = 8), and supportive care (n = 5). Retrospective analysis demonstrated a statistically significant difference in mean Pittsburgh severity index score (PSS) between esophageal perforation treatment groups (p < 0.01). In patients with confirmed perforations, there were 3 (8%) mortalities within 30 days. More patients in the esophageal level 1 program were transferred to our institution in less than 24 hours after diagnosis than in the historical comparison group (p < 0.01). CONCLUSIONS: Development of an esophageal emergency referral program has facilitated multidisciplinary care at a high-volume institution, and early outcomes appear favorable.


Assuntos
Gerenciamento Clínico , Emergências , Serviços Médicos de Emergência/métodos , Perfuração Esofágica/terapia , Estenose Esofágica/terapia , Esofagoscopia/métodos , Desenvolvimento de Programas/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Perfuração Esofágica/diagnóstico , Estenose Esofágica/diagnóstico , Feminino , Humanos , Indiana , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Tempo , Adulto Jovem
13.
Surg Endosc ; 30(8): 3402-8, 2016 08.
Artigo em Inglês | MEDLINE | ID: mdl-26537905

RESUMO

BACKGROUND: The initial 6-month data for MUSE™ (Medigus, Omer, Israel) endoscopic stapling device were reported (Zacherl et al. in Surg Endosc 29:220-229, 2015). The current study aims to evaluate the long-term clinical outcome of 37 patients who received endoscopic gastroesophageal reflux disease (GERD) treatment with the MUSE™ device. METHODS: Efficacy and safety data for 37 patients were analyzed at baseline, 6 months, and 4 years post-procedure. In one center (IU), efficacy and safety data were evaluated at baseline, 6 months post-procedure, and then annually up to 4 years. RESULTS: No new complications have been reported in our long-term analysis. The proportions of patients who remained off daily PPI were 83.8 % (31/37) at 6 months and 69.4 % (25/36) at 4 years post-procedure. GERD-Health Related Quality of Life (HRQL) scores (off PPI) were significantly decreased from baseline to 6 months and 4 years post-procedure. The daily dosage of GERD medications, measured as omeprazole equivalents (mean ± SD, mg), decreased from 66.1 ± 33.2 at baseline to 10.8 ± 15.9 at 6 months and 12.8 ± 19.4 at 4 years post-procedure (P < 0.01). CONCLUSIONS: In our multi-center prospective study, the MUSE™ stapling device appears to be safe and effective in improving symptom scores as well as reducing PPI use in patients with GERD. These results appeared to be equal to or better than those of the other devices for endoluminal GERD therapy. Future studies with larger patient series, sham control group, and greater number of staples are awaited.


Assuntos
Endoscopia Gastrointestinal , Refluxo Gastroesofágico/cirurgia , Grampeadores Cirúrgicos , Adulto , Uso de Medicamentos/estatística & dados numéricos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Omeprazol/uso terapêutico , Estudos Prospectivos , Inibidores da Bomba de Prótons/uso terapêutico , Qualidade de Vida
14.
Gastrointest Endosc ; 83(1): 166-71, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25952085

RESUMO

BACKGROUND: The value of narrow-band imaging (NBI) for detecting serrated lesions is unknown. OBJECTIVE: To assess NBI for the detection of proximal colon serrated lesions. DESIGN: Randomized, controlled trial. SETTING: Two academic hospital outpatient units. PATIENTS: Eight hundred outpatients 50 years of age and older with intact colons undergoing routine screening, surveillance, or diagnostic examinations. INTERVENTIONS: Randomization to colon inspection in NBI versus white-light colonoscopy. MAIN OUTCOME MEASUREMENTS: The number of serrated lesions (sessile serrated polyps plus hyperplastic polyps) proximal to the sigmoid colon. RESULTS: The mean inspection times for the whole colon and proximal colon were the same for the NBI and white-light groups. There were 204 proximal colon lesions in the NBI group and 158 in the white light group (P = .085). Detection of conventional adenomas was comparable in the 2 groups. LIMITATIONS: Lack of blinding, endoscopic estimation of polyp location. CONCLUSION: NBI may increase the detection of proximal colon serrated lesions, but the result in this trial did not reach significance. Additional study of this issue is warranted. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01572428.).


Assuntos
Adenoma/patologia , Colo/patologia , Neoplasias do Colo/patologia , Pólipos do Colo/patologia , Colonoscopia/métodos , Imagem de Banda Estreita/métodos , Adenoma/diagnóstico , Colo Ascendente/patologia , Colo Descendente/patologia , Colo Transverso/patologia , Neoplasias do Colo/diagnóstico , Pólipos do Colo/diagnóstico , Detecção Precoce de Câncer , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
15.
Surg Endosc ; 29(1): 220-9, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25135443

RESUMO

BACKGROUND: Both long-term proton pump inhibitor (PPI) use and surgical fundoplication have potential drawbacks as treatments for chronic gastroesophageal reflux disease (GERD). This multi-center, prospective study evaluated the clinical experiences of 69 patients who received an alternative treatment: endoscopic anterior fundoplication with a video- and ultrasound-guided transoral surgical stapler. METHODS: Patients with well-categorized GERD were enrolled at six international sites. Efficacy data was compared at baseline and at 6 months post-procedure. The primary endpoint was a ≥ 50 % improvement in GERD health-related quality of life (HRQL) score. Secondary endpoints were elimination or ≥ 50 % reduction in dose of PPI medication and reduction of total acid exposure on esophageal pH probe monitoring. A safety evaluation was performed at time 0 and weeks 1, 4, 12, and 6 months. RESULTS: 66 patients completed follow-up. Six months after the procedure, the GERD-HRQL score improved by >50 % off PPI in 73 % (48/66) of patients (95 % CI 60-83 %). Forty-two patients (64.6 %) were no longer using daily PPI medication. Of the 23 patients who continued to take PPI following the procedure, 13 (56.5 %) reported a ≥ 50 % reduction in dose. The mean percent of total time with esophageal pH <4.0 decreased from baseline to 6 months (P < 0.001). Common adverse events were peri-operative chest discomfort and sore throat. Two severe adverse events requiring intervention occurred in the first 24 subjects, no further esophageal injury or leaks were reported in the remaining 48 enrolled subjects. CONCLUSIONS: The initial 6-month data reported in this study demonstrate safety and efficacy of this endoscopic plication device. Early experience with the device necessitated procedure and device changes to improve safety, with improved results in the later portion of the study. Continued assessment of durability and safety are ongoing in a three-year follow-up study of this patient group.


Assuntos
Endoscopia Gastrointestinal , Fundoplicatura/instrumentação , Refluxo Gastroesofágico/cirurgia , Grampeadores Cirúrgicos , Ultrassonografia de Intervenção , Cirurgia Vídeoassistida , Adolescente , Adulto , Idoso , Terapia Combinada , Monitoramento do pH Esofágico , Feminino , Seguimentos , Fundoplicatura/métodos , Refluxo Gastroesofágico/diagnóstico , Refluxo Gastroesofágico/diagnóstico por imagem , Refluxo Gastroesofágico/tratamento farmacológico , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Inibidores da Bomba de Prótons/uso terapêutico , Qualidade de Vida , Resultado do Tratamento , Adulto Jovem
17.
Gastrointest Endosc ; 79(4): 589-98, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24125513

RESUMO

BACKGROUND: Factors associated with successful endoscopic therapy with temporary stents for esophageal leaks, fistulae, and perforations (L/F/P) are not well known. OBJECTIVES: To evaluate the safety, efficacy, and outcomes of esophageal stenting in these patients and identify factors associated with successful closure. DESIGN: Retrospective. SETTING: Academic tertiary referral center. PATIENTS: All patients with attempted stent placement for esophageal L/F/P between January 2003 and May 2012. INTERVENTION: Esophageal stent placement and removal. MAIN OUTCOME MEASUREMENTS: Factors predictive of therapeutic success defined as complete closure after index stent removal (primary closure) or after further endoscopic stenting (secondary closure). RESULTS: Sixty-seven patients with 132 attempted stents for esophageal L/F/P were considered; 13 patients were excluded. Among the remaining 54 patients, 117 stents were placed for leaks (29 patients; 64 stents), fistulae (15 patients; 36 stents), and perforations (10 patients; 17 stents). Procedural technical success was achieved in all patients (100%). Primary closure was successful in 40 patients (74%) and secondary closure in an additional 5 (83% overall). On short-term (<3 months) follow-up, 27 patients (50%) were asymptomatic, whereas 22 (41%) had technical adverse events, including stent migration in 15 patients (28%). Factors associated with successful primary closure include a shorter time between diagnosis of esophageal L/F/P and initial stent insertion (9.03 vs 22.54 days; P = .003), and a smaller luminal opening size (P = .002). LIMITATIONS: Retrospective, single-center study. CONCLUSIONS: Temporary stents are safe and effective in treating esophageal L/F/P. Defect opening size and time from diagnosis to stent placement appear to be candidate predictors for successful closure.


Assuntos
Fístula Anastomótica/cirurgia , Fístula Esofágica/cirurgia , Perfuração Esofágica/cirurgia , Esôfago/cirurgia , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Indução de Remissão , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
18.
Am J Gastroenterol ; 105(6): 1301-7, 2010 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-20179689

RESUMO

OBJECTIVES: Flat and depressed colon neoplasms are an increasingly recognized precursor for colorectal cancer (CRC) in Western populations. High-definition chromoscopy is used to increase the yield of colonoscopy for flat and depressed neoplasms; however, its role in average-risk patients undergoing routine screening remains uncertain. METHODS: Average-risk patients referred for screening colonoscopy at four U.S. medical centers were randomized to high-definition chromocolonoscopy or high-definition white light colonoscopy. The primary outcomes, patients with at least one adenoma and the number of adenomas per patient, were compared between the two groups. The secondary outcome was patients with flat or depressed neoplasms, as defined by the Paris classification. RESULTS: A total of 660 patients were randomized (chromocolonoscopy: 321, white light: 339). Overall, the mean number of adenomas per patient was 1.2+/-2.1, the mean number of flat polyps per patient was 1.4+/-1.9, and the mean number of flat adenomas per patient was 0.5+/-1.0. The number of patients with at least one adenoma (55.5% vs. 48.4%, absolute difference 7.1%, 95% confidence interval (-0.5% to 14.7%), P=0.07), and the number of adenomas per patient (1.3+/-2.4 vs. 1.1+/-1.8, P=0.07) were marginally higher in the chromocolonoscopy group. There were no significant differences in the number of advanced adenomas per patient (0.06+/-0.37 vs. 0.04+/-0.25, P=0.3) and the number of advanced adenomas<10 mm per patient (0.02+/-0.26 vs. 0.01+/-0.14, P=0.4). Two invasive cancers were found, one in each group; neither was a flat neoplasm. Chromocolonoscopy detected significantly more flat adenomas per patient (0.6+/-1.2 vs. 0.4+/-0.9, P=0.01), adenomas<5 mm in diameter per patient (0.8+/-1.3 vs. 0.7+/-1.1, P=0.03), and non-neoplastic lesions per patient (1.8+/-2.3 vs. 1.0+/-1.3, P<0.0001). CONCLUSIONS: High-definition chromocolonoscopy marginally increased overall adenoma detection, and yielded a modest increase in flat adenoma and small adenoma detection, compared with high-definition white light colonoscopy. The yield for advanced neoplasms was similar for the two methods. Our findings do not support the routine use of high-definition chromocolonoscopy for CRC screening in average-risk patients. The high adenoma detection rates observed in this study may be due to the high-definition technology used in both groups.


Assuntos
Adenoma/diagnóstico , Pólipos do Colo/diagnóstico , Colonoscopia/métodos , Neoplasias Colorretais/diagnóstico , Idoso , Pólipos do Colo/classificação , Detecção Precoce de Câncer , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
19.
Gastrointest Endosc ; 71(3): 551-6, 2010 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-20018280

RESUMO

BACKGROUND: Colonoscopy may fail to detect neoplasia located on the proximal sides of haustral folds and flexures. The Third Eye Retroscope (TER) provides a simultaneous retrograde view that complements the forward view of a standard colonoscope. OBJECTIVE: To evaluate the added benefit for polyp detection during colonoscopy of a retrograde-viewing device. DESIGN: Open-label, prospective, multicenter study evaluating colonoscopy by using a TER in combination with a standard colonoscope. SETTING: Eight U.S. sites, including university medical centers, ambulatory surgery centers, a community hospital, and a physician's office. PATIENTS: A total of 249 patients (age range 55-80 years) presenting for screening or surveillance colonoscopy. INTERVENTIONS: After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. MAIN OUTCOME MEASUREMENTS: The number and sizes of lesions (adenomas and all polyps) detected with the standard colonoscope and the number and sizes of lesions found only because they were first detected with the TER. RESULTS: In the 249 subjects, 257 polyps (including 136 adenomas) were identified with the colonoscope alone. The TER allowed detection of 34 additional polyps (a 13.2% increase; P < .0001) including 15 additional adenomas (an 11.0% increase; P < .0001). For lesions 6 mm or larger, the additional detection rates with the TER for all polyps and for adenomas were 18.2% and 25.0%, respectively. For lesions 10 mm or larger, the additional detection rates with the TER for all polyps and for adenomas were 30.8% and 33.3%, respectively. In 28 (11.2%) individuals, at least 1 additional polyp was found with the TER. In 8 (3.2%) patients, the polyp detected with the TER was the only one found. Every polyp that was detected with the TER was subsequently located with the colonoscope and removed. For all polyps and for adenomas, the additional detection rates for the TER were 9.7%/4.1% in the left colon (the splenic flexure to the rectum) and 16.5%/14.9% in the right colon (the cecum to the transverse colon), respectively. LIMITATIONS: There was no randomization or comparison with a separate control group. CONCLUSIONS: A retrograde-viewing device revealed areas that were hidden from the forward-viewing colonoscope and allowed detection of 13.2% additional polyps, including 11.0% additional adenomas. Additional detection rates with the TER for adenomas 6 mm or larger and 10 mm or larger were 25.0% and 33.3%, respectively. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00657371.).


Assuntos
Adenoma/diagnóstico , Neoplasias do Colo/diagnóstico , Colonoscópios , Colonoscopia , Idoso , Idoso de 80 Anos ou mais , Equipamentos Descartáveis , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Gravação em Vídeo
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