Conference looks at grading and staging of NASH
Presidential Profile
Advances in colorectal screening, Barrett's esophagus discussed
Knowledge of Stark Law, new revenue protect GI practice
Refinements to balloon-assisted enteroscopy deepen capability
ASGE will begin special sessions with Endoscopy for the Future
Joint symposium to address changes to GI surgical options
Surgical excellence focus of Monday's SSAT Opening Session



Conference looks at grading and staging of NASH

During Saturday's daylong AASLD Endpoints Conference on Non-alcoholic Fatty Liver Disease (NAFLD), two speakers focused on the grading and staging of non-alcoholic steatohepatitis, or NASH, with one examining the histologic evaluation of liver biopsies and the other assessing noninvasive methods of grading and staging.

Elizabeth M. Brunt, MD, professor of pathology and immunology, Washington University School of Medicine, St. Louis, MO, described the histopathology of NASH as a constellation of findings, including steatosis, ballooning lesions, Mallory bodies, fibrosis and both lobular and portal inflammation. In adults with NASH, steatosis begins in zone 3 and can be any grade.

The value of grading histopathologic findings for patients in clinical trials is that grading can demonstrate improvements after treatment for NASH and demonstrate a shift from lobular to portal inflammation, Dr. Brunt said.

She also discussed the eponymous "Brunt score" for NASH lesions as well as other scoring systems, including the NAFLD scoring system and the non-alcoholic steatosis (NAS) score, as clinical predictors of advanced NASH. The Brunt score was created for NASH specifically and not for the entire spectrum of NAFLD nor for lesion patterns seen in children. The NAFLD scoring system evaluates steatosis, lobular inflammation, ballooning lesions and fibrosis. NAS is an aggregate score that assesses overall changes in histology.

The results of grading and staging of biopsy specimens correlate with disease progression and can help researchers evaluate outcomes from NASH treatment.

"Careful histologic evaluation is justified and warranted in clinical studies," Dr. Brunt said. "Careful designing is needed, however, to assure that we are able to capture all the important features and findings we want to study."

Detlef Schuppan, MD, PhD, associate professor of gastroenterology at Harvard Medical School, Boston, MA, said that histologic grading and staging of biopsy samples could produce significant sampling errors for the diagnosis of NASH. He discussed options to liver biopsy for the assessment of NASH, including imaging and serologic evaluations.

The central parameters of the severity of NAFLD and key predictors of further progression to cirrhosis are inflammation, ballooning and fibrosis, Dr. Schuppan said. He called fibrosis is "the most important pre-endpoint parameter" and characterized the role of steatosis as minor.

The imaging studies used to evaluate NAFLD include ultrasound, CT scans and magnetic resonance imaging (MRI). MRI is the best technique but also the most costly, he said. Steatosis can be imaged, but not steatohepatitis or fibrosis. Novel imaging techniques under investigation include diffusion-weighted contrast MRI, MR spectroscopy and SPECT-CT for quantitative imaging of hepatic fibrosis and fibrogenesis, a technique Dr. Schuppan is researching.

Serologic evaluations are also available, such as the Steato test for steatosis and measurements of fibrosis, including the NAFLD fibrosis score, the BARD score to detect severe fibrosis, the enhanced liver fibrosis panel and the fibroscan, Dr. Schuppan said.

However, current tests for fibrosis progression may be accurate but need to be validated, he concluded.


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As president of the nation's leading organization for physicians and researchers confronting liver diseases, Scott L. Friedman, MD, brings years of academic, research and clinical experience to the job's most important role as AASLD's chief advocate for advancing the science and practice of hepatology.

Despite taking office in the midst of an economic crisis and deepening doubts about the health of medical research revenue sources this January, Dr. Friedman confidently looks ahead when asked what is the biggest challenge facing the society.

"I think it is translating decades of hard-won experience and knowledge at the bench and in the basic science realm into meaningful therapies for our patients," he said.

To achieve that goal, AASLD is focused on supporting research, continuing to build on its annual research meeting and advocating for hepatology with government regulators, elected officials and pharmaceutical companies to "remove what impediments we can to allow good, new medicines to reach the bedside," Dr. Friedman said.

As chief of the division of diseases of the liver at Mount Sinai School of Medicine in New York, NY, Dr. Friedman has been a hepatology researcher for more than 25 years. He has led pioneering research into liver fibrosis associated with chronic liver diseases and was the first investigator to isolate and identify the stellate cell, the key cell type responsible for the production of liver scarring.

Continuously funded by the NIH for more than two decades, Dr. Friedman watched with growing concern over the last several years as federal funding for medical research languished. The economic downturn has only worsened this situation and hepatology research funding now faces what Dr. Friedman describes as a perfect storm of convergent forces.

Those forces include a pharmaceutical industry increasingly reluctant to support research, stagnant NIH funding and the economic toll taken on AASLD's investments. Good news arrived recently with the passage of President Obama's stimulus package, the American Recovery and Reinvestment Act, which is injecting $10.4 billion into NIH funding and is expected to benefit hepatology.

"Challenge grants have been listed among several initiatives that are directly relevant to liver research, including projects identifying biomarkers and treatments for patients with liver disease, liver cancer, viral hepatitis and other programs," he said.

Despite the immediate boost in federal funding, there isn't a clear picture regarding research investment from the pharmaceutical industry, which is becoming more constrained by guidelines limiting interaction with professional associations.

"With constricted interaction, it's less appealing to support some of our research missions," Dr. Friedman said.

To help address the murky future of research funding, AASLD last year launched the New Challenges, New Solutions fundraising campaign. The society is currently more than 60 percent of the way to reaching a $5 million target to establish an endowment to support research.

Dr. Friedman said one of his most important duties as president is to be the face of the society's members when reaching out to government regulators and elected officials. In March, he joined members of the American Liver Foundation, the public education and outreach organization aligned with AASLD, on a trip to Washington to lobby Congress. The message was the human cost of further delays in expanding federal research funding. Dr. Friedman said he has embraced this new political role.

"If I can't articulate effectively for what we do and who we are, then I'm not fulfilling my responsibilities to my patients and to my specialty," he said.

Another important role for AASLD's president has been representing the society in building international partnerships with European and Asian hepatology research associations.

He recently represented AASLD at a Liver Global Summit held in Sao Paolo, Brazil. In February, he traveled to Hong Kong to sign a memorandum of understanding between AASLD and the Asian Pacific Association for the Study of the Liver, which followed a similar partnership already in place with the European Association for the Study of the Liver.

Those activities, Dr. Friedman said, recognize the growing need for global collaboration in drug development and testing, in regulatory issues and in the need to understand and share both differences and similarities in how diseases are treated around the world.

There is also a benefit to speaking with one international voice when calling for more research funding.

"We have the same message that would be strengthened by sharing our expertise and, wherever appropriate, advocating together for funding," Dr. Friedman said. "For example, the World Heath Organization, the UN and, of course, private groups like the Gates Foundation."

The AASLD is currently developing a global health session for The Liver Meeting, the society's fall annual meeting that will bring together representatives from each of the international liver research associations.

And to cap off the beginning of a busy year for the society president, AASLD is putting the finishing touches on what Dr. Friedman describes as an "ambitious" new strategic plan that establishes a series of milestones and initiatives designed to keep the organization focused on its major objectives.

"Our primary goal is to advance the science and practice of hepatology. We have to stay on track, to stay focused on that goal even when times get hard and we face challenges," he said.


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Advances in colorectal screening, Barrett's esophagus discussed

Strategies for colorectal cancer screening and the management of Barrett's esophagus (BE) were discussed during Saturday's first AGA Postgraduate Course general session, "Preventing Death from Gastrointestinal Malignancy."

One of the most visible changes is a split in recommendations for colorectal cancer screening. Current guidelines from the Multisociety Task Force (MSTF), the American Cancer Society and the American College of Radiology call for a menu of screening options. ACG and ASGE guidelines rely on colonoscopy every 10 years.

"It is impossible to determine which of these approaches will result in higher rates of screening, higher rates of cancer detection and lower rates of cancer mortality," said Douglas Rex, MD, FACP, FACG, professor of medicine and director of endoscopy at the Indiana University School of Medicine, Indianapolis. "What data we do have suggests that giving a menu of options is preferable in terms of patient adherence."

The MSTF-ACS-ACR menu ranges from annual fecal immunochemical testing (FIT) to Hemoccult SENSA tests (HOS) to flexible sigmoidoscopy every five to 10 years, CT colonography (CTC) every five years, fecal DNA testing, double-contrast barium enema (DCBE) every five years or colonososcopy every 10 years. The evidence strongly favors FIT over HOS because it is more reliable, more consistent and easier to use, he said.

Also new is a separation between cancer prevention and cancer detection. Prevention includes screening tests such as colonoscopy, flexible sigmoidoscopy, CTC, and DCBE. Cancer detection includes fecal blood tests (FIT or HOS) and fecal DNA tests.

Colonoscopy retains its vital role in reducing the toll of colorectal cancer, but technique must be improved, Dr. Rex said. The procedure is highly dependent on the operator, with a 10-fold variation in adenoma detection rates.

"Quality in colonoscopy should be the primary focus of gastroenterologists," he said. "We need to identify the low-detectors among us and help them to become better."

Quality is also a key concern in the management of BE. Esophageal adenomas have increased six-fold since the 1990s, said Nicholas Shaheen, MD, MPH, associate professor of medicine and epidemiology at the University of North Carolina, Chapel Hill. The five-year survival rate for esophageal cancer is only 15 percent.

"Barrett's doesn't kill anybody," Dr. Shaheen said. "It is a precursor. Most Barrett's doesn't progress, but we need to identify and deal with those that do."

Nodular disease must be removed by endomucosal resection, he said. Flat lesions can be effectively removed using thermal ablation, photodynamic therapy (PDT) or radiofrequency ablation (RFA). All three are effective, but PDT has a high rate of dense strictures. RFA has a much lower structure rate than PDT. A fourth technique, cryoablation, is being developed.

"The best data are currently associated with RFA, but the best technique is the one the endoscopist knows the best," Dr. Shaheen said.




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Knowledge of Stark Law, new revenue protect GI practice

GI managers and administrators learned about the importance of adhering to the Stark Law and innovative ways to expand practice offerings during Saturday's AGA course, Practice Management Essentials for Non-Physician Practice Managers and Administrators, at the InterContinental Chicago Hotel.

Attorney Daniel F. Gottleib discussed the basic rules and exceptions to the Stark Law in his presentation, "How the Stark Law Impacts Your Practice." The Stark Law, a strict-liability statute, governs physician self-referrals and reimbursements for Medicare patients, and serves as a "fraud and abuse" rule.

"The law does not care whether a violation is intentional or willful," said Gottleib, a partner in the Health Law Department of McDermott Will & Emery, Chicago, IL, and one of the authors of "A Guide to Complying with Stark Physician Self-Referral Rules."

"Stark does not care whether, or to what extent, a violation affected physician-referral patterns, increased utilization and costs, corrupted clinical judgment, or impinged on patient choice," he said. "Stark simply demands compliance, with an exception or a prompt refund of the Medicare payments."

A common question asked, Gottleib said, is, "Do anatomical pathology pod labs qualify for an exception?"

"The answer is 'yes' but there are challenges," he said. "CMS adopted a new diagnostic test anti-markup rule that prohibits an ordering physician from billing Medicare in excess of the 'net charge' of certain diagnostic tests unless one of two alternative tests for determining whether the test is performed by a physician sharing a practice with the billing physician is met."

Sanctions for violating the Stark Law are steep, Gottleib said, and could include civil monetary penalties of up to $15,000 per service; permissive exclusion from Federal programs; and false claims liability.

Kirk A. Brandon, AA, LA, NTR, Metropolitan Gastroenterology Group, presented "Adding Pathology and Other Business Lines to Your Practice."

A drop in demand for services, hiring and wage freezes, and other operating budget cuts have all contributed to declining income in GI practice, he said.

"We have to search for other reasonable, attainable revenue resources," Brandon said.

One viable option, he said, is adding a pathology lab to a GI practice. Other investments to consider that could add valuable income to a GI practice include endoscopy, infusion, research, specialty care, capsule studies, CT colonography and anesthesia services.

The AGA course will continue from 7:30 a.m. to noon today and will feature sessions on preventing embezzlement and medical identity theft, and frequent GI coding errors. The course is presented by the AGA Center for GI Practice Management and Economics.

Given Imaging provided partial support for this meeting.


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Refinements to balloon-assisted enteroscopy deepen capability

Distal gastrointestinal tissue that may otherwise elude diagnostic view now has the potential for deep visualization, thanks to advances in double-balloon enteroscopy and to bowel-conditioning approaches that allow scopes to travel farther down the tract.

During the opening session at the ASGE Masters Series Course on enteroscopy, Carol E. Semrad, MD, associate professor of gastroenterology at the University of Chicago, IL, and Charles Dye, MD, associate professor of gastroenterology at Penn State College of Medicine, Hershey, PA, described ways to overcome some past technical problems. They also offered recommendations to help assure safe, therapeutic use of this balloon-assisted technology, which can substantially boost diagnostic yield in the small bowel.

Both speakers stressed that there is still no substitute for experience. A learning curve of at least 20 procedures and about 200 hours continues to correlate with relatively shorter procedure times and better results, particularly with double-balloon enteroscopy (DBE).

DBE extends the capability for capture of biopsy specimens beyond the limits of traditional endoscopy. Citing a study by gastroenterologist Andrea May, MD, PhD, University of Mainz, Wiesbaden, Germany, and colleagues, Dr. Semrad said that the comparison of the oral and anal route of DBE versus push enteroscopy (PE) with overtube showed the former had a diagnostic yield of 73 percent compared with PE-overtube at 44 percent.

However, DBE is contraindicated for patients with fresh stoma, latex allergy or complete obstruction. Other limitations include cases in which there is a fixed bowel, altered anatomy or a potentially longer small bowel due to patient characteristics, such as height or obesity, Dr. Semrad said.

Steps that take account of sometimes hard-to-predict bowel morphology or position can help, Dr. Dye said.

"One solution is to try to straighten it out," he said. In the ileum, for example, intubation may be achievable with a straight scope preceding the balloon tube. Stiffeners and wires can help in that part of the intestine, too, for the same purpose – as can mineral oil, for lubrication. "Insist on a good bowel prep," he added.

And DBE takes some special considerations: a dedicated "tech" nurse, simethicone washes and a fluoroscopy room all are necessary, Dr. Semrad said. Also, because the procedure may exceed a couple of hours, conscious sedation may not be the right choice for most patients, she said.


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ASGE will begin special sessions with Endoscopy for the Future

On Monday afternoon, ASGE kicks off its Special Session series with Endoscopy for the Future: How to Teach Old Dogs New Tricks. The session, moderated by Robert A. Ganz, MD, FASGE, chief of gastroenterology at Abbott-Northwestern Hospital, Minneapolis, MN, and associate professor of medicine at the University of Minnesota, and Pankaj J. Pasricha, MD, FASGE, from Stanford University School of Medicine, Stanford, CA, will cover a variety of thought-provoking topics regarding new technologies and procedures.

A discussion about the future of screening colonoscopies is sure to spark a controversial debate. According to Dr. Ganz, in broad terms, refinement to many existing techniques and procedures will make them easier for the gastroenterologist to perform and easier for the patient to tolerate. In other respects, however, "endoscopy of the future will look a lot like endoscopy of the past," he predicted.

Attendees can also expect to learn about how new and emerging technologies and procedures such as confocal microscopy and NOTES® (Natural Orifice Translumenal Endoscopic Surgery) will impact gastroenterologists. A number of issues around these topics will be discussed, such as effectiveness, training and economics.

In addition to Dr. Ganz's presentation, this session will include:

• "Advances in Optical Imaging – Are We Blind to the Unmet Needs?" with Marcia I. Canto, MD, MHS, FASGE.
• "The Great Colonoscopy Bubble – Why and When It Will Burst?" with John I.Allen, MD.
• "The Gastroenterologist as Surgeon: Prodigy or Pariah?" with Peter B. Cotton, MD, FASGE.
• "Endoscopy and Unmet Needs in GI: How We Can Expand the Pie Instead of Just Slicing it into Smaller Pieces?" with Pankaj J. Pasricha, MD, FASGE.
• "Who Will Pay and for What in the Future: Irrational Reimbursement and How to Fix It" with Joel V. Brill, MD, FASGE.

Four gastrointestinal diseases whose surgical management options have evolved greatly in recent years will be discussed Monday during the SSAT/ASCRS Joint Symposium, Surgical Management of Complex Colorectal Disorders.

Surgeons will present updates on the latest treatment options for perforated diverticulitis, C. difficile colitis, Crohn's disease and ulcerative colitis during the two-hour session.

"These four topics were selected because they are fairly complex and acute surgical problems that a GI surgeon will encounter frequently," said Anthony J. Senagore, MD, moderator of the session. "There has been an evolution in thought in either the technical component or the decision-making component of treatment."

Many of those changes have occurred over the last five to seven years, and the changes in treatment often focus on timing and indication for surgery or technical advances, he said.

"The surgeons in each topic will discuss different surgical techniques – the tricks of the trade," said Dr. Senagore, professor of surgery at Michigan State University, Grand Rapids.

"Management Options for Perforated Diverticulitis: Diversion or No Diversion" will be presented by Martin A. Luchtefeld, MD, assistant professor at Michigan State University, Grand Rapids, who will discuss new surgical options.

"For perforated diverticulitis, there are a variety of new techniques so that oftentimes you can avoid a colostomy," Dr. Senagore said. "This is about appropriate intervention and strategies, as well as indications for one-stage resection and avoidance of stoma."

The increasingly common diagnosis of C. difficile colitis will be addressed by David A. Margolin, MD, director of colon and rectal research at Ochsner Health System, New Orleans, LA, in "Management Strategies for C. difficile Colitis: Operate Too Soon or Too Late?"

"With C. difficile, there is recognition that this is more of an epidemic," Dr. Senagore said. "There needs to be a greater respect for the illness and a bias toward a 'sooner–rather–than–later' surgical intervention. In the old days, fewer people came to surgery, but now the disease seems to be more virulent. The surgeon needs to have a clear understanding of the appropriate time to intervene to decrease morbidity and mortality."

Bowel-preservation techniques will be discussed by Eric G. Weiss, MD, in "Management Options for Complicated Crohn's Disease: Resection vs. Stricturoplasty vs. Bypass." Dr. Weiss is director of surgical endoscopy at Cleveland Clinic Florida, Weston.

"Crohn's is a less common disease, so the average GI surgeon sees a lower volume of cases," Dr. Senagore said. "This presentation is about coming up with strategies, primarily aimed at bowel preservation to avoid short-bowel syndrome, and stricturoplasty is the dominant strategy."

The increased implementation of immunosuppressive actions will be discussed by Eric J. Dozois, MD, associate professor of surgery at the Mayo Clinic, Rochester, MN, in his lecture "Management Options for Ulcerative Colitis in Acute Flares or After Prolonged Immunosuppressive Therapy: Does Too Much Medicine Make a Difference?"

"For ulcerative colitis, the game has changed because of the broader implementation of the biologic agents for irritable bowel disease. This has again changed the immunosuppression that patients face," Dr. Senagore said. "It has brought us back to a paradigm of broader use of a three-stage resection compared to a two-stage in the older days. Also, patients are coming to surgery a bit later and more chronically immunosuppressed than what we were used to seeing."

Dr. Senagore is vice president of research at Spectrum Health, Grand Rapids, MI. Dr. Luchtefeld is a clinical adviser in gastroenterology and oncology at Spectrum Health. Dr. Weiss is chief academic officer and chairman of Graduate Medical Education at Cleveland Clinic Florida.

A successful surgeon has a strong background in science, a knack for leading a support staff, strong communication skills and the drive to stay on top of the profession, so Monday's SSAT Opening Session should be just the ticket for society members.

The session will highlight seven of the top scientific abstracts submitted for the SSAT program, a guest orator who, as a physician, has metrics showing how to improve patient satisfaction and the reflections of the outgoing president on what it takes to make a surgeon "above average."

The day will begin with the science, when four top abstracts will be presented during Presidential Plenary A, and continue with even more science when Presidential Plenary B highlights three more top research papers.

In between, SSAT President David W. McFadden, MD, will deliver his Presidential Address, "Above Average," and at the end, a practicing physician, Stephen Beeson, MD, who has written two books and coached other physicians on improving patient satisfaction, will deliver the Doris and John L. Cameron Guest Oration.

"I think we have seven excellent examples of basic and clinical science that will be of interest to all surgeons. They span the entire alimentary tract, from the esophagus to the colon," Dr. McFadden said of the abstracts that will be presented.

In addition to featuring strong research, the abstracts were chosen because they cover a variety of subjects that do not overlap, he said. The result is a well-rounded and stimulating morning.

In his Presidential Address, "Above Average," Dr. McFadden will verbalize thoughts he has been collecting throughout his career and cataloging since his term in office began a year ago.

"I've been thinking about it for quite a while, and I want to discuss the quality and training of a surgeon, and the maintenance of surgical competency," he said. "What does it mean to be 'above average?' What is an average surgeon? We're all above average when we rate each other."

Concluding the Opening Session will be the Guest Oration, in which Dr. Beeson will discuss his efforts and successes in improving patient satisfaction at his practice in San Diego, CA.

Dr. Beeson, a family physician, is part of a health-care firm with seven hospitals and two medical groups that received the Malcolm Baldridge Award and has been ranked the No. 1 medical group in California for three consecutive years in patient experience and clinical quality.

"I've realized over the last few years that physicians are very interested in doing this, but there is very little curriculum on evidence-based behaviors to drive clinical outcomes, improve the patient experience and drive loyalty to a physician," Dr. Beeson said.

The author of Practicing Excellence: A Physician's Manual to Exceptional Health Care, Dr. Beeson has become a "physician coach," using evidence-based markers to help physicians optimize understanding to improve surgical communication, which he said helps reduce post-operative complications and malpractice risk.