International Consensus Recommendations for Safe Use of LAMS for On- and Off-Label Indications Using a Modified Delphi Process.

INTRODUCTION: The study aimed to develop international consensus recommendations on the safe use of lumen-apposing metal stents (LAMSs) for on- and off-label indications. METHODS: Based on the available literature, statements were formulated and grouped into the following categories: general safety measures, peripancreatic fluid collections, endoscopic ultrasound (EUS)-biliary drainage, EUS-gallbladder drainage, EUS-gastroenterostomy, and gastric access temporary for endoscopy. The evidence level of each statement was determined using the Grading of Recommendations Assessment, Development, and Evaluation methodology.International LAMS experts were invited to participate in a modified Delphi process. When no 80% consensus was reached, the statement was modified based on expert feedback. Statements were rejected if no consensus was reached after the third Delphi round. RESULTS: Fifty-six (93.3%) of 60 formulated statements were accepted, of which 35 (58.3%) in the first round. Consensus was reached on the optimal learning path, preprocedural imaging, the need for airway protection and essential safety measures during the procedure, such as the use of Doppler, and measurement of the distance between the gastrointestinal lumen and the target structure. Specific consensus recommendations were generated for the different LAMS indications, covering, among others, careful patient selection, the preferred size of the LAMS, the need for antibiotics, the preferred anatomic location of the LAMS, the need for coaxial pigtail placement, and the appropriate management of LAMS-related adverse events. DISCUSSION: Through a modified international Delphi process, we developed general and indication-specific experience- and evidence-based recommendations on the safe use of LAMS.

Safety and adverse events of EUS-guided gallbladder drainage using lumen-apposing metal stents and percutaneous cholecystostomy tubes: a systematic review and meta-analysis.

BACKGROUND AND AIMS: EUS-guided gallbladder drainage using lumen-apposing metal stents (EUS-GBD-LAMSs) and percutaneous cholecystostomy for gallbladder drainage (PTGBD) are the alternative treatment modalities in high-risk surgical patients with acute cholecystitis (AC). The aim of this study was to compare the safety of these procedures for AC in surgically suboptimal candidates. METHODS: Six studies compared the 2 groups' early, delayed, and overall adverse events; they also compared length of hospital stay, re-interventions, and re-admissions rate. A random effect model calculated odds ratios (ORs) with a 95% confidence interval (CI). RESULTS: The 2 groups had similar early adverse events; however, EUS-GBD-LAMS was associated with a lower rate of delayed (OR, .21; 95% CI, .07-.61; P ≤ .01) and overall (OR, .43; 95% CI, .30-.61; P ≤ .01) adverse events. Patients with EUS-GBD-LAMSs had a shorter hospital stay than PTGBD. CONCLUSIONS: EUS-GBD-LAMS is a safer option than PTGBD and is associated with a shorter hospital stay in nonsurgical candidates with AC.

Adjuvant Radiofrequency Ablation Along With Stenting Versus Stenting Alone for Biliary Tree Drainage in Patients With Malignant Biliary Strictures: A Systemic Review and Meta-analysis.

OBJECTIVE: This metanalysis aims to assess the efficacy and safety of biliary stenting along with radiofrequency ablation compared with stents alone to treat malignant biliary obstruction (MBO) due to extrahepatic biliary strictures secondary to cholangiocarcinoma, pancreatic cancer, and metastatic cancer. METHODS: A systemic search of major databases through April 2022 was done. All original studies were included comparing radiofrequency ablation with stenting versus stenting alone for treating malignant biliary strictures. The primary outcomes of interest were the difference in the mean stent patency and overall survival (OS) days between the 2 groups. The secondary outcome was to compare the adverse events of the 2 groups. The mean difference in the stent patency and OS days was pooled by using a random-effect model. We calculated the odds ratio to compare the adverse events between the 2 groups. RESULTS: A total of 13 studies with 1339 patients were identified. The pooled weighted mean difference in stent patency was 43.50 days (95% CI, 25.60-61.41), favoring the RFA plus stenting. Moreover, the pooled weighted mean difference in OS was 90.53 days (95% CI, 49.00-132.07), showing improved survival in the RFA group. Our analysis showed no statistically significant difference in adverse events between the 2 groups OR 1.13 (95% CI, 0.90-1.42). CONCLUSION: Our analysis showed that RFA, along with stent, is safe and is associated with improved stent patency and overall patient survival in malignant biliary strictures. More robust prospective studies should assess this association further.

Lateralizing calcaneal osteotomy performed with a percutaneous burr results in a significantly lower increase in tarsal tunnel pressure.

PURPOSE: Tarsal tunnel syndrome is well documented following lateralizing calcaneal osteotomy to manage varus hindfoot deformity. Traditionally, calcaneal osteotomy is performed with an oscillating saw. No studies have investigated the effect of alternative surgical techniques on postoperative tarsal tunnel pressure. The purpose of this study was to investigate the difference in tarsal tunnel pressures following lateralizing calcaneal osteotomy performed using a high-torque, low-speed "minimally invasive surgery" (MIS) Shannon burr versus an oscillating saw. METHODS: Lateralizing calcaneal osteotomy was performed on 10 below-knee cadaveric specimens. This was conducted on 5 specimens each using an oscillating saw (Saw group) or MIS burr (Burr group). The calcaneal tuberosity was translated 1 cm laterally and transfixed using 2 Kirschner wires. Tarsal tunnel pressure was measured before and after osteotomy via ultrasound-guided percutaneous needle barometer. Mean pre/post-osteotomy pressures were compared between groups. Differences were analyzed using Student's t test. RESULTS: The mean pre-procedure tarsal tunnel pressure was 25.8 ± 5.1 mm Hg in the Saw group and 26.4 ± 4.3 mm Hg in the Burr group (p = 0.85). The mean post-procedure pressure was 63.4 ± 5.1 in the Saw group and 47.8 ± 4.3 in the Burr group (p = 0.01). Change in tarsal tunnel pressure was significantly lower in the Burr group (21.4 ± 4.5) compared to the Saw group (37.6 ± 12.5) (p = 0.03). The increase in tarsal tunnel pressure was 43% lower in the Burr group. CONCLUSION: In this cadaveric study, tarsal tunnel pressure increase after lateralizing calcaneal osteotomy was significantly lower when using a burr versus a saw. This is likely because the increased width ("kerf") of the 3 mm MIS burr, compared to the submillimeter saw blade width, causes calcaneal shortening. Given the smaller increase in tarsal tunnel pressure, using the MIS burr for lateralizing calcaneal osteotomy may decrease the risk of postoperative tarsal tunnel syndrome. Future research in vivo should explore this.

Genome Editing and Fatty Liver.

Fatty liver disease is characterized as nonalcoholic fatty liver disease (NAFLD) and alcoholic liver disease (ALD). Fatty liver disease is one of the most common causes of chronic liver disease worldwide among adults and children. It is characterized by excessive fat accumulation in the liver cells. It has a genetically heterogenous background with complex pathogenesis and progressions and is accompanied by significant morbidity, mortality, and healthcare costs. NAFLD's risk factors include metabolic syndrome, abdominal obesity, type 2 diabetes, and atherogenic dyslipidemia. ALD is associated with the excessive consumption of alcohol. Here, we describe the functions of various proteins encoded by gene variants contributing to the pathogenesis of nonalcoholic fatty liver disease and alcoholic fatty liver disease. Advancements in genome engineering technology have generated various in vivo and in vitro fatty liver disease models reflecting the genetic abnormalities contributing toward fatty liver disease. We will discuss currently developed different ALD and NAFLD models using the clustered regularly interspaced short palindromic repeats (CRISPR/Cas9) genome editing tool.Furthermore, we will also discuss the salient features of CRISPR/Cas9 editing technology and Cas9 variants such as prime and base editors to replicate genetic topographies linked specifically to ALD and NAFLD. The advantages and limitations of currently available genome delivery methods necessary for optimal gene editing will also be discussed in this review. This review will provide the essential guidance for appropriate genome editing tool selection and proper gene delivery approaches for the effective development of ALD and NAFLD models, leading to the development of clinical therapeutics for fatty liver disease.

Modernizing Our Understanding of Total Hip Arthroplasty in the Pediatric and Young Adult Patient: A Single-center Experience.

INTRODUCTION: Pediatric hip disorders represent a broad range of pathology and remain a significant source of morbidity for children and young adults. Surgical intervention is often required for joint preservation, but when salvage is not possible, joint replacement may be indicated to eliminate pain and preserve function. Although there have been significant updates in the management of both pediatric hip disease and the field of total hip arthroplasty (THA), there is a paucity of literature reflecting advancements in the area of pediatric and young adult (PYA) arthroplasty. No study has investigated the impact of approach on outcomes after PYA THA. The purpose of this study is to describe the indications, techniques, and early outcomes of THA in the PYA population in a modern practice setting. METHODS: We performed a retrospective descriptive analysis of all patients undergoing primary THA performed at a tertiary care children's hospital from 2004 to 2019. Ninety-three hips in 76 patients were evaluated. Demographics, intraoperative variables, postoperative pain and function ratings, and complication and revision rates were collected. RESULTS: Eighty-five hips in 69 patients were included. Patients were aged 12 to 23 years old, with males and females represented equally (33 vs. 36, respectively). The most common cause of hip pain was avascular necrosis (AVN, 56/85, 66%), most commonly due to slipped capital femoral epiphysis (13/56, 23%) idiopathic AVN (12/56, 21%), and chemotherapy (12/56, 21%). Half of all hips had been previously operated before THA (43/85). Thirty-six procedures were performed via the posterolateral approach (36/85, 42%), 33 were performed via direct anterior approach (33/85, 39%), and 16 were performed via the lateral approach (LAT, 16/85, 19%). At final follow-up, 98% (83/85) of patients had complete resolution of pain, 82% (70/85) had no notable limp, and 95% (81/85) had returned to all activities. There were 6 complications and 1 early revision. Average Hip disability and Osteoarthritis Outcomes Score for Joint Replacement scores increased by 37 points from 56 to 93. The overall revision-free survival rate for PYA THA was 98.8% (at average 19-mo follow-up). CONCLUSIONS: Modern PYA THA is dissimilar in indications and surgical techniques to historic cohorts, and conclusions from prior studies should not be generalized to modern practice. In our practice, PYA patients most commonly carry a diagnosis of AVN, and THA can be performed with modern cementless fixation with large cup and head sizes and ceramic-on-cross-linked polyethylene bearings utilizing any approach. Further study is required to better characterize middle-term and long-term results and patient-reported outcomes. LEVEL OF EVIDENCE: Therapeutic Level IV-retrospective case series.

Treatments and Sequelae of Pediatric Pathologic Proximal Femur Fractures Due to Benign Bone Cyst.

BACKGROUND: The proximal femur is a common location for pathologic fractures in children, yet there is little published information regarding this injury. The purpose of this study was to investigate the outcomes of pediatric pathologic proximal femur fractures due to benign bone tumors. METHODS: A retrospective review of patients treated for pathologic proximal femur fractures from 2004 to 2018 was conducted. Inclusion criteria were age below 18 years and pathologic proximal femur fracture secondary to a benign bone tumor. Patients were excluded if they had <1 year of follow-up. Medical charts and serial radiographs were reviewed for fracture classification, underlying pathology, treatment, complications, and time to fracture healing. RESULTS: A total of 14 patients were included. Mean age was 6±3 (3 to 11) years, and mean follow-up was 44±21 (22 to 86) months. Index treatment was spica casting in 9/14 (68%) patients, while 5/14 (32%) were treated with internal fixation. Of the 9 patients initially treated with casting, 22% (2/9) required repeat spica casting at a mean of 0.6 months after index treatment, 67% (6/9) required internal fixation at a mean of 20.3 months after index treatment, and 11% (1/9) did not require revision treatment. Eighty-eight percent (8/9) of patients treated with casting required revision treatment compared with 40% (2/5) of those treated with internal fixation (P=0.05). Nonunion occurred after 1 refracture, malunion with coxa vara occurred in 2 fractures, and the remaining 11/14 (84%) fractures had a union at a mean of 4.9±3.0 months All cases of malunion occurred in patients initially treated nonoperatively. There were 19 distinct complications in 10/14 (71%) patients. The incidence of any revision surgery was 64% (9/14). CONCLUSIONS: In this series, pediatric pathologic proximal femur fractures demonstrated prolonged time to union, high incidence of revision surgery (64%), and substantial complication rate (71%). In children with pathologic proximal femur fractures, treatment with internal fixation is recommended as this series showed a 78% failure rate of initial conservative management. LEVEL OF EVIDENCE: Level IV.

The effect of coffee consumption on the non-alcoholic fatty liver disease and liver fibrosis: A meta-analysis of 11 epidemiological studies.

INTRODUCTION AND OBJECTIVES: Non-alcoholic fatty liver disease (NAFLD) is a widespread chronic liver disease. It is considered a multifactorial disorder that can progress to liver fibrosis and cause a worldwide public health concern. Coffee consumption may have a protective impact on NAFLD and liver fibrosis. However, the evidence from the previous studies is inconsistent. This meta-analysis summarizes available literature. MATERIALS AND METHODS: This study comprises two meta-analyses. The first meta-analysis summarizes the effect of coffee consumption on NAFLD in those who did or did not drink coffee. The second analysis compares the risk of liver fibrosis development between NAFLD patients who did or did not drink coffee. Pooled risk ratios (RR) and confidence intervals (CI) of observational studies were estimated. RESULTS: Of the total collected 321 articles, 11 met our eligibility criteria to be included in the analysis. The risk of NAFLD among those who drank coffee compared to those who did not was significantly lower with a pooled RR value of 0.77 (95% CI 0.60-0.98). Moreover, we also found a significantly reduced risk of liver fibrosis in those who drink coffee than those who did not drink in the NAFLD patients with the relative risk (RR) of 0.68 (95% CI 0.68-0.79). CONCLUSIONS: Regular coffee consumption is significantly associated with a reduced risk of NAFLD. It is also significantly associated with decreased risk of liver fibrosis development in already diagnosed NAFLD patients. Although coffee consumption may be considered an essential preventive measure for NAFLD, this subject needs further epidemiological studies.

An Inverted Acetabular Labrum Is Predictive of Pavlik Harness Treatment Failure in Children With Developmental Hip Dysplasia.

INTRODUCTION: The failure rate of Pavlik harness treatment for developmental dysplasia of the hip (DDH) has been reported as high as 55%. The purpose of this study is to investigate the effect of an inverted acetabular labrum on outcomes of Pavlik harness treatment for DDH. METHODS: A retrospective review was conducted on DDH patients at a tertiary care pediatric hospital from 2004 to 2016. DDH patients that underwent index treatment with Pavlik harness and had minimum 12 months follow-up were included. Medical charts were reviewed for demographics, treatment, and outcomes. Outcomes were compared between patients with an inverted labrum versus those without an inverted labrum. RESULTS: A total of 156 patients with 229 dysplastic hips were included. The mean age at initiation of Pavlik harness treatment was 1.9±1.4 months and mean follow-up was 37.7±23.0 months. Bilateral DDH was diagnosed in 46% (73/156) of patients. In all, 37% (75/229) of hips failed Pavlik harness index treatment. Second-line treatment was rigid hip abduction bracing in 91% (68/75) of hips, closed reduction in 5% (4/75) of hips, and open reduction in 4% (3/75) of hips. An inverted labrum was present in 10% (22/229) of all hips. The incidence of Pavlik harness treatment failure was 91% (20/22) in the inverted labrum group compared with 27% (55/207) in the control group (P<0.001). Closed or open reduction was required in 86% (15/22) of the inverted labrum group compared with 3% (7/207) of hips in the control group (P<0.001). The incidence of avascular necrosis was 18% (4/22) in hips with an inverted labrum compared with 0.4% (1/207) in the control group (P<0.001). CONCLUSIONS: In children with DDH undergoing index treatment in a Pavlik harness, the presence of an inverted acetabular labrum is strongly predictive of treatment failure. Dysplastic hips with an inverted labrum also have a significantly higher risk of requiring closed or open reduction and developing avascular necrosis compared with those without an inverted labrum. LEVEL OF EVIDENCE: Level III.

Pain for Greater Than 4 Days Is Highly Predictive of Concomitant Osteomyelitis in Children With Septic Arthritis.

BACKGROUND: There is no evidence-based consensus on the risk factors for concomitant osteomyelitis and septic arthritis. The purpose of this study was to investigate clinical parameters predictive of concomitant osteomyelitis in children with septic arthritis. METHODS: A retrospective review was conducted on patients with septic arthritis with magnetic resonance imaging (MRI) between January 2004 and October 2016 at a tertiary care pediatric hospital. Medical charts were reviewed for information including symptoms, diagnosis of osteomyelitis, serum laboratory studies, joint fluid analyses, imaging results, and treatment. Positive diagnosis of osteomyelitis was defined as a hyperintense signal of osseous structures on T2-weighted MRI consistent with infection per attending pediatric radiologist final read. RESULTS: A total of 71 patients with 73 septic joints were included. The mean age was 6±4 (0.1 to 17) years and the mean follow-up was 14.9±24.1 (1.0 to 133.1) months. Septic arthritis with concomitant osteomyelitis occurred in 43 of 71 (61%) patients, whereas 28 of 71 (39%) patients had septic arthritis alone. Inflammatory markers such as white blood cell count, erythrocyte sedimentation rate, and C-reactive protein on admission were not associated with concomitant osteomyelitis. Multivariate logistic regression revealed that positive joint fluid bacterial culture (P=0.021) and pain for >4 days before admission (P=0.004) are independent risk factors for concomitant osteomyelitis in children with septic arthritis. Among the 24 septic arthritis patients with pain for >4 days before presentation, 96% (23/24) had concomitant osteomyelitis, whereas 43% (20/47) of patients with pain for ≤4 days had concomitant osteomyelitis. CONCLUSION: Pain for >4 days before presentation is an independent predictor of osteomyelitis in children with septic arthritis. In pediatric septic arthritis, MRI should be considered, particularly in patients presenting with pain for >4 days as 96% of these patients had concomitant osteomyelitis. LEVEL OF EVIDENCE: Level III-retrospective comparative study.

Slipped Capital Femoral Epiphysis in Children without Obesity.

OBJECTIVE: To evaluate rates and characteristics of slipped capital femoral epiphysis (SCFE) in children who are not obese to prevent missed diagnoses and subsequent complications. STUDY DESIGN: A multicenter, retrospective review identified all patients with SCFE from January 1, 2003 to December 31, 2012. Patients were excluded if they received previous surgery at an outside institution, had no recorded height and weight, or had medical co-morbidity associated with increased risk of SCFE. Body mass index (BMI) percentile for age was calculated and categorized for each patient (patients without obesity vs with obesity). RESULTS: In total, 275 patients met inclusion criteria. Average BMI was 91.2 percentile (range: 8.4-99.7). Thirteen percent (34 patients) were considered "normal weight" (BMI 5%-85%), 17% (48 patients) were considered "overweight" (BMI 85%- 95%), and 70% (193 patients) were considered "obese" (BMI >95%). Average BMI percentile was higher in male than female patients (93.2 ± 12.7 vs 88.5 ± 21.4, P = .034). Patients without obesity were older compared with patients with obesity (12.2 ± 1.7 vs 11.7 ± 1.6 years, P = .015). Fewer patients without obesity were seen at the hospital in the southwest. The southwest had fewer patients without obesity than the northeast (18.3% vs 36.1%, P = .002). Patients without obesity were more likely to present with a severe slip as graded by Wilson percent displacement (27.2% vs 11.4%, P = .007) and an unstable slip (32.9% vs 14.7%, P = .001). CONCLUSION: Rates of nonobese SCFE in this study are higher than reported in the previous literature. Normal weight patients with SCFE are more likely to be older, female, and present with a severe and unstable SCFE.

Titanium Elastic Nails Are a Safe and Effective Treatment for Length Unstable Pediatric Femur Fractures.

BACKGROUND: Controversy exists regarding the treatment of length unstable pediatric femoral shaft fractures. The purpose of this study was to investigate the outcomes of skeletally immature children with length unstable femur fractures treated with titanium elastic nails (TENs). METHODS: A retrospective review was conducted on all patients with femoral shaft fractures at a tertiary care pediatric hospital from April 2006 to January 2018. Patients with femoral shaft fractures treated with TEN and minimum 6 months follow-up were included. Exclusion criteria were age 11 years or above, weight >50 kg, pathologic fracture, and neuromuscular disorders. Femur fractures were categorized into 2 groups: length unstable (spiral, comminuted, or long oblique fractures) versus length stable (transverse and short oblique). Complications and reoperations were compared between the groups. RESULTS: A total of 57 patients with 58 femoral shaft fractures were included. The mean age was 5±2 (1 to 11) years and mean follow-up was 20.4±18.1 (6.0 to 81.2) months. The mean weight was 22.9±7.7 (11.0 to 40.5) kg. There was no difference in age (P=0.32), weight (P=0.28) or follow-up length (P=0.57) between patients with length unstable fractures and those with length stable fractures. A total of 32/58 (55%) fractures were length unstable and 26/58 (45%) were length stable. Mean time to union was 4.6 months, and there was no significant difference in mean time to union between the 2 groups (P=0.71). Thirty-one complications occurred in 27 patients. There was no difference between groups in the incidence of major complications requiring revision surgery (P=0.68) and minor complications that did not require revision surgery (P>0.99). CONCLUSIONS: In children with femoral shaft fractures treated with TEN, there was no difference in the incidence of complications or reoperations between those with length unstable fractures and those with length stable fractures. TEN are a safe and effective choice for operative fixation of length unstable femoral shaft fractures in children. LEVEL OF EVIDENCE: Level III-retrospective comparative study.

EUS-guided drainage of postsurgical fluid collections using lumen-apposing metal stents: a multicenter study.

BACKGROUND AND AIMS: Postsurgical fluid collections (PSFCs) are traditionally drained either percutaneously or surgically. Endoscopic drainage offers several advantages compared with either percutaneous or surgical approaches, including avoiding repeat surgery or the need to have a percutaneous drain in place for weeks. There are very little data regarding the use of lumen-apposing metal stents (LAMSs) in the drainage of PSFCs. We aim to study the technical and clinical success and adverse events (AEs) of using LAMSs in the drainage of PSFCs. METHODS: Collaborators from 8 centers retrospectively reviewed their endoscopic databases to find procedures using LAMSs for drainage of PSFCs. Technical success (successful placement of LAMSs into the fluid collection), clinical success (complete resolution of the fluid collection on repeat imaging or endoscopy), and intraprocedure and postprocedure AEs were measured. RESULTS: Forty-seven patients were identified with PSFCs after various surgeries. Thirteen patients had failed previous percutaneous or surgical drainage attempts. Fluid collections averaged 78.6 mm (range, 47-150 mm) in size. The most common site of stent placement was transgastric, followed by rectum and duodenum. Technical success rate was 93.6% and clinical success rate 89.3%. The intraprocedural AE rate was 4.25% and postprocedural AE rate 6.4%. There was 1 death unrelated to the procedure. CONCLUSIONS: The use of LAMSs to drain PSFCs has a high technical and clinical success rate with low AEs. For collections that are favorably located adjacent to the stomach, duodenum, or rectum, LAMS placement is a viable alternative to repeat surgery or percutaneous drainage.

Digital pancreatoscopy in the evaluation of main duct intraductal papillary mucinous neoplasm: a multicenter study.

BACKGROUND: The aim of this study was to investigate the outcomes of digital pancreatoscopy in main duct intraductal papillary mucinous neoplasm (MD-IPMN). METHODS: This was a multicenter retrospective study. Outcomes analyzed were safety, incremental pathology yield compared with previous cross-sectional/endoscopic ultrasound (EUS) imaging, and whether the surgical procedure was dictated by the pancreatoscopy. RESULTS: A total of 31 patients were enrolled from six tertiary care centers. Overall, 42 % of cases had findings on pancreatoscopy that were not seen on cross-sectional imaging or EUS. Digital pancreatoscopy dictated the type of surgery performed in 13 patients (42 %) who underwent surgery. However, in patients with a diffusely dilated pancreatic duct (> 10 mm), the pancreatoscopy dictated the type of surgery in 77 % of cases vs. 17 % of cases in the focally dilated pancreatic duct group (10/13 vs. 3/18; P = 0.001). CONCLUSION: Digital pancreatoscopy should be considered in the diagnostic algorithm of MD-IPMN in patients with a diffusely dilated pancreatic duct and without any focal lesions seen on cross-sectional imaging or EUS.

Clinical outcomes in patients with bile leaks treated via ERCP with regard to the timing of ERCP: a large multicenter study.

BACKGROUND AND AIMS: Postsurgical or traumatic bile duct leaks (BDLs) can be safely and effectively managed by endoscopic therapy via ERCP. The early diagnosis of BDL is important because unrecognized leaks can lead to serious adverse events (AEs). Our aim was to evaluate the relationship between timing of endotherapy after BDL and the clinical outcomes, AEs, and long-term results of endoscopic therapy. METHODS: We conducted a multicenter, retrospective study on patients with BDLs who underwent ERCP between 2006 and 2014. Data were assembled on patient demographics, etiology of BDL, and procedural details. Endotherapy for BDLs were classified a priori into 3 groups based on timing of ERCP from time of biliary injury: within 1 day of BDL, on day 2 or 3 after BDL, and greater than 3 days after BDL. The relationship among timing of ERCP after BDL injury and outcomes, procedure-related AEs, and patient AEs and mortality were evaluated. RESULTS: From February 2006 to June 2014, 518 patients (50% male; mean age, 51.7 years) underwent ERCP for therapy of BDLs. The etiology of the BDL was laparoscopic cholecystectomy (70.7%), post-liver transplantation (11.2%), liver resection (14.1%), trauma (2.5%), and other causes (1.5%). Endotherapy was performed by placing a transpapillary stent alone (73.5%) or with a sphincterotomy (26.5%). The timing of ERCPs was as follows: ≤1 day = 57 patients, day 2 or 3 = 140 patients, and >3 days = 321 patients. There was no statistical difference in patient demographics, etiology/site of BDL, or type of endotherapy performed among the 3 groups. On multivariate analysis there was no statistically significant difference in BDL success rate for ERCPs performed within 1 day compared with those performed on day 2 or 3 or after 3 days of bile duct injury (91.2%, 90%, and 88.5%, respectively; P = .77). Similarly, there was no significant difference in the overall patient AE rate among the 3 groups (21.1%, 22.9%, and 24.6%, respectively; P = .81). AEs in men occurred significantly more frequently when compared with women, even after adjusting for age, BDL etiology, and location of leak (27.6% vs 19.9%; OR, 1.53; P = .04). Patients whose BDL was due to a cholecystectomy had a lower AE and mortality rate compared with those who had biliary injury from other etiologies (OR, .42; P < .001). CONCLUSIONS: The overall success rates and AEs after ERCP were not dependent on the timing of the procedure relative to the discovery of the bile leak. This suggests that ERCP in these patients can usually be performed in an elective, rather than an urgent, manner.

Fully covered self-expanding metal stents versus lumen-apposing fully covered self-expanding metal stent versus plastic stents for endoscopic drainage of pancreatic walled-off necrosis: clinical outcomes and success.

BACKGROUND AND AIMS: Endoscopic transmural drainage/debridement of pancreatic walled-off necrosis (WON) has been performed using double-pigtail plastic (DP), fully covered self-expanding metal stents (FCSEMSs), or the novel lumen-apposing fully covered self-expanding metal stent (LAMS). Our aim was to perform a retrospective cohort study to compare the clinical outcomes and adverse events of EUS-guided drainage/debridement of WON with DP stents, FCSEMSs, and LAMSs. METHODS: Consecutive patients in 2 centers with WON managed by EUS-guided debridement were divided into 3 groups: (1) those who underwent debridement using DP stents, (2) debridement using FCSEMSs, (3) debridement using LAMSs. Technical success (ability to access and drain a WON by placement of transmural stents), early adverse events, number of procedures performed per patient to achieve WON resolution, and long-term success (complete resolution of the WON without need for further reintervention at 6 months after treatment) were evaluated. RESULTS: From 2010 to 2015, 313 patients (23.3% female; mean age, 53 years) underwent WON debridement, including 106 who were drained using DP stents, 121 using FCSEMSs, and 86 using LAMSs. The 3 groups were matched for age, cause of the pancreatitis, WON size, and location. The cause of the patients' pancreatitis was gallstones (40.6%), alcohol (30.7%), idiopathic (13.1%), and other causes (15.6%). The mean cyst size was 102 mm (range, 20-510 mm). The mean number of endoscopy sessions was 2.5 (range, 1-13). The technical success rate of stent placement was 99%. Early adverse events were noted in 27 of 313 (8.6%) patients (perforation in 6, bleeding in 8, suprainfection in 9, other in 7). Successful endoscopic therapy was noted in 277 of 313 (89.6%) patients. When comparing the 3 groups, there was no difference in the technical success (P = .37). Early adverse events were significantly lower in the FCSEMS group compared with the DP and LAMS groups (1.6%, 7.5%, and 9.3%; P < .01). At 6-month follow-up, the rate of complete resolution of WON was lower with DP stents compared with FCSEMSs and LAMSs (81% vs 95% vs 90%; P = .001). The mean number of procedures required for WON resolution was significantly lower in the LAMS group compared with the FCSEMS and DP groups (2.2 vs 3 vs 3.6, respectively; P = .04). On multivariable analysis, DP stents remain the sole negative predictor for successful resolution of WON (odds ratio [OR], 0.18; 95% confidence interval, 0.06-0.53; P = .002) after adjusting for age, sex, and WON size. Although there was no significant difference between FCSEMSs and LAMSs for WON resolution, the LAMS was more likely to have early adverse events (OR, 6.6; P = .02). CONCLUSIONS: EUS-guided drainage/debridement of WON using FCSEMSs and LAMSs is superior to DP stents in terms of overall treatment efficacy. The number of procedures required for WON resolution was significantly lower with LAMSs compared with FCSEMSs and DP stents.

Efficacy, Safety, and Outcomes of Endoscopic Retrograde Cholangiopancreatography With Per-Oral Pancreatoscopy: A Multicenter Experience.

INTRODUCTION: Per-oral pancreatoscopy can be used for both evaluation and treatment of pancreatic duct stones during endoscopic retrograde cholangiopancreatography, evaluating and treating pancreatic duct strictures of indeterminate etiology, and visual inspection and direct biopsy of pancreatic duct mucosa for diagnosis of intraductal papillary mucinous neoplasm (IPMN). We aim to describe the efficacy, safety, and outcomes of pancreatoscopy in a large, multicenter series of patients. MATERIALS AND METHODS: A multicenter retrospective review was conducted of all patients who underwent per-oral pancreatoscopy at 2 large tertiary-care medical centers. Review of relevant medical records, laboratory data, imaging studies, endoscopic procedure notes, telephone follow-up notes, and progress notes was performed. RESULTS: Thirty-three patients underwent 41 pancreatoscopy procedures. Indications included: 20 (48.8%) for diagnosis and treatment of pancreatic duct stones, 16 (39%) for investigation of IPMN, and 5 (12.2%) for evaluation of pancreatic duct strictures.In 20 procedures performed for stone disease, complete pancreatic duct clearance was achieved in 17 of 20 (85%) cases. Strictures were successfully dilated in 5 of 5 (100%) procedures. Direct visualization and biopsy demonstrated IPMN in 11 of 11 (100%) cases. Adverse events occurred in 3 of 41 (7.3%) of procedures, all of which were mild. CONCLUSIONS: In this large series, we demonstrate that in patients with difficult to manage stone disease, strictures and possible malignant ductal pathology, pancreatoscopy is an effective and safe tool that can facilitate both diagnosis and effective therapy. Adverse events in our study were mild and within acceptable limits, further demonstrating that this is a safe procedure that should be offered to appropriate patients.

A Comparison of Bilateral Side-by-Side Metal Stents Deployed Above and Across the Sphincter of Oddi in the Management of Malignant Hilar Biliary Obstruction.

BACKGROUND AND AIMS: The optimal method for endoscopic placement of bilateral self-expanding metal stents (SEMS) for the management of malignant hilar biliary obstruction has not been determined. The aim of this study was to compare the efficacies and complication rates between SEMS placed above and across the sphincter of Oddi (SO) in patients with malignant hilar biliary obstruction. MATERIALS AND METHODS: A retrospective review of patients with malignant hilar strictures who underwent bilateral SEMS placement at 3 centers was performed. Patients were divided into 2 groups: group A (above SO, n=52) or B (across SO, n=120). Patient demographics, technical success (successful SEMS placement across the stricture), functional success (decrease in pretreatment bilirubin level), complications, stent occlusion, and patient survival in the 2 groups were evaluated. RESULTS: We identified 172 patients with malignant hilar biliary obstruction (106 males, mean age 67 y). Significantly more early complications (1.9% vs. 11.7%, P=0.04) were seen in group B, mainly post-endoscopic retrograde cholangio-pancreatography pancreatitis. Mean SEMS patency periods were 33 weeks for group A and 29.6 weeks for group B (P=0.3). Occlusion rates were 50% and 45% for groups A and B (P=0.61); occlusion was due to tumor in-growth or overgrowth in all patients. SEMS occlusion was successfully treated endoscopically in 85% (22/26) patients in group A and 96% (52/54) in group B (P=0.24). The median survival time was 26 weeks in the group A and 29 weeks in group B (P=0.49). DISCUSSION: Bilateral side-by-side SEMS placement above or below the SO results in similar success rates, stent patency duration, and stent occlusion rates. Significantly fewer complications, with a trend toward lower rates of pancreatitis, were observed for SEMS placed above the SO.

Endoscopic Management of Esophagorespiratory Fistulas: A Multicenter Retrospective Study of Techniques and Outcomes.

BACKGROUND AND AIMS: Esophagorespiratory fistulas (ERF) are a devastating complication of benign and malignant etiologies. ERF are associated with high mortality, short survival, and poor quality of life. We performed a multicenter analysis of patients with ERF undergoing endoscopic treatment. METHODS: Multicentre retrospective study. RESULTS: We analyzed 25 patients undergoing 35 procedures over an 8-year period. Our data showed high technical success rates (97.1% of procedures) and with good, but not ideal, clinical success rates (60% of procedures, 80% of patients), which were defined as fistula closure confirmed by radiographic or repeat endoscopic evaluation and/or a lack of recurrent episodes of clinical aspiration to focus on durable ERF closure as opposed to only initial success. Proximal ERF were the most difficult to manage with the lowest overall clinical success rates, highest rates of recurrent aspiration despite endoscopic therapy, highest adverse events, and shortest survival times. Adverse events occurred in 40.0% of our patients and were all minor. Treatment allowed for diet advancement in 75% of patients. CONCLUSION: This represents the largest recent collection of US data and the first multicenter study evaluating the clinical success of multiple treatment modalities while stratifying data by fistula etiology and esophageal location. The endoscopic approaches detailed in this study offer a minimally invasive and safe choice for intervention with the potential to improve quality of life despite overall suboptimal clinical success and survivorship rates for in with ERF.

Esophageal stent fixation with endoscopic suturing device improves clinical outcomes and reduces complications in patients with locally advanced esophageal cancer prior to neoadjuvant therapy: a large multicenter experience.

BACKGROUND: Endoscopic placement of fully covered self-expanding metal stents (FCSEMS) to treat malignant dysphagia in patients with esophageal cancer significantly improves dysphagia; however, these stents have a high migration rate. AIM: To determine whether FCSEMS fixation using an endoscopic suturing device treated malignant dysphagia and prevented stent migration in patients with locally advanced esophageal cancer receiving neoadjuvant therapy when compared to patients with FCSEMS placement alone. METHOD: A review of patients with locally advanced esophageal cancer who underwent FCSEMS placement at 3 centers was performed. Patients were divided into two groups: Group A (n = 26) was composed of patients who underwent FCSEMS placement with suture placement, and Group B (n = 67) was composed of patients with FCSEMS placement alone. RESULTS: There were no significant differences between Groups A and B in demographics, and tumor characteristics. The technical success rate for stent placement was 100 %. There was no difference between Groups A and B in the median stent diameter and stent lengths. Mean dysphagia score obtained at 1 week after stent placement had improved significantly from baseline (2.4 and 1, respectively, p < 0.001). Patients had a median follow-up of 4 months. Immediate adverse events were mild chest discomfort in 4 patients in Group A and 2 patients in Group B (p = 0.05), and significant acid reflux in 3 patient in Group A compared to 2 patients in Group B (p = 0.1). The stent migration rate was significantly lower in Group A compared to compared to Group B (7.7 vs 26.9 %, respectively, p = 0.004). There was a delayed perforation in 1 patient and 1 death due to aspiration pneumonia in Group B. CONCLUSION: Fixation of esophageal FCSEMSs by using an endoscopic suturing device in patients receiving neoadjuvant therapy was shown to be feasible, safe, and relatively effective at preventing stent migration compared to those who had stent placed alone.