Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Persistent pain is a common yet debilitating complication after breast cancer surgery. Given the pervasive effects of this pain disorder on the patient and healthcare system, post-mastectomy pain syndrome (PMPS) is becoming a larger population health problem, especially as the prognosis and survivorship of breast cancer increases. Interventions that prevent persistent pain after breast surgery are needed to improve the quality of life of breast cancer survivors. An intraoperative intravenous lidocaine infusion has emerged as a potential intervention to decrease the incidence of PMPS. We aim to determine the definitive effects of this intervention in patients undergoing breast cancer surgery. METHODS: PLAN will be a multicenter, parallel-group, blinded, 1:1 randomized, placebo-controlled trial of 1,602 patients undergoing breast cancer surgery. Adult patients scheduled for a lumpectomy or mastectomy will be randomized to receive an intravenous 2% lidocaine bolus of 1.5 mg/kg with induction of anesthesia, followed by a 2.0 mg/kg/h infusion until the end of surgery, or placebo solution (normal saline) at the same volume. The primary outcome will be the incidence of persistent pain at 3 months. Secondary outcomes include the incidence of pain and opioid consumption at 1 h, 1-3 days, and 12 months after surgery, as well as emotional, physical, and functional parameters, and cost-effectiveness. DISCUSSION: This trial aims to provide definitive evidence on an intervention that could potentially prevent persistent pain after breast cancer surgery. If this trial is successful, lidocaine infusion would be integrated as standard of care in breast cancer management. This inexpensive, widely available, and easily administered intervention has the potential to reduce pain and suffering in an already afflicted patient population, decrease the substantial costs of chronic pain management, potentially decrease opioid use, and improve the quality of life in patients. TRIAL REGISTRATION: This trial has been registered on clinicaltrials.gov (NCT04874038, Dr. James Khan. Date of registration: May 5, 2021).

Does intra-operative margin assessment improve margin status and re-excision rates? A population-based analysis of outcomes in breast-conserving surgery for ductal carcinoma in situ.

BACKGROUND AND OBJECTIVES: Using a 2 mm margin criteria, we evaluated the effect of intra-operative margin assessment on margin status and re-excisions following breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS). METHODS: We identified patients undergoing BCS for DCIS from a prospective, population-based database. Multivariable logistic regression was used to determine the effect of specimen mammography, ultrasound and macroscopic assessment by a pathologist on margins and re-excision rates. RESULTS: In 588 patients, 52% (95% confidence interval [CI], 48%-56%) had positive margins (<2 mm), 39% (95% CI, 35%-43%) had a re-excision and 15% (95% CI, 12%-18%) had completion mastectomy. There were few re-excisions for margins ≥2 mm (2%). Adjusting for confounders, any margin assessment versus wire localization alone did not reduce positive margins (odds ratio [OR], 0.75; P = 0.202) or re-excisions (OR, 1.14; P = 0.564), however both outcomes varied by type of technique ( P < 0.001). Individually, only macroscopic assessment by pathologist reduced positive margins (OR, 0.54; P = 0.002) and re-excisions (OR, 0.61; P = 0.036). CONCLUSIONS: Despite adherence to a 2 mm margin criteria, re-excision rates remain high following BCS for DCIS, with 39% converted to mastectomy when re-excision is required. Intra-operative margin assessment does not appear to reduce re-excisions; in particular, surgeons should be aware of the limitations of specimen mammography for margin assessment in DCIS.

Evaluating wait times from screening to breast cancer diagnosis among women undergoing organised assessment vs usual care.

BACKGROUND: Timely coordinated diagnostic assessment following an abnormal screening mammogram reduces patient anxiety and may optimise breast cancer prognosis. Since 1998, the Ontario Breast Screening Program (OBSP) has offered organised assessment through Breast Assessment Centres (BACs). For OBSP women seen at a BAC, an abnormal mammogram is followed by coordinated referrals through the use of navigators for further imaging, biopsy, and surgical consultation as indicated. For OBSP women seen through usual care (UC), further diagnostic imaging is arranged directly from the screening centre and/or through their physician; results must be communicated to the physician who is then responsible for arranging any necessary biopsy and/or surgical consultation. This study aims to evaluate factors associated with diagnostic wait times for women undergoing assessment through BAC and UC. METHODS: Of the 2 147 257 women aged 50-69 years screened in the OBSP between 1 January 2002 and 31 December 2009, 155 866 (7.3%) had an abnormal mammogram. A retrospective design identified two concurrent cohorts of women diagnosed with screen-detected breast cancer at a BAC (n=4217; 47%) and UC (n=4827; 53%). Multivariable logistic regression analyses examined associations between wait times and assessment and prognostic characteristics by pathway. A two-sided 5% significance level was used. RESULTS: Screened women with breast cancer were two times more likely to be diagnosed within 7 weeks when assessed through a BAC vs UC (OR=1.91, 95% CI=1.73-2.10). In addition, compared with UC, women assessed through a BAC were significantly more likely to have their first assessment procedure within 3 weeks of their abnormal mammogram (OR=1.25, 95% CI=1.12-1.39), ⩽3 assessment procedures (OR=1.54, 95% CI=1.41-1.69), ⩽2 assessment visits (OR=1.86, 95% CI=1.70-2.05), and ⩾2 procedures per visit (OR=1.41, 95% CI=1.28-1.55). Women diagnosed through a BAC were also more likely than those in UC to have imaging (OR=1.99, 95% CI=1.44-2.75) or a biopsy (OR=3.69, 95% CI=2.64-5.15) vs consultation only at their first assessment visit, and two times more likely to have a core or FNA biopsy than a surgical biopsy (OR=2.08, 95% CI=1.81-2.40). Having ⩽2 assessment visits was more likely to reduce time to diagnosis for women assessed through a BAC compared with UC (BAC OR=10.58, 95% CI=8.96-12.50; UC OR=4.47, 95% CI=3.94-5.07), as was having ⩽3 assessment procedures (BAC OR=4.97, 95% CI=4.26-5.79; UC OR=2.95, 95% CI=2.61-3.33). Income quintile affected wait times only in women diagnosed in UC, with those in the two highest quintiles more likely to receive a diagnosis in 7 weeks. CONCLUSIONS: Women with screen-detected breast cancer in OBSP were more likely to have shorter wait times if they were diagnosed through organised assessment. This might be as a result of women diagnosed through a BAC having more procedures per visit, procedures scheduled in shorter intervals, and imaging or biopsy on their first visit. Given the significant improvement in timeliness to diagnosis, women with abnormal mammograms should be managed through organised assessment.

Intraoperative Margin Assessment in Wire-Localized Breast-Conserving Surgery for Invasive Cancer: A Population-Level Comparison of Techniques.

BACKGROUND: Various intraoperative margin assessment techniques have been shown to improve margin status in breast-conserving surgery (BCS) for cancer. Our study sought to evaluate multiple margin assessment techniques on a population level and determine their effects on margin status. METHODS: Patients undergoing wire-localized BCS for invasive cancer in Alberta, Canada, were assessed using a prospectively entered database of patient and tumor characteristics. Margin status was obtained from chart review. Four margin assessment techniques were studied: specimen mammography (SM), intraoperative ultrasound (US), gross assessment by pathologist (GP), and frozen section analysis (FS). Multivariable logistic regression adjusting for confounders was used to assess effect of any technique on margin status, with secondary analysis evaluating effects of individual techniques. RESULTS: Margin assessment was performed in 1165 of 1649 patients (71 %). The overall positive margin rate was 20.8 %. Adjusting for confounders, we found no difference in the odds of a positive margin with any margin assessment technique versus wire localization alone (OR 0.79, p = 0.22, 95 % CI 0.54-1.16). Individually, both GP and FS reduced the risk of a positive margin (GP-OR 0.56, p = 0.002, 95 % CI 0.39-0.81; FS-OR 0.43, p = 0.046, 95 % CI 0.19-0.98), whereas SM and US showed no effect (SM-OR 1.23, p = 0.29, 95 % CI 0.84-1.81; US-OR 1.09, p = 0.83, 95 % CI 0.50-2.37). CONCLUSIONS: Use of any margin assessment technique did not improve margin status compared to wire localization alone. Gross assessment by pathologist and frozen section analysis improved margin status compared to imaging-alone techniques. Further exploration is required to refine optimal margin assessment methods.

A population-based assessment of melanoma: Does treatment in a regional cancer center make a difference?

BACKGROUND: Regionalization of care to specialized centers has improved outcomes for several cancer types. We sought to determine if treatment in a regional cancer center (RCC) impacts guideline adherence and outcomes for patients with melanoma. METHODS: In Alberta, Canada, 561 patients with stage I-IIIC primary melanoma were diagnosed between January 2009 and December 2010. The electronic health record was used to capture demographic and pathologic data. Provincial guidelines for sentinel lymph node biopsy (SLNB) and wide local excision (WLE) are based on recommendations of several pre-existing guidelines including the National Comprehensive Cancer Network. RESULTS: 148 of 561 patients were identified as having been treated at a RCC. Median follow-up was 45 months. Patients treated at the RCC presented with higher stage melanomas. The RCC was more likely to follow guideline recommendations for performing SLNB (81.3% vs. 55.4%, P < 0.0001) but not for the extent of WLE (76.6% vs. 84.1%, P = 0.054). Overall survival was impacted by tumor thickness (HR 1.14, P < 0.0001), ulceration (HR 5.58, P < 0.0001), and mitoses (HR 0.59, P = 0.05). CONCLUSIONS: The RCC more closely followed guidelines for SLNB but not for WLE. Despite patients treated at the RCC presenting with a more advanced stage, overall survival and disease-free survival appear to not be affected by treatment center.

Improving work-up of the abnormal mammogram through organized assessment: results from the ontario breast screening program.

PURPOSE: Women with an abnormal screening mammogram should ideally undergo an organized assessment to attain a timely diagnosis. This study evaluated outcomes of women undergoing work-up after abnormal mammogram through a formal breast assessment affiliate (BAA) program with explicit care pathways compared with usual care (UC) using developed quality indicators for screening mammography programs. METHODS: Between January 1 and December 31, 2007, a total of 320,635 women underwent a screening mammogram through the Ontario Breast Screening Program (OBSP), of whom 25,543 had an abnormal result requiring further assessment. Established indicators assessing timeliness, appropriateness of follow-up, and biopsy rates were compared between women who were assessed through either a BAA or UC using χ(2) analysis. RESULTS: Work-up of the abnormal mammogram for patients screened through a BAA resulted in a greater proportion of women attaining a definitive diagnosis within the recommended time interval when a histologic diagnosis was required. In addition, use of other quality measures including specimen radiography for both core biopsies and surgical specimens and preoperative core needle biopsy was greater in BAA facilities. CONCLUSION: These findings support future efforts to increase the number of BAAs within the OBSP, because the pathways and reporting methods associated with them result in improvements in our ability to provide timely and appropriate care for women requiring work-up of an abnormal mammogram.

Acute care surgery: the impact of an acute care surgery service on assessment, flow, and disposition in the emergency department.

BACKGROUND: Acute care surgery (ACS) services are becoming increasingly popular. METHODS: Assessment, flow, and disposition of adult ACS patients (acute, nontrauma surgical conditions) through the emergency department (ED) in a large health care system (Calgary) were prospectively analyzed. RESULTS: Among 447 ACS ED consultations over 3 centers (70% admitted to ACS), the median wait time from the consultation request to ACS arrival was 36 minutes, and from ACS arrival to the admission request it was 91 minutes. The total ACS-dependent time was 127 minutes compared with 261 minutes for initial ED activities and 104 minutes for transfer to a hospital ward (P < .05). Forty percent of patients underwent computed tomography (CT) imaging (76% before consultation). The time to ACS consultation was 305 minutes when a CT scan was performed first. CONCLUSIONS: An ACS service results in rapid ED assessment of surgical emergencies. Patient waiting is dominated by the time before requesting ACS consultation and/or waiting for transfer to the ward.

Predicting in-hospital mortality in patients undergoing complex gastrointestinal surgery: determining the optimal risk adjustment method.

OBJECTIVE: To compare the performance of Charlson/Deyo, Elixhauser, Disease Staging, and All Patient Refined Diagnosis-Related Groups (APR-DRGs) algorithms for predicting in-hospital mortality after 3 types of major abdominal surgeries: gastric, hepatic, and pancreatic resections. DESIGN: Cross-sectional nationwide sample. SETTING: Nationwide Inpatient Sample from 2002 to 2007. PATIENTS: Adult patients (≥18 years) hospitalized with a primary or secondary procedure of gastric, hepatic, or pancreatic resection between 2002 and 2007. MAIN OUTCOME MEASURES: Predicting in-hospital mortality using the 4 comorbidity algorithms. Logistic regression analyses were used and C statistics were calculated to assess the performance of the indexes. Risk adjustment methods were then compared. RESULTS: In our study, we identified 46,395 gastric resections, 18,234 hepatic resections, and 15,443 pancreatic resections. Predicted in-hospital mortality rates according to the adjustment methods agreed for 43.8% to 74.6% of patients. In all types of resections, the APR-DRGs and Disease Staging algorithms predicted in-hospital mortality better than the Charlson/Deyo and Elixhauser indexes (P < .001). Compared with the Charlson/Deyo algorithm, the Elixhauser index was of higher accuracy in gastric resections (0.847 vs 0.792), hepatic resections (0.810 vs 0.757), and pancreatic resections (0.811 vs 0.741) (P < .001 for all comparisons). Higher accuracy of the Elixhauser algorithm compared with the Charlson/Deyo algorithm was not affected by diagnosis rank, multiple surgeries, or exclusion of transplant patients. CONCLUSIONS: Different comorbidity algorithms were validated in the surgical setting. The Disease Staging and APR-DRGs algorithms were highly accurate. For commonly used algorithms such as Charlson/Deyo and Elixhauser, the latter showed higher accuracy.

The evolution of lymph node assessment in breast cancer.

Lymph node evaluation remains integral in the management of breast cancer for prognostic and therapeutic purposes. The introduction of sentinel lymph node biopsy has revolutionized axillary surgery, presenting new challenges relating to clinical implications and quality which will be reviewed in this article.