The Role of Probe-Based Confocal Laser Endomicroscopy (pCLE) in the Diagnosis of Sustained Clinical Complete Response Under Watch-and-Wait Strategy After Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Adenocarcinoma: a Score Validation.

BACKGROUND: Watch-and-wait strategy has been increasingly accepted for patients with clinical complete response (cCR) after multimodal treatment for locally advanced rectal adenocarcinoma. Close follow-up is essential to the early detection of local regrowth. It was previously demonstrated that probe-based confocal laser endomicroscopy (pCLE) scoring using the combination of epithelial and vascular features might improve the diagnostic accuracy of cCR. AIM: To validate the pCLE scoring system in the assessment of patients with cCR after neoadjuvant chemoradiotherapy (nCRxt) for advanced rectal adenocarcinoma. METHODS: Digital rectal examination, pelvic magnetic resonance imaging (MRI), and pCLE were performed in 43 patients with cCR, who presented either a scar (N = 33; 76.7%) or a small ulcer with no signs of tumor, and/or biopsy negative for malignancy (N = 10; 23.3%). RESULTS: Twenty-five (58.1%) patients were men, and the mean age was 58.4 years. During the follow-up, 12/43 (27.9%) patients presented local regrowth and underwent salvage surgery. There was an association between pCLE diagnostic scoring and final histological report (for patients who underwent surgical resection) or final diagnosis at the latest follow-up (p = 0.0001), while this association was not observed with MRI (p = 0.49). pCLE sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 66.7%, 93.5%, 80%, 88.9%, and 86%, respectively. MRI sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 66.7%, 48.4%, 66.7%, 78.9%, and 53.5%, respectively. CONCLUSIONS: pCLE scoring system based on epithelial and vascular features improved the diagnosis of sustained cCR and might be recommended during follow-up. pCLE might add some valuable contribution for identifying local regrowth. Trial Registration This protocol was registered at the Clinical Trials (ClinicalTrials.gov identifier NCT02284802).

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.

Tube-in-tube endoscopic vacuum therapy for the closure of upper gastrointestinal fistulas, leaks, and perforations.

BACKGROUND : Although endoscopic vacuum therapy (EVT) has been successfully used to treat postoperative upper gastrointestinal (UGI) wall defects, its use demands special materials and several endoscopic treatment sessions. Herein, we propose a technical modification of EVT using a double tube (tube-in-tube drain) without polyurethane sponges for the drainage element. The tube-in-tube drainage device enables irrigation and application of suction. A flowchart for standardizing the management of postoperative UGI wall defects with this device is presented. METHODS : An EVT modification was made to achieve frequent fistula cleansing, with 3 % hydrogen peroxide rinsing, and the application of negative pressure. A tube-in-tube drain without polyurethane sponges can be inserted like a nasogastric tube or passed through a previously positioned surgical drain. This was a retrospective two-center observational study, with data collected from 30 consecutive patients. Technical success, clinical success, adverse events, time under therapy, interval time from procedure to fistula diagnosis and treatment start, size of transmural defect, volume of cavity, number of endoscopic treatment sessions, and mortality were reviewed. RESULTS : 30 patients with UGI wall defects were treated. The technical and clinical success rates were 100 % and 86.7 %, respectively. Three patients (10 %) had adverse events and three patients (10 %) died. The median time under therapy was of 19 days (range 1-70) and the median number of endoscopic sessions was 3 (range 1-9). CONCLUSIONS : This standardized approach and EVT modification using a tube-in-tube drain, with frequent fistula cleansing, were successful and safe in a wide variety of UGI wall defects.

Long-term results of an endoscopic screening program for superficial esophageal cancer in patients with head and neck squamous cell carcinoma.

Background and study aims Patients with head and neck squamous cell carcinoma (HNSCC) are at risk of a second primary tumor in the gastrointestinal tract, most commonly in the esophagus. Screening these patients for esophageal carcinoma may help detect asymptomatic dysplasia and early cancer, thus allowing curative treatment and more prolonged survival, but the impact of endoscopic screening remains uncertain. Here we aimed to describe the long-term results of an esophageal SCC screening program in patients with head and neck cancer in terms of prevalence, associated risk factors, and survival. Patients and methods We performed an observational study of a prospectively collected database including patients with HNSCC who had undergone high-definition endoscopy with chromoscopy between 2010 and 2018 at a Brazilian tertiary academic center. Results The study included 1,888 patients. The esophageal SCC prevalence was 7.9 %, with the majority (77.8 %) being superficial lesions. Significant risk factors for esophageal high-grade dysplasia (HGD) and invasive cancer included tumors of the oral cavity and oropharynx and the presence of low-grade dysplasia (LGD). Overall survival (OS) was significantly shorter among patients in whom esophageal cancer was diagnosed at an advanced stage ( P  < .001). OS did not significantly differ between patients with HGD and early esophageal cancer versus those without esophageal cancer ( P  = .210) Conclusions Endoscopic screening for superficial esophageal neoplasia in patients with HNSCC improves esophageal cancer detection. Screening could potentially benefit patients with primary cancer located at the oropharynx or oral cavity. In addition, the detection of esophageal LGD indicates a need for endoscopic surveillance.

Long-term outcomes of endoscopic submucosal dissection and transanal endoscopic microsurgery for the treatment of rectal tumors.

BACKGROUND AND AIM: Endoscopic submucosal dissection and transanal endoscopic microsurgery are good options for the treatment of rectal adenomas and early rectal carcinomas, but whether long-term outcomes of these procedures are comparable is not known. The aim of this study was to address this question. METHODS: A retrospective single-center study evaluating 98 consecutive procedures between June 2008 and December 2017 was performed in a tertiary cancer center. Consecutive patients who had undergone either endoscopic submucosal resection or transanal endoscopic microsurgery for rectal adenomas and early rectal carcinomas were evaluated, and long-term recurrence and complication rates were compared. RESULTS: Both groups were similar regarding sex, age, preoperative surgical risk, and en bloc resection rate (95.7% in the endoscopic and 100% in the surgical group, P = 0.81). Mean follow-up period was 37.6 months. Lesions resected endoscopically were significantly larger (68.5 mm) than those resected by transanal resection (44.5 mm), P = 0.003. Curative resections occurred in 97.2% of endoscopic resections and 85.2% of the surgical ones (P = 0.04). Comparing resections that fulfilled histologic curative criteria, there were no recurrences in the endoscopic group (out of 69 cases) and two recurrences in the transanal group (8.3% of 24 cases), P = 0.06. Late complications occurred in 12.7% of endoscopic procedures and 25.9% of surgical procedures (P = 0.13). CONCLUSIONS: In our experience, endoscopic submucosal resection seems to have advantages over transanal endoscopic microsurgery, with similar en bloc resection rate and lower rate of late complications and recurrences. Multicenter randomized controlled trials are needed to support our findings.

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.

Endoscopic Injection of Mitomycin C for the Treatment of Pharyngoesophageal Stenosis Refractory to Endoscopic Treatment with Dilatation in Patients Treated for Head and Neck Cancer.

BACKGROUND: Management of pharyngoesophageal stenosis (PES) in patients after head and neck cancer (HNC) treatment remains a challenge. It is not uncommon that PES is refractory to dilation sessions. This study aimed at evaluating the efficacy of Mitomycin C (MMC) endoscopic injection for the treatment of refractory pharyngoesophageal stenosis. PATIENTS AND METHODS: This is a prospective study in patients with dysphagia following head and neck cancer treatment, without evidence suggestive of tumor recurrence, and refractory to endoscopic treatment. These patients were submitted to endoscopic dilation of the stenotic segment with thermoplastic bougies, followed by injection of MMC. We repeated the endoscopic sessions every three weeks. RESULTS: From January 2015 to May 2015, we treated 13 patients with PES. Three patients were initially enrolled in the study for refractory stricture. We observed adverse events in all of them, with intense neck pain and ulcer development, justifying the interruption of the trial. CONCLUSION: The repeated injection in the short interval of MMC in refractory PES is not recommended, because it resulted in serious adverse events.

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.).

II Brazilian consensus statement on endoscopic ultrasonography.

BACKGROUND AND OBJECTIVES: At the time of its introduction in the early 80s, endoscopic ultrasonography (EUS) was indicated for diagnostic purposes. Recently, EUS has been employed to assist or to be the main platform of complex therapeutic interventions. METHODS: From a series of relevant new topics in the literature and based on the need to complement the I Brazilian consensus on EUS, twenty experienced endosonographers identified and reviewed the pertinent literature in databases. The quality of evidence, strength of recommendations, and level of consensus were graded and voted on. RESULTS: Consensus was reached for eight relevant topics: treatment of gastric varices, staging of nonsmall cell lung cancer, biliary drainage, tissue sampling of subepithelial lesions (SELs), treatment of pancreatic fluid collections, tissue sampling of pancreatic solid lesions, celiac neurolysis, and evaluation of the incidental pancreatic cysts. CONCLUSIONS: There is a high level of evidence for staging of nonsmall cell lung cancer; biopsy of SELs as the safest method; unilateral and bilateral injection techniques are equivalent for EUS-guided celiac neurolysis, and in patients with visible ganglia, celiac ganglia neurolysis appears to lead to better results. There is a moderate level of evidence for: yield of tissue sampling of pancreatic solid lesions is not influenced by the needle shape, gauge, or employed aspiration technique; EUS-guided and percutaneous biliary drainage present similar clinical success and adverse event rates; plastic and metallic stents are equivalent in the EUS-guided treatment of pancreatic pseudocyst. There is a low level of evidence in the routine use of EUS-guided treatment of gastric varices.

Guidelines for the management of neuroendocrine tumours by the Brazilian gastrointestinal tumour group.

Neuroendocrine tumours are a heterogeneous group of diseases with a significant variety of diagnostic tests and treatment modalities. Guidelines were developed by North American and European groups to recommend their best management. However, local particularities and relativisms found worldwide led us to create Brazilian guidelines. Our consensus considered the best feasible strategies in an environment involving more limited resources. We believe that our recommendations may be extended to other countries with similar economic standards.

Adverse events of self-expandable esophageal metallic stents in patients with long-term survival from advanced malignant disease.

BACKGROUND AND AIMS: Self-expandable metallic stents are considered the best palliative treatment of dysphagia for patients with advanced esophageal cancer. Adverse events (AEs) are a major concern, especially in patients with better prognosis and longer survival. The present study aimed to evaluate the AEs of patients who survived longer than 6 months with esophageal stents in place. METHODS: This is a retrospective analysis of a prospectively collected database including all patients submitted to esophageal stent placement for the palliation of malignant diseases during the period from February 2009 to February 2014 at a tertiary care academic center who had stents longer than 6 months. RESULTS: Sixty-three patients were included. Mean follow-up was 10.7 months. Clinical success was achieved in all patients, and the median stent patency was 7.1 months. AEs occurred in 40 patients (63.5%), totaling 62 AEs (mean, 1.5 AEs per patient). Endoscopic management of AEs was successful in 84.5% of cases, with a mean of 1.6 reinterventions per patient. The univariate analysis revealed that performance status, age, and post-stent radiotherapy presented a trend to higher risk of AEs. The multivariate analysis revealed that only performance status was associated with AEs (P = .025; hazard ratio, 4.1). CONCLUSIONS: AEs are common in patients with long-term esophageal stenting for malignancy. However, AEs were not related to higher mortality rate, and most AEs could be successfully managed by endoscopy. Only performance status was a risk factor for AEs. Our data suggest that metallic stenting is a valid option for the treatment of malignant esophageal conditions, even when survival longer than 6 months is expected.

Sedation in gastrointestinal endoscopy: a prospective study comparing nonanesthesiologist-administered propofol and monitored anesthesia care.

INTRODUCTION: Adequate sedation is one of the cornerstones of good quality gastrointestinal endoscopy (GIE). Propofol sedation has increased significantly but there has been much debate over whether it can be administered by endoscopists. The aim of this prospective trial was to compare nonanesthesiologist-administered propofol (NAAP) and monitored anesthesia care (MAC). METHODS: A total of 2000 outpatients undergoing GIE at Hospital Albert Einstein (São Paulo, Brazil), a tertiary-care private hospital, were divided into two matched groups: NAAP (n = 1000) and MAC (n = 1000). In NAAP, propofol doses were determined by the endoscopist. A second physician stayed in the room during the entire procedure, according to local regulations. In MAC, the anesthesiologist administered propofol. RESULTS: In total, 1427 patients (71.3 %) were ASA (American Society of Anesthesiologists) class I and 573 were ASA class II. In NAAP, patients received more propofol + fentanyl (61.1 % vs. 50.5 %; P < 0.05) and there were fewer cases of deep sedation (44.7 % vs. 66.1 %; P < 0.05). Hypoxemia rates were similar (12.8 % for NAAP and 11.2 % for MAC; P = 0.3) but these reverted more rapidly in MAC (4.22 seconds vs. 7.26 seconds; P < 0.05). Agitation was more frequent in MAC (14.0 % vs. 5.6 %; P < 0.05). No later complications were observed. Patient satisfaction was very high and similar in both groups. CONCLUSION: In this setting, NAAP was as safe and effective as MAC for healthy patients undergoing GIE. Clinical trial ref. no.: U1111-1134-4430.

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.

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.