Factors influencing the presence of potentially explosive gases during colonoscopy: Results of the SATISFACTION study.

This study tested the hypothesis that bowel preparation with mannitol should not affect the colonic concentration of H2 and CH4 . Therefore, the SATISFACTION study, an international, multicenter, randomized, parallel-group phase II-III study investigated this issue. The phase II dose-finding part of the study evaluated H2 , CH4 , and O2 concentrations in 179 patients randomized to treatment with 50 g, 100 g, or 150 g mannitol. Phase III of the study compared the presence of intestinal gases in 680 patients randomized (1:1) to receive mannitol 100 g in single dose or a standard split-dose 2 L polyethylene glycol (PEG)-Asc preparation (2 L PEG-Asc). Phase II results showed that mannitol did not influence the concentration of intestinal gases. During phase III, no patient in either group had H2 or CH4 concentrations above the critical thresholds. In patients with H2 and/or CH4 levels above detectable concentrations, the mean values were below the risk thresholds by at least one order of magnitude. The results also highlighted the effectiveness of standard washing and insufflation maneuvers in removing residual intestinal gases. In conclusion, bowel cleansing with mannitol was safe as the concentrations of H2 and CH4 were the same as those found in patients prepared with 2 L PEG-Asc. In both groups, the concentrations of gases were influenced more by the degree of cleansing achieved and the insufflation and washing maneuvers performed than by the preparation used for bowel cleansing. The trial protocol was registered with ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04759885) and with EudraCT (eudract_number: 2019-002856-18).

Endoscopic therapy using a self-expandable metallic stent with an anti-migration system for postorthotopic liver transplantation anastomotic biliary stricture.

BACKGROUND: Endoscopic therapy using multiple plastic stents (MPSs) is the standard therapy for postorthotopic liver transplantation (p-OLT) anastomotic biliary stricture (ABS). However, this approach demands repeated procedures. Recent studies using fully covered self-expandable metallic stents (FCSEMS) have shown encouraging results, but migration occurs in 10% to 40% of cases. The objective of this retrospective study was to evaluate the efficacy of endoscopic treatment using FCSEMS with an anti-migration system (Am-FCSEMS) in patients with p-OLT ABS. AIM: To evaluate the efficacy of endoscopic treatment using an Am-FCSEMS in patients with p-OLT ABS. METHODS: This study was conducted in a private tertiary care centre in São Paulo, Brazil and was approved by our institution's Human Research Committee. From April 2018 to October 2020, regardless of previous endoscopic treatment (MPS or FCSEMS), 17 patients with p-OLT ABS and indications for endoscopic therapy were included in this study. The exclusion criteria were pregnancy, nonanastomotic biliary or hilar stricture, hepatic artery stenosis/thrombosis, isolated biliary fistulae, a distance shorter than 2 cm from the stricture to the hepatic hilum, and patient refusal. The primary endpoint was the efficacy of p-OLT ABS endoscopic treatment using an Am-FCSEMS that remained in place for a 12-mo period. Biliary sphincterotomy was performed in patients with native papilla, and an Am-FCSEMS (10 mm in final diameter and 60 or 80 mm in length) was placed (HanarostentTM MI Tech, Co). Balloon stricture dilation was performed only if necessary to introduce the stent. RESULTS: Three patients were excluded due to loss to follow-up before stent removal. Among the 14 patients included and followed, 7 were women, and the average age was 56 years (range: 28-76). The average period of Am-FCSEMS placement was 362 ± 109 d. Technical success occurred in all 14 patients (100%). There were no cases of distal stent migration. Complete resolution of the stricture occurred in 13/14 patients (92.85%). Adverse events occurred in 3/14 patients (21.42%): 2 patients with mild acute pancreatitis (14.28%) and 1 patient (7.14%) with stent dysfunction (occlusion by biliary sludge and stones, which was treated endoscopically without the need for stent removal). No deaths occurred related to therapy. All stents were removed using foreign body forceps or snares without difficulty. After Am-FCSEMS removal, all 13 patients who had ABS resolution were followed-up for an average of 411 ± 172 d, and there was no stricture recurrence or need for further endoscopic therapy. CONCLUSION: In this retrospective study, endoscopy therapy using an Am-FCSEMS for p-OLT ABS was safe and effective, with a high stricture resolution rate that was probably due to the absence of stent migration.

Implementation and results of a gastrointestinal cancer screening program in an Amazon rainforest village: A descriptive study.

Background and study aims Gastrointestinal cancer is an important cause of death worldwide. Remote populations are especially vulnerable to these conditions due to reduced access to screening and adequate treatment. In this context, the Belterra project was designed as a pilot taskforce to deliver gastrointestinal screening to an underserved Amazonian population and to spread knowledge and practice to local health workers. This study aimed to describe the implementation and present the results of the Belterra Project. Patients and methods The project took place between October 2014 and December 2017 in Belterra, Pará, Brazil. Public-private partnerships were obtained and were essential for funding. The project required complex logistic solutions to provide gastrointestinal screening to every inhabitant between 50 and 70 years of age, including medical equipment and personal transportation to a remote area. Subjects were asked about their medical history, and received a physical examination, endoscopic examinations, and stool tests. Results Over the course of 19 expeditions, we screened 2,022 inhabitants of Belterra, aged 50 to 70 years. Five colorectal and six gastric adenocarcinomas were diagnosed, as were several lower-stage lesions. Overall, 26 % of the participants undergoing colonoscopy showed some type of colonic lesion. Conclusions Notwithstanding the geographical, cultural, and financial barriers, this study suggests that the implementation of a gastrointestinal cancer screening program for remote Brazilian populations is feasible, reaching high adherence. Although logistics is very demanding, such campaigns may be a good strategy to provide mass gastrointestinal cancer screening for underserved populations.

Há lugar para a avaliação colangioscópica na estenose biliar anastomótica pós-transplante hepático de doador cadáver? / Is there a place for cholangioscopic evaluation of biliary anastomotic stricture after deceased donor liver transplant?

ABSTRACT BACKGROUND Biliary complications remain one of the most important causes of morbidity and graft loss after liver transplant (LT). Endoscopic therapy of biliary complications has proven to be effective over time, leaving surgical treatment restricted to only very few cases. However, we cannot yet predict which patients will have the greatest potential to benefit from endoscopic treatment. OBJECTIVE On this premise we decide to conduct this study to evaluate the role and safety of single operator cholangioscopy (SOC) in the endoscopic treatment of post-LT biliary anastomotic strictures (AS). METHODS: Between March/2016 and June/2017, 20 consecutive patients referred for endoscopic treatment for biliary anastomotic stricture were included in this prospective observational cohort study. Inclusion criteria were age over 18 years old, and a deceased LT performed within at least 30 days. Exclusion criteria were non-anastomotic biliary stricture, biliary leakage, cast syndrome, any previous endoscopic therapy, pregnancy and inability to provide informed consent. All patients underwent SOC before endoscopic therapy with fully covered self-expandable metal stent (FCSEMS) and after stent removal. RESULTS: At pre-treatment SOC, stricture orifice and fibrotic changes could be visualized in all patients, vascular changes and surgical sutures in 60% and acute inflammatory changes in 30%. SOC was essential for guidewire placement in five cases. FCSEMS was successfully deployed in all patients. Stricture resolution rate was 44.4% (median stent indwelling 372 days). Stricture recurrence was 12.5% (median follow-up of 543 days). Adverse events were distal (66.6%) and proximal (5.5%) stent migration, stent occlusion (16.6%), severe abdominal pain (10%) and mild acute pancreatitis (10%). SOC was repeated after FCSEMS removal. Post-treatment SOC showed fibrotic changes in all but one patient; vascular and acute inflammatory changes were less frequent in comparison to index procedure. The disappearance of suture material was remarkable. None of the cholangioscopic findings were statistically correlated to treatment outcome or stricture recurrence. CONCLUSION: Endoscopic retrograde cholangiography with SOC is feasible in post-LT patients with AS. Cholangioscopic findings can be classified into fibrotic, vascular and acute inflammatory changes. Cholangioscopy may be helpful to assist guidewire passage, but Its overall role for changing management is post-LT patients was not demonstrated.

RESUMO CONTEXTO: As complicações biliares continuam sendo uma das principais causas de morbidade e perda do enxerto após o transplante hepático. O tratamento endoscópico das complicações biliares provou ser eficaz ao longo do tempo, deixando o tratamento cirúrgico restrito a casos de exceção. No entanto, ainda não podemos prever quais pacientes terão maior potencial de se beneficiar da terapia endoscópica. OBJETIVO: Nesta premissa, decidimos realizar este estudo para avaliar o papel e a segurança da colangioscopia peroral de operador único (CPO) no tratamento endoscópico das estenoses anastomóticas biliares (EA) pós-transplante hepático. MÉTODOS: Entre março de 2016 e junho de 2017, 20 pacientes consecutivos encaminhados para tratamento endoscópico da EA biliar foram incluídos neste estudo prospectivo de coorte observacional. Os critérios de inclusão foram idade superior a 18 anos e um transplante hepático de doador falecido realizado há pelo menos 30 dias. Pacientes com estenose biliar não anastomótica, fístula biliar, "cast" síndrome, qualquer terapia endoscópica prévia, gravidez e incapacidade de fornecer consentimento informado foram excluídos. Todos os pacientes foram submetidos à CPO antes da terapia endoscópica com prótese metálica autoexpansível totalmente coberta (PMAEC) e após a sua remoção. RESULTADOS: Na CPO realizada antes do tratamento endoscópico, o orifício de estenose e alterações fibróticas foram visualizadas em todos os pacientes, alterações vasculares e a presença de suturas cirúrgicas em 60%, enquanto alterações inflamatórias agudas em 30%. A CPO foi determinante para a transposição do fio-guia através da estenose em cinco casos. Uma PMAEC foi implantada com sucesso em todos os pacientes. A taxa de resolução da estenose foi de 44,4% (tempo médio de permanência de 372 dias). A recorrência da EA foi de 12,5% (acompanhamento médio de 543 dias). Os eventos adversos foram migração distal (66,6%) e proximal (5,5%) da prótese metálica, oclusão da PMAEC (16,6%), dor abdominal intensa (10%) e pancreatite aguda leve (10%). A CPO foi repetida após a remoção da PMAEC. A colangioscopia realizada após o tratamento endoscópico mostrou alterações fibróticas em todos, exceto em um paciente; alterações vasculares e inflamatórias agudas foram menos frequentes em comparação à CPO inicial. O desaparecimento do material de sutura, observado em todos os casos, foi notável. Nenhum dos achados colangioscópicos foram estatisticamente correlacionados ao resultado do tratamento ou à recorrência de estenose. CONCLUSÃO: A colangioscopia peroral é viável nos pacientes pós-transplante hepático com estenose biliar anastomótica. Os achados colangioscópicos podem ser classificados em alterações inflamatórias agudas, fibróticas e vasculares. A colangioscopia pode ser útil para auxiliar na passagem do fio-guia, mas seu papel geral na mudança de tratamento nos pacientes pós-transplante hepático não foi demonstrado.

IS THERE A PLACE FOR CHOLANGIOSCOPIC EVALUATION OF BILIARY ANASTOMOTIC STRICTURE AFTER DECEASED DONOR LIVER TRANSPLANT?

BACKGROUND: Biliary complications remain one of the most important causes of morbidity and graft loss after liver transplant (LT). Endoscopic therapy of biliary complications has proven to be effective over time, leaving surgical treatment restricted to only very few cases. However, we cannot yet predict which patients will have the greatest potential to benefit from endoscopic treatment. OBJECTIVE: On this premise we decide to conduct this study to evaluate the role and safety of single operator cholangioscopy (SOC) in the endoscopic treatment of post-LT biliary anastomotic strictures (AS). METHODS: Between March/2016 and June/2017, 20 consecutive patients referred for endoscopic treatment for biliary anastomotic stricture were included in this prospective observational cohort study. Inclusion criteria were age over 18 years old, and a deceased LT performed within at least 30 days. Exclusion criteria were non-anastomotic biliary stricture, biliary leakage, cast syndrome, any previous endoscopic therapy, pregnancy and inability to provide informed consent. All patients underwent SOC before endoscopic therapy with fully covered self-expandable metal stent (FCSEMS) and after stent removal. RESULTS: At pre-treatment SOC, stricture orifice and fibrotic changes could be visualized in all patients, vascular changes and surgical sutures in 60% and acute inflammatory changes in 30%. SOC was essential for guidewire placement in five cases. FCSEMS was successfully deployed in all patients. Stricture resolution rate was 44.4% (median stent indwelling 372 days). Stricture recurrence was 12.5% (median follow-up of 543 days). Adverse events were distal (66.6%) and proximal (5.5%) stent migration, stent occlusion (16.6%), severe abdominal pain (10%) and mild acute pancreatitis (10%). SOC was repeated after FCSEMS removal. Post-treatment SOC showed fibrotic changes in all but one patient; vascular and acute inflammatory changes were less frequent in comparison to index procedure. The disappearance of suture material was remarkable. None of the cholangioscopic findings were statistically correlated to treatment outcome or stricture recurrence. CONCLUSION: Endoscopic retrograde cholangiography with SOC is feasible in post-LT patients with AS. Cholangioscopic findings can be classified into fibrotic, vascular and acute inflammatory changes. Cholangioscopy may be helpful to assist guidewire passage, but Its overall role for changing management is post-LT patients was not demonstrated.

Experimental study for evaluation of a low-cost spray cryotherapy system.

OBJECTIVE: To evaluate the feasibility and applicability of a low-cost cryotherapy system. METHODS: Experimental study with 25kg Landrace pigs submitted to a longitudinal cervico-thoraco-abdominal incision for exposure of the trachea, thorax and abdomen. The tissues were frozen by continuous spray application at different periods of time (5, 10 and 15 seconds). Spray cryotherapy was performed using a fluorinated gas (tetrafluorethane) delivered at - 47°C temperature (DermaFreeze®, Emdutos; ANVISA registration 80409950001; price R$ 394,00). via an adapted, disposable 1.8mm cholangiography catheter (Olympus; price R$ 280,00). The specimens were resected for histopathological analysis. RESULTS: Thirty samples were obtained from ten different organs and divided according to spray cryotherapy application time. System activation for 5, 10 or 15 seconds led to consumption of 14g, 27g and 40g of gas respectively (average gas consumption, 2.7g/s using a 1.8mm catheter). The system comprising a spray tube and catheter proved user-friendly and effective, with constant gas dispersion and adequate tissue freezing. In spite of effective freezing, microscopy failed to reveal tissue changes. This may have reflected methodological constraints precluding evaluation at tissue damage peak time (48 hours). CONCLUSION: The low-cost spray cryotherapy system proved feasible and safe.

Experimental study for evaluation of a low-cost spray cryotherapy system / Estudo experimental para avaliação de um sistema de baixo custo para crioterapia em spray

ABSTRACT Objective To evaluate the feasibility and applicability of a low-cost cryotherapy system. Methods Experimental study with 25kg Landrace pigs submitted to a longitudinal cervico-thoraco-abdominal incision for exposure of the trachea, thorax and abdomen. The tissues were frozen by continuous spray application at different periods of time (5, 10 and 15 seconds). Spray cryotherapy was performed using a fluorinated gas (tetrafluorethane) delivered at - 47°C temperature (DermaFreeze®, Emdutos; ANVISA registration 80409950001; price R$ 394,00). via an adapted, disposable 1.8mm cholangiography catheter (Olympus; price R$ 280,00). The specimens were resected for histopathological analysis. Results Thirty samples were obtained from ten different organs and divided according to spray cryotherapy application time. System activation for 5, 10 or 15 seconds led to consumption of 14g, 27g and 40g of gas respectively (average gas consumption, 2.7g/s using a 1.8mm catheter). The system comprising a spray tube and catheter proved user-friendly and effective, with constant gas dispersion and adequate tissue freezing. In spite of effective freezing, microscopy failed to reveal tissue changes. This may have reflected methodological constraints precluding evaluation at tissue damage peak time (48 hours). Conclusion The low-cost spray cryotherapy system proved feasible and safe.

RESUMO Objetivo Avaliar a exequibilidade e a aplicação de um sistema de baixo custo de crioterapia. Métodos Estudo experimental realizado com um suíno da raça Landrace, 25kg, submetido à cervicotoracolaparotomia longitudinal, com exposição de traqueia, tórax e abdome. Procedemos ao congelamento das estruturas em tempos diferentes (5, 10 e 15 segundos) com jato contínuo. A crioterapia foi realizada com gás fluoretado (tetrafluoretano), na forma de spray em tubo, que atinge a temperatura de -47°C (DermaFreeze®, Emdutos; registro ANVISA 80409950001; preço R$ 394,00). A este tubo, adaptamos um cateter descartável de colangiografia de 1,8mm (Olympus; preço R$ 280,00). As peças foram ressecadas para análise histopatológica. Resultados Foram obtidas 30 amostras em 10 órgãos diferentes, divididos em três intervalos de tempo distintos. Quando o sistema foi acionado por 5 segundos, gastaram-se 14g de gás; por 10 segundos, 27g; e por 15 segundos, 40g; o gasto médio foi de 2,7g/s pelo cateter de 1,8mm. O sistema confeccionado com tubo de gás e cateter proporcionou resultado efetivo, com dispersão adequada e constante do gás, congelamento adequado e de fácil execução. Apesar da técnica evidenciar congelamento efetivo, na microscopia não houve alteração tecidual. Isso ocorreu porque o pico de lesão tecidual por congelamento ocorre após 48 horas, o que não foi possível avaliar por este método proposto. Conclusão O sistema de crioterapia em spray de baixo custo foi exequível e seguro.

Metal versus plastic stents for anastomotic biliary strictures after liver transplantation: a randomized controlled trial.

BACKGROUND AND AIMS: Biliary anastomotic stricture occurs in 15% to 20% of patients after deceased orthotopic liver transplantation (OLT). It is usually treated endoscopically with multiple plastic stents (MPSs), although the use of fully covered self-expandable metal stents (cSEMSs) is emerging. This study aims to compare the efficacy and safety of cSEMSs versus MPSs in these patients. METHODS: A single-center, open-label, randomized clinical trial was performed. Patients were randomized to single cSEMSs for 6 months or to MPS placement, exchanged every 3 months over 1 year. The primary outcome was stricture resolution. Crossover therapy was considered for failure or recurrence. Secondary outcomes were sustained improvement, morbidity, and mortality. RESULTS: Between October 2009 and January 2014, 162 patients with post-OLT biliary adverse events were assessed for eligibility. Sixty-four were prospectively randomized (1:1) to cSEMSs or MPSs. Baseline characteristics were comparable. Technical success was 100%. Median follow-up was 36.4 and 32.9 months for the cSEMS and MPS groups, stricture resolution at last stent removal was achieved in 83.3% and 96.5% (P = .19), and stricture recurrence was observed in 32% and 0%, respectively (P < .01). Adverse events occurred in 23.3% and 6.4% of ERCPs in the cSEMS and MPS groups, respectively (P < .01), with 13.3% of acute pancreatitis in the cSEMS group and 2.1% in the MPS group (P < .01). CONCLUSIONS: cSEMSs were comparable with MPSs regarding post-OLT biliary anastomotic stricture resolution. cSEMSs allowed fewer procedures and had a positive effect on cost. Duration of treatment with cSEMSs should be further investigated. Sphincterotomy should be considered for all patients. (Clinical trial registration number: NCT 01148199.).

Endoscopic surveillance of extensive esophageal papillomatosis not amenable to endoscopic therapy / Controle endoscópico de papilomatose esofágica extensa sem indicação para tratamento endoscópico

ABSTRACT We present two cases of esophageal papillomatosis, a very rare reported disease leading to dysphagia and did not improve after endoscopic treatment. Both patients refused surgery and they were followed-up for 3 years, but no significant clinical or endoscopic changes were seen.

RESUMO Apresentamos dois casos de papilomatose esofágica, lesão raramente relatada, que pode levar à disfagia, e que não teve melhora após tratamento endoscópico. Ambos os pacientes recusaram cirurgia e foram acompanhados por até 3 anos, sem alterações clínicas ou endoscópicas importantes.

Endoscopic surveillance of extensive esophageal papillomatosis not amenable to endoscopic therapy.

We present two cases of esophageal papillomatosis, a very rare reported disease leading to dysphagia and did not improve after endoscopic treatment. Both patients refused surgery and they were followed-up for 3 years, but no significant clinical or endoscopic changes were seen.

Safety of mannitol use in bowel preparation: a prospective assessment of intestinal methane (CH4) levels during colonoscopy after mannitol and sodium phosphate (NaP) bowel cleansing / Segurança do uso do manitol no preparo para colonoscopia: avaliação prospectiva do nível de metano (CH4) intestinal durante colonoscopia após preparo com manitol e fosfato de sódio (NaP)

ABSTRACT Background - Adequate bowel preparation is critical for the quality of colonoscopy. Despite reported occurrence of colonic explosion due to methane and hydrogen production by bacterial fermentation during colonoscopy, gas exchange during the procedure is believed to be effective in lowering existing methane concentration, allowing for safe utilization of mannitol for bowel preparation. Thus, mannitol is widely used for bowel cleansing prior to colonoscopy, considering its low cost and effectiveness for bowel preparation. Objective - The aim of this study was to assess the safety of mannitol for bowel preparation, when compared to sodium phosphate (NaP). Methods - We conducted a prospective observational study in which 250 patients undergoing colonoscopy at Universidade Federal de São Paulo and Hospital Albert Einstein (São Paulo, Brazil) were approached for inclusion in the study. Patients received either mannitol (n=50) or NaP (n=200) for bowel preparation, based on physician indication. Study was conducted from August 2009 to December 2009. The main outcome of interest was presence of detectable levels of methane (CH4) during colonoscopy and reduction in such levels after gas exchange during the procedure. Methane concentrations were measured in three intestinal segments during scope introduction and withdrawal. Safety was assessed as the absence of high levels of methane, defined as 5%. Measurements were made using a multi-gas monitor (X-am 7000, Dräger Safety AG & Co. KGaA, Lübeck, Germany) connected to a plastic catheter introduced into the working channel of the colonoscope. Additional outcomes of interest included levels of O2. Methane and O2 levels are reported as ppm. Mean, difference and standard deviation of levels of gas measured in both moments were calculated and compared in both groups. Proportions of patients with detectable or high levels of methane in both groups were compared. Continuous variables were analyzed using t test and categorical variables using qui-square tests. The Ethics Committee in both study sites approved the study protocol. Results - Patients in both groups were similar regarding demographics, colonoscopy indication, ASA status and quality of bowel preparation. Seven (3.5%) patients in the NaP group had methane detected during introduction of the endoscope. Methane levels became undetectable during withdrawal of the scope. None of the patients in the mannitol group had detectable levels of methane. O2 levels did not differ in the groups. Conclusion - This is the largest study to assess the safety of mannitol for bowel preparation, considering methane measurements. Our results indicate that mannitol use is as safe as NaP, and gas exchange was efficient in reducing methane concentrations.

RESUMO Contexto - Preparo adequado é fundamental para garantia de boa qualidade em colonoscopia. Apesar de relatos de explosão do cólon durante colonoscopia, secundários à produção de metano e hidrogênio pela fermentação bacteriana, acredita-se que a troca gasosa durante o procedimento diminua a concentração existente de metano, permitindo a utilização com segurança, de manitol para o preparo de cólon. Assim, manitol é largamente utilizado para limpeza dos cólons antes da colonoscopia, especialmente devido ao seu baixo custo e eficácia. Objetivo - O objetivo do estudo foi avaliar a segurança do uso de manitol no preparo dos cólons, quando comparado ao uso de fosfo-soda (NaP). Métodos - Este foi um estudo observacional retrospectivo no qual foram incluídos 250 pacientes submetidos a colonoscopia na Universidade Federal de São Paulo e Hospital Albert Einstein (São Paulo - Brasil). Os pacientes receberam preparo de cólon com manitol (n=50) ou NaP (n=200), de acordo com preferências dos médicos que encaminharam os pacientes. O estudo foi realizado entre agosto e dezembro de 2009. O principal resultado pesquisado foi a presença de níveis detectáveis de metano (CH4) durante a colonoscopia, e a redução nestes níveis após troca gasosa durante o procedimento. As concentrações de metano foram dosadas com detector multi-gas (X-am 7000, Dräger Safety AG & Co., KGaA, Lübeck, Alemanha) conectado a um cateter plástico que foi introduzido no canal de instrumentação do colonoscópio. Outro achado de interesse foram níveis de O2. Níveis de metano e O2 foram relatados em ppm. Média, diferença entre as médias e desvio padrão nos níveis dos gases em ambos momentos foram comparados nos dois grupos. A proporção de pacientes com níveis detectáveis ou altos de metano em ambos os grupos foram comparados. Variáveis contínuas foram analisadas com teste t e variáveis categóricas com o teste do qui-quadrado. Os Comitês de Ética de ambas instituições aprovaram o protocolo do estudo. Resultados - Pacientes nos dois grupos foram comparáveis quanto aos dados demográficos, indicação para colonoscopia, classificação ASA e qualidade do preparo do cólon. Sete (3,5%) pacientes no grupo NaP tinham níveis detectáveis de metano durante a introdução do colonoscópio. Os níveis de metano se tornaram indetectáveis durante a retirada do aparelho. Nenhum dos pacientes no grupo manitol tinha níveis detectáveis de metano. Níveis de O2 foram semelhantes nos dois grupos. Conclusão - Este é o estudo com maior casuística que avaliou a segurança do uso de manitol para preparo de cólon, no que diz respeito a dosagem de metano. Nossos resultados indicam que o emprego do manitol é tão seguro quanto o NaP, e que a troca gasosa é eficaz na redução da concentração de metano.

SAFETY OF MANNITOL USE IN BOWEL PREPARATION: a prospective assessment of intestinal methane (CH4) levels during colonoscopy after mannitol and sodium phosphate (NaP) bowel cleansing.

BACKGROUND: - Adequate bowel preparation is critical for the quality of colonoscopy. Despite reported occurrence of colonic explosion due to methane and hydrogen production by bacterial fermentation during colonoscopy, gas exchange during the procedure is believed to be effective in lowering existing methane concentration, allowing for safe utilization of mannitol for bowel preparation. Thus, mannitol is widely used for bowel cleansing prior to colonoscopy, considering its low cost and effectiveness for bowel preparation. OBJECTIVE: - The aim of this study was to assess the safety of mannitol for bowel preparation, when compared to sodium phosphate (NaP). METHODS: - We conducted a prospective observational study in which 250 patients undergoing colonoscopy at Universidade Federal de São Paulo and Hospital Albert Einstein (São Paulo, Brazil) were approached for inclusion in the study. Patients received either mannitol (n=50) or NaP (n=200) for bowel preparation, based on physician indication. Study was conducted from August 2009 to December 2009. The main outcome of interest was presence of detectable levels of methane (CH4) during colonoscopy and reduction in such levels after gas exchange during the procedure. Methane concentrations were measured in three intestinal segments during scope introduction and withdrawal. Safety was assessed as the absence of high levels of methane, defined as 5%. Measurements were made using a multi-gas monitor (X-am 7000, Dräger Safety AG & Co. KGaA, Lübeck, Germany) connected to a plastic catheter introduced into the working channel of the colonoscope. Additional outcomes of interest included levels of O2. Methane and O2 levels are reported as ppm. Mean, difference and standard deviation of levels of gas measured in both moments were calculated and compared in both groups. Proportions of patients with detectable or high levels of methane in both groups were compared. Continuous variables were analyzed using t test and categorical variables using qui-square tests. The Ethics Committee in both study sites approved the study protocol. RESULTS: - Patients in both groups were similar regarding demographics, colonoscopy indication, ASA status and quality of bowel preparation. Seven (3.5%) patients in the NaP group had methane detected during introduction of the endoscope. Methane levels became undetectable during withdrawal of the scope. None of the patients in the mannitol group had detectable levels of methane. O2 levels did not differ in the groups. CONCLUSION: - This is the largest study to assess the safety of mannitol for bowel preparation, considering methane measurements. Our results indicate that mannitol use is as safe as NaP, and gas exchange was efficient in reducing methane concentrations.

Propranolol associated with endoscopic band ligation reduces recurrence of esophageal varices for primary prophylaxis of variceal bleeding: a randomized-controlled trial.

OBJECTIVE: The aim of this study was to compare the recurrence of esophageal varices (EVs) after endoscopic band ligation (EBL) associated with propranolol (PP) versus EBL alone. PATIENTS AND METHODS: Sixty-six cirrhotic outpatients (EBL group, n=32 and EBL+PP group, n=34) with high-risk EVs without previous bleeding were studied. MAIN OUTCOME MEASUREMENTS: The primary outcome was recurrence of EV. The secondary outcomes were EV eradication, bleeding before EV eradication, mortality, and adverse events. RESULTS: Demographic characteristics and the initial endoscopic findings were similar. EV eradication was achieved in all patients. Three patients presented gastrointestinal bleeding before variceal eradication, two in the EBL group and one in the EBL+PP group (P=0.13). Six patients died (liver failure), two in the EBL group and four in the EBL+PP group (P=0.27). Twelve (38%) patients in the EBL group and three (9%) patients in the EBL+PP group had variceal recurrence. The risk of recurrence of EVs after eradication was significantly higher among patients in the EBL group (P=0.003). CONCLUSION: EBL alone and EBL+PP were effective in the primary prophylaxis of bleeding from EVs in cirrhotic patients (EV eradication, bleeding before EV eradication, mortality, and adverse events were similar in both groups). However, variceal recurrence was lower in the EBL+PP group than band ligation alone.

Efficacy and safety of endoscopic prophylactic treatment with undiluted cyanoacrylate for gastric varices.

AIM: To evaluate the efficacy and safety of undiluted N-butyl-2 cyanoacrylate plus methacryloxysulfolane (NBCM) as a prophylactic treatment for gastric varices (GV) bleeding. METHODS: This prospective study was conducted at a single tertiary-care teaching hospital between October 2009 and March 2013. Patients with portal hypertension (PH) and GV, with no active gastrointestinal bleeding, were enrolled in primary prophylactic treatment with NBCM injection without lipiodol dilution. Initial diagnosis of GV was based on endoscopy and confirmed with endosonography (EUS); the same procedure was used after treatment to confirm eradication of GV. After puncturing the GV with a regular injection needle, 1 mL of undiluted NBCM was injected intranasally into GV. The injection was repeated as necessary to achieve eradication or until a maximum total volume of 3 mL of NBCM had been injected. Patients were followed clinically and evaluated with endoscopy at 3, 6 and 12 mo. Later follow-ups were performed yearly. The main outcome measures were efficacy (GV eradication), safety (adverse events related to cyanoacrylate injection), recurrence, bleeding from GV and mortality related to GV treatment. RESULTS: A total of 20 patients (15 male) with PH and GV were enrolled in the study and treated with undiluted NBCM injection. Only 2 (10%) patients had no esophageal varices (EV); 18 (90%) patients were treated with endoscopic band ligation to eradicate EV before inclusion in the study. The patients were followed clinically and endoscopically for a median of 31 mo (range: 6-40 mo). Eradication of GV was observed in all patients (13 patients were treated with 1 session and 7 patients with 2 sessions), with a maximum injected volume of 2 mL NBCM. One patient had GV recurrence, confirmed by EUS, at 6-mo follow-up, and another had late recurrence with GV bleeding after 35 mo of follow-up; overall, GV recurrence was observed in 2 patients (10%), after 6 and 35 mo of follow-up, and GV bleeding rate was 5% (1 patient). Mild epigastric pain was reported by 3 patients (15%). No mortality or major complications, including embolism, or damage to equipment were observed. CONCLUSION: Endoscopic injection with NBCM, without lipiodol, may be a safe and effective treatment for primary prophylaxis of gastric variceal bleeding.

New "introducer" PEG-gastropexy with T fasteners: a pilot study.

CONTEXT: Enteral feeding is indicated for patients unable to maintain appropriate oral intake, and percutaneous endoscopic gastrostomy (PEG) is the most adequate long-term enteral access. Peristomal infections are the most common complications of PEG, occurring in up to 8% of patients, despite the use of prophylactic antibiotics. The "introducer" PEG-gastropexy technique avoids PEG tube passage through the oral cavity, preventing microorganisms' dislodgment to the peristomal site. OBJECTIVES: To compare the incidence of peristomal wound infection at 7-day post-procedure after conventional "pull" technique versus a new "introducer" PEG-gastropexy kit. Secondary outcomes included success rates, procedure time, and other complications. METHODS: Eighteen patients referred for PEG placement between June and December 2010 were randomly assigned to "pull" PEG with antibiotics or "introducer" PEG-gastropexy technique without antibiotics. RESULTS: Overall success rate for both methods was 100%, although mean procedure duration was higher in the "introducer" PEG-gastropexy group (12.6 versus 6.4 minutes, P = 0.0166). Infection scores were slightly higher in patients who underwent "pull" PEG with antibiotics compared with "introducer" PEG-gastropexy without antibiotics (1.33 ± 0.83 versus 0.75 ± 0.67, P = 0.29). CONCLUSION: Although procedure duration was longer in the "introducer" PEG-gastropexy, infection scores were marginally higher in the "pull" PEG technique.

New "introducer" PEG-gastropexy with T fasteners: a pilot study / Gastrostomia endoscópica percutânea pela técnica de introdução com gastropexia com T-tags: um estudo piloto

CONTEXT: Enteral feeding is indicated for patients unable to maintain appropriate oral intake, and percutaneous endoscopic gastrostomy (PEG) is the most adequate long-term enteral access. Peristomal infections are the most common complications of PEG, occurring in up to 8 percent of patients, despite the use of prophylactic antibiotics. The "introducer" PEG-gastropexy technique avoids PEG tube passage through the oral cavity, preventing microorganisms' dislodgment to the peristomal site. OBJECTIVES: To compare the incidence of peristomal wound infection at 7-day post-procedure after conventional "pull" technique versus a new "introducer" PEG-gastropexy kit. Secondary outcomes included success rates, procedure time, and other complications. METHODS: Eighteen patients referred for PEG placement between June and December 2010 were randomly assigned to "pull" PEG with antibiotics or "introducer" PEG-gastropexy technique without antibiotics. RESULTS: Overall success rate for both methods was 100 percent, although mean procedure duration was higher in the "introducer" PEG-gastropexy group (12.6 versus 6.4 minutes, P = 0.0166). Infection scores were slightly higher in patients who underwent "pull" PEG with antibiotics compared with "introducer" PEG-gastropexy without antibiotics (1.33 ± 0.83 versus 0.75 ± 0.67, P = 0.29). CONCLUSION: Although procedure duration was longer in the "introducer" PEG-gastropexy, infection scores were marginally higher in the "pull" PEG technique.

CONTEXTO: A nutrição enteral está indicada para pacientes incapazes de manter aporte voluntário adequado e a gastrostomia endoscópica percutânea (GEP) é a via preferencial para acesso enteral de longa duração. As infecções periostomais são as principais complicações da GEP, ocorrendo em até 8 por cento dos pacientes, a despeito do uso de antibiótico profilático. A GEP pela técnica de introdução com gastropexia evita a passagem da sonda de gastrostomia pela cavidade oral, prevenindo contra o deslocamento de microorganismos ali presentes até o sítio da ostomia. OBJETIVO: Comparar a incidência de infecção periostomal no 7º dia após GEP por técnica de tração versus GEP pela técnica de introdução com gastropexia. Objetivos secundários incluíram: taxa de sucesso, tempo de procedimento e outras complicações. MÉTODOS: Dezoito pacientes encaminhados ao setor de endoscopia do Hospital Albert Einstein, São Paulo, SP, para realização de GEP entre junho e dezembro de 2010, foram randomizados para realização de gastrostomia pela técnica de tração com antibioticoterapia profilática ou pela técnica de introdução com gastropexia sem antibiótico profilaxia. RESULTADOS: A taxa de sucesso para ambos os métodos foi de 100 por cento, apesar do tempo do procedimento ter sido mais longo no grupo da técnica de introdução (12,6 versus 6,4 min, P = 0,0166). Os índices de infecção foram discretamente superiores no grupo de GEP por tração, com antibioticoterapia profilática, em comparação ao grupo GEP por introdução com gastropexia (1,33 ± 0,83 versus 0,75 ± 0,67, P = 0,29). CONCLUSÃO: Apesar da duração do procedimento ter sido mais longa no grupo GEP por introdução com gastropexia, a taxa de infecção foi discretamente mais elevada no grupo GEP por tração.

Incidence, risk factors and ERCP outcome for biliary complications after cadaveric OLT.

BACKGROUND/AIMS: Biliary complications (BC) occur in up to 39.5% of patients after orthotopic liver transplantation (OLT), being an important source of post-transplant morbidity. The aim is to evaluate the incidence of BC after OLT, associated risk factors and outcome after endoscopic treatment. METHODOLOGY: A retrospective case series between June 2005 and December 2008, including 195 patients that underwent 216 OLT from deceased donors. Thirty-one patients (14.3%) presented at least 1 BC, anastomotic stricture being the most frequent (83.8%). Non-anastomotic stricture was present in 1 (3.2%) and anastomotic fistula in 1. One patient presented anastomotic disconnection at ERCP. RESULTS: BC occurred 94.6 (7-487) days after OLT. Twenty-seven patients underwent endoscopic treatment, on average 2.6 ERCPs were performed per patient. Global endoscopic treatment success rate was 77.3%; being 73.7% for stenosis and 100% (3/3) for anastomotic fistula with stenosis. Recurrence of biliary stricture was observed in 3 patients, all referred to endoscopic re-treatment. ERCP complications: 2 (2.8%) stent migrations, 1 (1.4%) early stent occlusion, 1 (1.4%) respiratory distress and 1(1.4%) severe acute pancreatitis and death. There was no correlation between studied risk factors and BC's occurrence. CONCLUSION: ERCP was effective for the treatment of BC after OLT. Studied risk factors had no correlation with BC.