Long-term outcomes after temporary placement of a self-expanding fully covered metal stent for benign biliary strictures secondary to chronic pancreatitis.

BACKGROUND AND AIMS: Temporary single, fully covered self-expanding metal stent (FCSEMS) placement for benign biliary strictures (BBSs) associated with chronic pancreatitis (CP) may require fewer interventions than endotherapy with multiple plastic stents and may carry less morbidity than biliary diversion surgery. This study aimed to assess long-term outcomes in CP-associated BBSs after FCSEMS placement and removal. METHODS: In this open-label, multinational, prospective study, subjects with CP and a BBS treated with FCSEMS placement with scheduled removal at 10 to 12 months were followed for 5 years after FCSEMS indwell. Kaplan-Meier analyses assessed BBS resolution and cumulative probability of freedom from recurrent stent placement to 5 years after FCSEMS indwell. RESULTS: One hundred eighteen patients were eligible for FCSEMS removal. At a median of 58 months (interquartile range, 44-64) post-FCSEMS indwell, the probability of remaining stent-free was 61.6% (95% confidence interval [CI], 52.5%-70.7%). In 94 patients whose BBSs resolved at the end of FCSEMS indwell, the probability of remaining stent-free 5 years later was 77.4% (95% CI, 68.4%-86.4%). Serious stent-related adverse events occurred in 27 of 118 patients (22.9%); all resolved with medical therapy or repeated endoscopy. Multivariate analysis identified severe CP (hazard ratio, 2.4; 95% CI, 1.0-5.6; P = .046) and longer stricture length (hazard ratio, 1.2; 95% CI, 1.0-1.4; P = .022) as predictors of stricture recurrence. CONCLUSION: In patients with symptomatic BBSs secondary to CP, 5 years after placement of a single FCSEMS intended for 10 to 12 months indwell, more than 60% remained asymptomatic and stent-free with an acceptable safety profile. Temporary placement of a single FCSEMS may be considered as first-line treatment for patients with CP and BBSs. (Clinical trial registration number: NCT01014390.).

Réplica a la carta: in response to the editorial 'Sedation in endoscopy in 2016: is it safe sedation with propofol led by the endoscopist in complex situations?' / Author's reply to the letter: in response to the editorial 'Sedation in endoscopy in 2016: Is it safe sedation with propofol led by the endoscopist in complex situations?'

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Author´s reply to the letter: In response to the editorial "Sedation in endoscopy in 2016: Is it safe sedation with propofol led by the endoscopist in complex situations?"

Author's reply to the letter: In response to the editorial "Sedation in endoscopy in 2016: is it safe sedation with propofol led by the endoscopist in complex situations?"

Sedación en endoscopia en el año 2016: ¿es segura la sedación con propofol dirigida por el endoscopista en situaciones complejas? / Sedation for endoscopy in 2016. Is endoscopist-guided sedation safe in complex situations?

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Sedation for endoscopy in 2016 - Is endoscopist-guided sedation safe in complex situations?

The higher number of adverse events reported with anesthetist-delivered sedation are likely due to the fact that anethesia professionals induce deeper sedation as compared to sedation delivered by endoscopists. The former are trained to induce general anesthesia in their daily practice, where protective reflexes are more commonly depressed and the risk for undesired cardiopulmonary events is higher.

Successful management of benign biliary strictures with fully covered self-expanding metal stents.

BACKGROUND & AIMS: Fully covered self-expanding metal stents (FCSEMS) are gaining acceptance for the treatment of benign biliary strictures. We performed a large prospective multinational study to study the ability to remove these stents after extended indwell and the frequency and durability of stricture resolution. METHODS: In a nonrandomized study at 13 centers in 11 countries, 187 patients with benign biliary strictures received FCSEMS. Removal was scheduled at 10-12 months for patients with chronic pancreatitis or cholecystectomy and at 4-6 months for patients who received liver transplants. The primary outcome measure was removal success, defined as either scheduled endoscopic removal of the stent with no removal-related serious adverse events or spontaneous stent passage without the need for immediate restenting. RESULTS: Endoscopic removal of FCSEMS was not performed for 10 patients because of death (from unrelated causes), withdrawal of consent, or switch to palliative treatment. For the remaining 177 patients, removal success was accomplished in 74.6% (95% confidence interval [CI], 67.5%-80.8%). Removal success was more frequent in the chronic pancreatitis group (80.5%) than in the liver transplantation (63.4%) or cholecystectomy (61.1%) groups (P = .017). FCSEMS were removed by endoscopy from all patients in whom this procedure was attempted. Stricture resolution without restenting upon FCSEMS removal occurred in 76.3% of patients (95% CI, 69.3%-82.3%). The rate of resolution was lower in patients with FCSEMS migration (odds ratio, 0.22; 95% CI, 0.11-0.46). Over a median follow-up period of 20.3 months (interquartile range, 12.9-24.3 mo), the rate of stricture recurrence was 14.8% (95% CI, 8.2%-20.9%). Stent- or removal-related serious adverse events, most often cholangitis, occurred in 27.3% of patients. There was no stent- or removal-related mortality. CONCLUSIONS: In a large prospective multinational study, removal success of FCSEMS after extended indwell and stricture resolution were achieved for approximately 75% of patients. ClincialTrials.gov number, NCT01014390.

Criterios de calidad que deben exigirse en la indicación y en la realización de la colonoscopia / Essential quality criteria in the indication and performance of colonoscopy

La colonoscopia es el método de referencia para el diagnóstico y el tratamiento de las enfermedades colónicas y, fundamentalmente, para el cribado y la vigilancia del cáncer colorrectal. El aumento rápido y progresivo en el número de procedimientos realizados en los últimos años y los riesgos inherentes a éste obligan a que se definan criterios de calidad para su indicación y su realización. Estos criterios deberían estandarizarse para todos los endoscopistas y las unidades de endoscopia, y deberían requerirse, además, una evaluación continua de los actores y las áreas en donde se realizan estas exploraciones. Las sociedades médicas y la administración sanitaria deberían auditar a los endoscopistas y a las unidades de endoscopia (apéndice 1) para garantizar la correcta aplicación de una técnica que pueda permitir la prevención, el diagnóstico y el tratamiento de algunas de las enfermedades graves más frecuentes en España. Garantizar una indicación apropiada requiere métodos de gestión efectivos en la asistencia primaria y en la atención gastroenterológica básica. Para su correcta realización, son necesarias una formación y una experiencia adecuadas de los endoscopistas, disponibilidad de medios para su programación rápida, aplicación de sistemas que mejoren la tolerancia, correcta preparación, establecimiento de intervalos adecuados entre las exploraciones, capacidad para realizar la técnica de forma correcta, conocimiento de las lesiones y sistemas de detección, y tratamiento de las complicaciones relacionadas con ésta (AU)

Colonoscopy is the gold standard for the diagnosis and treatment of diseases of the colon and, especially, for screening and surveillance of colorectal cancer. Because of the rapid and progressive rise in the number of procedures performed in the last few years and the inherent risks of this increase, quality criteria for the indication and performance of this procedure are required. These criteria should be standardized for all endoscopists and endoscopy units; moreover, continual evaluation of the staff and units performing this procedure should be carried out. Medical societies and the health administration should audit endoscopists and endoscopy units (appendix 1) to guarantee correct application of this technique, which could allow the prevention, diagnosis and treatment of some of the most frequent severe diseases in our environment. Guaranteeing appropriate indications requires effective management methods in primary care and basic gastroenterology care. For the correct performance of colonoscopy, the following factors are required: appropriate endoscopist training and experience, resources for rapid scheduling, the application of systems that improve tolerance, correct preparation, the establishment of appropriate intervals between procedures, the conditions required to perform the technique correctly, and knowledge of the lesions, detection systems, and treatment of the complications associated with colonoscopy (AU)

[Essential quality criteria in the indication and performance of colonoscopy]. / Criterios de calidad que deben exigirse en la indicación y en la realización de la colonoscopia.

Colonoscopy is the gold standard for the diagnosis and treatment of diseases of the colon and, especially, for screening and surveillance of colorectal cancer. Because of the rapid and progressive rise in the number of procedures performed in the last few years and the inherent risks of this increase, quality criteria for the indication and performance of this procedure are required. These criteria should be standardized for all endoscopists and endoscopy units; moreover, continual evaluation of the staff and units performing this procedure should be carried out. Medical societies and the health administration should audit endoscopists and endoscopy units (appendix 1) to guarantee correct application of this technique, which could allow the prevention, diagnosis and treatment of some of the most frequent severe diseases in our environment. Guaranteeing appropriate indications requires effective management methods in primary care and basic gastroenterology care. For the correct performance of colonoscopy, the following factors are required: appropriate endoscopist training and experience, resources for rapid scheduling, the application of systems that improve tolerance, correct preparation, the establishment of appropriate intervals between procedures, the conditions required to perform the technique correctly, and knowledge of the lesions, detection systems, and treatment of the complications associated with colonoscopy.