DigestiveINSIGHTS A Publication of Baylor Health Care System Digestive Care Services and Baylor Charles A. Sammons Cancer Center at Dallas Volume 1 • Number 3
The Role of Robotics in Treating Colorectal Cancer Surgeons first began to perform laparoscopic surgery to remove colorectal tumors in the early 1990s. Numerous multi-institutional, randomized trials conducted around the world have proved that the outcomes for laparoscopic (performed through small openings in the abdomen using long, thin instruments) procedures are identical to those for open procedures. “We’ve known for some time that minimally invasive surgery (laparoscopy) is the right way to go with colon cancer. It offers less pain, shorter stays and fewer complications. The question now is which type of minimally invasive —robotic or traditional laparoscopy,” said James W. Fleshman, Jr., MD,
chief of surgery at Baylor University Medical Center at Dallas. A newly developed form of robotic surgery called Single-Site™ may propel the robot to the forefront of colon cancer treatment, Dr. Fleshman said. In these systems, the robotic arms James W. Fleshman, Jr., MD
In This Issue: Enhanced Recovery Protocols Improve Outcomes after Colorectal Surgery
and camera go through a single incision at the umbilicus, which reduces the number of punch holes required to resect the colon. The specimen is extracted through that same incision.
Newly Approved Drugs Show High Cure Rates for Hepatitis C 4 The Challenges of Treating Chronic Pancreatitis
Endoscopic Ultrasound Proves Effective Diagnostic and Therapeutic Tool
Whipple Procedure Requires Extensive Skill and Experience
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“We need to further evaluate the role of the robot in treating colon cancer,” Dr. Fleshman said. “The real advantage of the robot is with rectal cancer. Technically, laparoscopic surgery to remove rectal cancer is far more challenging than for tumors in the colon. The robot facilitates working in
2 Digestive Insights | Baylor Health Care System Digestive Care Services
the deep pelvis through its long instrumentation, with 360-degree wristed graspers and scissors tips that allow complete range of motion in a very small area.” Dr. Fleshman is the lead investigator of a nationwide clinical trial comparing laparoscopic surgery to the conventional open approach in patients with rectal cancer. The trial’s three endpoints include radial (measured around the circumference of rectum)
and distal (measured from the lowest edge of the tumor and the cut edge of the bowel) margins, and the completeness (the quality of the specimen in terms of cancer resection) of the resection of the rectum and the fat and lymph nodes around it (mesorectum).
resection of rectal cancer. Dr. Fleshman is the investigator for Baylor. “We expect the trial will show robotic laparoscopy and open procedures are equivalent,” he said. “But as with any new technology, patients must be selected appropriately.”
Colon and rectal surgeons on the medical staff at Baylor Dallas also are participating in an international trial comparing robotic and laparoscopic
“We’ve known for some time that minimally invasive surgery (laparoscopy) is the right way to go with colon cancer. It offers less pain, shorter stays and fewer complications. The question now is James W. Fleshman, Jr., MD which type of minimally invasive—robotic or traditional laparoscopy.”
Baylor Charles A. Sammons Cancer Center at Dallas | Digestive Insights 3
Enhanced Recovery Protocols Improve Outcomes after Colorectal Surgery Over the last 20 years, there has been a paradigm shift in the approach to perioperative care of patients undergoing major colorectal surgery. With conventional care protocols, patients stayed in the hospital an average of 10 to 14 days, often in the ICU, with nasalgastric tubes and a high degree of IV narcotics. The introduction of laparoscopic colorectal surgery reduced stays to about seven to nine days. Enhanced recovery protocols are a set of perioperative interventions that are designed to expedite a patient’s recovery after major surgery. When these advanced protocols are adopted, hospital stays can be reduced to an average of just one to three days. According to the ERAS® (Enhanced Recovery After Surgery) Society, use of these protocols can reduce care time by more than 30 percent and reduce post-operative complications by up to 50 percent. Enhanced recovery uses a collaborative approach among several disciplines, including surgery, anesthesia, nursing and pharmacy. All work together to determine what is appropriate for a patient’s specific situation, including the expected length of the procedure.
The four key areas of enhanced recovery are 1) avoidance of perioperative fluid overload, 2) minimization of systemic opioid consumption, 3) early oral diet, and 4) ambulation. “In my experience, avoiding fluid overload reduces all surgical complications, including cardiopulmonary problems. Traditionally, it was believed patients were dehydrated due to the bowel prep, but now not all patients get that bowel prep. And if they do, the new bowel preps require much less volume, reducing the likelihood of severe dehydration and electrolyte disturbances,” said Sarah Y. Boostrom, MD, a colorectal surgeon on the
medical staff at Baylor University Medical Center at Dallas. “Fluid overload can cause a variety of problems, including pneumonia, atrial fibrillation in the elderly, and edema in the bowels, which can increase the risk of ileus.” Dr. Boostrom said enhanced recovery protocols emphasize the use of oral pain medications over IV narcotics to enable patients to walk sooner, thereby decreasing the risk of blood clots. “There is significant research that shows these perioperative interventions have scientifically proven clinical benefits,” she said.
Hepatitis C Newly Approved Drugs Show High Cure Rates for Hepatitis C Two new drugs are providing hope to the approximately 3.2 million people in the United States who are infected with the hepatitis C virus. Unlike the previous therapy, the new drugs have minimal side effects and offer most patients an almost 90 percent chance at cure in just 12 weeks. Sofosbuvir, a polymerase inhibitor, is approved for use interferon free in combination with just ribavirin for patients with genotypes 2 and 3. Twelve weeks of therapy for naïve genotype 2 and 24 weeks of therapy for naïve genotype 3 patients result in sustained virologic response (SVR) in more than 90 percent of patients. “The new drug has essentially no side effects, and when combined with ribavirin is extremely well tolerated,” said Jacqueline G. O’Leary, MD, MPH, medical director of hepatology research at Baylor University Medical Center at Dallas. “Patients who have had interferon in the past are amazed. Interferon makes you feel like you have the flu the whole time.”
Treatment-naive patients with genotype 1 have a 12-week option of triple therapy with sofosbuvir, ribavirin and interferon. This regimen showed an SVR of 89 percent. Sofosbuvir also is approved for re-treatment patients, although cure rates are not yet available. “Patients with genotype 1 who can’t tolerate interferon may be treated with 24 weeks of sofosbuvir and ribavirin,” Dr. O’Leary said. “It’s good to have that as an option for interferonineligible or intolerant patients.” Simeprevir, a protease inhibitor, has also been approved for use in combination with interferon and ribavirin for patients with genotype 1. However,
when simeprevir was combined with sofosbuvir for just 12 weeks in a small phase II study, more than 90 percent of patients with advanced fibrosis who were prior null responders to pegylated interferon and ribavirin achieved SVR. “We literally had no new drugs for a decade,” Dr. O’Leary said. “Then in 2011, there was the first release of direct-acting anti-viral agents. Although this was a major advance, tolerability remained an issue that limited who could be treated and cured. Now just two years later, we have curative therapies for the vast majority of patients. There has been a complete revolution in how we care for patients with hepatitis C.”
“The new drug has essentially no side effects, and when combined with ribavirin is extremely well tolerated. Patients who have had interferon in the past are amazed. Interferon makes you feel like Jacqueline G. O’Leary, MD, MPH you have the flu the whole time.”
Baylor Charles A. Sammons Cancer Center at Dallas | Digestive Insights 5
The Challenges of Treating Chronic Pancreatitis The severe abdominal pain that can result from chronic pancreatitis is often debilitating for patients and difficult for physicians to manage. Patients are high users of medical facilities, with frequent trips to the emergency room and hospital admissions. They also can experience significant lifestyle disruptions. Initial treatment may include pancreatic enzyme therapy, a low-fat diet, abstinence from alcohol, smoking cessation and non-narcotic analgesics. When non-prescription pain medications fail to control the pain, narcotic pain medication may be prescribed. However, because of the severity and chronic nature of the pain, patients frequently develop long-term narcotic dependence. Nerve blocks can provide temporary relief for many patients. Endoscopic stents that improve ductal drainage may alleviate pain. But when these procedures fail to provide sustained relief, an innovative therapy may be considered. At Baylor University
Medical Center at Dallas, patients with chronic pancreatitis may be evaluated for a total pancreatectomy followed by an autologous islet cell transplant. In this procedure, the pancreas is surgically removed and taken to the lab, where the patient’s own islet cells are extracted. These cells are then infused into the patient’s liver through the portal vein, where they take hold and ideally begin to produce insulin again on their own. This may allow the patient to become less dependent on insulin or not dependent on insulin at all, thus avoiding the diagnosis of brittle diabetes. In addition, the patient is relieved of much or all of the pain they had experienced.
“This is a very attractive alternative, because we’re able to treat a patient population that has run out of options and has little hope for improvement,” said Marlon Levy, MD, FACS, medical director, Islet Cell Transplant Program, Baylor Health Care System, and surgical director of transplantation at Baylor All Saints Medical Center at Fort Worth. “More than 90 percent of patients report good to excellent pain relief.” Baylor was the first center in Texas to have a cellular laboratory approved by the FDA to produce islet cells for therapy.
Total Pancreatectomy Followed by an Autologous Islet Cell Transplant
The pancreas is removed and prepared for transport to the islet cell lab.
In the lab, the patient’s islet cells are extracted from the pancreas.
The patient’s islet cells are infused into the liver through the portal vein.
6 Digestive Insights | Baylor Health Care System Digestive Care Services
Endoscopic Ultrasound Proves Effective Diagnostic and Therapeutic Tool Endoscopic ultrasound (EUS) combines endoscopy and ultrasound to produce high-quality images of the digestive tract and the surrounding tissue and organs. In EUS, a transducer is placed on the tip of the endoscope, which allows the transducer to get close to the organs inside the body. Because of this close proximity, high-frequency ultrasound waves are able to create much more detailed images than traditional ultrasound or other types of techniques. EUS also can visualize underneath the layers of the gastrointestinal tract to see other structures. EUS is most commonly used to diagnose or stage cancers of the GI tract and to evaluate abnormal findings from other imaging studies. A major use of the technology is finding cysts inside the pancreas. EUS also may be used to sample lesions or bumps underneath the surface of the GI tract that are discovered with other imaging modalities.
Baylor University Medical Center at Dallas utilizes on-site pathology during all endoscopic ultrasound procedures.
pancreatic necrosis or drain pancreatic cysts. EUS also may be an option for treating early tumors or cancers in the colon.
“This has been shown to make a difference in outcomes,” said James S. Burdick, MD, a gastroenterologist on the medical staff at Baylor Dallas. “With a pathologist in the room, we can get immediate feedback as to whether more tissue or a different type of tissue is needed. This can save a patient from having to undergo a follow-up procedure.”
“Various endoscopic units have been able to treat colonic tumors effectively in 60 to 85 percent of cases that were previously treated surgically,” Dr. Burdick said. “As endoscopic approaches offer a less-invasive means of therapy, they are employed at a lower cost with much less risk to the patient.”
In addition to its use as a diagnostic tool, EUS is increasingly being utilized for therapy. In what used to be a surgical procedure, physicians can now perform a pancreatic necrosectomy by inserting an endoscope through the wall of the intestines to debride
In addition to Baylor Dallas, endoscopic ultrasound is available at Baylor All Saints Medical Center in Fort Worth, Baylor Regional Medical Center at Grapevine, Baylor Medical Center at Irving and Baylor Medical Center at McKinney.
Baylor Charles A. Sammons Cancer Center at Dallas | Digestive Insights 7
Whipple Procedure Requires Extensive Skill and Experience For some patients with pancreatic cancer, a pancreaticoduodenectomy, commonly referred to as the Whipple procedure, may extend a patient’s life and lead to a potential cure. This complex surgical procedure is available at Baylor University Medical Center at Dallas and Baylor Regional Medical Center at Plano. “Since pancreatic cancer spreads early, only a minority of patients are candidates for the procedure. But for those who are eligible, outcomes have improved dramatically over the last 10 to 15 years,” said Jeffrey Lamont, MD, a surgeon on the medical staff at Baylor Dallas and Baylor Plano. During the Whipple procedure, the head of the pancreas, first portion of the small intestine, gallbladder, a portion of the bile duct, and sometimes a small portion of the stomach are removed, with the goal of removing the entire tumor. After resection, the gastrointestinal tract is reconstructed. “This is a technically demanding procedure, and the best results are
achieved by those surgeons and surgical teams who perform a high volume of the surgeries. The complication rate for the procedure can be high, but is generally lower at high-volume centers,” said Scott Celinski, MD, a surgeon on the medical staff at Baylor Dallas. “We’re working in a part of the body with incredibly complex anatomy with large blood vessels that are adherent to surrounding structures,” he said. “It requires a surgical connection between the intestine and remaining pancreas, and this connection is prone to leaking. The pancreas sits right on top of the blood vessels that supply the intestines, so surgeons have to be careful not to damage them.”
The Whipple procedure also may be used in patients with bile duct cancer, duodenal cancers, benign tumors causing symptoms, premalignant lesions like pancreatic cysts, and other cancers that have metastasized to the pancreas, such as renal cell cancers. “These are patients with significant cancers that require multidisciplinary assessment by a strong team of surgeons, medical oncologists, radiation oncologists and gastroenterologists,” Dr. Lamont said. “Baylor also offers excellent ancillary support staff, such as nutritionists and patient navigators. These patients will see a lot of different doctors and have many different tests in a short period of time.”
“This is a technically demanding procedure, and the best results are achieved by those surgeons Scott Celinski, MD and surgical teams who perform a high volume of the surgeries.”
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Baylor Brings Research to the Patient’s Bedside Baylor is working with the National Institutes of Health and other centers across the nation to study a variety of issues regarding digestive diseases. For more information, go to www.BaylorHealth.edu/Research.