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Larson, David W.

https://orcid.org/0000-0001-9177-4586

Mayo Clinic

Mayo Clinic

Citations 117

Phase II study of neoadjuvant short-course radiotherapy combined with CAPEOX plus envafolimab in patients with microsatellite stable locally advanced rectal cancer: Updated results of PRECAM study.
Zhang, Feixiang , Shi, Liming , Wang, Yunfei , Shen, Yanbin , Xu, Lingna , Hu, Peng , Tang, Wen, Xu, Dengyong, Shan, Lina , Jia, Xiya, Chen, Yiyi , Wang, Da , Lao, Weifeng , Sun, Xiaonan , Dai, Sheng , Wang, Fei , Lv, Yiming , Hu, Peng, Larson, David W. , Gu, Hongcang , Huang, Xuefeng

Journal of Clinical Oncology | June 17, 2024 | Volume: 42 | Issue: 16_suppl | Pages: 3614-3614

10.1200/jco.2024.42.16_suppl.3614 Get It

3614 Background: Conventional neoadjuvant chemoradiotherapy (nCRT) yields a pathologic complete response (pCR) rate of about 15%–- 30% for locally advanced rectal cancer (LARC). This PRECAM study aimed to investigate the efficacy and safety of neoadjuvant short-course radiotherapy combined with CAPEOX plus Envafolimab in Patients with Microsatellite Stable (MSS) LARC, redefining the standard of care (SOC) for LARC. Methods: The study is an open-label, prospective, single-arm, phase II clinical study . Eligible patients with MSS LARC were consecutively enrolled. Participants received short-course radiotherapy (25Gy/5f) with subsequent two cycles of CAPEOX (capecitabine and oxaliplatin) and 6 cycles of Envafolimab (subcutaneous injection, 150 mg, QW ) followed by total mesorectal excision surgery. The primary endpoint was pathological complete response (pCR) rate, and the secondary endpoint was major pathologic (MPR) rate and safety. Results: From April to December 2022, 34 patients were enrolled, of whom 32 completed the study. Remarkably, The pCR rate was62.5% (20/32), and the (MPR) rate was 75% (24/32). Furthermore, 65.6% (21/32) patients achieved a neoadjuvant rectal (NAR) score below 8, suggesting an effective treatment response. Common adverse events included tenesmus (78.1%), diarrhea (62.5%), and leukocyte decrease (40.6%), with two cases of Grade 3 adverse events. Surgical procedures were performed in all 32 cases, with minor complications observed. During the follow-up period of up to 20 months, no recurrence or death were reported. Conclusions: Short-course radiotherapy combined with CAPEOX plus Envafolimab showed favorable pCR rate with manageable adverse effects and surgical complications in LARC, underscoring the potential of the combination therapy for MSS LARC. A Randomized controlled trial is warranted for further exploration and validation. Clinical trial information: NCT05216653 .
A Method for Continuous Surgeon Improvement in Rectal Cancer
Violante, Tommaso , Merchea, Amit , Dozois, Eric J. , Dozois, Eric, Violante, Tommaso , Ferrari, Davide , Vierkant, Robert A. , Larson, David W.

Annals of Surgery | May 6, 2024 | Volume: 282 | Issue: 2 | Pages: 304-310

10.1097/sla.0000000000006330 Get It

Objective: To develop and analyze a risk-adjusted cumulative sum (RA-CUSUM) chart as a potential method to monitor individual surgeon performance in robotic total mesorectal excision (TME) for rectal cancer. Background: Currently, surgeons lack real-time tools to monitor and enhance their performance beyond residency completion. While national quality programs exist, granular, individual-level data are crucial for continuous improvement. Previous studies suggest cumulative sum charts hold promise in identifying performance trends and outliers. Methods: This retrospective study analyzed data from 640 robotic TME cases performed by 12 surgeons at 2 institutions. RA-CUSUM charts were generated for 3 outcomes: (1) complications, (2) operative time, and (3) length of stay. Results: The overall RA-CUSUM curves for operative time and complications showed an initial learning phase, followed by a plateau or downward slope, indicating proficiency or improvement. However, individual surgeon curves revealed significant heterogeneity. Three surgeons consistently excelled in operative time, while 5 minimized complications most effectively. Potential quality improvement could be implemented to drive performance toward positive outliers. No differences were found in unadjusted outcomes, including conversion, number of lymph nodes harvested, and positive circumferential margins. Conclusions: The RA-CUSUM chart is a promising method for identifying individual surgeon performance in robotic TME. It could help surgeons, teams, and leaders identify improvement areas and benchmark themselves against positive outliers. Further studies are needed to explore the potential of RA-CUSUM for implementing interventions to improve surgical quality.
Rate of undetected dysplasia at colectomy in patients with IBD – What are we missing at colonoscopy?
Centorrino, E, Ferrari, Davide , Larson, David W. , Coelho–Prabhu, Nayantara

Endoscopy | April 23, 2024 | Volume: 56 | Issue: S 02 | Pages: S77-S77

10.1055/s-0044-1782855 Get It

Same-day Ileostomy Closure Discharge Reduces Costs Without Compromising Outcomes
Violante, Tommaso , Merchea, Amit , Stocchi, Luca , Moriarty, James P. , Violante, Tommaso , Ferrari, Davide , Borah, Bijan J. , Larson, David W.

Annals of Surgery | March 28, 2024 | Volume: 280 | Issue: 6 | Pages: 973-978

10.1097/sla.0000000000006285 Get It

Objective: This study aims to assess the costs of a same-day discharge (SDD) enhanced recovery pathway for diverting loop ileostomy (DLI) closure compared with a standard institutional enhanced recovery protocol. Background: Every year, 50,155 patients in the United States undergo temporary stoma reversal. While ambulatory stoma closure has shown promise, widespread adoption remains slow. This study builds on previous research, focusing on the costs of a novel SDD protocol introduced in 2020. Methods: A retrospective case-control study was conducted at Mayo Clinic, Rochester, Minnesota, and Mayo Clinic, Jacksonville, Florida, comparing patients undergoing SDD DLI closure from August 2020 to February 2023 to those in a matched cohort receiving standard inpatient enhanced recovery protocol. Patients were matched based on age, sex, american society of anesthesiologists score, surgery period, and hospital. Primary outcomes included direct hospitalization and additional costs in the 30 days postdischarge. Results: The SDD group (n = 118) demonstrated a significant reduction in median index episode hospitalization and 30-day postoperative costs compared with the inpatient group (n = 236), with savings of $4827 per patient. Complication rates were similar, and so were readmission and reoperation rates. Conclusions: Implementation of the SDD for DLI closure is associated with substantial cost savings without compromising patient outcomes. The study advocates for a shift towards SDD protocols, offering economic benefits and potential improvements in health care resource utilization.
Unveiling the Hidden Consequences: Initial Impact of COVID-19 on Colorectal Cancer Operation
Violante, Tommaso , Day, Courtney N. , Mathis, Kellie L. , Dozois, Eric J. , Violante, Tommaso , Ferrari, Davide , McKenna, Nicholas P. , Larson, David W.

Journal of the American College of Surgeons | March 25, 2024 | Volume: 239 | Issue: 2 | Pages: 85-97

10.1097/xcs.0000000000001042 Get It

BACKGROUND: The COVID-19 pandemic has severely affected healthcare systems globally, resulting in significant delays and challenges in various medical treatments, particularly in cancer care. This study aims to investigate the repercussions of the pandemic on surgical interventions for colorectal cancer (CRC) in the US, using data from the National Cancer Database. STUDY DESIGN: We conducted a retrospective analysis of the National Cancer Database, encompassing adult patients who underwent surgical procedures for colon and rectal cancer in 2019 (pre-COVID) and 2020 (COVID). We examined various demographic and clinical variables, including patient characteristics, tumor staging, surgical approaches, and socioeconomic factors. RESULTS: The analysis included 105,517 patients, revealing a 17.3% reduction in surgical cases during the initial year of the pandemic. Patients who underwent surgery in 2020 displayed more advanced clinical and pathological tumor stages compared to those treated in 2019. After diagnosis, no delay was reported in the treatment. Patients operated during the pandemic, Black patients, uninsured, and Medicaid beneficiaries had worse stage colon and rectal cancer, and individuals with lower incomes bore the burden of advanced colon cancer. CONCLUSIONS: The impact of the COVID-19 pandemic on CRC surgery transcends a mere decline in case numbers, resulting in a higher prevalence of patients with advanced disease. This study underscores the exacerbated disparities in cancer care, particularly affecting vulnerable populations. The COVID-19 pandemic has left a significant and enduring imprint on CRC surgery, intensifying the challenges faced by patients and healthcare systems. Comprehensive studies are imperative to comprehend the long-term consequences of delayed screenings, diagnoses, and treatments as healthcare planning for the future must consider the unintended repercussions of pandemic-related disruptions.
Perioperative Fluid Management in Colorectal Surgery: Institutional Approach to Standardized Practice
Deslarzes, Philip , Jurt, Jonas, Blanc, Catherine , Hübner, Martin , Grass, Fabian , Hübner, Martin , Grass, F , Larson, David W.

Journal of Clinical Medicine | January 30, 2024 | Volume: 13 | Issue: 3 | Pages: 801

10.3390/jcm13030801 Get It

The present review discusses restrictive perioperative fluid protocols within enhanced recovery after surgery (ERAS) pathways. Standardized definitions of a restrictive or liberal fluid regimen are lacking since they depend on conflicting evidence, institutional protocols, and personal preferences. Challenges related to restrictive fluid protocols are related to proper patient selection within standardized ERAS protocols. On the other hand, invasive goal-directed fluid therapy (GDFT) is reserved for more challenging disease presentations and polymorbid and frail patients. While the perfusion rate (mL/kg/h) appears less predictive for postoperative outcomes, the authors identified critical thresholds related to total intravenous fluids and weight gain. These thresholds are discussed within the available evidence. The authors aim to introduce their institutional approach to standardized practice.
P1126 Navigating the Future: Minimally Invasive Surgery Trends in Ulcerative Colitis
Violante, Tommaso , Novelli, Marco , Violante, Tommaso , Ferrari, Davide , Larson, David W.

Journal of Crohn's and Colitis | January 24, 2024 | Volume: 18 | Issue: Supplement_1 | Pages: i2006-i2006

10.1093/ecco-jcc/jjad212.1256 Get It

Abstract Background Minimally invasive surgery (MIS) has been associated with lower rates of postoperative complications in ulcerative colitis (UC), both in the elective and emergency setting, compared to the traditional open approach. Despite these findings, some clinical guidelines state that minimally invasive surgery is not superior to open surgery in UC and emphasize an individual approach based on the surgeon’s judgment. This study analyzed the trends in open and minimally invasive approaches in total colectomies for UC. Methods A retrospective analysis was conducted on the ACS-NSQIP database encompassing all patients undergoing total colectomy for UC from 2012 to 2021. The primary endpoint involved analyzing open, laparoscopic, hand-assisted, and robotic surgery trends. A time series analysis was performed to forecast the future direction of these surgical techniques. Quarter (Q) and admission year were reported for time trend analysis. Dynamic relationships between various time series representing different surgical techniques were modeled using Vector Autoregressive (VAR) models. These models were employed to predict future trends in operative approaches until Q2 of 2025, along with 95% confidence intervals. Results A total of 7099 patients (44.5% female) were included, with a mean age of 45.1 (±17.8) years and mean BMI of 25.5 (±7.7) kg/m². Smoking was reported in only 8.7% of patients, with 49.1% classified as ASA 3 and 41.4% as ASA 2. Most patients (71.5%) were on steroids or immunosuppressants at the time of intervention. At the beginning of the study period, nearly half of the interventions were performed with an open approach (45.2%), followed by laparoscopy (35.7%) and hand-assisted laparoscopy (19%). Trends indicated a decline in open surgery to 17.7% by Q2 of 2021, with an increase in laparoscopic (45%), hand-assisted (25%), and a consistent growth of robotic surgery to 12.3%. Forecasting shown in Figure 1 suggested a continuous decrease in open surgery until Q2 of 2025 (8.7%, 95% CI 0-32.5%), with laparoscopic (51.2%, 95% CI 26.4-75.9%), hand-assisted (29.1%, 95% CI 11.9-46.3%), and robotic (11.0%, 95% CI 7.5-14.6%) approaches on the rise. Conclusion Minimally invasive surgical techniques have steadily grown over the past decade in the treatment of ulcerative colitis. Predictions indicate continued growth, displacing traditional open approach, which may persist as a rescue procedure.
P1104 Shifting Surgical Landscape in Crohn's Colitis: Laparoscopic Supremacy and Robotic Upsurge
Violante, Tommaso , Novelli, Marco , Violante, Tommaso , Ferrari, Davide , Larson, David W.

Journal of Crohn's and Colitis | January 24, 2024 | Volume: 18 | Issue: Supplement_1 | Pages: i1971-i1972

10.1093/ecco-jcc/jjad212.1234 Get It

Abstract Background Crohn's disease (CD) is a chronic inflammatory bowel disorder that can cause transmural inflammation throughout the digestive tract. When CD affects the colon, it is known as Crohn's colitis (CC), a serious condition often requiring surgical resection. Surgical trends in CC have changed significantly over the past decade, shifting towards minimally invasive surgery, with laparoscopic and robotic procedures becoming increasingly common. This study examines how surgical trends in CC have changed in recent years and predicts how they may change. Methods We conducted a retrospective analysis using the ACS-NSQIP database, focusing on patients who underwent colonic resections for CC between 2012 and 2021, including 20,109 patients. Our main goal was to examine trends in open, laparoscopic, hand-assisted, and robotic surgery. We utilized time series analysis, specifically quarter and year of admission data, and employed Vector Autoregressive (VAR) models to explore the dynamic relationships among these surgical techniques. To analyze the time trends, we reported the quarter (Q) and year of admission. These models enabled us to forecast future trends, accompanied by 95% confidence intervals, extending our predictions up until Q2 of 2025. Results As shown in Figure 1, open surgery has been the most common approach to CC since Q1 2012, accounting for 52.3% of all procedures. Laparoscopic surgery was the next most common approach, at 33.3%, followed by hand-assisted laparoscopy at 14.4%. Laparoscopy rapidly expressed market supremacy, by steadily becoming the most widespread approach by Q2 of 2017, representing 42.2% of CC surgery and peaking in Q2 2020 at 43.5%. This growth in laparoscopy came at the expense of open surgery, which experienced a significant decline, reaching its lowest point of 28.5% in Q2 2021. Hand-assisted procedures gradually increased in popularity over the years but remained less popular than open and laparoscopic methods, peaking at 24.0% in Q4 2019. Robotic procedures experienced slow but steady growth, from 1.9% in Q1 2013 to 10% in Q2 2021. Future trends suggest that laparoscopy will continue to grow steadily, reaching 45% (95% CI 28.2-61.7%) by the end of our prediction period. Robotic surgery is poised to significantly shift CC surgery trends, with resections expected to reach 12.6% (95% CI 9.3-15.8%) by Q2 2025, while a subsequent decline in open procedures to 20.8% (95% CI 0-43%). Conclusion Laparoscopic surgery has emerged as the favored surgical approach in CC and is expected to maintain its supremacy into the near future. Open colonic resections are anticipated to decline, making way for the increasing prevalence of robotic surgery.
Preoperative lateral lymph node features and impact on local recurrence after neoadjuvant chemoradiotherapy and total mesorectal excision for locally advanced rectal cancer: results from a multicentre international cohort study
Achilli, Pietro , Ferrari, Davide , Calini, Giacomo , Bertoglio, Camillo Leonardo , Magistro, Carmelo , Origi, Matteo , Carnevali, Pietro , Alampi, Bruno , Giusti, Irene , Calafiore, Eleonora , Spinelli, Antonino , Deslarzes, Philip , Bertoglio, Camillo L , Alampi, Bruno D , Ferrari, Giovanni , Calafiore, Eleonora , Spinelli, Antonino , Grass, F , Deslarzes, Philip , Hahnloser, Dieter , Solafah, A , Larson, David W , Achilli, P , Calini, G , Origi, Matteo , Grass, Fabian , Hahnloser, Dieter , Larson, David W.

Colorectal Disease | January 20, 2024 | Volume: 26 | Issue: 3 | Pages: 466-475

10.1111/codi.16875 Get It

AbstractAimLocally advanced rectal cancer (LARC) is commonly treated with neoadjuvant chemoradiotherapy (nCRT) and total mesorectal excision (TME) to reduce local recurrence (LR) and improve survival. However, LR, particularly associated with lateral lymph node (LLN) involvement, remains a concern. The aim of this study was to investigate preoperative factors associated with LLN involvement and their impact on LR rates in LARC patients undergoing nCRT and curative surgery.MethodThis multicentre retrospective study, including four academic high‐volume institutions, involved 301 consecutive adult LARC patients treated with nCRT and curative surgery between January 2014 and December 2019 who did not undergo lateral lymph node dissection (LLND). Baseline and restaging pelvic MRIs were evaluated for suspicious LLNs based on institutional criteria. Patients were divided into two groups: cLLN+ (positive nodes) and cLLN– (no suspicious nodes). Primary outcome measures were LR and lateral local recurrence (LLR) rates at 3 years.ResultsAmong the cohort, 15.9% had suspicious LLNs on baseline MRI, and 9.3% had abnormal LLNs on restaging MRI. At 3 years, LR and LLR rates were 4.0% and 1.0%, respectively. Ten out of 12 (83.3%) patients with LR showed no suspicious LLNs at the baseline MRI. Abnormal LLNs on MRI were not independent risk factors for LR, distant recurrence or disease‐free survival.ConclusionAbnormal LLNs on baseline and restaging MRI assessment did not impact LR and LLR rates in this cohort of patients with LARC submitted to nCRT and curative TME surgery.
How I do it: a standardized approach to robotic‐assisted oncological sigmoid resection – a video vignette
Giron, Héloïse, Kefleyesus, Amaniel , Grass, F , Larson, David W. , Grass, Fabian

Colorectal Disease | January 19, 2024 | Volume: 26 | Issue: 3 | Pages: 578-579

10.1111/codi.16881 Get It