SURGERY RESEARCH INSIGHT
Winter 2022



Surgery and Translational Research
Translational Research applies laboratory approaches and discoveries to clinical problems and leads to advances in new drugs, assays, devices, interventions, and training (“bench-to-bedside”).
Currently, two of three surgery involved extramurally funded translational research projects are in Surgical Oncology are investigating immune responses to cancer. Both projects have the potential to impact the patients served by ECU surgeons and ECU Health.
Dr. Vohra (PI), Dr. Verbanac (Co-I), Dr. Ghosh and other collaborators are funded by the American Cancer Society to study sentinel node immune signatures and outcome in Triple Negative Breast Cancer. The overall hypothesis is that the sentinel node immune signature will provide clinically meaningful information that can be used to guide immunotherapy approaches. Preliminary data for this study (generated using RNA isolated as part of an early, prospective ECU-based breast cancer multicenter sentinel node trial) found that T helper cell and dendritic cell immune signatures in negative nodes were associated with risk of recurrence and disease-free survival. Transcriptome and immunohistochemical analysis of tumor-node pairs from FFPE patient blocks is underway in this expanded study.
In 2022, Dr. Nasreen Vohra and Dr. Fisher-Wellman (Co-PI in Physiology/ECDOI) received a 2-year award from the Department of Defense to study Anticancer Immunity in patients with melanoma. An emergent ‘targeted’ treatment approach involves the use of immune checkpoint inhibitors (e.g., anti PD-1/PD-L1 therapy) that work by bolstering the body’s own anti-tumor immunity. Although immune checkpoint inhibitors have shown remarkable efficacy, a substantial portion of patients fail to respond. A growing body of evidence causally links immune cell failure to disruptions in the cell’s major energy producing organelles – mitochondria. This project investigates differences in immune cell mitochondria in the context of anti-melanoma immunity. The short-term goal of this application is to identify immune-specific drug targets such that, in the long-term, patients diagnosed with melanoma can be afforded more effective immune therapies. Analysis of tumor-infiltrating cells and circulating immune cells from patients enrolled in this prospective, IRB-approved study is underway.
General/Bariatric Surgery is involved with the MetFlex (Metabolic inflexibility is related to elevated muscle anaerobic glycolysis NIH DK120296) study in collaboration with the Department of Physiology, including Dr. Joseph Houmard (Co-PI), Dr. G. Lynis Dohm (Co-PI), Dr. Walter Pories (Co-I), Dr. Terry Jones (Co-I), Dr. Eric DeMaria (Co-I), and Dr. Nick Broskey (Co-I). This NIH funded study began July 1, 2019, and is currently completing year three of five, with a budget of $2,195,564.
The title of the NIH funded MetFlex study is “Metabolic inflexibility is related to elevated muscle anaerobic glycolysis”. The main focus of the study is on overweight subjects, as these individuals exhibit a high risk of becoming obese and/or developing metabolic diseases. We hypothesize that in some overweight individuals there is a “metabolic program” in skeletal muscle which predisposes them to the development of obesity. A second goal is to investigate if metabolic surgery, which is known to reverse metabolic diseases, changes the muscle metabolic program. Findings from this study may lead to clinical screening tools for determining risk for obesity in non-obese individuals and targeting this group for prevention.
Conference | Conference Dates | Location | |||
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Safe States | August 20, 2024 | Portland, OR | |||
NC/SC - American College of Surgeons (ACS)- Annual Meeting | August 23, 2024 | Isle of Palms, SC | |||
American Association for the Surgery of Trauma (AAST)(TACS) | September 11, 2024 | Las Vegas, NV | |||
Society of Black Academic Surgeons (SBAS) | September 19, 2024 | Davis, CA | |||
American Society of Plastic Surgeons (ASPS) | September 26, 2024 | San Diego, CA | |||
American Academy of Pediatrics (AAP) | September 27, 2024 | Orlando, FL | |||
CHEST Annual Meeting | October 6, 2024 | Boston, MA | |||
Association of Women Surgeons (AWS) | October 18, 2024 | San Francisco, CA | |||
American College of Surgeons (ACS) | October 19, 2024 | San Francisco, CA | |||
Surgical Outcomes Club (SOC) | October 19, 2024 | San Francisco, CA | |||
Patient Centered Outcomes Research Institute (PCORI) | October 22, 2024 | Washington, D.C. | |||
Kidney Week (ASN) | October 23, 2024 | San Diego, CA | |||
Society of Immunotherapy of Cancer (SITC) | November 6, 2024 | Houston, TX | |||
ACS TQIP | November 12, 2024 | Denver, CO | |||
Southern Surgical Association (SSA) | December 8, 2024 | Palm Beach, FL | |||
National Research Conference for the Prevention of Firearm Related Harms | December 9, 2024 | Seattle, WA | |||
San Antonio Breast Cancer Symposium | December, 10, 2024 | San Antonio, TX |
Advancing Medical Science in Surgical Disparities
(SEI)Surgical Equity Index
Despite immense attention directed to the public health priority of disparities in access to surgical care, reducing these disparities has been a particularly vexing issue. Access, defined as “the timely use of personal health services to achieve the best possible health outcomes”, continues to be a major challenge in the United States and remains a priority of the Healthy People 2023 initiative. Personal health services may include access to surgical services in a substantial proportion of the population. Surgical access is influenced by the complex interaction of numerous factors including race/ethnicity, social economic status (SES), insurance, and even the willingness to undergo surgery while outcomes and access maybe influenced by disparities in disease burden and co-morbid conditions, surgeon volume, and hospital volume all of which may result in surgical health care disparities. However, limited access to health care is closely associated with surgical health care disparities. The American College of Surgeons Committee on Health Care Disparities states “there is no quality without access”.
Current strategies to understand, reduce, and/or eliminate disparities in access to surgical care, to date, have been disappointing. These approaches utilize traditional quantitative analytic techniques which typically rely on strict assumptions of independence, linearity, and quantitating the contribution of individual factors using regression techniques to detect surgical disparities. The results are largely descriptive and fail to address mechanisms that may explained why observed disparities occur. Most importantly, however, is that these analytic approaches fail to consider the dynamic interactions of multiple pathways at multiple levels that characterize complex systems and that simultaneously contribute to disparities in access to surgical cancer care. Additionally, these research strategies do not have a validated metric to identify and quantify a disparity and to ultimately ascertain progress or success in reducing disparities. There is a critical need to identify unrecognized patterns, correlations, and non-linear relationships and identify key leverage points and pathways which result in disparities in access to surgical care.
To address this critical need, the Division of Surgical Research has adopted a disparities research framework described by Kilbourne and colleagues of detecting, understanding, and ultimately reducing disparities in access to surgical care. We have described a quantitative methodology which defines vulnerable populations and identifies potential disparities in surgical access which we have termed the surgical equity index (SEI) and populated a robust data platform that will allow us to apply big data analytics, machine learning, and complex system science approaches to understanding the dynamic interrelationships between patient, provider, healthcare systems, social relationships, physical environment, and social conditions and policies that will lead to evidence-based interventions. Our long-term goal is to identify and model intervention(s) that are predicted to have the greatest efficacy in reducing disparities in access to surgical cancer care and develop novel informed interventions to mitigate these disparities.
- Webex meeting recording: Surgical Grand Rounds 12.7.22 – Drs. Wong and Irish
- Password: nPw4D2K*
- Recording link: https://ecu.webex.com/ecu/ldr.php?RCID=fe630db9ba34ca39cae0d53127aff48e
A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients (IMAGINE)
A major milestone for the Division of Surgical Research and Division of Surgical Immunology and Transplantation at ECU was reached in December 2022. This site was selected for enrollment in an interventional drug trial. This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of CABMR in recipients of a kidney transplant. This randomized double-blinded trial has two arms inclusive of either a placebo consisiting of physiologic saline solution that is administered subcutaneously and no treatment of CABMR for 5.5 years or clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6 that is administered subcutaneously. The primary endpoint is defined as time to all-cause composite allograft loss.
The study start-up will commence in 2023. Drs. David Leeser and William Irish will serve as Co-Principal Investigators. The current end date will be 2030.
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Investigator Initiated Kidney Cancer Research at ECU Health Medical Center
The study titled “Graft Survival and Function of Transplant Patients at East Carolina University” is intended to do exactly what the title says. In summary, the study goal is to monitor the renal function of kidney transplant recipients as well as incidence of rejection, infections, and cancer.
Investigators: Lorita Rebellato-de Vente, Dr. Carl Haisch and Dr. William Irish
- Aim: Transplant recipients have a 2-4 fold increased risk of developing malignancies over the general population. Cancer is the second most common cause of death for recipients. In order to obtain a more comprehensive incidence of cancer in transplant recipients, we requested cancer data from the State of North Carolina Center for Health Statistics.
- Public Health Benefit: This study will provide important information about the long-term risks for cancer development in our patient population since kidney transplant recipients have a significantly increased risk of malignancy compared to the general population. The increased risk is attributed to the need for chronic immunosuppression that is required to preserve graft function. Increased occurrence of cancer has been one of the main medical burdens in transplant recipients.
- Project Description: We requested cancer data from recipients that received a kidney or kidney/pancreas transplant between 01/01/1995 to 12/31/2020. Data analysis will be performed soon. An abstract will be submitted to the American Society of Transplantation to be presented in the 2023 meeting. In addition, a summary of the findings will be submitted for publication.
- Project Significance: It is important that patients and their providers be aware of the cancer risks associated with transplantation. Each patient should be properly screened and receive medical management after transplantation.
Team Recognized as High Enrolling Site
Congratulations to team’s research specialist Peyton Garris and transplant team for achieving our site’s enrollment goal for the ProActive – The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry.
Due to her excellent recruiting skills, she has garnered ECU transplant research national attention as a top enrolling site back-to-back months with ECU being the 2nd highest enrolling site for November and 6th overall in the country out of 52 sites for TRULO – TruGraf Long-term clinical Outcomes Registry.
Peyton’s hard work continues to help grow the research efforts for our department. These sponsors have reached out for more enrollment and increase in budgets due to her timely data entry and high recruitment and retention.
Dr. Kathryn Verbanac
As of November 1, 2022, Dr. Kathryn Verbanac returned to the department as professor in the Division of Surgical Oncology after completing her administrative role as assistant vice chancellor of research development in REDE. She will be splitting her time with the Division of Surgical Research and will serve as Director of the North Carolina Tissue Consortium. She conducts translational cancer research from the perspective of a biochemist and immunologist. She has also been heavily involved in institutional efforts to increase student and faculty diversity in STEM and biomedical research, including being one of the ECU Multi-PIs on an extramural Faculty Institutional Recruitment for Sustainable Transformation (FIRST) U54 grant submission that is under NIH review
Dr. Debjani Ghosh
Dr. Debjani Ghosh has joined the Department of Surgery in the Surgical Oncology Division in August 2022 as a Research Specialist. Dr. Ghosh earned her PhD degree from India. She worked at University of Missouri at Columbia, initially as post-doctoral fellow with extensive training in molecular biology and finished her work as Research Assistant Professor. Due to funding crunch, she moved to Harvard Medical School, Beth Israel Deaconess Medical Center at Boston and worked as T32 trainee on Lupus autoimmune disease. From Harvard, she joined East Carolina University and worked initially as fellow and later research instructor and developed IFN beta mediated vaccine to cure autoimmune disease of multiple sclerosis. Currently, she is working on sentinel node immune signature and outcome in triple negative breast cancer with Dr. Vohra and Dr. Verbanac. She is also involved in active research project entitled “Bioenergetic characterization of solid tumors and primary leukemias” and “Sentinel node immune signatures and outcome in stage II melanoma cancer” with Dr. Vohra and in collaboration with Dr. Kelsey Fisher-Wellman, Assistant Professor of Department of Physiology
Moses McDaniel
In May 2022, Moses McDaniel rejoined the Division of Surgical Oncology as a Research Specialist. He is the coordinator for the North Carolina Tissue Consortium for ECU. He is a native son of Eastern NC hailing from Halifax County, specifically Enfield, NC. He has earned a Bachelor of Science degree in Biology with a Minor in Biotechnology from Elizabeth City State University and a Master of Science degree in Biology from North Carolina Central University. He is currently in a Doctor of Health Science program at Campbell University. Professionally he aims to join ECU in the ongoing struggle of addressing Health Disparities in Eastern North Carolina and to increase minority participation in all aspects of research.
Fun fact he considers himself an amateur entomologist. However not only in collecting specimens, but also researching and studying insects for micro molecules that can potentially fight cancer.
North Carolina Tissue Consortium | Brody School of Medicine | ECU
Crystal Harris
Crystal Harris, started in May of 2022 as an Administrative Support Specialist, for the Division of Surgical Research. She is located at the front desk area of our new office location, BSOM 4S-10 Suite. Crystal has administrative, medical, and customer service, experience that supports our team and mission.
She can be reached Monday – Friday 8:00 am -5:00 pm at harriscr21@ecu.edu or 252-744-5292.
Crystal has lived in Eastern NC her entire life, and resides with her husband (Jason), three sons (Christian, Andrew and Kole), two cats (Sugar Pie and Grace), dog (Lolly), and two hamsters (Swervo and Juice). She enjoys learning all the responsibilities of her new role here in the Department of Surgery, spending time with her family, and making new friends.
NIH Requirement for Data Management Plan Updates coming in 2023
The NIH has issued a Data Management and Sharing (DMS) policy, effective January 25, 2023, to promote the sharing of scientific data. Specifically, regarding Human Data Sharing, the NIH’s mission is to improve the health of the public through support of biomedical research and the training of biomedical scientists. To further advance and accelerate research to benefit the public health, data developed in the NIH Intramural Research Program (IRP) should be collected in a manner that permits and promotes the broadest sharing possible. Data sharing may be complicated or limited, in certain cases, by agreements with outside collaborators, e.g., Clinical Research and Development Agreements (CRADAs) or Clinical Trial Agreements, by Institutional Review Board (IRB) rules or by other constraints. NIH IRP investigators should share data broadly for secondary research purposes, in all cases consistent with applicable laws, regulations and policies.
UPDATED FORM ALERT
The subrecipient Letter of Intent form template has been updated. Revised language that more clearly articulates the attestation for subrecipients that have a PHS-compliant FCOI policy has been added. The updated template can be found at its home base page:
https://rede.ecu.edu/ora/ecu-subrecipient-letter-of-intent/.
If you’re working from a downloaded copy, please update your downloaded copy with the latest version!
Faculty can Receive Support to Publish Open Access Through: Open Access Phishing Support Fund
The Open Access Publishing Support Fund (OAPSF), sponsored by ECU Libraries, is available to help with article processing and open access charges for open access publishing. We welcome applications from current faculty, staff, graduate students, postdoctoral scholars or resident physicians.
Spring applications will be accepted until April 15, 2023. Applications will be reviewed shortly after the deadline.
For more information about the OAPSF and to apply, please visit: go.ecu.edu/openaccess.
For additional information and support for open access publishing, visit our Sustainable Scholarship website: https://sustainablescholarship.ecu.edu/.
QUESTIONS? Please contact us at scholarlycomm@ecu.edu with any questions.
Importance of Research to Maintain Level 1 Trauma ACS Accreditation
As our site prepares for a site visit early in 2024, it is important to understand the research and scholarly activities required to maintain a Level 1 Trauma Center that services eastern North Carolina. See the ongoing ACS Level 1 trauma research requirement list below:
Level I trauma centers must demonstrate the following scholarly activities during the verification cycle:
- At least 10 trauma-related research articles*
- At least three articles must be authored by general surgery/pediatric trauma providers
- Research activity must be performed at the trauma center
- If case series are to be counted, they must include more than five patients
- Basic science research must involve topics directly related to the pathophysiology of injury
- At least three articles must be from disciplines other than general/pediatric surgery
- All articles must be published or accepted for publication in peer-reviewed and indexed journals
- Authors from the trauma center must meet accepted authorship requirements of the International Committee of Medical Journal Editors
- One paper from acute care surgery may be included.
Participation by at least one trauma program faculty member as a visiting professor, invited lecturer, or speaker at a regional, national, or international trauma conference
Support of residents or fellows in any of the following scholarly activities: laboratory experiences; clinical trials; resident trauma paper competitions at the state, regional, or national level; and other resident trauma research presentations
Process Change Memo 12/2/2022: CRG pricing process
Going forward, we are going to change the process for receiving pricing from CRG in Study Startup. If your study will involve the health system for services, procedures, and/or treatment, please email crg.ancillary@vidanthealth.com and Abner Abner.MarriagaCastillo@Vidanthealth.com while preparing your IRB application once your have your SRF drafted. Please also attach a copy of the study protocol.
Please use the following template email:
Subject: New Study Pricing Request [UMCIRB #]
Body of message:
Study Title: [Short title is fine]
UMC IRB #: [Should match ePirate]
PI: [Full name and Department]
Where will the study take place: [Outpatient, Inpatient, or Mix (for studies where patient may receive treatment in ECU Health Day Hospitals)]
If “Inpatient” or “Mix” – a protocol breakdown will be scheduled.
If “Inpatient” or “Mix” – please provide target MM/YY of SIV (if industry) or first enrollment (if not industry)
ECU Health Engagement: [Vendor for Labs / Imagining, Treatment (Hospital Pharmacy would be responsible for drug/device), or Other]
Please list any unusual tests / procedures in email. Please also consult the CPT code book on the CTO intranet when finalizing your SRF to ensure you are using a code that hospital has in their system.
Type of Study: [Industry sponsored, Federally Funded (medicare rates would apply), Cooperative Group, or Other]
Please be sure to attach a copy of the draft SRF and protocol to your price request email. CRG uses these to verify that they are just a lab / imagining vendor and not responsible for other aspects of the study.
We are trying to find ways to expedite the study startup process. For example, with this new workflow, CRG would no longer perform a protocol breakdown for outpatient studies where they are only a vendor for lab work. Please let me know if you have any questions or concerns.
Thank you,
Cierra Buckman, MHS
Interim Director, Clinical Trials Office
Director of Research Administration, Department of Pediatrics
ECU Brody School of Medicine
CONGRATULATIONS to our Residents on their abstract submissions, presentations, education advancements and awards accomplished in 2022!
Abstract Submissions:
- Dec 2022: Seth Quinn’s, MD submission Ketamine for pre-hospital analgesia and sedation in the trauma population: a narrative review has been accepted for publication in SN Comprehensive Clinical Medicine
- Nov 2022: Hao S,Parikh A, Snyder R. Defining socioeconomic disadvantage: Geography and context matter [published online ahead of print, 2022 Nov 3]. J Surg Oncol. 2022;10.1002/jso.27127. doi:10.1002/jso.27127
- Hao S, Meyer DB, Klose C, Irish W, Honaker MD. Association of Distance Traveled on Receipt of Surgery in Patients with Locally Advanced Rectal Cancer. Accepted for publication in the International Journal of Colorectal Disease.
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The Road Less Traveled: Transportation Barriers to Cancer Care Delivery in the Rural Patient Population Ashley N. Wercholuk, Alexander A. Parikh, and Rebecca A. Snyder JCO Oncology Practice 2022 18:9, 652-662
Presentations
Upcoming: Hao MD Bridges L, Kennamer K, Honaker MD. Infectious Complications After Modified Stomal Purse-string Closure. Accepted for Quickshot podium presentation at the upcoming 18th Annual Academic Surgical Congress (Feb 7-9, 2023 in Houston TX)
Upcoming: Josh Aldridge, MD to present “A STATEWIDE ANALYSIS OF PREDICTORS OF TRAUMA CENTER TRANSFER: THE BURDEN OF NON-CLINICAL FACTORS” as a short oral presentation at the SESC 2023 Annual Meeting, February 11–14.
Oct 2022: Ashley Quinn, MD went to ACS Clinical Conference this past October to present her abstract on missed appointments in surgical oncology.
Oct 2022: Preston Bethea, MD Presented a video depiction of a per oral endoscopic excision of leiomyoma at the gastroesophageal junction.
The below video was presented at ACS Cardiothoracic Video Session (10/18/2022)
July 2022: Scarlett Hao, MD presented SDOH screening in ENC patients with cancer at the ACS Quality and Safety Conference.
Education:
May 2022: During her spare time, Dr. Hao earned her Master of Public Health from ECU!
Scholarships, Awards & Achievements:
Congrats to Caitlin Takahashi, MD who was accepted into the AOA (American Osteopathic Association) Training in Policy Studies (TIPS) Program! Caitlin was accepted based on her leadership, passion for service and interest in making positive population-level change policy.
December 2022: Congrats to Brandon Peine, MD for receiving one of the 2023 STS Looking to the Future Resident Scholarships! This scholarship, sponsored by The Society of Thoracic Surgeons (STS) and its members, grants admission to the STS 59th Annual Meeting.
June 2022: Resident Awards Day:
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- Password: 5rMKaes@
- Recording link: https://ecu.webex.com/ecu/ldr.phpRCID=63570909bee563da300d397c7be442aa
May 2022: ECU Health Medical Center Staff GME Research Week Award Winners
Congrats to Seth and Tasos!
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- Educational Research & Innovation: Honorable Mention Poster: Resident Perception of Clinical Benefit and Educational Value of a Novel Low-Fidelity Simulation Curriculum: Anastasios Mitsakos, MD (General Surgery)
- Clinical and Basic Science Research: Best Poster, Prospective Multi-Institutional Evaluation of the Use of Cholecystostomy: Seth Quinn, MD (General Surgery)
32nd Annual Department of Surgery – Resident Research Day
Congratulations to Winners!
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- Josh Aldridge, MD – A Statewide Analysis of Predictors of Trauma Center Transfer: The Burden of Non-Clinical Factors
- Anastasios Mitsakos, MD – The Role of Institutional Growth and Maturation in Creating a Reliable Pancreatic Surgery Program
2023 Graduate Medical Education Research Week – Call for Oral and Poster Presentation Abstracts
ALL Abstracts Submission Deadline: Tuesday, February 14, 2023 – 5:00pm
The GME Office invites abstract submissions for oral and/or poster presentation at the 2023 ECU Health Medical Center Medical Staff Graduate Medical Education Research Week to be held: Tuesday, May 16 – Thursday, May 18, 2023.
Abstract submission categories are as follows:
Medical Education Initiatives (Program Director, Program Coordinator and faculty presenters only)
- Educational Research & Innovation
- Quality Improvement and Patient Safety
- Clinical and Basic Science Research
- Case Report with Literature Review
Please note that awards will be given in each submission category listed above, as well as for oral presentations.
Please see the attached Abstract Submission Form, as well as the Abstract Instructions and Submission Guidelines and other reference information, for further details.
Contact kelley.whitehurst@vidanthealth.com with any questions and your submissions.
First Division MPH Intern: Jacob Mitrious
This past summer was the inauguration of our MPH internship curriculum. Our first intern was Jacob Mitrious. He completed numerous projects to introduce him to the application of epidemiological theory in clinical research. He composed sample surveys that patients can fill out to help collect data for any necessary research. In addition, he collected data from past research articles to identify rates and trends of disparities among sample patients. Jacob also learned how to create an electronic data capturing system within REDCap. He shadowed the staff in the Department of Surgical Research to get a glimpse of what it’s like consenting patients and include them in current/future studies. He was introduced to regulatory through creating a sample IRB application. Currently, he is Social Clinical Research Assistant with the Internal Medicine/Pulmonary Department at Brody School of Medicine. He assists in clinical trials with this department which includes coordinating, consenting, data collecting and entering data into vendor specific sites and platforms. He is most interested in data collection and coordination as this position has taught me a lot about the field especially with clinical trials. He has career goals to continue with clinical trials and research including interventions among patients to improve health outcomes.
ASN Kidney Week, M4 Karen Kennamer Presented for ECU Transplant Team: Karen Kennamer (M4)
Authors: David Leeser, MD, Karen Kennamer, Laurel Kartchner, Margaret Romine, MD, Ashley Aaron, MD, Kristel McLawhorn, MD, Heather Jones, MD, William Irish, MSc, PhD
Medical Students interested in surgical research
There is always a problem to solve. The mission of the Division of Surgical Research is to improve patient care, provide education in the pursuit of clinical and basic science investigations and health services research, and offer support to faculty, residents and students in the conduct, analysis and reporting of scientific inquiry.
If you are interested in getting involved in surgical research, there are a few basic steps you can initiate that will help expedite involvement in surgical research.
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- All key research personnel must complete required CITI courses. For most research in this department, you must complete this module:
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- Group 1 – All Biomedical Investigators and Key Personnel: Medical, physiological or pharmacological studies that typically involve direct contact with participants. Includes, but is not limited to, research with drugs, devices or other interventions.
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- All key research personnel must complete required CITI courses. For most research in this department, you must complete this module:
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2. Registering for an ePirate account (PDF): Step by step instructions for registering your ePirate account and linking your CITI training modules.
Contact surgeryresearch@ecu.edu to provide a brief orientation and review of your research interest/s.
Surgical Research Clinical Trials
Currently Enrolling Studies
Area of Study | Title | Type | Accrual | PI | Contact Info |
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Surg Onc | Transportation Barriers to Care in Rural Cancer Patients | Observational | Dr. Drew Honaker | Study Coordinator Kelly Martin martinke21@ecu.edu 744-5723 |
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Surg Onc/Pancreas | Trans Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer | Phase II Trial | 11/12 | Dr. Emmanuel Zervos Dr. Andrew Ju | Study Coordinator Denise Brigham brighamd@ecu.edu 744-4924 |
Surg Onc/Pancreas | Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs | Interventional | 3/10 | Dr. Emmanuel Zervos Dr. Andrew Ju | Study Coordinator Leslie Corbett corbettl@ecu.edu 744-0456 |
Surg Onc/Soft Tissue | A Phase III Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma (NCT) | Phase III Trial | 3/2 | Dr. Nasreen Vohra | Study Coordinator Leslie Corbett corbettl@ecu.edu 744-0456 |
Surg Onc/Soft Tissue | A Phase II Randomized Study of Adjuvant Versus NeoAdjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High Risk Melanoma | Phase II Trial | Closed to enrollment 5 in follow-up | Dr. Nasreen Vohra | Study Coordinator Leslie Corbett corbettl@ecu.edu 744-0456 |
Transplant | TRULO - TruGraf Long-term clinical Outcomes | Observational | Closed to enrollment 81 in follow-up | Dr. David Leeser | Study Coordinator Peyton Garris garrisp21@ecu.edu 744-0114 |
Transplant | ProActive - The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry | Observational | Closed to enrollment 70 in follow-up | Dr. David Leeser | Study Coordinator Peyton Garris garrisp21@ecu.edu 744-0114 |
Transplant | APOLLO - APOL1 Long-term Kidney Transplantation Outcomes Network | Observational | Closed to enrollment 29 enrolled | Dr. David Leeser | Study Coordinator Peyton Garris garrisp21@ecu.edu 744-5363 |
(January 2022-December 2022)
- Hao S, Parikh A, Snyder R. Defining socioeconomic disadvantage: Geography and context matter. J Surg Oncol. 2023;127(1):209-210.https://pubmed.ncbi.nlm.nih.gov/?term=rebecca%20snyder%202022. doi: 10.1002/jso.27127.
- Snyder RA. Survival benefit of neoadjuvant therapy for extrahepatic cholangiocarcinoma: Real or artifact? Ann Surg Oncol. 2023;30(1):15-17.https://pubmed.ncbi.nlm.nih.gov/?term=rebecca%20snyder%202022. doi: 10.1245/s10434-022-12352-z.
- Snyder RA, Katz MHG. Fundamentals of conducting cooperative group trials through the national clinical trials network. Surg Oncol Clin N Am. 2023;32(1):1-12.https://pubmed.ncbi.nlm.nih.gov/?term=rebecca%20snyder%202022. doi: 10.1016/j.soc.2022.07.002.
- Gaynor M, BeLue R, Tuttle-Newhall JE, Martin M, Patejdl F, Vogt C. Blockchain and population health. J Public Health (Oxf). 2022;44(4):e530-e536. doi: 10.1093/pubmed/fdac028.
- Burch AE, Irish WD, Wong JH. A population health assessment of screening mammography on breast cancer mortality in north carolina. Breast Cancer Res Treat. 2022;196(3):647-656.https://pubmed.ncbi.nlm.nih.gov/?term=william%20irish%202022. doi: 10.1007/s10549-022-06773-3.
- Burch AE, Irish WD, Wong JH. A population health assessment of screening mammography on breast cancer mortality in north carolina. Breast Cancer Res Treat. 2022;196(3):647-656.https://pubmed.ncbi.nlm.nih.gov/?term=jan+wong+2022. doi: 10.1007/s10549-022-06773-3.
- Altieri MS, Pryor A, Torres MB, et al. Support of pregnancy and parental leave for trainees and practicing surgeons. Am J Surg. 2022;224(6):1501-1503.https://pubmed.ncbi.nlm.nih.gov/?term=maria%20altieri%202022. doi: 10.1016/j.amjsurg.2022.08.005.
- Weaver ML, Sundland R, Adams AM, et al. The art of peer review: Guidelines to become a credible and constructive peer reviewer. Semin Vasc Surg. 2022;35(4):470-478.https://pubmed.ncbi.nlm.nih.gov/?term=maria%20altieri%202022. doi: 10.1053/j.semvascsurg.2022.10.002.
- Oliver AL, Takahashi-Pipkin C, Wong JH, Burch AE, Irish WD. ASO visual abstract: Disparate access to surgery for operable carcinoma of the lung in north carolina. Ann Surg Oncol. 2022;29(12):7496-7497.https://pubmed.ncbi.nlm.nih.gov/?term=william+irish+2022. doi: 10.1245/s10434-022-12275-9.
- Oliver AL, Takahashi-Pipkin C, Wong JH, Burch AE, Irish WD. Disparate access to surgery for operable carcinoma of the lung in north carolina. Ann Surg Oncol. 2022;29(12):7485-7493.https://pubmed.ncbi.nlm.nih.gov/?term=william+irish+2022. doi: 10.1245/s10434-022-12101-2.
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- Josef AP, Garcia NM. Systemic anticoagulation and reversal. Surg Clin North Am. 2022;102(1):53-63.https://pubmed.ncbi.nlm.nih.gov/?term=nicole+garcia+2022. Accessed Dec 15, 2022. doi: 10.1016/j.suc.2021.09.011.
- Keller DS, Snyder RA, Talimini M, et al. “How to” course for resident reviewers: From the resident and fellow education committee of the society for surgery of the alimentary tract (SSAT). J Gastrointest Surg. 2022;26(2):466-468.https://pubmed.ncbi.nlm.nih.gov/?term=rebecca%20snyder%202022. Accessed Dec 15, 2022. doi: 10.1007/s11605-021-05202-y.
- Hao S, Snyder RA, Irish W, Parikh AA. Correction: Association of race and health insurance in treatment disparities of colon cancer: A retrospective analysis utilizing a national population database in the united states. PLoS Med. 2022;19(2):e1003937.https://pubmed.ncbi.nlm.nih.gov/?term=rebecca%20snyder%202022&page=2. Accessed Dec 15, 2022. doi: 10.1371/journal.pmed.1003937.
- Altieri MS, DeMaria E, Lensing C, et al. Retrospective comparative study of the effectiveness of bariatric surgery on 3-year outcomes in the real-world clinical setting. Surg Obes Relat Dis. 2022;18(2):196-204.https://pubmed.ncbi.nlm.nih.gov/?term=maria%20altieri%202022. Accessed Dec 15, 2022. doi: 10.1016/j.soard.2021.11.013.
- Aminian A, Vosburg RW, Altieri MS, Hinojosa MW, Khorgami Z, American Society for Metabolic and Bariatric Surgery Clinical Issues Committee. The american society for metabolic and bariatric surgery (ASMBS) updated position statement on perioperative venous thromboembolism prophylaxis in bariatric surgery. Surg Obes Relat Dis. 2022;18(2):165-174.https://pubmed.ncbi.nlm.nih.gov/?term=maria%20altieri%202022. Accessed Dec 15, 2022. doi: 10.1016/j.soard.2021.10.023.
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- Five-year attrition, active enrollment, and predictors of level of participation in the longitudinal assessment of bariatric surgery (LABS-2) study. . .https://pubmed.ncbi.nlm.nih.gov/?term=walter+pories+2022. Accessed Dec 15, 2022.
- ASO author reflections: Identifying and understanding disparities in access to surgery: Operable lung cancer in north carolina. . .https://pubmed.ncbi.nlm.nih.gov/?term=jan+wong+2022. Accessed Dec 15, 2022.
- Improvement in surgical quality following pancreaticoduodenectomy with increasing case volume in a rural hospital. . .https://pubmed.ncbi.nlm.nih.gov/?term=nasreen+vohra+2022. Accessed Dec 15, 2022.
- Strangulated jejunogastric intussusception: A unique complication following billroth II reconstruction. . .https://pubmed.ncbi.nlm.nih.gov/?term=Eric+toschlog+2022. Accessed Dec 15, 2022.
- Racial disparities in the management of locoregional colorectal cancer. . .https://pubmed.ncbi.nlm.nih.gov/?term=rebecca%20snyder%202022. Accessed Dec 15, 2022.
- Conservation psychology strategies for collaborative planning and impact evaluation. . .https://pubmed.ncbi.nlm.nih.gov/?term=rebecca%20snyder%202022. Accessed Dec 15, 2022.
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