Diagnostic performance of narrowed spectrum endoscopy, autofluorescence imaging, and confocal laser endomicroscopy for optical diagnosis of colonic polyps: a meta-analysis
Novel endoscopic technologies could allow optical diagnosis and resection of colonic polyps without histopathological testing. Our aim was to establish the sensitivity, specificity, and real-time negative predictive value of three types of narrowed spectrum endoscopy (narrow-band imaging [NBI], image-enhanced endoscopy [i-scan], and Fujinon intelligent chromoendoscopy [FICE]), confocal laser endomicroscopy (CLE), and autofluorescence imaging for differentiation between neoplastic and non-neoplastic colonic lesions.
We identified relevant studies through a search of Medline, Embase, PubMed, and the Cochrane Library. Clinical trials and observational studies were eligible for inclusion when the diagnostic performance of NBI, i-scan, FICE, autofluorescence imaging, or CLE had been assessed for differentiation, with histopathology as the reference standard, and for which a 2 × 2 contingency table of lesion diagnosis could be constructed. We did a random-effects bivariate meta-analysis using a non-linear mixed model approach to calculate summary estimates of sensitivity and specificity, and plotted estimates in a summary receiver-operating characteristic curve.
We included 91 studies in our analysis: 56 were of NBI, ten of i-scan, 14 of FICE, 11 of CLE, and 11 of autofluorescence imaging (more than one of the investigated modalities assessed in eight studies). For NBI, overall sensitivity was 91·0% (95% CI 88·6—93·0), specificity 85·6% (81·3—89·0), and real-time negative predictive value 82·5% (75·4—87·9). For i-scan, overall sensitivity was 89·3% (83·3—93·3), specificity 88·2% (80·3—93·2), and real-time negative predictive value 86·5% (78·0—92·1). For FICE, overall sensitivity was 91·8% (87·1—94·9), specificity 83·5% (77·2—88·3), and real-time negative predictive value 83·7% (77·5—88·4). For autofluorescence imaging, overall sensitivity was 86·7% (79·5—91·6), specificity 65·9% (50·9—78·2), and real-time negative predictive value 81·5% (54·0—94·3). For CLE, overall sensitivity was 93·3% (88·4—96·2), specificity 89·9% (81·8—94·6), and real-time negative predictive value 94·8% (86·6—98·1).
All endoscopic imaging techniques other than autofluorescence imaging could be used by appropriately trained endoscopists to make a reliable optical diagnosis for colonic lesions in daily practice. Further research should be focused on whether training could help to improve negative predictive values.
Endoscopy costs too much to be sustained as the diagnostic test for celiac
Endoscopy is an expensive medical procedure done to diagnose [or more usually confirm] the presence of the intestinal damage of celiac disease – and celiac disease is in turn defined by endoscopy (the diagnostic procedure). This is inter-dependence on each other is what’s known as a tautology. In other words, you cannot officially have celiac disease without endoscopic proof. This drives the business of endoscopy, especially as celiac disease is now recognised as a very common condition.
However, the majority of gluten related illnesses cannot be assessed/confirmed/diagnosed by endoscopy. A negative endoscopy result does not rule out a gluten problem. In fact. most gluten-related diseases have a normal endoscopy result.
Nowadays, the blood tests that pick up intestinal damage are more accurate than endoscopy. These tissue-damage blood tests are: tTG (tissue TransGlutaminase), DGP (Deamidated Gliadin Peptide) and EMA (EndoMesial Antibody). But these tests do not tell you about other gluten-related illnesses.
Finally, endoscopy is very expensive. It costs several thousands of dollars. In the USA that are over 300 million people, of whom 1% have celiac disease. To diagnose them all by endoscopy would cost a lot of money (maybe 30,000,000 x $4,000 = a huge amount of dollars). Why go to such extreme measures? Why spend so much money?
Endoscopy is very useful in many patients, but should not be mandatory for the diagnosis of Celiac disease. In fact, this is now being recognised in the newer guidelines for making a diagnosis of celiac disease ( the “Joint BSPGHAN and Coeliac UK Guidelines for the Diagnosis and Management of Celiac Disease in Children” http://www.medscape.com/viewarticle/811355_2?nlid=36263_455). With a statement that if the tTG is very high, then a biopsy iI, as well as the high tTG the EMA+ and patient either DQ2 or DQ8, the diagnosis is confirmed without the need for a duodenal biopsy.
The American Society for Gastrointestinal Endoscopy has recognized six Texas endoscopy centers through its ASGE Endoscopy Unit Recognition Program.
The program’s guidelines include quality assurance, privileging, endoscope reprocessing, staff competency assurance and CDC infection control guidelines.
The newly-honored endoscopy centers include:
• Endoscopy Center at Central Park (Bedford, Texas)
• Endoscopy Center at Redbird Square (Dallas)
• Humble (Texas) Kingwood Endoscopy Center
• North Richland Hills (Texas) Endoscopy Center
• Old Town Endoscopy Center (Dallas)
• Preston Crossing Endoscopy Center (Plano, Texas)
In addition to these six centers, the ASGE recognized Avista Endoscopy Suites in Louisville, Colo., and Texas Health Resources Harris Methodist Hospital HEB Endoscopy & Special Procedures in Bedford.
The ASGE also granted three-year renewal of recognition to 24 endoscopy units.
Advances in imaging and interventional endoscopy are improving cancer detection and enabling less invasive approaches to diagnose and treat disorders in the gastrointestinal tract. These emerging procedures are poised to fuel growth in the $7 billion global market for GI endoscopy.
Technological advances in imaging and interventional endoscopy are paving the way for new and improved approaches to diagnosing and treating gastrointestinal (GI) disorders. At this year’s Digestive Disease Week (DDW) meeting, held in Chicago in May, researchers and manufacturers were showcasing new endoscopes, tools, and imaging technologies designed to improve diagnostic performance, clinical workflow, and safety during GI endoscopy. These technologies are helping to improve cancer detection and are allowing gastroenterologists to use less invasive approaches to procedures that have typically been performed using surgical or percutaneous techniques. These emerging procedures are poised to fuel growth in the global market for GI endoscopy, which is currently valued at $7 billion, according to EndoChoice Inc., a competitor in this space.
Colonoscopy is widely accepted as the gold standard for detecting colorectal cancer and precancerous polyps known as adenomas. However, physicians still “miss” a certain number of adenomas during colonoscopy and interval cancers do occur. The adenoma miss rate varies considerably in the literature, but researchers have reported a miss rate ranging from 24% to 42%.
Over the last 10 years, device manufacturers have been developing new technologies and different imaging modalities in an effort to improve visualization and to decrease the adenoma miss rate during colonoscopy. (See “GI Endoscopy: Thriving on Innovation” — Medtech Insight, June 2010.) And yet, the colonoscope’s field of view has not really changed much in the past three decades. Most forward-viewing colonoscopes available today provide no more than a 170-degree field of view. But a new groundbreaking colonoscope with a 330-degree field of view debuted at this year’s DDW that could potentially revolutionize colorectal cancer screening by allowing physicians to visualize almost twice as much anatomy as traditional forward-viewing colonoscopes.
Pamlico Capital has made a “significant” investment in Physicians Endoscopy. Financial terms weren’t announced. The seller was Silver Oak Services Partners. Jamison, Pa.-based Physicians Endoscopy develops and manages freestanding, single-specialty endoscopic Ambulatory Surgery Centers in partnership with practicing physicians and hospitals. Piper Jaffray & Co. provided financial advice to Physicians Endoscopy.
JAMISON, Pa.–(BUSINESS WIRE)–Pamlico Capital and the management team of Physicians Endoscopy announced today that Pamlico has completed a significant equity investment in Physicians Endoscopy, LLC (“PE” or the “Company”) from Silver Oak Services Partners, LLC. Physicians Endoscopy, founded in 1998, is the leading developer and manager of freestanding, single-specialty endoscopic Ambulatory Surgery Centers (“ASCs”) in partnership with practicing physicians and hospitals. CEO Barry Tanner and his executive management team will retain significant ownership of Physicians Endoscopy and will continue to manage the growth of the Company in partnership with Pamlico. Detailed terms of the transaction have not been disclosed.
PE partners with physicians and provides a comprehensive suite of billing and management services. The Company typically owns a significant minority interest in each of its partner centers, which are located throughout the United States. Several more centers are expected to open within the next 12 months.
“We chose to partner with Pamlico because of its track record of accelerating its portfolio companies’ growth and its extensive healthcare investing experience,” said Barry Tanner, PE CEO. “PE is poised to continue its growth across the country by opening and acquiring new ASCs and by expanding our product offerings with gastroenterologists. PE has enjoyed substantial growth under Silver Oak Services Partners’ stewardship and now with Pamlico, the Company will benefit from a continuation of that track record. Pamlico provides our company with strong financial and advisory resources with which to build upon our market leadership position.”
Pamlico Partner Art Roselle said, “Our focus on making equity investments in growing and high-efficacy healthcare companies led us to PE. We were tremendously impressed by the caliber and breadth of the management team, as well as the opportunity PE has to capitalize on the favorable trends in the ASC market.”
I’ve heard it dozens of times:
My gastroenterologist says s/he can’t do my endoscopy and colonoscopy on the same day.
Sometimes it’s because it was considered too “dangerous”. Occasionally it’s because “that’s not the way we do it”. Sorry, that doesn’t fly with me. And it shouldn’t with you.
Yes, there are true medical reasons that some people shouldn’t have an upper endoscopy and a colonoscopy (sometimes called “bidirectional endoscopy” or a “double dip“) on the same day. But these are few and far between.
Years ago, my mother told me the same thing…after her procedures. I nearly flipped out.
The real reason is that (in the USA) the doctor and/or the facility gets paid less for doing them on the same day than when they do them on different days.
What does having your 2 procedures done on separate days mean for you?
2 days away from work or your personal life
Undergoing anesthesia/sedation twice
Getting someone else to drive you to and from the procedure on 2 days
More money out of your pocket (or out of your insurance company’s)
If you do need to have both done, think carefully. A patient-center doctor would usually have no problem doing them both on the same day, instead of caring more about the bottom line.
What is your background and training?
Dr. Gress: I completed my medical school training at Mt. Sinai School of Medicine, my residency in internal medicine at Montefiore Medical Center in the Bronx, and my gastroenterology and hepatology fellowship at the SUNY Downstate Medical Center affiliated program with the Brooklyn Hospital Center, and Methodist Hospital. After my fellowship, I decided to become a therapeutic endoscopist, which required another year of training. I received a scholarship from the American Society of Gastrointestinal Endoscopy which allowed me to train at Indiana University Medical Center, which is well known for its therapeutic endoscopy (TE) unit. I trained in endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS), and endoscopic lasers, after which I remained on the faculty for four years. Beginning in 1997 I joined the faculty at Winthrop University Hospital and SUNY Stony Brook where I was director of endoscopy. I was recruited to the faculty at Duke University Medical Center in 2003 as a member of the pancreatobiliary service. I was also clinical chief of the GI division at the Durham VA Medical Center. I returned to New York in 2007 to be division chief of the division of gastroenterology and hepatology at SUNY Downstate Medical Center until I joined the faculty at Columbia in the fall of 2013.
Why did you choose to focus on pancreatic disease?
Dr. Gress: I was intrigued by how ERCP and EUS could impact patients’ outcomes and quality of life for pancreatic diseases such as chronic pancreatitis, pancreatic cysts and pancreatic cancer. That interest evolved into wider interest in pancreatic disease. I am especially interested in diagnosing and treating pancreatic cancer at earlier stages and in helping patients with chronic pancreatitis to live a more normal life.
What are the benefits of ERCP and EUS?
Dr. Gress: ERCP is a tool used by therapeutic endoscopists to evaluate the pancreatic and bile ducts. It lets us see the size of the ducts, their contour and shape, whether there is anything inside the duct, and it lets us view the ampulla, which is the opening into the duodenum. We can now insert an optic light into the scope using a device called SPY, which lets us look into the pancreatic duct or bile duct and take a biopsy to make a diagnosis. In addition to its value in diagnosing a problem, ERCP can also be used to treat it. During ERCP we can sample suspicious areas inside or outside the bile or pancreatic duct, and we can remove pancreatic or bile duct stones. We can also treat strictures by placing a stent or a drain tube, and we can manage difficult-to-treat disorders of the bile duct including Sphincter of Oddi dysfunction using specialized equipment.
EUS is also used for both diagnostic and therapeutic purposes. The ultrasound technology is situated on the tip of the endoscope which lets us look through the wall of the GI tract and beyond the wall, particularly in the bile duct, pancreatic duct, and liver. EUS provides high definition fine detail of the pancreas and surrounding structures, including the lymph nodes. If someone has abnormal findings on an MRI or a CT scan, EUS can provide a much closer look at the abnormality. We can also attach a special needle in order to sample lesions. This is called fine needle aspiration, or FNA, and it is very accurate for diagnosing suspicious lesions. We can use it to sample many types of lesions, such as masses in the pancreas, bile ducts and even kidney , adrenal masses, lung masses and others, and it is a great tool for staging cancers.
How is EUS used to treat patients with pancreatic disease?
Dr. Gress: Therapeutic EUS is an evolving field. One example of a new application is EUS guided celiac plexus block, which is a procedure that controls pain related to pancreatic cancer or chronic pancreatitis. More than 75% of patients find pain relief from this procedure, which is essentially a pain block. Another therapeutic application is the drainage of pseudocysts that can cause pain in pancreatitis, or to drain the bile duct if it can’t be drained by ERCP.
Can you summarize the difference between ERCP and EUS?
Dr. Gress: ERCP is more invasive as we actually go into the duct, and requires contrast dye and fluoroscopy. EUS is more of an ultrasound imaging tool so it is less invasive; we look at the pancreas from the outside looking in, while in ERCP we look deep inside the pancreatic and bile ducts.
Please tell us about confocal laser endomicroscopy, or CLE.
Dr. Gress: CLE is a device that allows us to view cells in high definition, much like you would see under a microscope, but doing so while inside the body. Some studies suggest that it may replace the need for biopsies. This technology is very exciting because it allows us to detect early cancer and changes suggestive of early cancer such as dysplasia at the cellular level. CLE can be put through our scope into the bile duct or pancreatic duct and used to see any abnormal tissue in the duct lining. It can also be used during EUS to see inside pancreatic cysts, so we can tell whether they warrant further treatment.
Are you using CLE in the Pancreas Center?
Dr. Gress: Columbia is one of only two centers in New York that has CLE – it is a very innovative technology in the U.S. and is just beginning to be studied in more detail. We are beginning to use CLE in the pancreas and pancreatic cysts, and insurance does cover it.
Which patients will benefit from the use of CLE?
Dr. Gress: CLE may be useful for patients with chronic pancreatitis, pancreatic cysts, with pancreatic and bile duct strictures, and patients with family history of pancreatic cancer or intraductal papillary mucinous neoplasm (IPMN), an early form of pancreatic cancer). In the case of pancreatic cysts, we have not been able to predict with very high accuracy if a cyst is malignant or not, so patients have had to come for regular followup in order to be vigilant about any potential cancers. The ability to characterize cells with CLE is a game changer. We can place it on a probe (probe-based CLE, or PCLE) and perform what is called an optical biopsy – determine whether cells are malignant or not by looking at them rather than extracting samples. It is also very helpful for targeting areas to biopsy; for now we are still taking tissue biopsies and using CLE to validate the findings, but in the future, we hope to be able to make determinations without taking tissue.
Can CLE be used to treat patients with other types of cancer?
Physicians at Columbia are using CLE in patients with Barrett’s Esophagus, and it is used elsewhere for gastric lesions (to check for stomach cancer).
Can you describe your research on CLE?
As we mentioned above, we are collecting patient data in our registry and comparing the data to the images collected during probe-based CLE procedures. Because this technology is so new to us, part of our research is to verify that the images seen during the procedure correlate with the tissue pathology samples. This work will allow us to independently verify the positive outcomes that others have experienced with PCLE.
A second part of our research entails the use of EUS-guided fine needle aspiration (FNA) CLE, also known as nCLE, in patients with pancreatic cysts. This is a multicenter study (Columbia is one of three sites) in which we insert an EUS needle into the pancreatic cyst, put the CLE probe through the needle, and examine the cells lining the walls of cysts. We will soon be expanding this to the lymph nodes as well. We are hoping that nCLE will be able to provide high detailed and accurate characterization of pancreatic cysts such that pancreatic cysts can be more accurately differentiated into benign and malignant cysts.
The American Society for Gastrointestinal Endoscopy (ASGE) has recognized eight endoscopy units as part of its program specifically dedicated to promoting quality in endoscopy in all settings where it is practiced in the United States. ASGE renewed the recognition for 24 units previously honored. The ASGE Endoscopy Unit Recognition Program honors endoscopy units that have demonstrated a commitment to patient safety and quality in endoscopy as evidenced by meeting the program’s rigorous criteria which includes following the ASGE guidelines on privileging, quality assurance, endoscope reprocessing, CDC infection control guidelines and ensuring endoscopy staff competency. To date, more than 450 endoscopy units have been recognized by ASGE.
“We are proud to acknowledge these endoscopy units through our Endoscopy Unit Recognition Program for their commitment to promoting the highest standards of safety and quality,” says Jonathan Cohen, MD, FASGE, chair of the ASGE Quality Assurance in Endoscopy Committee. “By ensuring infection control principles are adhered to, continually assessing the competency of staff, and monitoring patient satisfaction, ASGE-recognized units contribute to the public’s confidence in endoscopy, a life-saving technology.”
To be recognized by ASGE, a unit, through a peer-reviewed application process, must attest to the continued competence of all staff relative to their roles, demonstrate the adoption of unit policies specific to ongoing assessment of performance relative to key quality indicators, and attest that the unit has an established infrastructure and personnel dedicated to infection control and prevention. The program is applicable to all settings in the United States and Puerto Rico where endoscopy is practiced, including office-based endoscopy units, hospital-based endoscopy units, and stand-alone ambulatory endoscopy or surgery centers. An important component of the program is an educational course entitled, “Improving Quality and Safety in Your Endoscopy Unit,” that thoroughly reviews related guidelines. Upon completion of the program, successful applicants are awarded ASGE’s Certificate of Recognition of Quality in Endoscopy.
A new endoscopy suite opened at Mallow General Hospital recently as part of a €4.5 million capital investment in the hospital. The new suite is a modern, patient-centred build with two procedures rooms, a first stage recovery room and a discharge lounge, which replaces the existing endoscopy facility. Patients are referred for an endoscopy by their GP or consultant to investigate symptoms such as vomiting or bleeding. It is performed as a day procedure whereby a narrow tube with a camera at the end is passed into an organ such as the stomach or colon to view the inside. The following endoscopies can be performed at Mallow General Hospital: gastroscopy (upper intestine) sigmoidoscopy, colonoscopy (lower intestine) and bronchoscopy (lung and airways).
The new endoscopy suite has the capacity to do an additional 1,000 endoscopies annually. Currently there are approximately 2,000 endoscopies per year performed at Mallow General Hospital, which means that the hospital now has the capacity to do in excess of 3,000 annually.
Ms. Mary Owens, Director of Nursing at Mallow General Hospital, said, “I’m delighted that we have this new endoscopy suite for the people of Mallow and surrounding areas. It is a beautiful new purpose-built facility and meets all the international standards required for such a unit.”
Dr. Neil Cronin, Consultant Physician and clinical lead for the new unit at Mallow General Hospital, welcomed the opening of the endoscopy suite and stated, “We have been working towards re-organising services at Mallow General Hospital over the last number of years. Part of this was a major extension to Mallow General Hospital for a replacement endoscopy suite and a new medical assessment unit. The management team is pleased that the new build is now complete, which brings the re-organisation of services at the hospital near to completion. The hospital is now in a very strong position to continue delivering healthcare services to benefit patients, staff and the local community in Mallow and north Cork.”
The opening of the new endoscopy suite follows on from the re-organisation of other services. A Local Injury Unit (LIU) and Medical Assessment Unit (MAU) opened in March 2013. Both are now operating well and treating increasing patient numbers.
The LIU is open seven days per week from 8am to 8pm. Staff in the unit treat adults and children aged over five years of age with minor injuries such as a suspected broken bone, a sprain, a facial injury or a minor scald or burn. Staff can take x-rays, apply plaster casts and stitches.
The MAU is also open seven days a week from 8am to 8pm, with staff treating patients referred directly by their GP/SouthDoc, who are suffering from a recent onset of symptoms such as breathlessness, chest pain or blackouts. The MAU only accepts patients referred by their GP or SouthDoc to ensure that only patients suitable for treatment present at this Unit. Patients referred to the MAU are seen by a senior doctor within an hour of arrival who has ready access to diagnostics such as x-rays, blood tests, scans, etc.
According to Ms. Owens, “In the eight months since opening, over 3,000 patients have been seen in our Local Injury Unit and over 3, 500 attended the Medical Assessment Unit. Feedback received from patients attending is highly satisfactory.”
KARL STORZ and Livedata Announce an Exclusive Distribution Agreement to Combine OR1 and OR-Dashboard Technologies
CULVER CITY, CA (July 16, 2008) – KARL STORZ Endoscopy-America, Inc., a global leader in minimally invasive endoscopic technologies and operating room integration, has announced an exclusive OR integration distribution agreement with LiveData, Inc., the leader in real-time data integration and display technology. Under terms of the agreement, KARL STORZ will add LiveData’s latest data integration and display capabilities to the KARL STORZ OR1® system. Combining LiveData’s OR-Dashboard™ with the latest OR1® technologies brings hospitals a true Patient-Aware Operating Room™, where the surgical team can focus more fully and effectively on the patient.
“Combining the strengths of our OR1® technologies with the innovative data integration and display capabilities of OR-Dashboard helps give surgical teams a complete picture of what is going on in the operating room right as it is happening,” said Connie Padden, Director of Technology Integration, KARL STORZ. “Additionally, hospitals gain a greater ability to optimize OR activities by streamlining and strengthening resource management. Most importantly, enhanced OR communication and smoother-running procedures mean enhanced levels of care for patients.”
The LiveData OR-Dashboard™ technology gives surgical teams a number of key benefits, including easy-to-read displays, comprehensive data integration, real-time updates of vital information, and enhanced communication among OR team members and other personnel. Vital information about both the patient and surgical procedure are seamlessly integrated and made available for the entire OR team to view.
Equipped with OR-Dashboard™ technology, OR1® suites offer surgical teams a Wall of Knowledge™ that combines comprehensive real-time data from nursing, surgery and anesthesia systems, as well as surgical equipment, PACS images and lab reports. This data is then displayed on a large wall-mounted screen that is visible to the entire OR team.
Using these technologies to create a true Patient-Aware OR™ helps ensure that surgical teams have the right information at the right time, improving patient safety, easing communication among team members, promoting OR workflow efficiency and productivity, and helping hospitals capitalize on existing IT investments.
KARL STORZ will also provide sales and integration support for LiveData OR-Dashboard™ installations in hospitals nationwide. “LiveData has always been committed to partnerships that result in the strongest integration and visualization solutions for our customers,” said Philip Brzezinski, Vice President of Healthcare Systems for LiveData. “This integration distribution agreement signals a further advancement in patient safety and OR workflow. Combined with their established distribution and world-class, worldwide support network, KARL STORZ can now make this important technology more broadly available.”
By automatically gathering and displaying real-time data from disparate sources, the Patient-Aware OR™ reinforces consistent adherence to safety protocols and helps eliminate so-called “never events,” which are errors generally considered so threatening to patient safety that they should never happen. Communication within the OR team is also facilitated since each member has clear and automatic access to critical information about the patient, procedure and equipment.
Additionally, OR workflow efficiency and productivity are increased by streamlining interaction with other parts of the hospital to improve OR and PACU scheduling, ensuring that surgeon preferences are understood, and identifying missing tray and cart items before the team’s arrival. Hospitals can capitalize on their existing IT investments and accelerate payback from currently installed IT technology by collecting vital data from various systems, such as electronic medical records, pharmacy, lab and pathology systems.
“The addition of LiveData’s integration and display capabilities represents a logical extension of operating room advancement by collecting information from disparate medical and surgical systems to deliver real-time data streams to the latest visual display configurations,” said Padden.