An international study of interobserver variability of "string sign" of pancreatic cysts among experienced endosonographers.

BACKGROUND AND OBJECTIVES: No single optimal test reliably determines the pancreatic cyst subtype. Following EUS-FNA, the "string sign" test can differentiate mucinous from nonmucinous cysts. However, the interobserver variability of string sign results has not been studied. METHODS: An experienced endosonographer performed EUS-FNA of pancreatic cysts on different patients and was recorded on video performing the string sign test for each. The videos were shared internationally with 14 experienced endosonographers, with a survey for each video: "Is the string sign positive?" and "If the string sign is positive, what is the length of the formed string?" Also asked "What is the cutoff length for string sign to be considered positive?" Interobserver variability was assessed using the kappa statistic (κ). RESULTS: A total of 112 observations were collected from 14 endosonographers. Regarding string sign test positivity, κ was 0.6 among 14 observers indicating good interrater agreement (P < 0.001) while κ was 0.38 when observers were compared to the index endosonographer demonstrating marginal agreement (P < 0.001). Among observations of the length of the string in positive samples, 89.8% showed >5 mm of variability (P < 0.001), indicating marked variability. There was poor agreement on the cutoff length for a string to be considered positive. CONCLUSION: String sign of pancreatic cysts has a good interobserver agreement regarding its positivity that can help in differentiating mucinous from nonmucinous pancreatic cysts. However, the agreement is poor on the measured length of the string and the cutoff length of the formed string to be considered a positive string sign.

Do Nontechnical Skills Affect Legal Outcomes After Endoscopic Perforations?

INTRODUCTION: Health systems often emphasize technical skills to reduce iatrogenic injuries. Nontechnical skills such as clinical and communication skills are mostly overlooked or not readily retrievable from medical records. Our aim was to estimate the association of technical and nontechnical skills of endoscopists with indemnity payments to patients after endoscopic perforations. METHODS: This is an observational registry-based study of closed claims against gastroenterologists involved in endoscopic perforations. RESULTS: We analyzed 175 closed claims related to perforations, all of which involved allegations of improper performance of the endoscopic procedure. Inadequate communication (n = 71, 41%) and clinical judgment (n = 60, 34%) on the part of the endoscopists were observed. Inadequate communication and clinical judgment were associated with over 3-fold odds of indemnity payment (odds ratio [OR] 3.31; 95% confidence interval [CI], 1.46-7.48, and OR 3.18; 95% CI, 1.44-7.01, respectively). However, if there were no communication breakdown or clinical judgment issues and the only allegation was poor technical skill, the odds of indemnity payments were less than half of those cases (OR 0.43; 95% CI 0.15-0.80). There was no evidence of a statistically significant interaction among age, procedure type, trainee involvement, clinical severity, need for surgery, and procedure-related death. DISCUSSION: We observed that inadequate communication and clinical judgment were associated with indemnity payment, independent of the severity of clinical outcomes. On the other hand, cases wherein there was an allegation of poor technical skills alone, without communication breakdown or clinical judgment issues, were associated with favorable legal outcomes for the defendant. (See the Visual Abstract at http://links.lww.com/AJG/B568.).

Longitudinal assessment of colonoscopy quality indicators: a report from the Gastroenterology Practice Management Group.

BACKGROUND: There is increasing demand for colonoscopy quality measures for procedures performed in ambulatory surgery centers. Benchmarks such as adenoma detection rate (ADR) are traditionally reported as static, one-dimensional point estimates at a provider or practice level. OBJECTIVE: To evaluate 6-year variability of ADRs for 370 gastroenterologists from across the nation. DESIGN: Observational cross-sectional analysis. SETTING: Collaborative quality metrics database from 2007 to 2012. PATIENTS: Patients who underwent colonoscopies in ambulatory surgery centers. INTERVENTIONS: Colonoscopy. MAIN OUTCOME MEASUREMENTS: The number of colonoscopies with an adenomatous polyp divided by the total number of colonoscopies (ADR-T), inclusive of indication and patient's sex. RESULTS: Data from 368,157 colonoscopies were included for analysis from 11 practices. Three practice sites (5, 8, and 10) were significantly above and 2 sites (3, 7) were significantly below mean ADR-T, with a 95% confidence interval (CI). High-performing sites had 9.0% higher ADR-T than sites belonging to the lowest quartile (P < .001). The mean ADR-T remained stable for 9 of 11 sites. Regression analysis showed that the 2 practice sites where ADR-T varied had significant improvements in ADR-T during the 6-year period. For each, mean ADR-T improved an average of 0.5% per quarter for site 2 (P = .001) and site 3 (P = .021), which were average and low performers, respectively. LIMITATIONS: Summary-level data, which does not allow cross-reference of variables at an individual level. CONCLUSION: We found performance disparities among practice sites remaining relatively consistent over a 6-year period. The ability of certain sites to sustain their high-performance over 6 years suggests that further research is needed to identify key organizational processes and physician incentives that improve the quality of colonoscopy.

A pilot study of endoluminal US for stool liquefaction.

BACKGROUND: There is a need to cleanse patients who are poorly prepared for colonoscopy safely and efficiently during the procedure to minimize rescheduling. US is already being used in catheter-based intravascular thrombolysis, and time-reversal acoustic (TRA) has been explored in assisting drug delivery to the brain. OBJECTIVE: To explore the efficacy and safety of a miniaturized endoluminal US device in stool dissolution as a means to salvage poor bowel preparation. DESIGN: Proof of concept experimental study. SETTINGS: Animal laboratory. INTERVENTIONS: Low-frequency US and TRAs. MAIN OUTCOME MEASUREMENTS: Feasibility, efficacy, and safety of US to liquefy stools ex vivo. RESULTS: Depending on parameters, such as pulse rate, acoustic intensity, and duration, increases in liquefaction speeds by a factor of 50 and 100 times were obtained. There was a significant difference in weight change between the 20-kHz-treated sample compared with controls (P ≤ .0001). There was no difference in sloughing of mucosa and mechanical injury among the US, water spray, and control groups. LIMITATIONS: Animal model. CONCLUSION: Endoluminal US can liquefy stools at acoustic exposure levels that do not damage ex vivo colonic mucosa. Endoluminal US should be able to dissolve stools more rapidly than water spray alone, thereby optimizing colonoscopic evaluation in vivo.

Clinical decision making in the management of pancreatic cystic neoplasms.

Pancreatic cystic lesions continue to pose diagnostic and management dilemmas for physicians. This may be related, in part, to the fact that these lesions represent a range of diagnostic possibilities, from inflammatory cysts and nonmucinous cysts to mucinous cysts, which may or may not have foci of invasive malignancy. Adequate characterization of cystic lesions is necessary to help devise a management plan. Moreover, patient-related factors such as comorbid conditions are often essential in deciding whether patients should be managed by a conservative approach of watchful waiting versus surgical resection, if so indicated. This review summarizes the recent advances in the management of pancreatic cystic neoplasms.

Malpractice claims for endoscopy.

AIM: To summarize the magnitude and time trends of endoscopy-related claims and to compare total malpractice indemnity according to specialty and procedure. METHODS: We obtained data from a comprehensive database of closed claims from a trade association of professional liability insurance carriers, representing over 60% of practicing United States physicians. Total payments by procedure and year were calculated, and were adjusted for inflation (using the Consumer Price Index) to 2008 dollars. Time series analysis was performed to assess changes in the total value of claims for each type of procedure over time. RESULTS: There were 1901 endoscopy-related closed claims against all providers from 1985 to 2008. The specialties include: internal medicine (n = 766), gastroenterology (n = 562), general surgery (n = 231), general and family practice (n = 101), colorectal surgery (n = 87), other specialties (n = 132), and unknown (n = 22). Colonoscopy represented the highest frequencies of closed claims (n = 788) and the highest total indemnities ($54 093 000). In terms of mean claims payment, endoscopic retrograde cholangiopancreatography (ERCP) ranked the highest ($374  794) per claim. Internists had the highest number of total claims (n = 766) and total claim payment ($70  730  101). Only total claim payments for colonoscopy and ERCP seem to have increased over time. Indeed, there was an average increase of 15.5% per year for colonoscopy and 21.9% per year for ERCP after adjusting for inflation. CONCLUSION: There appear to be differences in malpractice coverage costs among specialties and the type of endoscopic procedure. There is also evidence for secular trend in total claim payments, with colonoscopy and ERCP costs rising yearly even after adjusting for inflation.

Quality-adjusted life expectancy benefits of laparoscopic bariatric surgery: a United States perspective.

OBJECTIVES: The method of choice for bariatric surgery remains controversial. The aim of this study was to compare the outcome of laparoscopic Roux-en-Y gastric bypass (L-RYGB) versus laparoscopic adjustable gastric banding (LAGB) using quality-adjusted life-years (QALYs). METHODS: We developed a Markov model of the quality of life and survival of L-RYGB and LAGB in obese patients. Using census data, we estimated the probability of dying and quality of life for each year of each cohort. RESULTS: For all cohorts, L-RYGB offers the highest advantage in QALYs compared with gastric banding. The youngest cohort showed the greatest discrepancy between the two surgical methods, with 7.8, 6.4, and 4.7 QALYs gained with L-RYGB over LAGB for the age groups 35, 45, and 55, respectively. Those with the highest presurgical body mass index (BMI) acquired the most advantage with L-RYGB, with 2.8, 6.4, and 9.6 QALYs gained with L-RYGB over LAGB for the BMI groups 40, 50, and 60. Males had a slightly higher advantage with L-RYGB, with 6.5 QALYs gained with L-RYGB over LAGB compared with 6.0 QALYs for females. CONCLUSIONS: For the cohorts studied, L-RYGB is the preferred surgical treatment for obesity if the sole metric is QALYs. The young and extremely obese are core groups who will gain the most QALYs following L-RYGB.

EUS-guided FNA aspiration of kidney masses: a multicenter U.S. experience.

BACKGROUND: Tissue sampling of renal lesions is traditionally performed with percutaneous US or CT guidance. To date, only 3 known cases of EUS-guided FNA (EUS-FNA) of a renal mass have been reported. OBJECTIVE: To describe a multicenter experience with the indications, yield, and complications from attempted EUS-FNA of a kidney mass. DESIGN: Retrospective case series. SETTING: Six tertiary referral hospitals in the United States. PATIENTS: Consecutive subjects undergoing attempted EUS-FNA of a kidney mass. Endosonographers at 15 other teaching hospitals were contacted regarding EUS findings and follow-up of any EUS-guided renal biopsies previously attempted or considered at that institution. INTERVENTIONS: EUS-FNA of a kidney mass. MAIN OUTCOME MEASUREMENTS: Biopsy indications, yield, diagnosis, and complications. RESULTS: Fifteen procedures in 15 patients (9 men; median age 67 years) were performed at 6 (37%) of 16 hospitals (Indiana University plus 15 other hospitals). Kidney masses (median diameter 32 mm; range 11-60 mm) were located in the upper (n = 12) and lower (n = 3) poles of the left (n = 10) and right (n = 5) kidneys, respectively. Initial mass detection was by previous imaging in 13 (87%) patients or by EUS in 2 (13%) patients. Results of EUS-FNA (median 3 passes; range 2-4 passes) in 13 (87%) procedures were diagnostic of (n = 7) or highly suspicious for (n = 1) renal cell carcinoma (RCC), atypical cells (n = 2), oncocytoma (n = 1), benign cyst (n = 1), and nondiagnostic (n = 1). No complications were encountered. Surgical resection confirmed RCC in 7 patients in whom preoperative EUS-FNA demonstrated RCC (n = 5) or oncocytoma (n = 1) or was not performed (n = 1). LIMITATIONS: Retrospective series, small number of patients. CONCLUSIONS: EUS-FNA of renal masses is rarely performed at the U.S. teaching hospitals surveyed. This technique appears safe and feasible and should be considered when results would affect patient management.

EUS-based criteria for the diagnosis of chronic pancreatitis: the Rosemont classification.

BACKGROUND: EUS is increasingly used in the diagnosis of chronic pancreatitis (CP). A number of publications in this field have used different EUS terminology, features, and criteria for CP, making it difficult to reproduce their findings and apply them in clinical practice. Moreover, traditional criteria such as the Cambridge classification for CP are arguably outdated and have lost their relevance. OBJECTIVE: Our purpose was to establish consensus-based criteria for EUS features of CP. DESIGN: Consensus study. MAIN OUTCOME MEASUREMENTS: Thirty-two internationally recognized endosonographers anonymously voted on terminology of EUS features, rank order, and category (major vs minor criteria). Consensus was defined as greater than two thirds agreement among participants. RESULTS: Major criteria for CP were (1) hyperechoic foci with shadowing and main pancreatic duct (PD) calculi and (2) lobularity with honeycombing. Minor criteria for CP were cysts, dilated ducts > or =3.5 mm, irregular PD contour, dilated side branches > or =1 mm, hyperechoic duct wall, strands, nonshadowing hyperechoic foci, and lobularity with noncontiguous lobules. LIMITATION: Lack of broadly accepted reference standard. CONCLUSION: In a complex disease such as CP that has no universally accepted reference standard, an EUS-based criterion for diagnosis can be determined by expert consensus opinion and the existing body of evidence. Here we present the new "Rosemont criteria" for the EUS diagnosis of CP.

Non-surgical tissue biopsy among patients with advanced pancreatic cancer: effect on survival.

OBJECTIVE: The aim was to determine the survival of patients with advanced, unresectable pancreatic cancer in relation to whether they underwent nonsurgical biopsy of their primary tumor. METHODS: A total of 1481 patients with distant stage pancreatic cancer diagnosed between 1992 and 2001 who underwent radiation treatment but not cancer-directed surgery were analyzed. The design is a retrospective cohort study from the Surveillance, Epidemiology, and End Results program of the US National Cancer Institute. Survival curves were created using Kaplan-Meier method and compared via log-rank test. RESULTS: Of 1481 patients (median age, 66 years) included in our analysis, 1406 (95%) underwent nonsurgical biopsy (95%) and 75 (5%) did not. There was no statistically significant difference in overall median survival according to receipt of nonsurgical biopsy (Kaplan-Meier curve, log-rank test = 0.09). A subgroup analysis of patients younger than 65 years who did not undergo biopsy revealed a hazard ratio of 1.76 (95% confidence interval, 1.14-2.72); that is, there was a 76% higher hazard for death among younger patients who did not undergo biopsy compared with those who did (P = 0.011). CONCLUSION: Nonsurgical biopsy did not seem to negatively impact survival among patients with advanced pancreatic cancer.

Emerging applications of endoscopic ultrasound in gastrointestinal cancers.

Endoscopic ultrasound (EUS) has been adopted into numerous interventional techniques and strategies that promise to improve diagnosis and management of gastrointestinal (GI) cancers. EUS-guided fine-needle aspiration (EUS-FNA) is recommended as a procedure of choice for tissue diagnosis of pancreatic cancer. Potential benefits of EUS-FNA in diagnosis of pancreatic cancer include the ability to detect small, discrete lesions compared with conventional imaging and the ability to provide staging information by examination of blood vessels surrounding the pancreas. EUS-FNA currently is being evaluated in strategies for improving diagnosis in pancreatic cancer through analysis of molecular markers, including strategies for distinguishing malignant pancreatic cysts. EUS-guided fineneedle injection currently is being investigated in a broad range of settings in GI cancers, including use in intratumoral injection in pancreas and esophageal cancers, ethanol lavage for nonmalignant pancreatic cystic tumors, and brachytherapy in nonresectable pancreatic cancer. Other applications of EUS currently being evaluated include EUS-guided biliary access in patients with unsuccessful endoscopic retrograde cholangiopancreatography and EUS-guided anastamoses in the GI tract. EUS-guided interventions have enormous potential to advance diagnosis and treatment of GI cancers.

Endoscopic papillectomy.

PURPOSE OF REVIEW: Although few controlled trials exist in the field, endoscopic papillectomy has evolved over the recent years with new data on preoperative staging and improved methods for its safe and successful completion. In 2006, a consensus guideline was published by the American Society of Gastrointestinal Endoscopy evaluating the role of endoscopy in managing ampullary adenomas. RECENT FINDINGS: The recent literature of endoscopic papillectomy has focused on the preoperative management of ampullary tumors, with a paper evaluating the role of endoscopic ultrasound. Also, a randomized controlled trial has shown that the use of pancreatic duct stents is associated with less incidence of postendoscopic papillectomy pancreatitis, although the study was probably underpowered. Several methods can be used to help locate the pancreatic duct postendoscopic papillectomy (endoscopic ultrasound-guided rendezvous and methylene blue injection). The recurrence and complication rate in more recent papers continue to be acceptable, at about 30 and 20%, respectively. SUMMARY: Endoscopic papillectomy is a reasonable alternative to transduodenal surgical excision, but more controlled studies with long-term data are needed to evaluate preoperative staging accuracy and recurrence rates.

Usefulness of endoscopic ultrasound to diagnose the severity of chronic pancreatitis.

Endoscopic ultrasonography (EUS) is considered the most sensitive imaging method for the diagnosis of chronic pancreatitis (CP). Several investigators have shown that EUS findings of CP correlate with the presence of CP on endoscopic retrograde pancreatography (ERP). In general, for diagnosing CP using EUS, the presence or absence of the following EUS criteria is determined: hyperechoic foci, hyperechoic strands, lobularity, shadowing calcifications, cysts, hyperechoic duct margins, visible side branches, main pancreatic duct dilatation, and main pancreatic duct irregularity. Using these criteria, we reviewed the number of EUS criteria required to diagnose early CP and whether each EUS criterion correlates with the severity of CP on ERP. CP is likely when more than three criteria (for "early CP") or more than five criteria (for "moderate CP") are present. Moreover, each EUS criterion has its own importance at each ERP classification level. However, the obtained images can be operator dependent, and interobserver variability may affect interpretation of CP by EUS. Therefore, we performed a quantitative computer analysis of parenchymal echogenicity and compared it with the EUS diagnosis of CP so that the diagnosis of CP on the basis of EUS criteria could be objectively supported by the quantitative analysis of EUS images. In conclusion, EUS can objectively distinguish between a normal pancreas and CP, and can be used to evaluate the severity of the CP. EUS is a useful modality for diagnosing CP and is relatively less invasive than other available modalities.

The underutilization of EUS-guided FNA in the lymph-node staging of non-small-cell lung cancer: perceptions of chest physicians in Wisconsin.

BACKGROUND: Recently, the American College of Chest Physicians (ACCP) published evidence-based guidelines for the invasive staging of non-small-cell lung cancer (NSCLC), which shows the potential value of transesophageal sampling by EUS-guided FNA (EUS-FNA). The objective of the study was to determine the perceptions and the clinical practice of chest physicians regarding EUS-FNA as a staging modality for NSCLC. METHODS: We mailed a questionnaire to all members of the ACCP in Wisconsin. RESULTS: Seventy-one of 173 members (41%) responded. Chest physicians were more likely to perceive positron emission tomography, transbronchial needle aspiration, transthoracic needle aspiration, and mediastinoscopy to be able to make a difference in managing patients with NSCLC instead of EUS-FNA (p=0.01). Of the 40 chest physicians who believed that EUS-FNA can change the management of NSCLC, only 8 (20%) have sent a patient for EUS-FNA in the past year. Our findings may not necessarily reflect the opinions of chest physicians in other areas of the United States. CONCLUSIONS: Many of the chest physicians surveyed do not believe EUS-FNA impacts the management of NSCLC. This limited awareness may represent a barrier to successful utilization of EUS-FNA in lung-cancer staging.