Investigational Therapy May Treat Life-Threatening GI Leaks Without Surgery

Researchers repurposing E-Vac procedure to treat issues in the gastrointestinal tract

Gastroenterologists on the medical staff at Baylor University Medical Center at Dallas are evaluating a new procedure for patients with gastrointestinal (GI) leaks and perforations, a complication that can result from laparoscopic surgery on the esophagus, stomach and small intestines—and outcomes have been promising.

Steven G. Leeds, MD, medical director of minimally invasive surgery research and a gastroenterologist on the medical staff at Baylor University Medical Center, describes the procedure—referred to as endoluminal vacuum (E-Vac) therapy—as "source control" for leaks that spring up in the gastrointestinal tract, which can cause life-threatening infections. During the procedure, a surgical sponge is adhered to the hole in the GI tract and covered with a cellophane membrane. Negative pressure is then applied to generate inflammation between the sponge and the tissue; the inflammation expedites healing.

Dr. Leeds' latest paper on the subject, Endoluminal Vacuum Therapy for Esophageal and Upper Intestinal Anastomotic Leaks, was published online by the journal JAMA Wednesday. Co-authors are James S. Burdick, MD, and James W. Fleshman, MD., also on the medical staff at Baylor University Medical Center and investigators with Baylor Scott & White Research Institute.

Repurposing E-Vac Therapy for GI Needs
This procedure isn't new—at least not in general surgery. Surgeons have used the method to promote healing for decades. It wasn't until 2008 that researchers in Germany used this method for GI wounds. Then, in 2013, surgeons at Baylor tried the procedure on a patient who had exhausted all other options for treating an esophageal leak.

By using the tried-and-true method for treating surgical wounds inside the body, researchers were able to effectively patch the hole, stop the leakage and heal patients who were otherwise too sick for surgery.

"It actually works really well," Dr. Leeds said. "It's probably changed the face of how surgeons take care of wounds." He added, "We have been able to rescue patients from hospice, accept patients from other hospitals who have had major surgical complications and use this technique in ways it's never been described before. In all these situations, the patients have had good outcomes and restored their ability to eat when they hadn't been able to in the past."

A Novel Approach with Remarkable Results
Since 2013, Dr. Leeds and fellow gastroenterologists on the medical staff at Baylor University Medical Center have performed this procedure on 46 patients, published a paper in Surgical Endoscopy (with one more pending) and presented the E-Vac method at three conferences. Most recently, Dr. Leeds discussed successes with this procedure at the North Texas Chapter - American College of Surgeons 2016 Annual Meeting.

In the paper printed in Surgical Endoscopy in August 2015, Dr. Leeds reported the effects of E-Vac therapy in patients with upper intestinal leaks. Ultimately, he and his team treated a total of six patients using this method, and all six patients were completely healed in an average of 36 days. For a surgical complication that can result in death, a success rate this high shows promise, Dr. Leeds said.

"The outcomes have been remarkable," he said. "It's very exciting. This is truly a novel approach to healing GI perforations and leaks from surgery."

Currently, gastroenterologists on the medical staff at Baylor Scott & White are creating a registry of patients who have been treated with E-Vac therapy and hope to use this data to know more about the effects and uses of this procedure. Doctors also hope to develop an algorithm to treat more complicated leaks and introduce the method to other areas of surgery, such as transplant, thoracic and trauma.

 

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As the largest not-for-profit health system in the state of Texas, Baylor Scott & White promotes the health and well-being of every individual, family and community it serves. It is committed to making quality care more accessible, convenient and affordable through its integrated delivery network, which includes the Baylor Scott & White Health Plan, Baylor Scott & White Research Institute, the Baylor Scott & White Quality Alliance and its leading digital health platform – MyBSWHealth. Through 51 hospitals and more than 1,200 access points, including flagship academic medical centers in Dallas, Fort Worth and Temple, the system offers the full continuum of care, from primary to award-winning specialty care. Founded as a Christian ministry of healing more than a century ago, Baylor Scott & White today serves more than three million Texans. For more information, visit: BSWHealth.com