De-implementation of Axillary Dissection in Women With Breast Cancer is Largely Driven By Site-level Contextual Effects.

OBJECTIVE: To assess the contribution of unknown institutional factors (contextual effects) in the de-implementation of cALND in women with breast cancer. SUMMARY OF BACKGROUND DATA: Women included in the National Cancer Database with invasive breast carcinoma from 2012 to 2016 that underwent upfront lumpectomy and were found to have a positive sentinel node. METHODS: A multivariable mixed effects logistic regression model with a random intercept for site was used to determine the effect of patient, tumor, and institutional variables on the risk of cALND. Reference effect measureswere used to describe and compare the contribution of contextual effects to the variation in cALND use to that of measured variables. RESULTS: By 2016, cALND was still performed in at least 50% of the patients in a quarter of the institutions. Black race, younger women and those with larger or hormone negative tumors were more likely to undergo cALND. However, the width of the 90% reference effect measures range for the contextual effects exceeded that of the measured site, tumor, time, and patient demographics, suggesting institutional contextual effects were the major drivers of cALND de-implementation. For instance, a woman at an institution with low-risk of performing cALND would have 74% reduced odds of havinga cALND than if she was treated at a median-risk institution, while a patient at a high-risk institution had 3.91 times the odds. CONCLUSION: Compared to known patient, tumor, and institutional factors, contextual effects had a higher contribution to the variation in cALND use.

Adjuvant Therapy for Stage III Melanoma Without Immediate Completion Lymph Node Dissection.

INTRODUCTION: For patients with stage III melanoma with occult lymph node metastasis, the use of adjuvant therapy is increasing, and completion lymph node dissection (CLND) is decreasing. We sought to evaluate the use of modern adjuvant therapy and outcomes for patients with stage III melanoma who did not undergo CLND. METHODS: Patients with a positive SLNB from 2015 to 2020 who did not undergo CLND were evaluated retrospectively. Nodal recurrence, recurrence-free survival (RFS), distant metastasis-free survival (DMFS), and melanoma-specific survival were evaluated. RESULTS: Among 90 patients, 56 (62%) received adjuvant therapy and 34 (38%) underwent observation alone. Patients who received adjuvant therapy were younger (mean age: 53 vs. 65, p < 0.001) and had higher overall stage (Stage IIIb/c 75% vs. 54%, p = 0.041). Disease recurred in 12 of 34 patients (35%) in the observation group and 11 of 56 patients (20%) in the adjuvant therapy group. The most common first site of recurrence was distant recurrence alone (5/34 patients) in the observation group and nodal recurrence alone (8/90 patients) in the adjuvant therapy group. Despite more adverse nodal features in the adjuvant therapy group, 24-month nodal recurrence rate and RFS were not significantly different between the adjuvant and observation cohorts (nodal recurrence rate: 26% vs. 20%, p = 0.68; RFS: 75% vs. 61%, p = 0.39). Among patients with stage IIIb/c disease, adjuvant therapy was associated with a significantly improved 24-month DMFS (86% vs. 59%, p = 0.04). CONCLUSIONS: In this early report, modern adjuvant therapy in patients who forego CLND is associated with longer DMFS among patients with stage IIIb/c disease.

Single-Day Low-Residue Diet Prior to Colonoscopy Demonstrates Improved Bowel Preparation Quality and Patient Tolerance over Clear Liquid Diet: A Randomized, Single-Blinded, Dual-Center Trial.

BACKGROUND AND AIMS: Patients often refer to bowel preparation and associated dietary restrictions as the greatest deterrents to having a colonoscopy completed or performed. Large studies comparing a low-residue diet (LRD) and a clear liquid diet (CLD) are still limited. The aim of this study is to compare LRD and CLD with regard to bowel preparation quality, tolerance, and satisfaction among a diverse patient population. METHODS: This study is a dual-center, randomized, single-blinded, prospective trial involving adult patients undergoing outpatient colonoscopy at the University of California Irvine Medical Center and an affiliated Veterans Administration hospital. Patients were randomized to consume either a CLD or a planned LRD for the full day prior to colonoscopy. Both groups consumed 4L split-dosed PEG-ELS. The adequacy of bowel preparation was evaluated using the Boston Bowel Preparation Score (BBPS). Adequate preparation was defined as a BBPS ≥ 6 with no individual segment less than a score of 2. Hunger and fatigue pre - and post-procedure were graded on a ten-point scale. Nausea, vomiting, bloating, abdominal cramping, overall discomfort, satisfaction with the diet, willingness to repeat the same preparation and overall experience were assessed. RESULTS: A total of 195 subjects who underwent colonoscopy from October 2014 to October 2017 were included. The mean BBPS for the LRD and CLD groups was 8.38 and 7.93, respectively (p = 0.1). There was a significantly higher number of adequate preparations in the LRD group compared to CLD (p = 0.05). Evening hunger scores just before starting the bowel preparation were significantly lower in the LRD than the CLD group, 2.81 versus 5.97, respectively (p = 0.006). Subjects in the LRD group showed significantly less nausea (p = 0.047) and bloating (p = 0.04). Symptom scores for vomiting, abdominal cramping, and overall discomfort were similar between the groups. Satisfaction with diet was significantly higher in the LRD group than CLD, 72% versus 37.66%, respectively (p < 0.001). The overall colonoscopy experience and the satisfaction with the preparation itself were also better reported in the LRD group (p < 0.001 and p = 0.002, respectively). CONCLUSIONS: This study, which included a diverse group of patients, demonstrated that patients using a LRD before colonoscopy achieve a bowel preparation quality that is superior to patients on a CLD restriction. This study shows that a low-residue diet improves patient satisfaction and results in significantly better tolerability of bowel preparation. As a less restrictive dietary regimen, the low-residue diet may help improve patient participation in colorectal cancer screening programs.

A nomogram to predict node positivity in patients with thin melanomas helps inform shared patient decision making.

OBJECTIVE: To develop a nomogram to estimate the probability of positive sentinel lymph node (+SLN) for patients with thin melanoma and to characterize its potential impact on sentinel lymph node biopsy (SLNB) rates. METHODS: Patients diagnosed with thin (0.5-1.0 mm) melanoma were identified from the National Cancer Database 2012 to 2015. A multivariable logistic regression model was used to examine factors associated with +SLN, and a nomogram to predict +SLN was constructed. Nomogram performance was evaluated and diagnostic test statistics were calculated. RESULTS: Of the 21 971 patients included 10 108 (46.0%) underwent SLNB, with a 4.0% +SLN rate. On multivariable analysis, age, Breslow thickness, lymphovascular invasion, ulceration, and Clark level were significantly associated with SLN status. The area under the receiver operating curve was 0.67 (95% confidence interval, 0.65-0.70). While 15 249 (69.4%) patients had either T1b tumors or T1a tumors with at least one adverse feature, only 2846 (13.0%) had a nomogram predicted probability of a +SLN ≥5%. Using this cut-off, the indication for a SLNB in these patients would be reduced by 81.3% as compared to the American Joint Committee on Cancer 8th edition staging criteria. CONCLUSIONS: The risk predictions obtained from the nomogram allow for more accurate selection of patients who could benefit from SLNB.

Single-center experience demonstrating low adverse events and high efficacy with self-expandable metal esophageal and biliary stents for pseudocyst and walled off necrosis drainage.

Background and study aims Lumen-apposing metal stents (LAMS) have been designed as proprietary stents for the management of pseudocysts (PC)/walled off necrosis (WON). There has been concern about adverse events (AEs) with LAMS including bleeding, buried stent syndrome and migration. Prior to LAMS becoming available, fully-covered self-expandable metal esophageal and biliary stents (FCSEMSs) were used off-label for management of PC/WON with many centers demonstrating low rates of AEs. The primary aim of this study was to study the safety and efficacy of FCSEMS for the management of pseudocysts/WON. Patients and methods This was a retrospective review of all endoscopic ultrasound (EUS)-guided placement of FCSEMSs for drainage of PC/WON cases performed at our institution over 4-year period. The primary outcomes studied were technical success, AEs, PC/WON resolution, and salvage surgical/radiologic intervention. Results Technical success achieved in 65 of 65 (100 %) study patients. An AE occurred 0 of 25 patients (0 %) with PC, and in 10 of 40 patients (25 %) with WON: bleeding (3 %), migration (5 %) and stent dysfunction/infection (18 %). There was resolution in 25 of 25 patients (100 %) with a PC and 31 of 40 patients (78 %) with a WON. Salvage therapy by interventional radiology or surgery was performed in nine of 40 patients (22 %). Conclusions This single-center 4-year experience in the pre-LAMS era showed that FCSEMS was safe and effective in all patients with PC and over 75 % of patients with WON. Given the large cost differential between LAMS and FCSEMS and the efficacy and safety shown with FCSEMS, we believe that FCSEMS should still be considered a first-line option for patients with pancreatic fluid collections, particularly in patients with PCs.

EUS-guided through-the-needle biopsy for pancreatic cystic lesions.

BACKGROUND AND AIMS: Differentiating pancreatic cystic lesions remains a challenge when the current technique of EUS-guided FNA is used. Recently, a miniaturized biopsy forceps with an outer diameter of 0.8 mm has been developed, thus allowing it to be passed through the bore of a standard 19-gauge FNA needle to acquire tissue. METHODS: This study consisted of a retrospective review of all cases of EUS-guided through-the-needle forceps biopsy technique (TTNFB) performed for pancreatic cystic lesions at a single academic tertiary care center over a 12-month period. Technical success was defined as acquisition of adequate tissue for formal histologic analysis. Safety was assessed through the monitoring and recording of periprocedural and postprocedural adverse events. RESULTS: The technical success of EUS-guided TTNFB was 87% (13/15). EUS-guided TTNFB with histologic analysis yielded pancreatic cyst diagnoses in 11 of 15 (73%) patients, compared with 0 of 15 (0%) patients with the use of EUS-FNA and cytologic analysis (P < .001). Of the 15 cystic lesions, 8 were diagnosed as intrapapillary mucinous neoplasm based on EUS-TTNFB. CONCLUSION: This TTNFB technique has the potential to improve the diagnostic yield of EUS-FNA for pancreatic cystic neoplasms.

EUS-guided portal pressure gradient measurement with a simple novel device: a human pilot study.

BACKGROUND AND AIMS: Portal hypertension is a serious adverse event of liver cirrhosis. Recently, we developed a simple novel technique for EUS-guided portal pressure gradient (PPG) measurement (PPGM). Our animal studies showed excellent correlation between EUS-PPGM and interventional radiology-acquired PPGM. In this video we demonstrate the results of the first human pilot study of EUS-PPGM in patients with liver disease. METHODS: EUS-PPGM was performed by experienced endosonographers using a linear echoendoscope, a 25-gauge FNA needle, and a novel compact manometer. The portal vein and hepatic vein (or inferior vena cava) were targeted by use of a transgastric or transduodenal approach. Feasibility was defined as successful PPGM in each patient. Safety was based on adverse events captured in a postprocedural interview. RESULTS: Twenty-eight patients underwent EUS-PPGM with 100% technical success and no adverse events. PPG ranged from 1.5 to 19 mm Hg and had excellent correlation with clinical parameters of portal hypertension, including the presence of varices (P = .0002), PH gastropathy (P = .007), and thrombocytopenia (P = .036). CONCLUSION: This novel technique of EUS-PPGM using a 25-gauge needle and compact manometer is feasible and appears safe. Given the availability of EUS and the simplicity of the manometry setup, EUS-guided PPG may represent a promising breakthrough for procuring indispensable information in the management of patients with liver disease.