clinicaltrials

2014: A Year in Review

by Columbia Surgery on December 26, 2014

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Using 3D printing technology to repair a baby’s heart, discovering new ways to preserve livers for transplantation, helping chemotherapy drugs find their way to treat pancreatic cancer, and performing surgery with robots through pinhole incisions are just some of the breakthroughs that stood out during 2014 at Columbia University Department of Surgery. Some of these innovations are already saving and improving lives, while others under investigation have demonstrated significant success in advancing our understanding of the science behind the medicine. All will have far-reaching impact for years to come

Read more about this year’s highlights:

Three-Dimensional Printed Heart Helps to Save Baby’s Life

Even the most ardent advocates for 3-D printing may have may have been stunned in late 2014 when Dr. Emile Bacha, Chief of the Congenital and Pediatric Heart Surgery, used the technology to save the life of a two-week old baby.

The baby was born with complex heart defects including many holes and malformations. Dr. Bacha’s surgical team printed a 3-D model of the heart based on a CT scan, which they were able to study before operating. This process enabled them to plan exactly how they would approach the procedure, including the order of steps and where they would put patches and sutures.

According to Dr. Bacha, “the baby went from having a limited life expectancy to normal life expectancy. And instead of needing three or four surgeries to repair the multiple defects, we were able to correct all the defects in a single surgery.”

See CNBC’s coverage of the story:

Tackling Pancreatic Cancer: New Strategy to Help Chemotherapy Drugs Reach their Target

Pancreatic cancers are notoriously resistant to chemotherapy drugs because their dense tissue blocks penetration of systemic drugs. Thanks to the persistence of determined researchers and significant funding from the National Institutes of Health, that barrier may soon be overcome. A study led by Dr. Kazuki Sugahara, who joined Columbia University College of Physicians and Surgeons as a research scientist and surgical resident in 2014, aims to create a new type of chemotherapy delivery system that will be far more effective than what has been available to date.

Building on his earlier discovery that found that small pieces of proteins called peptides are able to penetrate deeply into pancreatic cancers and other fibrotic tissue, Dr. Sugahara and his colleagues are now working to test the safety of using the peptides as carriers for cancer drugs.

According to Dr. Sugahara, a delivery system that gets through the tissue barrier and directly infiltrates the tumor cells could have tremendous therapeutic impact.  The work in the Sugahara laboratory is part of the Department of Surgery’s broad mission to tackle pancreatic cancer from every angle, which includes initiatives in early detection, prevention and genetic testing, and the full range of medical and surgical options.

Learn more about our efforts to fight pancreatic cancer at PancreasMD.org.

First Robotic Whipple Procedure for Pancreatic Cancer

Use of the surgical robot gained a significant foothold during 2014 when Drs. Yanghee Woo, Director of the Global Center of Excellence in Gastric Cancer Care and John Chabot, Chief of the Division of GI/Endocrine Surgery and Executive Director of the Pancreas Center, performed the first robotic Whipple procedures at the NewYork-Presbyterian/Columbia University Medical Center.

The Whipple procedure, a common surgical procedure to remove pancreatic tumors, was first developed in 1935 by Dr. Allen Whipple, a professor of surgery at Columbia University.  It involves removal of the head of the pancreas, the first part of small intestine (duodenum), the gallbladder, the end of the common bile duct, and sometimes a portion of the stomach.

The robotic surgical approach was initially used it to treat benign conditions and less advanced cancers before reaching patients with pancreatic cancer. While this process revealed it to be less useful in some operations, it has great benefit for a number of colorectal, liver, and gastric operations where it reduced surgical trauma, shorter hospital stays, and shorter recovery times. Because of the surgical robot’s freedom of movement, precision, and magnified 3-D imaging capability, Dr. Woo is confident that she is able to do complex gastric operations better with the robot than without, and that robots will become an integral part of the OR in the coming decades.

Read the full story on our previous blog post.

Preventing and Reversing Lymphedema after Breast Surgery

The treatment of lymphedema, a disfiguring, painful swelling of the arms and hands that can occur after removal of the lymph nodes during breast cancer surgery, saw much innovation with the Clinical Breast Cancer Program in 2014.

The Department of Surgery is the first in the U.S. to perform LYMPHA, a procedure at the time of lymph node removal that could potentially prevent the development of lymphedema. This surgical procedure creates a bypass to restore lymphatic flow by connecting lymph vessels to a branch of the axillary vein, significantly reducing the risk of developing the condition.

In addition, following the success of a similar study among English-speaking patients, a new study by the Clinical Breast Cancer Program aims to reduce the incidence and severity of lymphedema in the Chinese community through implementation of a Chinese language educational intervention. The program emphasizes specific breathing techniques, arm exercises, proper skin care and protection, and behavioral interventions to promote lymph flow, prevent inflammation and infection, and maintain optimal body weight.

Check out ABC 12 KSAT’s coverage of this story.

Hypothermic Liver Perfusion: Closing the Gap between Supply and Demand for Donor Livers

To increase the number of healthy donor livers available for transplant, experts at the Center for Liver Disease and Transplantation and the Molecular Therapies and Organ Preservation Laboratory of the Department of Surgery have been working to find ways to better preserve and protect donated livers, rendering them eligible for transplantation. Dr. James Guarrera, Surgical Director of Adult Liver Transplantation, and his team became the first anywhere to successfully use hypothermic machine perfusion (HMP) in the liver.

Whereas traditional cold perfusion involves preserving the donor organ at cold temperature, hypothermic machine perfusion (HMP) entails infusing the donor organ with oxygen and nutrients to simulate aliveness and reduce injury to the organ. The continuous flow of nutrients not only preserves the organ, which has shown better outcomes, shorter hospital stays, and fewer long-term complications, but it can also improve the function of an imperfect liver.

These were considered “orphan” livers that were initially deemed too compromised for transplant and likely would have been among the 600 donor livers discarded each year, but with these advances,  “we should be able to expand the liver donor pool, making transplant available to many more patients,” says Dr. Guarrera.

Learn more about HMP here.

TAVR offers Lifesaving Option for Patients Unable to withstand Open-heart Surgery

The Columbia Heart Valve Center at the Department of Surgery marked a milestone in cardiac care upon completing its 1,000th transcatheter aortic valve replacement (TAVR) in March, 2014.

TAVR is a catheter-based procedure for patients with aortic stenosis who need a new heart valve but are too sick to undergo open-heart surgery.  During TAVR, a replacement valve is inserted through the groin and advanced to the heart using a specially designed delivery catheter. With this technique, the aortic valve can be replaced without incisions and without stopping the heart.

“Before we had TAVR, many of our patients had no clinical options to treat their aortic stenosis, a potentially fatal condition,” says Dr. Susheel Kodali, Director of the Columbia Heart Valve Center. “As of today, we have been able to treat more than 1,200 patients with exceptional outcomes, thanks to this lifesaving procedure.”  With this milestone, he Columbia Heart Valve Center remains the highest volume center in the US and plays an integral role in the development of the technique.

See CBS’s coverage of the story:

Unprecedented Studies in Human Immunology

Because of the near-impossibility in obtaining human immune cells from healthy lymphoid tissues, research has generally been done on peripheral blood and mouse models, leaving 98% of the immune function (the lymphatic system) almost entirely unstudied and very poorly understood. A new multicenter study led by Columbia Center for Translational Immunology (CCTI) is now exploring this frontier with unprecedented access to human lymph tissues (the spleen and lymph nodes, lungs and intestines, and skin and liver) from deceased organ donors, provided through the first-ever collaboration with the New York Organ Donor Network.

The first part of the 4-part study, directed by Dr. Donna Farber of CCTI has already led to new discoveries about T cells that have the potential to yield paradigm changes in the effectiveness of vaccines and immunotherapies.  Other segments of the study investigate how to effectively target B cells in vaccines and immunotherapies and to develop new tissue repair strategies. A fourth segment, which includes collaboration with Dr. Megan Sykes, Director of CCTI, and Dr. Tomoaki Kato, Surgical Director of Liver and Intestinal Transplantation at the Department of Surgery, may yield new methods of achieving immune tolerance after organ transplantation.

According to Dr. Farber, “We now have the technological tools for high-throughput analysis and for probing molecules and proteins. With these tissue samples, we can go far beyond what we were ever able to do in studying human physiology.”

Reducing the Toll of Liver Disease: Education Matters

Treatment of liver disease is only the first step; the next most important task may be educating the public about it. In a host of speaking engagement, television appearances, and publications, Dr. Robert Brown, Jr., Medical Director of the Transplantation Initiative at the Department of Surgery, has contributed powerfully to public awareness of trends in hepatitis C and fatty liver disease during 2014.

October 2014 marked the arrival of a single tablet regimen (Sofosbuvir/Ledipasvir) for Hepatitis C that cures 95% of patients in 8 weeks, with extremely low side effects. This regimen marks a radical departure from painful injections of interferon and oral medications, which cure less than half of patients while causing side effects so serious that many patients refuse therapy. Dr. Brown asserts that the new, highly effective regimen “should herald a long-awaited milestone in medicine: the beginning of the end of hepatitis C, the most common and deadly chronic liver disease plaguing millions of Americans.” Unfortunately, the high cost of the therapy currently presents a deterrent to insurers, physicians, and patients. Dr. Brown presents critical insight on what appears to be a conflict between curing millions of patients and managing health care costs – and calls on the medical community to consider long-term costs, quality of care, and ethics in their equation.

Dr. Brown also addressed another common liver disease, non-alcoholic fatty liver disease (also called NASH), which affects approximately 80 million Americans. Speaking on the New England Cable Network in the fall of 2014, he informs listeners about the silent but growing epidemic and its relationship to obesity and diabetes.

Read the Dr. Brown’s article in Pacific-Standard Magazine.

See the NECN coverage on fatty liver disease:

Perfecting the Mechanical Heart: 25 Years of Innovation

Initiation of a study of the HeartMate III Left Ventricular Assist System (also called a left ventricular assist device, or LVAD) in 2014 marks 25 years of pioneering work in the field of ventricular support and heart failure management for the Department of Surgery.

Implantable LVADs take over the pumping action of the left ventricle in patients whose hearts are too weak to sustain themselves. Candidates for the HeartMate III trial include patients with advanced heart failure who need a device either as a bridge to heart transplantation, or who are ineligible for transplant and who will use the device indefinitely (called ‘destination therapy’).

The Mechanical Circulatory Support Program at the Department of Surgery is the only New York area surgical group to participate in the HeartMate III study. Having been one of the first surgical centers to pioneer heart transplantation (beginning in 1971), The Department of Surgery has played an integral role in the development of many groundbreaking devices and procedures, including the FDA approval of the HeartMate® II LVAS, the predecessor to the HeartMate III.

Learn more about the history of the artificial heart in the TIME Magazine feature.

Find out more about the current Heartmate III trial here.

Preventing Diabetes after Surgery for Pancreatitis

Beginning in 2014, the Pancreas Center at the Department of Surgery became the first New York surgical center to offer autologous pancreatic islet cell transplantation providing many patients an option to prevent diabetes after undergoing pancreatic surgery.

Every year, roughly 87,000 people in the United States receive surgical treatment for pancreatitis, a debilitating condition that causes intense abdominal pain and, potentially, diabetes. Pancreatitis can be so painful that in some cases, patients must have the entire pancreas removed. While surgery to remove the pancreas (pancreatectomy) relieves pain in 90% of cases, patients are left without the ability to produce insulin, causing a difficult-to-treat form of Type 1 diabetes known as “brittle diabetes.”

In auto islet transplantation, the patient’s islet cells, which produce hormones that regulate the endocrine system, are extracted from the pancreas after it is removed. The cells are then processed and re-infused into the patient’s liver, where they may eventually produce insulin to regulate blood sugar.

According to Dr. Beth Schrope, who spearheaded the auto islet transplant protocol at the Department of Surgery, about one third of patients require no insulin therapy after autologous islet transplantation, another third require some insulin therapy after the procedure, and the procedure is still unsuccessful in preventing diabetes in the remaining third. For two thirds of patients, the reduction of prevention of diabetes represents a tremendous advantage

Learn more in our previous blog posting and Healthpoints newsletter.

We’re looking for to 2015 as a year of continued scientific progress, clinical innovation, and care for our patients!  Keep informed by following us on Facebook and Twitter!

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Gastric Cancer Registry

by Columbia Surgery on February 13, 2014

456095855Gastric cancer is the second leading cancer killer in the world. It is estimated that over 10,000 will die from gastric cancer this year in the United States.

One of the reasons for its poor mortality rate is its late diagnosis. Unfortunately, in the United States, more than 60% of gastric cancer cancers are diagnosed at later stages. This means that despite curative surgery, additional treatment with chemotherapy or radiation is needed and recurrence rate is high. Even worse prognosis is conferred on the patient whose tumor may be inoperable because it has spread to the distant lymph nodes, lining of the abdomen, or other organs. If diagnosed in earlier stages, the survival rate is approximately 50% at five years after diagnosis.

Early detection is key to successfully treating gastric cancer. Unfortunately, gastric cancer is frequently not found until its late stages because screening tests, considered part of routine care in higher-risk countries, are not standard care in the United States. Understanding your personal risk of gastric cancer and seeking proper screening can make early detection possible.

Who is at increased risk for gastric cancer?

Some main risk factors include:

    • Genetic predisposition. CDH1 gene mutation is known to cause hereditary diffuse gastric cancer syndrome. Other genetic mutations, including those implicated in Lynch Syndrome, also increase the risk of gastric cancer.
    • Gender: Men are twice as likely as women to develop gastric cancer
    • Race: Korean and other Asian Americans face the highest risk of all Americans. Black and Hispanic Americans are also at increased risk, followed by Caucasians.
    • Helicobacter pylori (H. pylori) infection: H. pylori is found in a vast majority of patients with gastric cancer.
    • Atrophic Gastritis: Chronic swelling and inflammation of the stomach.
    • Diet: Consumption of salted, pickled, and smoked food is associated with an increased risk for gastric cancer
    • Family History: There is a genetic link with some types of gastric cancers.

People with immediate family members diagnosed with gastric cancer should consider being evaluated by a specialist or undergo screening.

What can I do if I am at increased risk for gastric cancer?

86507521If you feel you are at risk for gastric cancer, it is important to talk to a specialist and develop a screening plan based on your needs. There is also a new initiative, which may act as a good first step for those concerned about their risk.

The Gastric Cancer Registry is an important initiative that seeks to identify risk factors for gastric cancer by collecting and analyzing patient information and tissue samples. There is no fee to take part, and patients currently diagnosed with gastric cancer as well as those believed to be at risk are encouraged to participate.

The registry has two main components:

      1. A ten-minute survey to evaluate participant’s risk. In this survey, the registry collects a patient history and, if applicable, additional information about his or her diagnosed gastric cancer or other related diseases, such as gastritis.
      2. If a participant is evaluated as high risk or has been previously diagnosed with gastric cancer or related disease, he or she can donate a bio-sample, such as a saliva or blood sample, to be analyzed and included in the registry. This information obtained from this sample will be invaluable for future researchers to improve treatment and prevention for gastric cancer.

In addition to providing an assessment of patients’ risk for gastric cancer, the registry helps provide guidance about next steps, such as the need to speak with a specialist or undergoing more vigorous testing.

If you are interested in participating in the gastric cancer registry, please contact the Center for Global Excellence in Gastric Cancer Care at 212.305.0374.

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Research Study Enrolling Women from the Bronx Who Have Survived Colorectal Cancer

January 24, 2014

TweetResearchers at NewYork-Presbyterian/Columbia University Medical Center are conducting a clinical trial to test whether an exercise and diet weight loss program can help overweight colon or rectal cancer survivors reach a healthy body weight. The National Cancer Institute-funded research study offers nutrition counseling and free membership to a weight loss facility to help women who […]

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New Procedure to Prevent Lymphedema Gains Media Attention

January 13, 2014

TweetA new protocol to help patients undergoing breast surgery is gaining widespread media attention as NewYork-Presbyterian/Columbia University Medical Center continues an important clinical trial of the LYMPHA protocol. The LYMPHA protocol combines microsurgery with advanced imaging in order to prevent, detect, and treat lymphedema. Lymphedema, painful swelling of the arm or hand, can be a […]

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TCT Conference Recap

December 9, 2013

TweetThis year marked the twenty-fifth annual Transcatheter Cardiovascular Therapeutics Conference (TCT). TCT is a yearly event where interventional cardiologists, cardiac and vascular surgeons, nurse practitioners, and other health care professionals meet to discuss the latest breakthroughs and developments in the field of interventional cardiology. This year’s conference in San Francisco had over 12,000 attendees, and […]

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A Multicenter “Ablate and Resect” Study of Novilase Interstitial Laser Therapy for the Ablation of Small Breast Cancers

October 2, 2013

TweetColumbia University Medical Center is helping to lead a new clinical trial examining the effectiveness of using laser therapy to treat early-stage breast cancer. This new research involves a non-surgical treatment called, Novilase® Interstitial Laser Therapy (ILT). Novilase Breast Therapy is already cleared by the FDA for the treatment of breast fibroadenomas, which are the […]

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LYMPHA Trial Seeks to Prevent Lymphedema in Breast Cancer Patients

July 29, 2013

TweetAttention breast cancer patients: a new protocol is available to help prevent lymphedema, a debilitating condition that can occur after lymph node dissection. The Clinical Breast Cancer Program is enrolling patients in a two-year pilot study to evaluate Lymphatic Microsurgical Preventive Healing Approach, or LYMPHA, This innovative protocol combines microsurgery with advanced imaging in order […]

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Bridging the Gap: Enhancing Breast Cancer Prevention, Screening & Wellness Q&A (3 of 4)

December 11, 2012

TweetThis year’s Bridging the Gap: Enhancing Breast Cancer Prevention, Screening and Wellness event covered topics such as disparities in health care, alternative medicines, survivorship studies, genetics and other concerns for breast cancer patients, survivors and caregivers. At the end of the day, audience members were asked submit their questions to expert speakers. Below are some […]

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Pancreatic Cancer Research: Optimism and Hope

November 21, 2012

TweetKenneth Olive, PhD is the leader of a laboratory dedicated to understanding the mechanisms of pancreatic cancer and applying that understanding toward finding cures. Dr. Olive is an Assistant Professor at Columbia University and a member of the Herbert Irving Comprehensive Cancer Center. He has a primary appointment in the Division of Digestive and Liver […]

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What You Need to Know about Breast Cancer: Advanced Stage Diagnosis

September 7, 2012

TweetA three-part series of Blog Talk Radio shows, sponsored by The Columbia University Department of Surgery Clinical Breast Cancer Program, ended on September 5th with a program covering Advanced Stage Breast Cancer. Before he answered live questions from listeners, Sheldon Feldman, MD, Chief of Breast Surgery and Associate Professor of Surgery, New-York Presbyterian Hospital/Columbia University […]

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