Clinical efficacy of anti-migration features in fully covered metallic stents for anastomotic biliary strictures after liver transplantation: comparison of conventional and anti-migration stents.

BACKGROUND AND AIMS: Anastomotic biliary strictures (ABSs) are one of the most frequent adverse events that occur after orthotopic liver transplantation (OLT). Multiple plastic stents (MPS) have been validated for this indication. More recently, fully covered self-expandable metallic stents (FCSEMSs) have been used with positive outcomes, but also have a higher rate of migration, which may limit success. Our primary objective was to compare stent migration rates observed with standard FCSEMSs (Std-FCSEMSs) and so-called anti-migration FCSEMSs (Am-FCSEMSs), which are newly designed with reversed proximal side flaps. Secondary objectives were to compare rates of stricture resolution and procedure-related morbidity. METHODS: We conducted a retrospective analysis of a subset of patients (FCSEMSs for post-OLT ABS) from 2 prospectively maintained databases of (1) OLT patients, and (2) ERCP and stent placement. Between January 2009 and January 2016, consecutive patients presenting with ABS after OLT referred to Cochin Hospital (Paris, France) for ERCP and receiving a FCSEMS were included. Exclusion criteria were any other cause of biliary stricture (ie, malignant stricture, ischemic origin), and biliary fistulae. RESULTS: One hundred twenty-five FCSEMSs (57 Am-FCSEMSs, 52 type 1 Std-FCSEMSs, and 16 type 2 Std-FCSEMSs) were used in 75 patients for ABS after OLT, with a planned stent placement period of 6 months in all patients. Patient characteristics and rates of previous endoscopic treatment or timing of ABS occurrence after OLT were not different between the groups. The rate of FCSEMS complete migration was 16% (20/125), consisting of 1.7% (1/57) for Am-FCSEMSs and 28% (19/68) for type 1 and 2 Std-FCSEMSs (P < .0001). All attempted stent removals (100% of patients) were successful. First follow-up ERCP after each FCSEMS highlighted a stricture resolution rate of 78.4% (98/125), including 93% (53/57) for Am-FCSEMSs and 66.2% (45/68) for type 1 and 2 Std-FCSEMSs (P < .001). After a median follow-up of 28 months after stent removal (range, 12-66 months), stricture recurrence was observed in 12.3% (range, 11%-17%) of patients treated with Am-FCSEMSs against 55.9% (range, 54%-56%) of those receiving Std-FCSEMSs (P < .0001). CONCLUSIONS: In patients with ABS after OLT, the use of Am-FCSEMSs significantly decreased the risk of stent migration, improved stricture resolution at the time of stent removal, and reduced the rate of stricture recurrence during follow-up. Endoscopic removal success and procedure-related morbidity were similar for both standard and anti-migration stents.

Comparative evaluation of two porcine ex vivo models for training in endoscopic ultrasound-guided drainage of pancreatic fluid collections.

INTRODUCTION: EUS-guided cystoenterostomy (EUCE), a technique used for the drainage of pancreatic pseudocysts and peri-enteric collections, requires specific skills for which dedicated models are needed. Based on a compact EASIE model (Erlangen Active Simulator for Interventional Endoscopy), we developed two ex vivo porcine models of retrogastric cysts and evaluated learning performance within the frame of a structured training program. MATERIAL AND METHODS: The first model was made of porcine colon (i. e. "natural cyst"), the second one with an ostomy bag (i. e. "artificial cyst"). All procedures were achieved with an EUS scope under fluoroscopy. Both models were evaluated prospectively over a 2-day session involving 14 students and five experts. The primary end point was overall satisfaction with each model. RESULTS: The "natural cyst" and "artificial cyst" were prepared within 10 and 16.5 minutes ( P  = 0.78), respectively. Model grading showed a non-significant trend for overall satisfaction in favor of the artificial model ( P  = 0.06). As secondary end points, difference was not significant for impression of realism ( P  = 0.75) whereas the "artificial cyst" was graded significantly better by experts and students in terms of ability to teach procedural steps ( P  = 0.01) and ease of puncture ( P  = 0.03). Moreover, experts considered the ability to improve students' proficiency to be superior with the "artificial cyst" ( P  = 0.008). CONCLUSION: Both "artificial" and "natural cysts" are efficient for EUCE training in terms of overall satisfaction. However, the "artificial cyst" model appears to make the procedure easier with a higher ability to teach procedural steps and improve the students' proficiency. Larger applications of this model are needed to validate as a standard of training.

Complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones: randomized multicenter study.

Background and study aims Endoscopic sphincterotomy plus large-balloon dilation (ES-LBD) has been reported as an alternative to endoscopic sphincterotomy for the removal of bile duct stones. This multicenter study compared complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones. This is the first randomized multicenter study to evaluate these procedures in patients with exclusively large common bile duct (CBD) stones. Methods Between 2010 and 2015, 150 patients with one or more common bile duct stones ≥ 13 mm were randomized to two groups: 73 without balloon dilation (conventional group), 77 with balloon dilation (ES-LBD group). Mechanical lithotripsy was subsequently performed only if the stones were too large for removal through the papilla. Endoscopic sphincterotomy was complete in both groups. Patients could switch to ES-LBD if the conventional procedure failed. Results There was no between-group difference in number and size of stones. CBD stone clearance was achieved in 74.0 % of patients in the conventional group and 96.1 % of patients in the ES-LBD group (P < 0.001). Mechanical lithotripsy was needed significantly more often in the conventional group (35.6 % vs. 3.9 %; P < 0.001). There was no difference in terms of morbidity (9.3 % in the conventional group vs. 8.1 % in the ES-LBD group; P = 0.82). The cost and procedure time were not significantly different between the groups overall, but became significantly higher for patients in the conventional group who underwent mechanical lithotripsy. The conventional procedure failed in 19 patients, 15 of whom underwent a rescue ES-LBD procedure that successfully cleared all stones. Conclusions Complete endoscopic sphincterotomy with large-balloon dilation for the removal of large CBD stones has similar safety but superior efficiency to conventional treatment, and should be considered as the first-line step in the treatment of large bile duct stones and in rescue treatment.Trial registered at ClinicalTrials.gov (NCT02592811).

Temporary placement of fully covered self-expandable metal stents for the treatment of benign biliary strictures.

BACKGROUND: Endoscopic treatment of benign biliary strictures (BBS) can be challenging. OBJECTIVE: To evaluate the efficacy of fully covered self-expandable metal stents (FCSEMS) in BBS. METHODS: Ninety-two consecutive patients with BBS (chronic pancreatitis (n = 42), anastomotic after liver transplantation (n = 36), and post biliary surgical procedure (n = 14)) were included. FCSEMS were placed across strictures for 6 months before endoscopic extraction. Early success rate was defined as the absence of biliary stricture or as a minimal residual anomaly on post-stent removal endoscopic retrograde cholangiopancreatography (ERCP). Secondary outcomes were the final success and stricture recurrence rates as well as procedure-related morbidity. RESULTS: Stenting was successful in all patients. Stenting associated complications were minor and occurred in 22 (23.9%) patients. Migration occurred in 23 (25%) patients. Stent extraction was successful in all but two patients with proximal stent migration. ERCP after the 6 months stenting showed an early success in 84.9% patients (chronic pancreatitis patients: 94.7%, liver transplant: 87.9%, post-surgical: 61.5%) (p = 0.01). Final success was observed in 57/73 (78.1%) patients with a median follow-up of 12 ± 3.56 months. Recurrence of biliary stricture occurred in 16/73 (21.9%) patients. CONCLUSIONS: FCSEMS placement is efficient for patients with BBS, in particular for chronic pancreatitis patients. Stent extraction after 6 months indwelling, although generally feasible, may fail in a few cases.

Core needle versus standard needle for endoscopic ultrasound-guided biopsy of solid pancreatic masses: a randomized crossover study.

BACKGROUND AND STUDY AIMS: A new core biopsy needle for endoscopic ultrasound (EUS)-guided sampling has recently been developed. The aim of this prospective multicenter study was to compare this needle with a standard needle in patients with solid pancreatic masses. PATIENTS AND METHODS: Consecutive patients with solid pancreatic masses referred to 17 centers for EUS-guided sampling were included. Each patient had two passes with a standard 22G needle and a single pass with a 22G core needle performed in a randomized order. Samples from both needles were separately processed for liquid-based cytology and cell-block preparation and were assessed independently by two blinded expert pathologists. The primary endpoint was the accuracy of the detection of malignancy. The reference standard was based on further cytohistological analysis obtained under ultrasound or computed tomography scanning, endoscopic or surgical guidance, and/or by clinical follow-up with repeated imaging examinations for at least 12 months. The secondary endpoints were the rate of technical failure and the quality of the cytohistological samples obtained. RESULTS: Of the 80 patients included (49 men; mean age 67.1 ±â€Š11.1), 87.5 % had final malignant diagnoses (adenocarcinoma n = 62, 77.5 %). There was no difference between the needles in diagnostic accuracy (standard needle 92.5 % vs. core needle 90 %; P = 0.68) or technical failure. Both pathologists found the overall sample quality significantly better for the standard needle (expert 1, P = 0.009; expert 2, P = 0.002). CONCLUSIONS: The diagnostic accuracy of EUS sampling for solid pancreatic masses using standard and core needles seems comparable but with a better overall histological sample quality for the former. ClinicalTrial.gov identifier: NCT01479803.

Effectiveness of combined endoscopic ultrasound-guided fine-needle aspiration biopsy and stenting in patients with suspected pancreatic cancer.

BACKGROUND: Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) can be coupled with endoscopic retrograde cholangiopancreatography in the same setting when biliary and/or duodenal stenting are required. AIMS: Our aim was to examine the effectiveness of EUS-FNA combined with stenting during the same session in patients with pancreatic cancer. METHODS: Consecutive patients referred for EUS-FNA of a pancreatic mass with symptoms of biliary (±upper digestive) obstruction were included. Consecutive patients undergoing biliary and/or duodenal stenting without EUS-FNA during the same period were used as controls. Procedure-related complications were the primary outcome measure. Duration of the procedure, ability to achieve biliary/duodenal stenting, the yield of EUS-FNA, and clinical outcomes were evaluated. RESULTS: A total of 122 patients underwent combined EUS-FNA and stenting and 68 underwent stenting alone (control group). In the combined group, histological proof of cancer was obtained in 88.52% at first EUS-FNA and 95.08% after a second EUS-FNA. Biliary stent placement was successful in 97.5 and 98% in the combined and the control groups, respectively. There was no statistical difference between the groups for length of stay after endoscopy and for procedure-related mortality and morbidity within 30 days. The median time from endoscopy to chemotherapy in the combined group was 12 days. CONCLUSION: Combined EUS-FNA and biliary and/or duodenal stenting is feasible in almost all patients with suspected pancreatic cancer, with no additional hazard and a high histological yield.

Temporary placement of partially covered self-expandable metal stents for anastomotic biliary strictures after liver transplantation: a prospective, multicenter study.

BACKGROUND: Management of anastomotic biliary strictures after liver transplantation deserves optimization. OBJECTIVE: To evaluate placement and removal of partially covered self-expandable metal stents (PCSEMSs) in this setting. DESIGN: Prospective, multicenter, uncontrolled study. SETTING: Three French academic hospitals with liver transplantation units and tertiary referral endoscopy centers. PATIENTS: Twenty-two patients (18 men, 4 women, aged 49.7 ± 12 years) with anastomotic biliary stricture. Seventeen (77.3%) presented stricture recurrence after plastic stenting. INTERVENTIONS: PCSEMSs were placed across the stricture for 2 months and then removed. Patients were followed by clinical examination and liver function tests 1, 3, 6, 9, and 12 months after PCSEMS removal. MAIN OUTCOME MEASUREMENT: The ability to remove PCSEMS. RESULTS: PCSEMS placement was successful in all patients, after sphincterotomy in 21 patients. Stent-related complications included minor pancreatitis (3 patients), transient pain (1 patient), and cholangitis (1 patient). Stent removal was achieved in all patients but 2 whose stents had migrated distally. Partial stent dislocation was noted in 5 patients (upward in 4, downward in 1). Complications associated with stent removal were minor, including self-contained hemorrhage (1 patient) and fever (1 patient). The stricture persisted at the end of treatment in 3 patients (13.6%), all of whom had stent migration or dislocation. Recurrence of anastomotic stricture after initial success occurred in 9 of 19 patients (47.4%) within 3.5 ± 2.1 months. Sustained stricture resolution was observed in 10 of 19 patients (52.6%), 45.6% from an intent-to-treat perspective. LIMITATIONS: Uncontrolled study with limited follow-up. CONCLUSIONS: Temporary placement and removal of PCSEMSs in anastomotic biliary strictures after liver transplantation is feasible, although sometimes demanding. Stent migration may impair final outcome.

Is there a role for endoscopic ultrasonography in evaluation of the left liver in colorectal liver metastasis patients selected for right hepatectomy.

BACKGROUND: Meticulous assessment of the left liver for patients scheduled for right hepatectomy is essential. Endoscopic ultrasonography (EUS) is frequently used for the locoregional staging or biopsy of pancreatic tumours and has shown some value in the evaluation of the left liver. METHODS: We prospectively enrolled 24 consecutive patients who were scheduled for at least a right hepatectomy and who underwent laparotomy for colorectal liver metastasis (CLMs). The left liver was assessed preoperatively with standard techniques [computed tomography (CT) scan, percutaneous ultrasonography] and EUS. These results were compared with those of intraoperative ultrasonography (IOUS). RESULTS: The study population consisted of 12 men and 12 women (mean age 64 years, range 47-79 years). Mean body mass index was 26 kg/m(2) (range 20-35 kg/m(2)). Standard preoperative evaluation detected 28 lesions in the left liver; EUS detected just 17 lesions, whereas IOUS detected 30 lesions in the left liver. For the left lobe of the liver (segments II and III), the standard evaluation had sensitivity of 85%, specificity of 64%, positive predictive value (PPV) of 50% and negative predictive value (NPV) of 91%; EUS had sensitivity of 55%, specificity of 86%, PPV of 71% and NPV of 76%; IOUS had sensitivity of 85.2%, specificity of 92%, PPV of 96.6% and NPV of 75%. In terms of the left liver (i.e. segments II, III and IV), the results of EUS were less good than for the left lobe of the liver. CONCLUSION: For segments II and III, EUS had higher specificity and positive predictive value than standard evaluation, but only changed our therapeutic strategy in three cases. Even though EUS can provide some valuable information, the technique is not accurate enough to merit systematic performance as part of a standard preoperative evaluation. This study underlines the main role of IOUS in the left liver, with better sensitivity, specificity, and positive predictive value than EUS and standard evaluation.

[Acute colitis closely following the beginning of celecoxib treatment]. / Colite aiguë apparue dans les jours suivant le début d'un traitement par célécoxib.

Selective inhibitors of cyclooxygenase-2 have less gastroduodenal toxicity than non selective anti-inflammatory drugs. However, there is little information on their effect on the distal gut. A 91 year old woman presented with acute diarrhoea 5 weeks after beginning celecoxib treatment. Laboratory results showed an inflammatory syndrome and increased alanine aminotransferase (ALT) to 13 N. Endoscopic examination of the colon showed diffuse erythematous lesions of the sigmoid and of part of the right colon. No aetiology has been found for colitis or hepatitis. Diarrhea and blood test anomalies disappeared one week after celecoxib was stopped. The role of celecoxib in the etiology of colitis was considered plausible but not for liver damage. This report and a few other cases in the literature suggest that cyclooxygenase-2 selective non-steroidal anti-inflammatory drug inhibitor toxicity should be investigated in case of unexplained acute colitis.