Walter G. Park

Quality Indicators for Colonoscopy

Colonoscopy is widely used for the diagnosis and treatment of colonic disorders. Properly performed, colonoscopy is generally safe, accurate, and well tolerated by most patients. Visualization of the mucosa of the entire large intestine and distal terminal ileum is usually possible at colonoscopy. In patients with chronic diarrhea, biopsy specimens can help diagnose the underlying condition. Polyps can be identified and removed during colonoscopy, thereby reducing the risk of colon cancer. Colonoscopy is the preferred method to evaluate the colon in most adult patients with bowel symptoms, iron deficiency anemia, abnormal radiographic studies of the colon, positive colorectal cancer screening tests, postpolypectomy and postcancer resection surveillance, surveillance in inflammatory bowel disease, and in those with suspected masses. The use of colonoscopy has become accepted as the most effective method of screening the colon for neoplasia in patients over the age of 50 years and in younger patients at increased risk (1). The effectiveness of colonoscopy in reducing colon cancer incidence depends on adequate visualization of the entire colon, diligence in examining the mucosa, and patient acceptance of the procedure. Preparation quality affects the ability to perform a complete examination, the duration the procedure, and the need to cancel or reschedule procedures (2, 3). Ineffective preparation is a major contributor to costs (4). Longer withdrawal times have been demonstrated to improve polyp detection rates, (5‐7) and conversely, rapid withdrawal may miss lesions and reduce the effectiveness of colon cancer prevention by colonoscopy. The miss rates of colonoscopy for large (≥1 cm) adenomas may be higher than previously thought (8, 9) Thus, careful examinations are necessary to optimize the effectiveness of recommended intervals between screening and surveillance examinations. Finally, technical expertise will help prevent complications that can offset any cost benefit ratio gained by removing neoplastic lesions. The following quality indicators have been selected to establish competence in performing colonoscopy and help define areas for continuous quality improvement. The levels of evidence supporting these quality indicators were graded according to Table 1. PREPROCEDURE The preprocedure period encompasses the time from first contact by the patient until administration of sedation or instrument insertion. The aspects of patient care addressed in prior documents apply here as well, including timely scheduling, patient preparation, identification, history and physical examination, appropriate choice of sedation and analgesia, evaluation of bleeding risk, etc. Because many examinations are currently being performed for colon cancer screening and are elective, care must be taken to be certain that all potential risks have been reduced to as low as practically achievable. The American Society for Gastrointestinal Endoscopy (ASGE) (10) and the U.S. Multi-Society Task Force on Colon Cancer have published appropriate indications for colonoscopy (11) (Tables 2 and 3).

Prevalence of Nonpolypoid (Flat and Depressed) Colorectal Neoplasms in Asymptomatic and Symptomatic Adults

CONTEXT Colorectal cancer is the second leading cause of cancer death in the United States. Prevention has focused on the detection and removal of polypoid neoplasms. Data are limited on the significance of nonpolypoid colorectal neoplasms (NP-CRNs). OBJECTIVES To determine the prevalence of NP-CRNs in a veterans hospital population and to characterize their association with colorectal cancer. DESIGN, SETTING, AND PATIENTS Cross-sectional study at a veterans hospital in California with 1819 patients undergoing elective colonoscopy from July 2003 to June 2004. MAIN OUTCOME MEASURES Endoscopic appearance, location, size, histology, and depth of invasion of neoplasms. RESULTS The overall prevalence of NP-CRNs was 9.35% (95% confidence interval [95% CI], 8.05%-10.78%; n = 170). The prevalence of NP-CRNs in the subpopulations for screening, surveillance, and symptoms was 5.84% (95% CI, 4.13%-8.00%; n = 36), 15.44% (95% CI, 12.76%-18.44%; n = 101), and 6.01% (95% CI, 4.17%-8.34%; n = 33), respectively. The overall prevalence of NP-CRNs with in situ or submucosal invasive carcinoma was 0.82% (95% CI, 0.46%-1.36%; n = 15); in the screening population, the prevalence was 0.32% (95% CI, 0.04%-1.17%; n = 2). Overall, NP-CRNs were more likely to contain carcinoma (odds ratio, 9.78; 95% CI, 3.93-24.4) than polypoid lesions, irrespective of the size. The positive size-adjusted association of NP-CRNs with in situ or submucosal invasive carcinoma was also observed in subpopulations for screening (odds ratio, 2.01; 95% CI, 0.27-15.3) and surveillance (odds ratio, 63.7; 95% CI, 9.41-431). The depressed type had the highest risk (33%). Nonpolypoid colorectal neoplasms containing carcinoma were smaller in diameter as compared with the polypoid ones (mean [SD] diameter, 15.9 [10.2] mm vs 19.2 [9.6] mm, respectively). The procedure times did not change appreciably as compared with historical controls. CONCLUSION In this group of veteran patients, NP-CRNs were relatively common lesions diagnosed during routine colonoscopy and had a greater association with carcinoma compared with polypoid neoplasms, irrespective of size.

Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011.

● The beneficial role of GI endoscopy for the prevention, diagnosis, and treatment of many digestive diseases and cancer is well established. Like many sophisticated medical devices, the endoscope is a complex, reusable instrument that requires reprocessing before being used on subsequent patients. The most commonly used methods for reprocessing endoscopes result in high-level disinfection. To date, all published occurrences of pathogen transmission related to GI endoscopy have been associated with failure to follow established cleaning and disinfection/ sterilization guidelines or use of defective equipment. Despite the strong published data regarding the safety of endoscope reprocessing, concern over the potential for pathogen transmission during endoscopy has raised questions about the best methods for disinfection or sterilization of these devices between patient uses. To this end, in 2003, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Healthcare Epidemiology of America collaborated with multiple physician and nursing organizations, infection prevention and control organizations, federal and state agencies, and industry leaders to develop evidence-based guidelines for reprocessing GI endoscopes.1,2 Since that ime, high-level disinfectants, automated reprocessing mahines, endoscopes and endoscopic accessories have all volved.3-6 However, the efficacy of decontamination and high-level disinfection is unchanged and the principles guiding both remain valid.7 Additional outbreaks of infection related to suboptimal infection prevention practices during endoscopy or lapses in endoscope reprocessing have been well publicized. A cluster of hepatitis C cases was attributed to grossly inappropriate intravenous medication and sedation practices.8 In numerous other instances, risk of infection transission has been linked to less willful, but incorrect, eprocessing as a result of unfamiliarity with endoscope hannels, accessories, and the specific steps required for eprocessing of attachments.9 Recent on-site ambulatory urgery center surveys confirm widespread gaps in infecion prevention practices.10 Given the ongoing occurrences of endoscopy-associated infections attributed to

DIAGNOSTIC PERFORMANCE OF CYST FLUID CARCINOEMBRYONIC ANTIGEN AND AMYLASE IN HISTOLOGICALLY CONFIRMED PANCREATIC CYSTS

Objectives: The objective of this study was to evaluate and validate cyst fluid carcinoembyronic antigen (CEA) and amylase in differentiating (1) nonmucinous from mucinous pancreatic cystic lesions (PCLs), (2) benign mucinous from malignant mucinous PCLs, and (3) pseudocysts from nonpseudocysts (amylase only). Methods: A retrospective analysis of patients with histologically confirmed PCLs from February 1996 to April 2007 was performed. Cyst fluid CEA (n = 124) and/or amylase (n = 91) were measured and correlated to cyst type. Results: Carcinoembyronic antigen levels (P = 0.0001), but not amylase, were higher in mucinous versus nonmucinous cysts. The sensitivity, specificity, and diagnostic accuracy of CEA 200 ng/mL or greater for the diagnosis of mucinous PCLs were 60%, 93%, and 72%, respectively. Carcinoembyronic antigen levels did not differentiate benign from malignant mucinous cysts. Whereas amylase levels were higher in pseudocysts than nonpseudocysts (P = 0.009), 54% of noninflammatory PCLs had a level greater than 250 IU/L, including mucinous cystic neoplasms (median, 6800 IU/L; interquartile range, 70-25,295 IU/L). Malignant mucinous cysts had lower amylase levels than benign mucinous cysts (P = 0.0008). Conclusions: Cyst fluid CEA and amylase levels are suggestive but not diagnostic in differentiating PCLs. Unlike CEA, amylase may help differentiate benign from malignant mucinous cysts. Novel biomarkers are needed.

EUS-guided gold fiducial insertion for image-guided radiation therapy of pancreatic cancer: 50 successful cases without fluoroscopy.

BACKGROUND Image-guided radiation therapy (IGRT) accurately delivers a high dose of potentially tumoricidal radiation to its target while sparing adjacent healthy tissue. Application of IGRT to unresectable pancreatic cancer requires the use of fiducials to track the precise location of the tumor. Fiducial markers have been successfully placed endoscopically. OBJECTIVE To determine the feasibility of EUS-guided gold fiducial placement for IGRT. DESIGN Prospective case series. SETTING Tertiary medical center. PATIENTS Consecutively referred patients with locally advanced unresectable pancreatic adenocarcinoma for EUS-guided insertion of gold fiducials from December 2006 to February 2009. INTERVENTIONS Under only EUS guidance, fiducial markers were deployed into or near the tumor by using a 19-gauge needle. In most cases, a sterile water injection technique was used to insert the fiducials. Fluoroscopy was not used in any case. MAIN OUTCOME MEASUREMENTS Successful placement of an adequate number of fiducials to proceed with IGRT as determined by CT. RESULTS Fifty-seven consecutive patients were included. Fifty cases (88%) were successful. Of the cases in which fiducial placement was attempted and follow-up was adequate, 94% (50 of 53) of cases were successful. LIMITATIONS Single-center, nonrandomized study. CONCLUSIONS EUS-guided fine-needle insertion was safe and effective in delivering gold fiducial markers for image-guided radiation therapy. Fluoroscopy was not required for successful fiducial placement.

Performance of the Microscopic Observation Drug Susceptibility Assay in Drug Susceptibility Testing for Mycobacterium tuberculosis

ABSTRACT The drug susceptibility testing performance of a broth-based method with microscopic reading of bacillary growth, the microscopic observation drug susceptibility (MODS) assay, was compared to that of the reference 7H10 agar method of proportion by using 53 isolates of Mycobacterium tuberculosis from persons at risk for multidrug-resistant TB. For isoniazid (0.1 μg/ml) and rifampin (2.0 μg/ml), there was 100% agreement between MODS results read at day 11 and the reference method. Levels of agreement for ethambutol tested at 2.5 and 7.5 μg/ml were 70 and 58%, respectively. Levels of agreement for streptomycin tested at 2.0 and 6.0 μg/ml were 77 and 51%, respectively. For isoniazid and rifampin drug susceptibility testing, MODS is as accurate as and more rapid than the reference method.

Quality Indicators for ERCP

ERCP is one of the most technically demanding and high-risk procedures performed by GI endoscopists. It requires significant focused training and experience to maximize success and to minimize poor outcomes (1, 2). ERCP has evolved from a purely diagnostic to a predominately therapeutic procedure (3). ERCP and ancillary interventions are effective in the non-surgical management of a variety of pancreaticobiliary disorders, most commonly the removal of bile duct stones and relief of malignant obstructive jaundice (4). The American Society for Gastrointestinal Endoscopy (ASGE) has published specific criteria for training and granting of clinical privileges for ERCP, which detail the many skills that must be developed to perform this procedure in clinical practice with high quality (5, 6, 7).

Quality Indicators Common to All GI Endoscopic Procedures

Quality of care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge (1). The American Society for Gastrointestinal Endoscopy (ASGE), the American College of Gastroenterology (ACG), and the American Gastroenterological Association (AGA) have continually promoted the ideal that all patients have access to high-quality GI endoscopy services. A high-quality endoscopy is an examination in which patients receive an indicated procedure, correct and relevant diagnoses are recognized or excluded, any therapy provided is appropriate, and all steps that minimize risk have been taken.

The epidemiology of idiopathic acute pancreatitis, analysis of the nationwide inpatient sample from 1998 to 2007.

Objective The study aimed to better define the epidemiology of idiopathic acute pancreatitis (IAP). Methods We identified admissions with primary diagnosis of acute pancreatitis (AP) in Nationwide Inpatient Sample between 1998 and 2007. Idiopathic AP was defined as all cases after excluding International Classification of Diseases, Ninth Revision, codes for other causes of AP (including biliary, alcoholic, trauma, iatrogenic, hyperparathyroidism, hyperlipidemia, etc). Results Among the primary admissions for AP, 26.9% had biliary pancreatitis, 25.1% alcoholic, and 36.5% idiopathic. Idiopathic AP had estimated 81,8025 admissions with a mean hospitalization of 5.6 days. Patients with IAP accounted for almost half of the fatalities among the cases of AP (48.2%) and had a higher mortality rate than both patients with biliary pancreatitis and patients with alcoholic pancreatitis (1.9%, 1.5%, and 1.0%, respectively, P < 0.01). Forty-six percent of patients with biliary pancreatitis underwent cholecystectomy during the index hospitalization, compared with 0.42% of patients with IAP. Patients with IAP had a demographic distribution similar to that of patients with biliary AP (female predominant and older), which was distinct from patients with alcoholic pancreatitis (male predominant and younger). There was a gradual but steady decrease in the incidence of IAP, from 41% in 1998 to 30% in 2007. Conclusions Despite improving diagnostics, IAP remains a common clinical problem with a significant mortality. Standardization of the clinical management of these patients warrants further investigation.

Pharmacologic therapy for acute pancreatitis

While conservative management such as fluid, bowel rest, and antibiotics is the mainstay of current acute pancreatitis management, there is a lot of promise in pharmacologic therapies that target various aspects of the pathogenesis of pancreatitis. Extensive review of preclinical studies, which include assessment of therapies such as anti-secretory agents, protease inhibitors, anti-inflammatory agents, and anti-oxidants are discussed. Many of these studies have shown therapeutic benefit and improved survival in experimental models. Based on available preclinical studies, we discuss potential novel targeted pharmacologic approaches that may offer promise in the treatment of acute pancreatitis. To date a variety of clinical studies have assessed the translational potential of animal model effective experimental therapies and have shown either failure or mixed results in human studies. Despite these discouraging clinical studies, there is a great clinical need and there exist several preclinical effective therapies that await investigation in patients. Better understanding of acute pancreatitis pathophysiology and lessons learned from past clinical studies are likely to offer a great foundation upon which to expand future therapies in acute pancreatitis.