Plastic pigtail vs lumen-apposing metal stents for drainage of walled-off necrosis (PROMETHEUS study): an open-label, multicenter randomized trial.

BACKGROUND: Lumen-apposing metal stents (LAMS) have displaced double-pigtail plastic stents (DPS) as the standard treatment for walled-off necrosis (WON),ß but evidence for exclusively using LAMS is limited. We aimed to assess whether the theoretical benefit of LAMS was superior to DPS. METHODS: This multicenter, open-label, randomized trial was carried out in 9 tertiary hospitals. Between June 2017, and Oct 2020, we screened 99 patients with symptomatic WON, of whom 64 were enrolled and randomly assigned to the DPS group (n = 31) or the LAMS group (n = 33). The primary outcome was short-term (4-weeks) clinical success determined by the reduction of collection. Secondary endpoints included long-term clinical success, hospitalization, procedure duration, recurrence, safety, and costs. Analyses were by intention-to-treat. CLINICALTRIALS: gov, NCT03100578. RESULTS: A similar clinical success rate in the short term (RR, 1.41; 95% CI 0.88-2.25; p = 0.218) and in the long term (RR, 1.2; 95% CI 0.92-1.58; p = 0.291) was observed between both groups. Procedure duration was significantly shorter in the LAMS group (35 vs. 45-min, p = 0.003). The hospital admission after the index procedure (median difference, - 10 [95% CI - 17.5, - 1]; p = 0.077) and global hospitalization (median difference - 4 [95% CI - 33, 25.51]; p = 0.82) were similar between both groups. Reported stent-related adverse events were similar for the two groups (36 vs.45% in LAMS vs. DPS), except for de novo fever, which was significantly 26% lower in LAMS (RR, 0.26 [0.08-0.83], p = 0.015). CONCLUSIONS: The clinical superiority of LAMS over DPS for WON therapy was not proved, with similar clinical success, hospital stay and similar safety profile between both groups, yet a significant reduction in procedure time was observed. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT03100578.

Endoscopic management of pancreatic collections. Endoscopic Ultrasound Group, Spanish Society of Digestive Endoscopy (GSEED-USE) Clinical Guidelines.

Acute pancreatitis is associated with significant morbidity and mortality. It can develop complications such as fluid collections and necrosis. Infection of necrosis occurs in about 20-40 % of patients with severe acute pancreatitis, and is associated with organ failure and worse prognosis. In the past few years the treatment of pancreatic collections has shifted from open surgery to minimally invasive techniques such as endoscopic ultrasound-guided drainage. These guidelines from a selection of experts among the Endoscopic Ultrasound Group, Spanish Society of Gastrointestinal Endoscopy (GSEED-USE) are intended to provide advice on the management of pancreatic collections based on a thorough review of the available scientific evidence. It also reflects the experience and clinical practice of the authors, who are advanced endoscopists or clinical pancreatologists with extensive experience in managing patients with acute pancreatitis.

Endoscopic ultrasound-guided gallbladder drainage with long-term lumen-apposing metal stent indwell: 1-year results from a prospective nationwide observational study.

BACKGROUND AND AIM: This study aimed to determine safety and risk factors for adverse events (AEs) of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with long-term indwell of lumen-apposing metal stents (LAMS). METHODS: This study is a multicenter prospective observational study on consecutive high surgical-risk patients requiring gallbladder drainage who underwent EUS-GBD with LAMS over 12 months. Centralized telephone follow-up interviews were conducted every 3 months for 1 year. Patients were censored at LAMS removal, cholecystectomy, or death. AE-free survival was determined using log-rank tests. Cumulative risks were estimated using life-table analysis. RESULTS: Eighty-two patients were included (53.7% male, median [interquartile range] age of 84.6 [76.5-89.8] years, and 85.4% with acute cholecystitis). Technical success was achieved in 79 (96.3%), and clinical success in 73 (89%). No patient was lost to follow-up; 45 patients (54.9%) completed 1-year follow-up with in situ LAMS. Median (interquartile range) LAMS indwell time was 364 (47-367) days. Overall, 12 (14.6%) patients presented 14 AEs, including 5 (6.1%) recurrent biliary events (3 acute cholangitis, 1 mild acute pancreatitis, and 1 acute cholecystitis). Patients with pancreatobiliary malignancy had an increased risk of recurrent biliary events (33% vs 1.5%, P = 0.001). The overall 1-year cumulative risk of recurrent biliary events was 9.7% (4.1-21.8%). The 1-year risk of AEs and of severe AEs was 18.8% (11-31.2%) and 7.9% (3.3-18.2%), respectively. Pancreatobiliary malignancy was the single risk factor for recurrent biliary events; LAMS misdeployment was the strongest risk factor for AEs. CONCLUSIONS: Long-term LAMS indwell does not increase the risk of delayed AEs following EUS-GBD.

Endoscopic ultrasonography-guided gastroenterostomy versus uncovered duodenal metal stenting for unresectable malignant gastric outlet obstruction (DRA-GOO): a multicentre randomised controlled trial.

BACKGROUND: Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is a novel endoscopic method to palliate malignant gastric outlet obstruction. We aimed to assess whether the use of EUS-GE with a double balloon occluder for malignant gastric outlet obstruction could reduce the need for reintervention within 6 months compared with conventional duodenal stenting. METHODS: The was an international, multicentre, randomised, controlled trial conducted at seven sites in Hong Kong, Belgium, Brazil, India, Italy, and Spain. Consecutive patients (aged ≥18 years) with malignant gastric outlet obstruction due to unresectable primary gastroduodenal or pancreatobiliary malignancies, a gastric outlet obstruction score (GOOS) of 0 (indicating an inability in intake food or liquids orally), and an Eastern Cooperative Oncology Group performance status score of 3 or lower were included and randomly allocated (1:1) to receive either EUS-GE or duodenal stenting. The primary outcome was the 6-month reintervention rate, defined as the percentage of patients requiring additional endoscopic intervention due to stent dysfunction (ie, restenosis of the stent due to tumour ingrowth, tumour overgrowth, or food residue; stent migration; or stent fracture) within 6 months, analysed in the intention-to-treat population. Prespecified secondary outcomes were technical success (successful placement of a stent), clinical success (1-point improvement in gastric outlet obstruction score [GOOS] within 3 days), adverse events within 30 days, death within 30 days, duration of stent patency, GOOS at 1 month, and quality-of-life scores. This study is registered with ClinicalTrials.gov (NCT03823690) and is completed. FINDINGS: Between Dec 1, 2020, and Feb 28, 2022, 185 patients were screened and 97 (46 men and 51 women) were recruited and randomly allocated (48 to the EUS-GE group and 49 to the duodenal stent group). Mean age was 69·5 years (SD 12·6) in the EUS-GE group and 64·8 years (13·0) in the duodenal stent group. All randomly allocated patients completed follow-up and were analysed. Reintervention within 6 months was required in two (4%) patients in the EUS-GE group and 14 (29%) in the duodenal stent group [p=0·0020; risk ratio 0·15 [95% CI 0·04-0·61]). Stent patency was longer in the EUS-GE group (median not reached in either group; HR 0·13 [95% CI 0·08-0·22], log-rank p<0·0001). 1-month GOOS was significantly better in the EUS-GE group (mean 2·41 [SD 0·7]) than the duodenal stent group (1·91 [0·9], p=0·012). There were no statistically significant differences between the EUS-GE and duodenal stent groups in death within 30 days (ten [21%] vs six [12%] patients, respectively, p=0·286), technical success, clinical success, or quality-of-life scores at 1 month. Adverse events occurred 11 (23%) patients in the EUS-GE group and 12 (24%) in the duodenal stent group within 30 days (p=1·00); three cases of pneumonia (two in the EUS-GE group and one in the duodenal stent group) were considered to be procedure related. INTERPRETATION: In patients with malignant gastric outlet obstruction, EUS-GE can reduce the frequency of reintervention, improve stent patency, and result in better patient-reported eating habits compared with duodenal stenting, and the procedure should be used preferentially over duodenal stenting when expertise and required devices are available. FUNDING: Research Grants Council (Hong Kong Special Administrative Region, China) and Sociedad Española de Endoscopia Digestiva.

A Longitudinal Analysis of Weight Changes before and after Total Knee Arthroplasty: Weight Trends, Patterns, and Predictors.

Longitudinal data on patient trends in body mass index (BMI) and the proportion that gains or loses significant weight before and after total knee arthroplasty (TKA) are scarce. This study aimed to observe patients longitudinally for a 2-year period and determine (1) clinically significant BMI changes during the 1 year before and 1 year after TKA and (2) identify factors associated with clinically significant weight changes.A prospective cohort of 5,388 patients who underwent primary TKA at a tertiary health care institution between January 2016 and December 2019 was analyzed. The outcome of interests was clinically significant weight changes, defined as a ≥5% change in BMI, during the 1-year preoperative and postoperative periods, respectively. Patient-specific variables and demographics were assessed as potential predictors of weight change using multinomial logistic regression.Overall, 47% had a stable weight throughout the study period (preoperative: 17% gained, 15% lost weight; postoperative: 19% gained, 16% lost weight). Patients who were older (odds ratio [OR] = 0.95), men (OR = 0.47), overweight (OR = 0.36), and Obese Class III (OR = 0.06) were less likely to gain weight preoperatively. Preoperative weight loss was associated with postoperative weight gain 1 year after TKA (OR = 3.03). Preoperative weight gain was associated with postoperative weight loss 1 year after TKA (OR = 3.16).Most patients maintained a stable weight before and after TKA. Weight changes during the 1 year before TKA were strongly associated with reciprocal rebounds in BMI postoperatively, emphasizing the importance of ongoing weight management during TKA and the recognition of patients at higher risk for weight gain.Level of evidence II (prospective cohort study).

Does Time to Aseptic Failure After Primary Total Hip Arthroplasty Affect Clinical and Patient-Reported Outcomes?

BACKGROUND: Evidence on the effects of time-to-failure from primary total hip arthroplasty (THA) to aseptic first-revision on clinical results and patient-reported outcome measures (PROMs) is scarce. Therefore, we sought to compare demographics, operative times, lengths of stay, discharge dispositions, 90-day readmissions, re-revision rates, mortalities, and PROMs between early and late aseptic THA revisions. METHODS: This study is a retrospective review of a prospectively collected institutional database of all elective hip procedures. In total, 572 patients who underwent aseptic revision after primary THA from August 2015 to December 2018 were analyzed. Patients were stratified into either early revision (<3-years; n = 176) or late revision (≥3-years; n = 396) cohorts. RESULTS: Significantly more patients were revised earlier for bone-related (ie, periprosthetic fractures) (22.7% versus 8.3%) or other various complications (19.9% versus 5.8%), whereas more late revisions were performed to treat implant-related failures (6.8% versus 37.1%), respectively. Operative time was significantly shorter in early versus late revisions (133 versus 157 minutes). A significantly higher delta-change/improvement from baseline/preoperative to 1-year postoperative was found for hip disability and osteoarthritis outcome score physical function (HOOS-PS), veterans-RAND-12 physical and mental components (VR-12-PCS and MCS, respectively) of early revisions. However, HOOS-PS and HOOS-Pain at 1-year of follow-up were significantly worse in early revisions. CONCLUSION: With exception of operative time, time-to-failure had no significant influence on clinical results. Despite greater improvements on PROMs from preoperative to postoperative, patients undergoing early revisions after primary THA perceive significantly higher levels of pain and worse physical functionality at 1-year of follow-up.

Biliary obstruction secondary to duodenal follicular lymphoma with papillary involvement.

Duodenal-type follicular lymphoma is a clinical variant of follicular lymphoma located in the intestine, presenting as multiple small polyps. The estimated frequency is 1/7000 people and extraduodenal involvement is rare. It predominantly affects middle-aged women, although some cases of young patients have been published in the literature. They are usually located in the second periampullary portion of the duodenum. It is diagnosed incidentally or after performing an imaging test due to non-specific digestive symptoms (abdominalgia, diarrhea or hyporexia). The prognosis is usually favorable without specific treatment5.

The Use of Oral Antibiotics After Total Joint Arthroplasty: A Critical Analysis Review.

¼ There is conflicting and insufficient evidence that extended oral antibiotic (EOA) therapy prevents infection in high-risk patients undergoing primary total joint arthroplasty (TJA), limiting recommendation for or against the practice.¼ In the case of aseptic revision TJA, the evidence is also conflicting and limited by underlying confounders, preventing recommendation for use of EOA.¼ There is fair evidence that use of EOA after debridement antibiotic therapy and implant retention of the prosthesis prolongs infection-free survival, but randomized controlled trials are needed. On the other hand, there is strong evidence that patients undergoing 2-stage revision should receive a period of suppressive oral antibiotics after the second stage.¼ The optimal duration of EOA in primary TJA, aseptic revision, and debridement antibiotic therapy and implant retention of the prosthesis is unknown. However, there is strong evidence that 3 months of EOA suppression may be appropriate after reimplantation as part of 2-stage exchange arthroplasty.¼ Complications secondary to EOA are reported to be between 0% and 13.7%, yet are inconsistently reported and poorly defined. The risks associated with antibiotic use, including development of antimicrobial resistance, must be weighed against a possible decrease in infection rate.

Robotic-Assisted Conversion of a Failed Medial Unicompartmental Knee Arthroplasty to Total Knee Arthroplasty: A Case Report.

CASE: An 81-year-old man with a history of left medial unicompartmental knee arthroplasty (mUKA) 8 years prior presented to the outpatient clinic with gradually increasing medial left knee pain of 6 years of duration. He underwent left conversion robotic-assisted total knee arthroplasty (RA TKA). At 1-year follow-up, the patient reported satisfactory clinical outcomes and excellent component alignment on x-rays. CONCLUSION: This case highlights using RA TKA for failed mUKA as a viable and promising conversion arthroplasty alternative technique that may improve surgical outcomes by enhancing implant alignment and positioning, protecting the soft tissues, and preserving bone stock.

EUS-guided fine needle biopsy of an anal gland adenocarcinoma with submucosal rectal invasion after normal colonoscopy. An uncommon histology.

We present the case of a 63-year-old male with long-term anal pain. A pelvic MRI was performed showing a tumor arising from the intersphincteric extending into the submucosal layer of the posterior rectal wall. The image was compatible with a cT4N0 ano-rectal carcinoma without any distant metastasis on the CT scan. Histopathology showed neoplastic proliferation cells arranged in nodules and nidus consistent with anal glands adenocarcinoma with a positive immunohistostaining for CK7 and MUC5+ .

Rectal ultrasound as unique diagnostic option in obstructive colorectal metastasis from breast adenocarcinoma.

We present the case of an uncommon manifestation of metastatic breast cancer as an occlusive colorectal stenosis with submucosal location. The endoscopic rectal ultrasound allowed to confirm the diagnosis with transmural biopsies.

Antimigration versus conventional fully covered metal stents in the endoscopic treatment of anastomotic biliary strictures after deceased-donor liver transplantation.

INTRODUCTION: Migration of fully covered metal stents (FCMS) remains a limitation of the endoscopic treatment of anastomotic biliary strictures (ABS) following orthotopic liver transplantation (OLT). The use of antimigration FCMS (A-FCMS) might enhance endoscopic treatment outcomes for ABS. METHODS: Single center retrospective study. Consecutive patients with ABS following OLT who underwent ERCP with FCMS placement between January 2005 and December 2020 were eligible. Subjects were grouped into conventional-FCMS (C-FCMS) and A-FCMS. The primary outcome was stent migration rates. Secondary outcomes were stricture resolution, adverse event, and recurrence rates. RESULTS: A total of 102 (40 C-FCMS; 62 A-FCMS) patients were included. Stent migration was identified at the first revision in 24 C-FCMS patients (63.2%) and in 21 A-FCMS patients (36.2%) (p = 0.01). The overall migration rate, including the first and subsequent endoscopic revisions, was 65.8% in C-FCMS and 37.3% in A-FCMS (p = 0.006). The stricture resolution rate at the first endoscopic revision was similar in both groups (60.0 vs 61.3%, p = 0.87). Final stricture resolution was achieved in 95 patients (93.1%), with no difference across groups (92.5 vs 93.5%; p = 0.84). Adverse events were identified in 13 patients (12.1%) with no difference across groups. At a median follow-up of 52 (IQR: 19-85.5) months after stricture resolution, 25 patients (24.5%) developed recurrences, with no difference across groups (C-FCMS 30% vs A-FCMS 21%; p = 0.28). CONCLUSIONS: The use of A-FCMS during ERCP for ABS following OLT results in significantly lower stent migration rates compared to C-FCMS. However, the clinical benefit of reduced stent migration is unclear. Larger studies focusing on stricture resolution and recurrence rates are needed.

The Microbiome of Osteoarthritic Hip and Knee Joints: A Prospective Multicenter Investigation.

BACKGROUND: Recent advances in high-throughput DNA sequencing technologies have made it possible to characterize the microbial profile in anatomical sites previously assumed to be sterile. We used this approach to explore the microbial composition within joints of osteoarthritic patients. METHODS: This prospective multicenter study recruited 113 patients undergoing hip or knee arthroplasty between 2017 and 2019. Demographics and prior intra-articular injections were noted. Matched synovial fluid, tissue, and swab specimens were obtained and shipped to a centralized laboratory for testing. Following DNA extraction, microbial 16S-rRNA sequencing was performed. RESULTS: Comparisons of paired specimens indicated that each was a comparable measure for microbiological sampling of the joint. Swab specimens were modestly different in bacterial composition from synovial fluid and tissue. The 5 most abundant genera were Escherichia, Cutibacterium, Staphylococcus, Acinetobacter, and Pseudomonas. Although sample size varied, the hospital of origin explained a significant portion (18.5%) of the variance in the microbial composition of the joint, and corticosteroid injection within 6 months before arthroplasty was associated with elevated abundance of several lineages. CONCLUSIONS: The findings revealed that prior intra-articular injection and the operative hospital environment may influence the microbial composition of the joint. Furthermore, the most common species observed in this study were not among the most common in previous skin microbiome studies, suggesting that the microbial profiles detected are not likely explained solely by skin contamination. Further research is needed to determine the relationship between the hospital and a "closed" microbiome environment. These findings contribute to establishing the baseline microbial signal and identifying contributing variables in the osteoarthritic joint, which will be valuable as a comparator in the contexts of infection and long-term arthroplasty success. LEVEL OF EVIDENCE: Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Does Performance of D-Dimer for Diagnosis of Periprosthetic Joint Infection Change With the Virulence of Infecting Organism?

BACKGROUND: The impact of the organism virulence on diagnostic accuracy of D-Dimer for periprosthetic joint infection (PJI) is unknown. Our objective was to assess if the performance of D-Dimer in PJI diagnosis changes with the virulence of the organism(s). METHODS: We retrospectively reviewed 143 consecutive revision total hip arthroplasties/total knee arthroplasties with D-Dimer ordered preoperatively. Operations were performed by 3 surgeons at a single institution (November 2017 through September 2020). There were 141 revisions with complete 2013-International Consensus Meeting-criteria initially included. This criteria was used to classify revisions as aseptic versus septic. Culture-negative septic revisions (n = 8) were excluded, and 133 revisions (47-hips/86-knees; 67-septic/66-aseptic) were analyzed. Based on culture results, septic-revisions were categorized into 'low-virulence (LV/n = 40)' or 'high-virulence (HV/n = 27)'. The D-Dimer threshold (850-ng/mL) was tested against 2013-International Consensus Meeting-criteria ("standard") in identifying septic-revisions (LV/HV) from aseptic-revisions. Sensitivity, specificity, and positive predictive values/negative predictive values (NPV) were determined. Receiver-operating-characteristic-curve-analyses were performed. RESULTS: Plasma D-Dimer showed high sensitivity (97.5%) and NPV (95.4%) in LV septic cases, which appeared to reduce by about 5% in HV septic cases (sensitivity = 92.5% and NPV = 91.3%). However, this marker had poor overall accuracy (LV = 57%; HV = 49.4%), low specificity (LV and HV = 31.8%), and positive predictive values (LV = 46.4%; HV = 35.7%) to diagnose PJI. The area under the curve was 0.647 and 0.622 in LV and HV versus aseptic revisions, respectively. CONCLUSION: D-Dimer performs poorly to identify septic from aseptic revisions in the setting of LV/HV infecting organisms alike. However, it shows high sensitivity for PJI diagnosis in cases of LV organisms which might be missed by most diagnostic tests.

Endoscopic ultrasound-guided resolution of right hydronephrosis secondary to local compression by an inflammatory pancreatic mass.

We present the case of 67 years-old man with unremarkable medical history. He was admitted to our department for abdominal pain compatible with choledocholithiasis associated with acute cholecystitis. ERCP was performed but direct papillary canulation attempts failed by means of conventional sphincterotome. So, pre- cut papillotomy was successfully attempted getting free access to distal choledochus and retrieving a small lithiasis. Unfortunately, the patient developed severe post-ERCP acute pancreatitis.

Endoscopic removal of lumen-apposing metal stents - risk factors for stent embedment, complex removals, and adverse events: analysis from a multicenter prospective case series.

BACKGROUND: Removing lumen-apposing metal stents (LAMSs) may be difficult and even harmful, but these features have seldom been analyzed. We aimed to generate a comprehensive assessment of the feasibility and safety of LAMS retrieval procedures. METHODS: A prospective multicenter case series including all technically successfully deployed LAMSs between January 2019 and January 2020 that underwent endoscopic stent removal. All retrieval-related data were prospectively recorded using standardized telephone questionnaires as part of centralized follow-up that ended after stent removal had been performed. Multivariable logistic regression models assessed the potential risk factors for complex removal. RESULTS: For the 407 LAMSs included, removal was attempted in 158 (38.8 %) after an indwell time of 46.5 days (interquartile range [IQR] 31-70). The median (IQR) removal time was 2 (1-4) minutes. Removal was labelled as complex in 13 procedures (8.2 %), although advanced endoscopic maneuvers were required in only two (1.3 %). Complex removal risk factors were stent embedment (relative risk [RR] 5.84, 95 %CI 2.14-15.89; P = 0.001), over-the-wire deployment (RR 4.66, 95 %CI 1.60-13.56; P = 0.01), and longer indwell times (RR 1.14, 95 %CI 1.03-1.27; P = 0.01). Partial and complete embedment were observed in 14 (8.9 %) and five cases (3.2 %), respectively. The embedment rate during the first 6 weeks was 3.1 % (2/65), reaching 15.9 % (10/63) during the following 6 weeks (P = 0.02). The adverse event rate was 5.1 %, including seven gastrointestinal bleeds (5 mild, 2 moderate). CONCLUSIONS: LAMS removal is a safe procedure, mostly requiring basic endoscopic techniques attainable in conventional endoscopy rooms. Referral to advanced endoscopy units should be considered for stents with known embedment or long indwell times, which may require more technically demanding procedures.

Is a Higher Number of Total Hip and Knee Arthroplasty Revisions Associated With Increased Mortality?

BACKGROUND: It remains uncertain whether patients who undergo numerous total hip arthroplasty (THA) and/or knee arthroplasty (TKA) revisions exhibit decreased survival. Therefore, we sought to determine if the number of revisions per patient was a mortality predictor. METHODS: We retrospectively reviewed 978 consecutive THA and TKA revision patients from a single institution (from January 5, 2015-November 10, 2020). Dates of first-revision or single revision during study period and of latest follow-up or death were collected, and mortality was assessed. Number of revisions per patient and demographics corresponding to first revision or single revision were determined. Kaplan-Meier, univariate, and multivariate Cox-regressions were utilized to determine mortality predictors. The mean follow-up was 893 days (range, 3-2,658). RESULTS: Mortality rates were 5.5% for the entire series, 5.0% among patients who only underwent TKA revision(s), 5.4% for only THA revision(s), and 17.2% for patients who underwent TKA and THA revisions (P = .019). In univariate Cox-regression, number of revisions per patient was not predictive of mortality in any of the groups analyzed. Age, body mass index (BMI), and American Society of Anesthesiologists (ASA) were significant mortality predictors in the entire series. Every 1 year of age increase significantly elevated expected death by 5.6% while per unit increase in BMI decreased the expected death by 6.7%, ASA-3 or ASA-4 patients had a 3.1 -fold increased expected death compared to ASA-1 or ASA-2 patients. CONCLUSION: The number of revisions a patient underwent did not significantly impact mortality. Increased age and ASA were positively associated with mortality but higher BMI was negatively associated. If health status is appropriate, patients can undergo multiple revisions without risk of decreased survival.