Clinical Trials

Department of Surgery Clinical Research

The clinical expertise found within the Department of Surgery is further enhanced by extensive and innovative research programs focused on the development of important new techniques and therapies that promote better outcomes and can improve quality of life for patients following surgery. The Department’s surgeons continue to be involved in groundbreaking clinical trials and other clinical research that are expanding the boundaries of surgical care. Between 2004 and 2011, the Department of Surgery has housed 91 clinical trials, with 30 trials currently in progress as of 2011.

Current Clinical Trials

Breast Surgery Section

As principal or co-investigators in numerous multicenter clinical trials, the faculty members of the Section of Breast Surgery continue to investigate the field of chemoprevention of breast cancer in high-risk women; the indications for drug therapy in postmenopausal women with ductal carcinoma in situ; the use of digital infrared imaging to enhance breast cancer detection; intraoperative radiation therapy; and the efficacy of pre-and post-treatment imaging to determine residual disease in patients with invasive breast carcinoma undergoing cryoablation. In addition, they have studied devices that aid in precision targeting for partial breast radiation therapy and conducted a feasibility study on breast specific gamma imaging to improve positive predictive value in patients with mammographic and/or sonographic abnormalities requiring breast biopsy.

Division of Burns, Critical Care and Trauma

Clinical research is an integral component of the Division of Burns, Critical Care and Trauma. Following a retrospective study of the Burn Center’s admissions that revealed worse outcomes among diabetic patients, including increased infection rates, graft complications and increased length of hospital stay, the Division’s Burn faculty members have designed a prospective study to carefully assess wound repair and recovery of diabetic and non-diabetic burn patients. Currently underway, the project’s long-term aim is to determine the characteristics of the wound milieu along with global responses to injury that may predict poor outcomes among diabetic patients.

The Division’s faculty members are also pursuing a number of wound healing projects, including the use of biological skin substitutes. Since 2003, the Division has served as co-principal investigator on a disaster planning grant for burn injury in New York City funded by the Federal Health Resources and Services Administration. Clinical management for the emergently ill and critically ill surgical patient is a focus of the Division’s Critical Care and Trauma faculty members. Studies focus on a variety of topics related to prognosis and outcomes, including the value of different laboratory markers in improving the degree of resuscitation; how gender affects outcomes in sepsis; epidemiology of critical surgical illness and multiple organ dysfunction syndrome; nosocomial infections in critically ill patients; and metabolic response to injury. Additional areas of interest include the development of improved treatment strategies for the management of emergent surgical conditions such as pancreatitis and appendicitis, and the study of factors most important in affecting end-of-life decision-making in critically ill patients. In collaboration with the Emergency Department, the Division is researching the optimal management of the acute abdomen in terms of the necessity of radiographic procedures versus expedient operative care.

Colon and Rectal Surgery Section

The faculty members of the Section of Colon and Rectal Surgery pursue clinical research in minimally invasive surgical techniques and the development of technology that will improve surgical outcomes. Over the years, studies have included the role of robotics in colorectal surgery, hand assisted laparoscopic surgery, CO2 laparoendoscopic surgery, innovative endoscopy and accelerated recovery pathways.

A seven-year prospective study conducted by the faculty of the Section of Colon and Rectal Surgery determined that the results obtained with laparoscopic or hand-assisted laparoscopic rectal resections compared favorably with open surgery in the treatment of patients with cancers of the rectum. The study has now expanded to multiple sites, with Weill Cornell colorectal surgeons collaborating with the American College of Surgeons Oncology Group (ACOSOG) on a national study and leading a second study involving several medical centers across the country.

The colorectal surgeons continue to be at the forefront of device innovation, designing new instruments and equipment for minimally invasive procedures. The Section’s innovations have precipitated the establishment of the Minimally Invasive New Technologies (MINT) program, an innovative collaboration between NewYork-Presbyterian Hospital and Weill Cornell Medical College. The MINT program, co-led by Dr. Jeffrey W. Milsom, taps into the experience and innovative skills of our colorectal surgeons, who, working together with engineers, develop technologies, devices and tools to advance the field of minimally invasive surgery. In the last two years, the program has submitted over 35 patents for new devices, with many more currently in various stages of development.

Endocrine Surgery Section

Faculty members in the Section of Endocrine Surgery pursue clinical research that involves thyroid, parathyroid, adrenal and gastrointestinal neuroendocrine disease, as well as benign and malignant foregut disease. Projects continue on the development of technology for tumor localization; evaluation of regional versus general anesthesia for patients undergoing thyroidectomy; preoperative localization for patients with hyperparathyroidism; laparoscopic approaches to treating conditions of the adrenal glands; and molecular analysis of thyroid biopsies to differentiate benign and malignant thyroid nodules.

The Section is also involved in multiple clinical studies focused on improved diagnosis and management of numerous endocrine disorders. Many of these studies are multicenter, involving other prominent centers for the management of endocrine disorders worldwide. A recent study has focused on surgery as an effective treatment for Type 1 gastric carcinoid tumors. While these tumors are rarely malignant, patients may experience pain, diarrhea and other abdominal complaints. Treatment options vary, but the study showed that surgery using a minimally invasive approach with laparoscopic gastric resection may provide a long-term durable cure.

Gastrointestinal Metabolic Surgery Section

Gastrointestinal Metabolic Surgery has become the subject of much interest in recent years. At Weill Cornell, numerous clinical investigations are underway, helping to provide insight into the physiology of the GI tract and its role in both the cause and the cure for diabetes, obesity and other metabolic disorders. The goal of research is to uncover how surgery can help identify new targets for drug development and to determine if the effects of surgery may, one day, be replicated by medications. One such clinical study based at Weill Cornell and initiated in 2010, is investigating whether gastric bypass surgery can reverse Type 2 diabetes. Other studies are comparing gastric bypass surgery versus intensive medical management in achieving glycemic control in diabetic patients with a BMI of <35 and a comparison of caloric restriction and gastric bypass on glucose homeostasis.

Laparoscopic and Bariatric Surgery Section

A vigorous clinical research program is underway by faculty members in the Section of Laparoscopic and Bariatric Surgery, which has established a patient registry with outcome data on complications, quality-of-life issues and body composition prior to and following the various bariatric surgical options available. With support from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, surgical investigators are leading a number of clinical trials with a goal of augmenting treatment options for obesity. These include developing and evaluating new instrumentation; an evaluation of 30-day mortality after bariatric procedures; a study of the long-term effects of weight loss on health, gender issues, behavioral factors, work and leisure activities; a longitudinal study of obese patients prior to gastric bypass surgery and interval follow up of changes in gene expression and metabolic changes from resultant weight loss; and clinical and pathophysiologic consequences of bariatric surgery. Weill Cornell’s bariatric faculty members are also participating in an NIH multimillion-dollar Bariatric Surgery Clinical Research Consortium of only six centers nationwide, which is conducting a longitudinal assessment of bariatric surgery.

Division of Oral and Maxillofacial Surgery and Dentistry

Clinical research in the Division of Oral and Maxillofacial Surgery on total prosthetic reconstruction of the temporomandibular joint (TMJ) with distraction osteogenesis and tissue-engineered cartilage. Research supported by the NIH continues on tissue engineering of temporomandibular cartilage. The Division recently completed a study to determine if there were differences in outcomes of arthroscopic surgery in patients with inflammatory degenerative TMJ disease who underwent early surgical intervention versus late surgical intervention. Results showed the early intervention group had better surgical outcomes than the late intervention group and that arthroscopic surgery should be considered early in the management of patients with inflammatory degenerative TMJ disease.

Division of Pediatric Surgery

In the Division of Pediatric Surgery, current clinical research initiatives include studies that evaluate the outcomes of infants and children undergoing surgical therapy for esophageal atresia and tracheoesophageal fistula, evaluation of neonates who present with intestinal strictures associated with necrotizing enterocolitis, studies on intestinal dysmotility disorders in children with Russell-Silver syndrome, risk factors associated with the development of pan-necrosis in neonatal necrotizing enterocolitis and surgical sequelae of congenital pancreatico-biliary anomalies. The Division’s esophageal atresia registry is one of the largest in the country with over 250 active patients being followed. The Division is also evaluating minimally invasive pediatric surgery, with an emphasis on further developing and refining single incision pediatric endosurgery.

Division of Plastic and Reconstructive Surgery

Plastic surgeons are studying different treatment options for the management of hemangiomas and vascular malformations and exploring treatments for keloids and other abnormal scar conditions for patients undergoing breast reconstruction after radiation therapy and for sternal reconstruction after postoperative infection or wound reopening. They are also evaluating hydrogen sulfide as a means to locally reduce overall tissue oxygen needs during surgery, thereby reducing complications resulting from ischemia and reperfusion. Ultrasound is being examined as a therapeutic tool for wound healing and its potential role in localizing the effect of medications. The Division has also undertaken an analysis of the socioeconomic outcomes of plastic surgery incorporating factors not often considered as surgical outcomes, such as self-esteem and career success.

Surgical Oncology

Weill Cornell’s surgical oncologists are at the forefront of clinical research, investigating laparoscopic techniques for removing tumors in patients with adenocarcinoma of the stomach; evaluating different chemotherapeutic agents for treatment in patients with pancreatic cancer and mucinous neoplasms of the pancreas; and surgical debulking associated with the use of hyperthermic chemotherapy for patients with carcinomatosis. Ongoing studies focus on colorectal cancer prevention and the impact of Polyphenon E, a natural extract from green tea, on the progression of Barrett’s esophagus to esophageal cancer. The surgical oncologists also participate in a number of national oncology study groups, including the American College of Surgeons Oncology Group and the Eastern Cooperative Oncology Group, registering patients in a variety of ongoing clinical trials for pancreatic, gastric and colorectal cancers.

Division of Transplantation Surgery

The Division of Transplantation Surgery has 15 ongoing research studies, including four investigator-initiated clinical trials studying immunosuppression minimization, gene expression in allograft biopsies, and comparison of surgical techniques used for living kidney donors. Seven industry-sponsored trials of pharmaceutical agents are underway, investigating novel pharmaceutical agents for immunosuppression, ischemia-reperfusion injury, and maturation of arteriovenous fistulas and grafts. There are also several retrospective database studies looking at outcomes in transplantation, living donation, immunosuppressive protocols and dialysis access procedures.

Weill Cornell’s surgical and medical transplant specialists have also developed a noninvasive test utilizing molecular signatures to more accurately predict organ rejection. Under molecular guidance, the transplant team hopes to be able to fine-tune medications for patients, minimizing their exposure to immunosuppression. Based on the tests developed at Weill Cornell, an NIH-sponsored multicenter study further tested the sensitivity and specificity of measuring RNA for key immune cell regulators in renal transplant patients, hopefully providing transplant physicians with tools for a more complete appraisal of graft function and risk of organ rejection.

The Division’s hepatobiliary and liver transplant faculty members seek answers to a number of challenging clinical questions in the areas of living donor liver transplantation, laparoscopic liver resection, primary and secondary liver cancers, pancreatic surgery and complex biliary surgery.

Division of Vascular and Endovascular Surgery

In the Division of Vascular and Endovascular Surgery, clinical research includes long-term outcome studies of minimally invasive techniques, including catheter-based interventions for carotid, aortic and lower extremity arterial disease; the evaluation of endovascular repair of aortic aneurysms as an alternative to traditional open surgery; new and advanced imaging techniques for peripheral vascular disease; and a bone marrow cell therapy trial for treatment of patients with limb-threatening lower extremity vascular disease. Weill Cornell was a major participant in the NIH-sponsored Carotid Revascularization Endarterectomy Versus Stent Trial (CREST), which studied symptomatic and asymptomatic patients undergoing stent placement or surgery, and studies evaluating carotid stenting for those at high risk for undergoing traditional carotid artery surgery. The Division is working to establish a prospective database to track clinical outcomes with the goal of improving patient care.

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