Endoscopy evolves from treatment to surgery
Doctors address issues in post-liver transplantation
Chronic hepatitis C: A breath test to determine fibrosis
Session presents advantages of CT colonography to GI practice
Concept of patient-centered care gains momentum
Researcher seeks blood test for pancreatic cancer
Quality initiatives make headway
Presidential Profile



Endoscopy evolves from treatment to surgery

Endoscopy is on the move. The specialty that created easier, faster and lower risk alternatives to surgical procedures is now challenging surgery itself.

“We have long seen and practiced endoscopy as a complement to surgery,” said Kenneth Binmoeller, MD, California Pacific Medical Center, San Francisco, in a state-of-the-art lecture during ASGE’s Topic Forum on New Technology. “We are in a paradigm shift from endoscopic treatment to endoscopic surgery.”

Dr. Binmoeller said the shift should be no surprise. Endoscopy began as a novel technology that allowed clinicians to visualize portions of the GI tract. But it wasn’t long before the diagnostic tool evolved into a biopsy tool.

By the late 1960s, endoscopy was used daily to remove polyps, to open lumens and to stop bleeding.

“These simple uses combined treatment with diagnosis on a routine basis,” Dr. Binmoeller said. “They also marked a change in the way we think about endoscopy.”

Simple polypectomy has evolved into endoscopic resections. Opening lumens has evolved into stenting. Hemorrhage control has evolved into coagulation, injection and ligation.

Technology continues to advance endoscopy, Dr. Binmoeller said. In the 1990s, new techniques allowed endoscopists to lift and cut mucosal tissue. When it became apparent that piecemeal resection was suboptimal, researchers developed en bloc techniques.

That development continues with new cutting technologies and novel methods to lift tissue from the field.

Horst Neuhaus, MD, Evangelisches Krankenhaus, Düsseldorf, Germany, reported a randomized controlled trial comparing traditional endoscopic mucosal resection (EMR) to endoscopic submucosal dissection with a Waterjet Hybridknife (ESDH) in pigs. ESDH combines cutting/coagulation with an axial high-pressure water channel for injection/flushing.

ESDH produced 100 percent en bloc resection, but EMR resection produced an average of 2.5 pieces of tissue. ESDH also produced a significantly greater number of complete resections. ESDH resection took a mean of 28 minutes versus 12 minutes for EMR, but total procedural time was less with ESDH because there was no need to change tools. Complication rates were similar with both techniques.

Two Japanese researchers reported new devices to lift tissue for easier en bloc resection. Nobuyuki Sakurazawa, MD, Nippon Medical School, Tokyo, used a stainless steel spring to provide tension as a stomach tumor is dissected.

One end of the two-centimeter spring is anchored in the lesion; the other end is clipped to the stomach. Tension springs lift the tumor during resection, providing a clear field of view at all times. The device has been used successfully in 10 patients.

“It is very easy to see blood vessels and submucosal layers with the spring and to pull the tumor out of the way as you proceed,” Dr. Sakurazawa said.

Kazuki Sumiyama, MD, Jikei University School of Medicine, Tokyo, reported a similar device that uses magnets to lift tissue during resection of GI cancers. One or more magnets are anchored in the lesion and a larger magnet is introduced into the cavity using a modified PEG technique. As the lesion is cut away using an IT knife, magnetic attraction lifts tissue away, leaving a clear field of view.

“The magnetic technique can be used in many cavities and techniques, including NOTES™,” Dr. Sumiyama said. “It is safe and extremely easy to use.”

Technology is also changing treatment for anastomotic strictures. Studies in Holland and Korea found that electrocautery is faster and more effective than traditional dilation for expanding opening strictures. Patients also report higher tolerability and satisfaction with electrocautery.

The next step is endoscopic surgery. Rudolf Stadlhuber, MD, Creighton University School of Medicine, Omaha, NE discussed a device that allows endoscopic gastroplasty under conscious sedation. The device has been used successfully in dogs and pigs; human trials are scheduled for 2009.

The device is one of many endoscopic surgical tools under development, Dr. Binmoeller said. He predicted that laparoscopy and endoscopy will meet in NOTES.

“Patients will benefit from the remarkable advances in endosurgery we are seeing from year to year,” he said.

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Doctors address issues in post-liver transplantation

In Monday afternoon’s AASLD Topic Forum on liver transplantation, several topics pertinent to improving post-transplant outcomes were addressed.

Yoshihide Ueda, MD, of Kyoto University and colleagues showed that treating patients with established recurrent HCV with interferon (IFN) and ribavarin following living donor liver transplantation (LDLT) — a common practice in Japan and Asia — was effective for obtaining a sustained virologic response (SVR). The study also concluded that biochemical response was not significant to evaluate histologic improvement in patients who did not show SVR.

Data were presented for 40 patients who received interferon three times a week for 12 months and ribavarin for six months. SVR was defined as undetectable serum HCV RNA for more than six months after the end of the treatment. Biochemical response was defined as sustained decrease of serum ALT to the normal range during treatment for at least three months.

For the 40 patients, average time from LDLT was 13 months. Thirty-three patients had the HCV 1b genotype and average ALT was 166 IU/L. Six months after treatment, 33 percent of patients (n=14) were shown to have SVR, a response similar to that observed in patients following deceased donor liver transplant (DDLT). Of 26 patients who did not show SVR, based on the definition, 14 patients were shown to have a biochemical response while 14 patients showed no response.

Compared to activity before treatment, liver activity grade was markedly lower at all times post-treatment in patients who showed SVR. Such differences were not seen in patients with biochemical responses. In fact, patients with a biochemical response showed similar liver activity grades as patients who did not show any response. For liver fibrosis, data were just the reverse. Fibrosis of significantly higher grades was seen post-treatment in patients with a biochemical response and no response compared to fibrosis grade before treatment. In patients with SVR, liver fibrosis was not significantly different post-treatment compared with fibrosis grade before treatment.

Thus, although SVR was good and compared favorably with that seen in patients with DDLT, in patients with biochemical responses, activity grade did not improve with treatment and the fibrosis stage deteriorated at two to four years to levels similar to those seen in patients with no response.

Shan L. Cheng, MD, of the University of California at San Francisco, used a Markov model that included disease-free survival, recurrent HCC and death to address whether screening for HCC after liver transplantation was cost-effective if done in all patients. Typically, screening for recurrent HCV is done for patients who exceed the Milan criteria following liver transplantation.

Screening for HCC and cost and benefits for screening over one to five years were factored into the model. Costs for screening, post-transplant care, and resection in 2007 dollars were derived from Medicare, Diagnostics Related Group and literature. Cost-effectiveness was determined from dollars per life-years gained.

Comparing cost-effectiveness over the five years of the study, Dr. Cheng concluded, “The incremental cost-effectiveness of screening is estimated to be high. In addition, screening for HCC after transplant yielded the most benefit in the first two years and screening patients who exceed Milan criteria on explant was most cost effective.”

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Chronic hepatitis C: A breath test to determine fibrosis

The ability to identify liver fibrosis in patients with chronic hepatitis C virus with a novel breath test was presented during the third and final AASLD Presidential Plenary session Tuesday.

Gadi Lalazar, MD, of Jerusalem’s Hadassah Hebrew University Medical Center, showed how the methacin breath test (MBT) may be an alternate to the current gold standard of doing liver biopsies at least in some patients with liver fibrosis.

In normal subjects, exhaled breath contains carbon dioxide of the normal 12C and some with the 13C isotope. The ratio of the 12C-carbon dioxide to 13C-carbon dioxide is a constant.

In MBT, the subject, hooked to a machine, drinks 13C labeled-methacetin. After absorption from the intestines, the liver rapidly metabolizes the compound and the exhaled breath has 13C- and 12C-carbon dioxide. The rate and magnitude of change in 13C/12C ratio in exhaled breath correlates to presence and severity of disease. The MBT test is therefore a good measure of liver function.

In the study, 278 patients with chronic HCV infection who underwent a liver biopsy within six months were enrolled in the study. After eight hours of fasting, subjects ingested 75 mg of 13C-methacetin and underwent the MBT. In the breath test, percent dose recovered (PDR) was estimated at 10, 20, 30 and 60 minutes after methacin ingestion. PDR peaks and cumulative PDR (CPDR) were determined. Ishak fibrosis score of greater than two was considered as significant fibrosis and the ability of MBT parameters to differentiate between significant and non-significant fibrosis was assessed.

The 278 patients were separated into training and validation sets of 196 and 82 patients, respectively. Patients in the two sets were similar with respect to age, body mass index degree of fibrosis.

The training set was used to generate an algorithm that used age, PDR peak, PDR peak time, PDR at 30 minutes and CPDR over 20 and 60 minutes.

The training set was used to generate a “Receiver Operated Curve” where a gray zone was identified for 29 percent of patients, where biopsies were warranted.

In their validation set of 82 patients, 36 patients were identified to have significant fibrosis and could be treated, and only 27 patients were in a “gray zone.”

The reproducibility of the test was shown in 74 subjects who had the test done between two and six times. In these patients, variability between the tests was less than 13 percent.

Dr. Lalazar concluded, “MBT accurately identifies significant fibrosis in patients with chronic HCV infection and the use of the developed algorithm may save 67 percent of liver biopsies.” He further showed that the test may have significant value in patients with chronic HCV disease with normal ALT and in patients with cirrhosis.

In another presentation, John A. Menghol, MD, PhD, of the University of Colorado Denver School of Medicine, provided data to show that HCV increased the expression of inflammatory chemokine receptor expression and chemotaxis on dendritic cells (DCs) and that antiviral therapy normalized some of the phenotypic and functional abnormalities of DCs.

Dr. Menghol used flow cytometry to isolate DCs and tested whether deficiencies in DC maturation and/or chemotaxis exist between DCs from patients who respond to therapy (n=30) versus non responders (n=34) before or after therapy. There was no difference in levels of pretreatment markers that were associated with virologic response. He showed that markers CXCR4, CXCR3, CD83 and CD40 were present at high levels before treatment and normalized with therapy.

He also used a chemotaxis assay to correlate whether chemotaxis of DC had any association with treatment. Dr. Menghol found that chemotaxis was high before treatment in patients who did not respond to therapy.

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Session presents advantages of CT colonography to GI practice

With the inevitable roll out of CT colonography (CTC), many questions are top of mind for gastroenterologists today. Addressing those questions and presenting practical information were speakers during Monday’s AGA session on Integrating CT Colonography into GI Practice. Speaking to the “The Economic Realities of CTC” was Joel V. Brill, MD, AGAF, FASGE, FACG, CHCQM.

“You want to be a market leader and ensure quality and continuity of care,” said Dr. Brill, chief medical officer, Predictive Health, LLC, Phoenix, AZ. “You want to be perceived in the community as an expert on colorectal screening.”

GI office-based imaging offers patients greater choice, convenience and access to service, Dr. Brill noted. This gastroenterologist-provided service will encourage patients not to delay and to follow through with appropriate screenings.

“CTC services also promote timely evaluation and diagnosis and offer patients the greater comfort of less invasive diagnostic techniques,” Dr. Brill said. “Patients will feel more at ease knowing a gastroenterologist will review images within the context of their full clinical history.”

If CTC becomes the primary CRC screening method, Dr. Brill cited current projections pointing to a 8.8 percent or 22.2 percent reduction in optical colonoscopies — if the size threshold for a polypectomy is at least 6mm or 10mm, respectively.

“I scope, therefore, I am” is the motto of someone solely in the endoscopy business. Dr. Brill encouraged gastroenterologists “to be in the colorectal cancer screening, detection and prevention business, with their practices serving as the referral center for all their patient’s CRC needs.”

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Concept of patient-centered care gains momentum

The Patient Centered Medical Home (PCMH) is a concept that is gaining momentum in medical and patient advocacy sectors. An AGA symposium Monday, “Is the Gastroenterology Patient Centered Medical Home the Next Practice Paradigm?” advised gastroenterologists how to work within the concept.

“We need a better system that recognizes and rewards added value. When we see a patient, we add value to health care and we should be reimbursed for it,” said Ronald P. Fogel, MD, Digestive Health Center of Michigan, Detroit.

Within the PCMH framework, care is based on the patient/personal physician relationship, Dr. Fogel noted. Patients develop an ongoing association with a personal physician, trained to provide first contact, continuous and comprehensive care. There are no “gatekeepers.”

PCMH provides all health-care needs or arranges care with other qualified professionals, Dr. Fogel said. Care is integrated across the health-care system, still retaining community-care focus. Patients would choose their PCMH and could change “medical homes” when they want. The PCMH uses system-based tools to deliver consistent, high-quality, patient-centered care and would earn external certification.

Some current PCMH reimbursement proposals call for patient visits based on fee-for-service and a prospective bundled practice component to cover practice expenses and to pay for care coordination.

The AGA Institute’s position on PCMH is that participation should be voluntary, with specialists deciding whether to participate. PCMHs should incorporate accountability mechanisms and be bound to best patient value. Evidence-based medicine would be the cornerstone for appropriate care and apply to primary care and specialty physicians.

It’s also the AGA Institute’s position that transition of care and appropriate referral guidelines should be developed. PCMHs should maintain quality and price transparency, and specialist reimbursement should not be decreased to pay for PCMH. Additional key components would include robust health-care information technology and patient education.

“There are implications for gastroenterology,” Dr. Fogel noted. “Will the PCMH criteria match the resources of a GI practice? Will quality measures match GI deliverables? Can gastroenterologists practice comprehensive longitudinal care? Will the investment in PCMH exceed the financial return? The nature of consultations may change and increased information will be required on quality and cost-of-care feed back to the PCMH.”

Carla H. Ginsburg, MD, MPH, AGAF, continued the discussion, addressing the question, “Can a gastroenterologist be a PCMH? Would we want to?”

“Any physician who has the training and expertise to provide first contact, continuous and comprehensive care can be the patient’s ‘personal physician’ in a PCMH,” said Dr. Ginsburg, a Newton, MA private-practice gastroenterology.

Qualifications for becoming the “personal physician” include responsibility for overall continuous care of the patient, leading a team in providing enhanced access to improved coordinated care, meeting requirements of an approved third-party PCMH recognition process and provide care as outlined in the “Joint Principles of the PCMH.”

Another alternative is to develop your own gastroenterology PCMH, which would require competency to provide primary care. Primary care responsibility would require a large capital investment, a practice redesign, an increase in medical liability and most likely an increase in support staff, Dr. Ginsburg noted. It would also require maintaining electronic medical records, analyzing episodes of service per disease, determining cost of care per episode, committing to practice transparency/accountability and measuring quality parameters.

A more feasible alternative, Dr. Ginsburg advised, may be to hire a nurse practitioner or physician assistant to provide primary care or team up with a primary care physician colleague. In yet another setting, separate third-party payment would go to specialists whose services facilitate coordinated care.

“Would we want to become a PCMH?” Dr. Ginsburg asked rhetorically. “A majority of us would say no. However, it could be appealing for those in a large GI group with a complex infrastructure.”

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Researcher seeks blood test for pancreatic cancer

Teri Brentnall, MD, has dedicated herself to the study of pancreatic cancer, from investigating the molecular events and early detection of pancreatic cancer to the surveillance and management of patients who inherit pancreatic cancer.

During the SSAT Maja and Frank G. Moody State-of-the-Art Lecture Tuesday, Dr. Brentnall discussed the study of patients genetically at risk for pancreatic cancer and how researchers are trying to apply that information to detect sporadic pancreatic cancer in the general population.

At the University of Washington School of Medicine, Seattle, where she is an associate professor of medicine, her research centers on the detection of early changes of pancreatic cancer in an effort to apply those lessons to the general population.

“We would like to eventually come up with a program in which we could detect sporadic pancreatic cancer,” she said.

Dr. Brentnall and her fellow researchers conducted a 10-year investigation of 100 patients from 75 families who inherited the disease. The patients either had two or more family members with cancer or a known gene that predisposes them to have pancreatic cancer.

According to Dr. Brentnall, management of these patients requires that the decision for a total pancreatectomy be based on histology, that patients require diabetes management training, and that the choice of continued surveillance versus surgery is the patient’s choice.

She has witnessed lack of compliance in patients who have undergone a total pancreatectomy, especially with regard to their ability to follow the need for regular insulin dosing, and she is adamant about helping them understand how their lives will change after the removal of their pancreas.

“These patients need careful and repeated glucose monitoring and training, training, training,” said Dr. Brentnall, who added that she purchased continuous glucose monitors for all of her patients.

Based on her findings, she said, endoscopic surveillance should be performed by a highly trained multispecialty team, glucose intolerance or elevated HgA1C may serve as an inexpensive biomarker, and endoscopic ultrasound (EUS) is the diagnostic tool of choice. Screening is cost effective if lifetime risk is 16 percent, pancreatic cancer is diagnosable and curable at the pre-invasive stage, and hypoglycemia is a serious consequence of total pancreatectomy, she added.

However, Dr. Brentnall cautioned that EUS is highly operator dependent and not widely available.

“You have to have someone who knows what they are looking for,” she said. “There is a lot of inter-observer variation with endoscopic ultrasound, so that makes it very tough.”

Her hope is that an inexpensive, reliable blood test with good sensitivity and excellent specificity could be developed for the general population. While a blood test might be able to be developed around a number of proteins, Dr. Brentnall said that the most likely blood test will be an ELISA assay.

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Quality initiatives make headway

As new quality initiatives continue to come down the pike, health-care organizations have been mandated to collect data for public reporting. Such mandates have left institutions with the need to evaluate their ability to appropriately measure and assess quality, while they also must dedicate the time and expense necessary to store and maintain vast amounts of data.

During the SSAT Public Policy Committee Panel on Tuesday, Andrea Snyder, RN, MBA, CPHQ, director of performance improvement and patient safety at the University of California Medical Center, San Diego (UCSD), described how such quality initiatives and public reporting can have an impact on the strategic, operational and quality-of-care aspects of hospitals.

Snyder, who has a longtime background in quality care management and patient safety, said that the strategy for UCSD was to position itself as “the quality provider.”

When it comes to showing patient mortality and complication rates, patients assume quality and safety are a given, she said.

She pointed to a Kaiser study showing that the majority of patients had not sought quality information in the last year. For those who had seen such information, less than half had used that information to make health-care decisions.

UCSD set out to be transparent to the consumer and focus organizational quality on several areas — medical and surgical mortality, core measure bundles, central line infections, hospital-acquired pressure ulcers and falls per 1,000 patient days.

UCSD’s performance improvement and patient safety department has 12 full-time equivalent employees, and a number of the nurses on staff conduct a great deal of extraction.

“We spend a lot of time analyzing and reporting in an effort to facilitate performance improvement. Another factor is that we factor in leveraging information systems,” said Synder, who pointed to the National Surgical Quality Improvement Program.

She advised attendees that CMS will expand its Final Rule for Hospital-Acquired Conditions in 2009, which could reduce Medicare payments. Those rules will include ventilator-associated pneumonia, Staphylococcus aureus septicemia, deep vein thrombosis, pulmonary embolism, MRSA and Clostridium difficile-associated disease.

Snyder said she remains optimistic, noting that UCSD has found success in a number of initiatives and their accompanying improvements.

“It’s impressive to understand and bring home to your organization how this can have an impact on outcomes,” she said.

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Presidential Profile

Grace H. Elta, MD, FASGE, made significant headway during her presidential tenure, advancing ASGE’s ability to communicate with members and expanding its educational offerings, along with a list of other improvements.

One of the most pressing issues on Dr. Elta’s plate was the revamping of the ASGE Web site, a project that began under the leadership of Past-President Gary W. Falk, MD, MS, FASGE, and the previous chair of the Web Committee, Yang Chen, MD, FASGE.

“We launched an entirely new version last June — a much more functional site with an entirely new look. We are still in phase one of the new launch, with further improvements planned,” said Dr. Elta, professor of medicine and associate chief for clinical programs at the University of Michigan, Ann Arbor.

“Dr. Steve Edmundowicz, current chair of the Web Committee, has infused a lot of passion into this project, so there are lots of ideas being put into play that I think the members will enjoy as the site becomes even more user-friendly and continues to improve,” she said.

Dr. Elta’s focus on expanding the educational and training offerings that ASGE provides to its membership also has paid dividends.

“We’ve continued to increase the number of courses offered at the Institute for Training & Technology (IT&T) in Oak Brook (IL),” she said. “One example is a special NIH-sponsored course I directed in March with Dr. Kenneth Wang on advanced imaging techniques. The workshop focused on changes coming to the field of endoscopy — molecular imaging and special techniques other than white light imaging — and which of those tools will end up being part of routine clinical practice in the next decade or so.”

With so many new technological and procedural candidates appearing, it is unclear which ones will dominate the profession, so ASGE needs to be in a position to facilitate the implementation process by training its members. With that in mind, ASGE began planning for a possible multimillion-dollar expansion of the IT&T hands-on training facility.

“The lease on that space is running out in the next year, and we needed to decide what the best decision would be with regard to the membership,” Dr. Elta said. “We made the decision to look into expanding the center and, in addition, building an adjacent auditorium. We often have to have lectures in a nearby hotel, so the extra space is necessary. If we are going to build this whole new educational space adjacent to our office space, it is a huge decision.”

The ASGE leadership has met with architects and others to determine an appropriate budget, but cost projections are difficult to create at this stage. In addition to the possible structure itself, Dr. Elta said the plans would include other upgrades.

“Having more hands-on stations, the ability to use live animals and cadavers instead of just pig stomachs, video capture technology and transmission technologies will allow us to broadcast to other sites,” she said. “This obviously won’t come to fruition for a few years, but the fact that we are making the investment states clearly that we believe in postgraduate education for our membership.”

The ASGE also needs the room because the society is getting larger, with double-digit percentage growth in international members.

“Our international membership continues to be the fastest growing portion of our membership, so it is critical to us,” Dr. Elta said. “The world is becoming smaller and medicine is an international field. We are interacting with many organizations across the world and met recently with the European Society of Gastrointestinal Endoscopy, agreeing to have some sharing of resources between the two societies.”

On the government regulation front, Dr. Elta credited Colleen Schmidt, MD, MHS, FASGE, with doing an “amazing job” heading up ASGE’s continued fight on the reimbursement, scope-of-practice and technology approval battlefields. Through the Health and Public Policy and Practice Management committees, ASGE has continued to monitor legislative and regulatory mandates and influence them when possible.

“Government regulation continues to be an uphill battle,” she said. “The government is broken and health care costs a lot. It’s critical that we have committees in Washington that stay on top of those issues for both our members and their patients.”

Looking back over the last year, Dr. Elta said she is most proud of the society itself and the many volunteers that make it run.

“It has been really remarkable during my presidency, just to see the incredible development and talent of our physician volunteers in all areas of the specialty,” she said. “We just have such a talented force of physicians willing to do this work. I think it is our greatest strength and I’m really proud to be a part of that.”

ASGE President Grace H. Elta, MD, FASGE
Grace H. Elta, MD, FASGE, holds several appointments at the University of Michigan, Ann Arbor — professor of medicine, director of the medical procedures unit and associate chief of clinical programs.

Her longtime affiliation with the university began in 1969, when she entered into her undergraduate education.

After receiving her medical degree from the University of Michigan and serving an internship at the University of Michigan Hospital, Dr. Elta was a resident and then a fellow in gastroenterology at Tufts New England Medical Center, Boston. In 1982, she returned to the University of Michigan, where she moved up through the ranks to professor.

She has been honored with several recognitions, including graduating Phi Beta Kappa and Alpha Omega Alpha, attaining fellowship in the American Association of University Women and being named a member in the Bockus International Society for Gastroenterology.

For ASGE, Dr. Elta has been chair of the Patient Education Task Force, councilor on the Governing Board, member of the Research Committee and the Training Committee, chair of program planning for DDW®, and secretary of the society.

With the AGA Institute, she has been a Governing Board member, National Digestive Diseases Information Clearinghouse representative and chair of the Patient Care Committee.

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