Temporary vs. permanent stoma: factors associated with the development of complications and costs for rectal cancer patients.

OBJECTIVE: To compare in-hospital complication rates and treatment costs between rectal cancer patients receiving permanent and temporary stomas. Surgical complications and costs associated with permanent stoma formation are still poorly understood. While choosing between the two stoma options is usually based on clinical and technical factors, disparities exist. METHODS: Patients with rectal cancer, stoma formation, complications, and cost of care were identified from the Florida Agency for Health Care Administration Discharge Database. Rectal cancer patients who underwent elective surgery and received a permanent or temporary stoma were identified using ICD-10 codes. Patients who underwent colostomy with resection were included in the "Permanent stoma" group, and those who underwent "resection with ileostomy" were included in the "temporary stoma" group. Multivariable models compared patients receiving temporary vs. permanent stomas. RESULTS: Regression models revealed no difference in the odds of having a complication between patients who obtained permanent versus temporary stoma (OR 0.96, 95% CI: 0.70-1.32). Further, after adjusting for the number of surgeries, demographic variables, socioeconomic and regional factors, comorbidities, and type of surgery, there was a significant difference between permanent and temporary stomas for rectal cancer (ß - 0.05, p = 0.03) in the log cost of creating a permanent stoma. CONCLUSION: Our findings suggest there are no differences associated with complications, and reduced cost for permanent compared to temporary stomas. Increased costs are also associated with receiving minimally invasive surgery. As a result, disparities associated with receipt of MIS could ultimately influence the type of stoma received.

Prognostic Significance of Complete Pathologic Response Obtained with Chemotherapy Versus Chemoradiotherapy in Gastric Cancer.

BACKGROUND: Few studies have compared the survival advantage of complete pathologic response (cPR) achieved through neoadjuvant chemotherapy (nCT) versus neoadjuvant chemoradiotherapy (nCRT) in gastric adenocarcinoma. Our study utilizes a large national cancer database to address this question. PATIENTS AND METHODS: This is a retrospective review of patients with clinical stage I to III gastric adenocarcinoma from 2004 to 2013 who received nCT or nCRT. Patients who achieved cPR were selected. Associations were evaluated using Mann-Whitney U and Fisher's exact tests. Survival information was summarized using standard Kaplan-Meier methods, where estimates of the median and 5-year survival rates were estimated with 95% confidence intervals. RESULTS: A total of 413 patients who had cPR were identified. Eighty-four patients received nCT and 329 patients received nCRT. Patients in the nCRT group had higher clinical stage (88.4% vs. 75.0%) and more proximal location of tumors (95.4% vs. 45.2%). The nCT group (n = 84) had a 94% 5-year survival rate, while the nCRT group's (n = 329) rate was 60% (p < 0.001). On Cox regression modeling using a propensity-weighted approach, nCT treatment was an independent predictor of improved overall survival (nCRT vs. nCT; HR 10.44, p < 0.001). CONCLUSIONS: The use of nCT leads to a significant increase in overall survival in patients when compared with nCRT for those who achieved cPR in gastric adenocarcinoma. While this study is limited in identifying the cause for this difference in overall survival, this important finding nonetheless requires further investigation and should be considered in the development of future gastric cancer trials.

Influence of surgeon specialty and volume on the utilization of minimally invasive surgery and outcomes for colorectal cancer: a retrospective review.

BACKGROUND: Utilization of minimally invasive surgery (MIS) has multiple determinants, one being the specialization of the surgeon. The purpose of this study was to assess the differences in the utilization of MIS, associated length of stay (LOS), and complications for colorectal cancer between colorectal (CRS) and general surgeons (GS). Previous studies have documented the influence of surgical volume and surgeon specialty on clinical outcomes and patient survival following colorectal cancer surgery. It is unclear whether there are differences in the utilization of MIS for colorectal cancer based on surgeon's specialization and how this influences clinical outcomes. METHODS: Using the 2013-2015 Florida Inpatient Discharge Dataset and the National Plan & Provider Enumeration System, colorectal cancer patients experiencing a colorectal surgery were identified as well as the operating physician's specialty. Mixed-effects regression models were used to identify associations between the use of MIS, complications during the hospital stay, and patient LOS with patient, physician, and hospital characteristics. RESULTS: There is no difference in the use of MIS, complication, nor LOS between GS and CRS for colorectal cancer surgery. However, physician volume was associated with increased use of MIS (OR 1.26, 95% CI 1.09, 1.46) and MIS was associated with decreases in certain complications as well as reductions in LOS overall (ß = - 0.16, p < 0.001) and for each specialty (GS: ß = - 0.18, p < 0.001; CRS ß = - 0.12, p < 0.001) CONCLUSIONS: Despite the higher amount of proctectomies performed by CRS, no difference in MIS utilization, complication rate, or LOS was found for colorectal cancer patients based on surgeon specialty. While there are some differences in clinical outcomes attributable to specialized training, results from this study indicate that differences in surgical approach (MIS vs. Open), as well as the patient populations encountered by these two specialties, are key factors in the outcomes observed.

Permanent stoma: a quality outcome in treatment of rectal cancer and its impact on length of stay.

BACKGROUND: This study aimed to identify socioeconomic predictors of permanent stoma in rectal cancer treatment and examine its association with length of stay at the treatment facility. METHODS: Rectal cancer patients who underwent elective surgery between January 2015 and December 2018 were identified from the Agency for Health Care Administration Florida Hospital Inpatient Discharge Dataset. Multivariate regression models were utilized to identify demographic and socioeconomic factors associated with receiving a permanent stoma as well as the associated length of stay of these patients. RESULTS: Of 2630 rectal cancer patients who underwent surgery for rectal cancer, 21% had a permanent stoma. The odds of receiving permanent stoma increased with higher Elixhauser score, metastatic disease, advanced age, having open surgery, residence in Southwest Florida, and having Medicaid insurance or no insurance/self-payers (p < 0.05). Patients with a permanent stoma had a significantly extended stay after surgery (p < 0.001). CONCLUSIONS: Patients with a permanent stoma following cancer resection were more likely to have open surgery, had more comorbidities, and had a longer length of stay. Having permanent stoma was higher in patients living in South West Florida, patients with Medicaid insurance, and in the uninsured. Additionally, the payer type significantly affected the length of stay.

Completion lymph node dissection in patients with sentinel lymph node positive cutaneous head and neck melanoma.

BACKGROUND: Relatively few cutaneous head and neck melanoma (CHNM) patients with were included in the multicenter selective lymphadenectomy trial II (MSLT-II). Our objective was to investigate whether immediate completion lymph node dissection completion of lymph node dissection (CLND) was associated with survival benefit for sentinel lymph node (SLN) positive CHNM using the National Cancer Database. METHODS: SLN positive patients with CHNM from 2012 to 2014 were retrospectively analyzed. Patients were divided into two groups: those who underwent SLN biopsy (SLNB) only versus those who underwent SLNB followed by CLND (SLNB + CLND). The primary outcome was 5-year overall survival (OS). RESULTS: Among 530 SLNB + patients, 342 patients underwent SLNB followed by CLND (SLNB + CLND). The SLNB only group had fewer positive SLN, less advanced pathologic stage, and a lower rate of adjuvant immunotherapy. There was no significant difference in 5-year OS between the two groups (51.0% vs 67%; P = .56). After adjusting for pathologic stage, there remained no difference in 5-year OS among patients with stage IIIA (63.0% vs. 73.6%, P = 0.22) or IIIB/IIIC disease (39.1% vs 57.8%; P = .52). Conclusions Using a large nationwide database, CLND was not shown to be associated with improved OS for patients with SLNB positive CHNM, validating the results of MSLT-II.

Trends in utilization of sentinel node biopsy and adjuvant radiation in women ≥ 70.

BACKGROUND AND OBJECTIVES: Omission of routine axillary staging and adjuvant radiation (XRT) in women ≥ 70 years old with early stage, hormone receptor-positive, clinically node-negative breast cancer has been endorsed based on several landmark studies. We sought to determine how much omission of axillary staging/XRT has been adopted. METHODS: Using the National Cancer Data Base, we selected malignant breast cancer cases in women ≥ 70 with ER + tumors, ≤2 cm with clinically negative lymph nodes who underwent breast conservation and had known XRT status in 2005-2015. The use of sentinel lymph node biopsy (SNB) and XRT status was summarized by year to determine trends over time. RESULTS: In total, 57 230/69 982 patients underwent SNB. Of the 12 752 patients in whom SNB was omitted, 6296 were treated at comprehensive community cancer programs. Regarding XRT, 33 891/70 114 received adjuvant XRT. There were no significant trends with regards to patients receiving SNB or those receiving XRT. CONCLUSION: Since 2005, there has been no change in SNB or XRT for early stage ER + breast tumors. However, there was a difference in omission of SNB based on facility type and setting. Future monitoring is needed to determine if these trends persist following the recently released Choosing Wisely® recommendations.

ERAS protocol validation in a propensity-matched cohort of patients undergoing colorectal surgery.

PURPOSE: Enhanced recovery after surgery (ERAS) provides many benefits. However, important knowledge gaps with respect to specific components of enhanced recovery after surgery remain because of limited validation data. The aim of the study was to validate a mature ERAS protocol at a different hospital and in a similar population of patients. METHODS: This is a retrospective analysis of patients undergoing elective colorectal surgery from 2009 through 2016. Patients enrolled in ERAS are compared with those undergoing the standard of care. Patient demographic characteristics, length of stay, pain scores, and perioperative morbidity are described. RESULTS: Patients (1396) were propensity matched into two equal groups (ERAS vs non-ERAS). No significant difference was observed for age, Charlson Comorbidity Index, American Society of Anesthesiologists score, body mass index, sex, operative approach, and surgery duration. Median length of stay in ERAS and non-ERAS groups was 3 and 5 days (P < .001). Mean pain scores were lower in the ERAS group, measured at discharge from the postanesthesia unit (P < .001), on postoperative day 1 (P = .002) and postoperative day 2 (P = .02) but were identical on discharge. CONCLUSIONS: This ERAS protocol was validated in a similar patient population but at a different hospital. ERAS implementation was associated with an improved length of stay and pain scores similar to the original study. Different than most retrospective studies, propensity score matching ensured that groups were evenly matched. To our knowledge, this study is the only ERAS validation study in a propensity-matched cohort of patients undergoing elective colorectal surgery.

Handheld metal detector versus conventional chest and abdominal plain radiography in children with suspected metallic foreign body ingestion: can we safely abandon X-rays?

BACKGROUND: Ingestion of metallic foreign bodies (MFBs) is a frequent occurrence in children and is commonly diagnosed via X-rays. In recent years, the handheld metal detector (HMD) has been increasingly adopted by several pediatric hospitals as it is considered an effective and accurate diagnostic tool that avoids exposure to ionizing radiations. Sensitivity of HMD has been reported high (99.4%) in case of coin ingestion, but significantly lower (46%) when considering the ingestion of other types of MFBs. METHODS: We tested the effectiveness of the HMD in diagnosing ingested MFBs in children less than 14 years of age, in our Pediatric Emergency Department (PED). We prospectively evaluated all cases of MFBs ingestion that presented at the PED of our hospital from March 2015 to July 2017. RESULTS: Ninety-eight patients were included. The overall sensitivity was 63.2% (79.5% for coins, 25.5% for batteries and 56% for other objects) while the specificity was 95%. The HMD could have replaced the X-ray examination only if a MFB was detected below the xyphoid process. CONCLUSIONS: Based on our findings, a negative result of HMD is not sufficient to exclude an ingestion of MFBs. Therefore, in case of an evocative history and depending on type and size of the foreign body, a radiological investigation is still necessary.

Geographic and Demographic Disparities in Colorectal Cancer: A National Cancer Database Analysis.

BACKGROUND AND OBJECTIVES: Area of residence may adversely affect survival and outcomes in many cancers. The objective of this study was to evaluate the impact of geographical and demographic disparities on survival of patients with colorectal cancer. MATERIALS AND METHODS: Data were obtained from the National Cancer Database (NCDB) colon, rectosigmoid, and rectal datasets. Patients were categorized by area of residence, namely, metropolitan (MA), urban (UA), or rural (RA). Sociodemographic and tumor-related data were collected and analyzed to evaluate variables affecting overall survival (OS). RESULTS: In total, 973,139 patients between 2004 and 2013 were included in the study, of which 83%, 15%, and 2% were MA, UA, and RA residents, respectively. RA and UA patients were mostly white male with low income and no comorbidities. In univariate analysis, OS was worse for RA (hazard ratio [HR] 1.10) and UA (HR 1.06) colorectal cancer patients than that for MA colorectal cancer patients. In multivariate analysis revealed significant association between OS and geographic residence, with worse OS for RA (HR 1.02, p = 0.04) and UA (HR 1.01, p = 0.003) patients. Black (HR 1.14) and Native American (HR 1.17) patients had worse outcomes, while Asians (HR 0.8), women (HR 0.88), and patients with higher income had improved OS (HR 0.88). CONCLUSION: The differences in the OS for RA and UA patients with colorectal cancer were significantly driven by economic disparity. Area of residence represents an important factor independently limiting access to care, particularly in geographically isolated individuals.

Hospital robotic use for colorectal cancer care.

The use of robotic surgery for colorectal cancer continues to increase. However, not all organizations offer patients the option of robotic intervention. This study seeks to understand organizational characteristics associated with the utilization of robotic surgery for colorectal cancer. We conducted a retrospective study of hospitals identified in the United States, State of Florida Inpatient Discharge Dataset, and linked data for those hospitals with the American Hospital Association Survey, Area Health Resource File and the Health Community Health Assessment Resource Tool Set. The study population included all robotic surgeries for colorectal cancer patients in 159 hospitals from 2013 to 2015. Logistic regressions identifying organizational, community, and combined community and organizational variables were utilized to determine associations. Results indicate that neither hospital competition nor disease burden in the community was associated with increased odds of robotic surgery use. However, per capita income (OR 1.07 95% CI 1.02, 1.12), average total margin (OR 1.01, 95% CI 1.001, 1.02) and large-sized hospitals compared to small hospitals (OR: 5.26, 95% CI 1.13, 24.44) were associated with increased odds of robotic use. This study found that market conditions within the U.S. State of Florida are not primary drivers of hospital use of robotic surgery. The ability for the population to pay for such services, and the hospital resources available to absorb the expense of purchasing the required equipment, appear to be more influential.

Prognostic models for stage I-III esophageal cancer: a comparison between existing calculators.

BACKGROUND: Determining the best approach for esophageal cancer and predicting accurate prognosis are critical. Multiple studies evaluated characteristics associated with overall survival, and several prediction models have been developed. This study aimed to evaluate existing models and perform external validation of selected models. METHODS: A retrospective investigation of a multi-site institutional enterprise for patients with a diagnosis of esophageal cancer between 2013-2014 was performed. Selected survival prediction models included the Roswell Park Comprehensive Cancer Center (RPCCC) calculator, Oregon Health & Science University (OHSU) calculator, and two nomograms published by Shapiro et al. and Sun et al. One-year overall survival, level of agreement, and performance for each model were evaluated. RESULTS: A total of 104 patients were included and used to assess the prediction models. One-year overall survival was 0.76. Different calculators tended to rank patients similarly; however, they did not agree on predicted overall survival. The least disparity in correlation was observed between OHSU and Shapiro calculators. Shapiro's model achieved the highest performance [area under the curve (AUC) =0.63]. CONCLUSIONS: Selected models showed fair results in estimating individual overall survival, although none achieved a high performance. While these tools may support the decision-making process for esophageal cancer patients, their implementation in clinical practice requires improved refinement to optimize their clinical utility.

Gastric Cancer Disparities Among Asian American Subpopulations.

BACKGROUND/AIM: Asian Americans (AA) are one of the largest and fastest growing minority groups in the United States consisting of 18 million people. This population is an ethnically diverse group that tends to be classified as one cohort resulting in hidden survival disparities among AA subgroups. PATIENTS AND METHODS: The National Cancer Data Base was queried for patients of Korean, Japanese or Filipino ancestry with gastric adenocarcinoma or esophageal adenocarcinoma between 2004 and 2013. RESULTS: A total of 28,213 patients met the inclusion criteria: 1,542 with gastric adenocarcinoma and 26,671 with esophageal adenocarcinoma. The Korean group with gastric cancer (0.42) showed improved 5-year survival over the Japanese (0.31) and Filipino (0.21; p<0.001) groups. CONCLUSION: A significant difference in survival exists among AA subgroups signifying a need to acknowledge the heterogeneity of AA in future studies. Thus, individual-specific medicine with respect to race-related outcomes is extremely important.

Age-Based Trends of Gastric Adenocarcinoma in the United States.

BACKGROUND: Recent studies have shown an increase in the incidence of gastric cancer (GC) among young adults in Asia and Latin America. However, it is unknown if a similar trend is happening in the United States. METHODS: A retrospective review of the National Cancer Database was conducted to identify patients diagnosed with gastric adenocarcinoma between the years of 2004 and 2013. RESULTS: A total of 93 734 patients were included. The two age groups below 40 did not see a change in GC incidence; however, age groups above 40 had increasing incidence. Patients aged 18 to 25 had the largest proportion of stage 4 disease and a poor survival (median 11.5 months), compared to older patients. CONCLUSION: Despite the increasing trend of GC among individuals, the incidence of GC among young adults is not increasing. However, this subpopulation presents at more advanced stages (clinical stage 4) and thus has worse survival.

Age-Based Trends of Gastric Adenocarcinoma in the United States.

BACKGROUND: Recent studies have shown an increase in the incidence of gastric cancer (GC) among young adults in Asia and Latin America. However, it is unknown if a similar trend is happening in the United States (US). METHODS: A retrospective review of the National Cancer Data Base was conducted to identify patients diagnosed with gastric adenocarcinoma between the years of 2004 and 2013. RESULTS: A total of 93 734 patients were included. The 2 age groups below 40 did not see a change in GC incidence; however, age groups above 40 had increasing incidence. Patients aged 18-25 had the largest proportion of stage 4 disease and a poor survival (median 11.5 months), compared to older patients. CONCLUSION: Despite the increasing trend of GC among individuals, the incidence of GC among young adults is not increasing. However, this subpopulation presents at more advanced stages (clinical stage 4) and thus has worse survival.

Racial Disparities in Outcomes Among Asians With Gastric Cancer in the USA.

BACKGROUND/AIM: We aimed to evaluate disparities in presentation and treatment of gastric cancer (GC), including time between diagnosis and treatment, based on race, focusing on Japanese patients within the USA. PATIENTS AND METHODS: The National Cancer Database was queried for patients diagnosed with GC between 2004-2013. Clinical and treatment variables were summarized by race (White, non-Japanese Asian, Japanese). The association between race and overall survival (OS) was evaluated using the log-rank test. RESULTS: A total of 79,481 patients were included. Japanese patients received surgery the earliest after diagnosis in all stages. Regarding radiotherapy, white patients had the shortest waiting time followed by Asian and Japanese patients. Asian patients had better OS at both 3 and 5 years of follow-up. White patients were associated with the lowest OS. CONCLUSION: Japanese and Asian GC patients have better OS compared to White patients. Moreover, there were disparities in time to both GC diagnosis and treatment, with Japanese patients being sooner diagnosed and surgically treated, which may ultimately impact patient experience.

Disparities influencing rates of urgent/emergent surgery for diverticulitis in the state of Florida.

BACKGROUND: Patients with diverticulitis have a 20% risk of requiring urgent/emergent treatment. Since morbidity and mortality rates differ between elective and urgent/emergent care, understanding associated disparities is critical. We compared factors associated with treatment setting for diverticulitis and evaluated disparities regarding access to Minimally Invasive Surgery (MIS) and development of complications. METHODS: The Florida Inpatient Discharge Dataset was queried for patients diagnosed with diverticulitis. Three multivariate models were utilized: 1) elective vs urgent/emergent surgery, 2) MIS vs open and 3) presence of complications. RESULTS: The analysis included 12,654 patients. Factors associated with increased odds of urgent/emergent care included being uninsured or covered by Medicaid, African American, obese, or more comorbid. MIS was associated with reduced odds of complications. Patients treated by high-volume or colorectal surgeons had increased odds of receiving MIS. CONCLUSIONS: Patients were more likely to receive MIS if they were treated by a colorectal surgeon, or a high-volume surgeon (colorectal, or general surgeon). Additionally, patients that were older, had increased comorbidities, or did not have health insurance were less likely to receive MIS.

Socio-Demographic Disparities in Gastric Adenocarcinoma: A Population-Based Study.

Background: Gastric cancer is one of the leading causes of cancer-related mortality worldwide, accounting for 8.2% of cancer-related deaths. The purpose of this study was to investigate the geographic and sociodemographic disparities in gastric adenocarcinoma patients. METHODS: We conducted a retrospective study in gastric adenocarcinoma patients between 2004 and 2013. Data were obtained from the National Cancer Data Base (NCDB). Univariate and multivariable analyses were performed to evaluate overall survival (OS). Socio-demographic factors, including the location of residence [metro area (MA) or rural area (RA)], gender, race, insurance status, and marital status, were analyzed. RESULTS: A total of 88,246 [RA, N = 12,365; MA, N = 75,881] patients were included. Univariate and multivariable analysis showed that RA had worse OS (univariate HR = 1.08, p < 0.01; multivariate HR = 1.04; p < 0.01) compared to MA. When comparing different racial backgrounds, Native American and African American populations had poorer OS when compared to the white population; however, Asian patients had a better OS (multivariable HR = 0.68, p < 0.01). From a quality of care standpoint, MA patients had fewer median days to surgery (28 vs. 33; p < 0.01) with fewer positive margins (6.3% vs. 6.9%; p < 0.01) when compared to RA patients. When comparing the extent of lymph node dissection, 19.6% of MA patients underwent an extensive dissection (more than or equal to 15 lymph nodes) in comparison to 18.7% patients in RA (p = 0.03). DISCUSSION: This study identifies socio-demographic disparities in gastric adenocarcinoma. Future health policy initiatives should focus on equitable allocation of resources to improve the outcomes.

Impact of travel distance on quality outcomes in colorectal cancer.

OBJECTIVES: This study sought to examine the impact of distance traveled from place of residence to surgical facility for elective colorectal surgery on surgical outcomes, length of stay, and complication rate. STUDY DESIGN: Retrospective study. METHODS: Patients with colorectal cancer were identified from the Florida Inpatient Discharge Database. Distance traveled from primary residence to surgical facility was estimated using zip code. After adjusting for patient and hospital characteristics, multivariate regression models compared bypassed hospitals, the length of stay, and complication rates for patients traveling different distances to receive care. RESULTS: Patients residing in rural areas and in South (odds ratio [OR], 2.37; 95% CI, 1.55-3.63) and Central Florida (OR, 5.86; 95% CI, 3.86-8.89) were more likely to travel more than 50 miles for treatment. Teaching status of the hospital (OR, 9.99; 95% CI, 6.98-14.31), a hospital's availability of a colorectal surgeon (OR, 1.83; 95% CI, 1.45-2.31), and metastasized cancer (OR, 1.43; 95% CI, 1.17-1.82) influenced the patient's decision to travel farther for treatment. Length of stay was significantly higher for patients traveling farther (P < .0343). However, there was no significant difference in the rate of complications among the groups (those traveling 25-50 miles vs < 25 miles [P = .5766] and those traveling > 50 miles vs < 25 miles [P = .4516]). CONCLUSIONS: A greater number of patients travel more than 50 miles to the surgical facility at a later stage of disease. These patients do not significantly differ from those traveling less than 50 miles in their rates of complications; however, they stay longer at the surgical facility.

Factors associated with worse outcomes for colorectal neuroendocrine tumors in radical versus local resections.

BACKGROUND: Colorectal neuroendocrine tumors (NETs) are the most common NETs of the gastrointestinal tract. Due to the rarity, colorectal NETs are understudied and are not clearly understood. Our study sought to identify the factors associated with worse outcomes for colorectal NETs following resection. METHODS: We identified patients diagnosed with colorectal NETs [2004-2014] who underwent resection from the National Cancer Data Base. Non-NETs were excluded. Overall survival (OS) was evaluated using the Kaplan Meier method. Cox proportional hazards and logistic regression models were used to assess factors associated with radical versus local resection, OS and LOS. RESULTS: A total of 7,967 colon and 11,929 rectal NETs were analyzed. The majority of colon (93.4%) and rectal (89.1%) NETs underwent radical and local resection respectively. The 5-year OS was 69% and 92% for colon and rectal NETs respectively. Older age (OR 1.45, CI 1.37-1.53) and clinical stage 4 (OR 9.91, CI 4.56-21.52) were associated with higher odds for colonic radical resection. Lowest median income quartile (OR 1.41, CI 1.21-1.64) and African Americans (OR 1.26, CI 1.07-1.49) experienced higher mortality for colon and rectal NETs respectively. CONCLUSIONS: Racial minority and low-income patients experience worse outcomes for colorectal NETs following resection.

Intravital Microscopy (IVM) in Human Solid Tumors: Novel Protocol to Examine Tumor-Associated Vessels.

BACKGROUND: Intravital microscopy (IVM) allows the real-time, direct visualization of microscopic blood vessels. This pilot clinical trial will elucidate the physical and functional characteristics of vessels associated with solid tumors. OBJECTIVE: The main objective of this study is to determine the feasibility of performing IVM in patients with solid tumors during the standard course of surgical resection. IVM will also be performed when vasopressors or fluid boluses are administered during the standard course of the operation. METHODS: This is an open-label, nonrandomized, single-center, pilot study of IVM observation in subjects with solid tumors undergoing surgical resection. RESULTS: This study was active on January 1, 2019 (NCT03823144) and funded by the Mayo Clinic Florida Cancer Focused Research Team Award. As of September 27, 2020, we had enrolled 20 patients. Accrual period is expected to end by December 31, 2021. CONCLUSIONS: This trial will support the development of interventions to improve patient treatment by extending the application of IVM to the tumor microenvironment. IVM observations during volume and pressor management at the time of surgery may aid in the development of strategies to augment responses to systemic treatments. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/15677.