Thomas E. Kowalski

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

Perceptions of Gastroenterology Fellows Regarding ERCP Competency and Training

BACKGROUND The adequacy of ERCP training in the United States may be suboptimal because many training programs do not provide fellows with the exposure to the procedures necessary to achieve competence. METHODS A short survey questionnaire, which assesses the training program, the personal ERCP experience, the perceptions regarding training adequacy, and the post-training practice plans, was sent to all fellows graduating from gastroenterology training programs. RESULTS Graduating fellows performed a median of 140 ERCPs and 35 sphincterotomies during training, with an associated median comfort level for independently performing sphincterotomy of 7.5 on a scale of 1 to 10. The median estimated success rate for independent free cannulation was 75%. Based on nonparametric correlation and regression analysis, 180 ERCPs would be necessary to achieve a free cannulation rate of 80% and 69 sphincterotomies to achieve a comfort level of 8 on a scale of 1 to 10. Thirty-six percent of fellows achieved the number of procedures and cannulation success determined by this study to indicate procedural competence. Sixty-four percent of fellows did not achieve procedural competence and 33% reported inadequate ERCP training. Nevertheless, 91% of fellows expected to perform unsupervised ERCP after training. CONCLUSIONS The results of this study are consistent with those of previously published studies demonstrating that 160 to 200 ERCP procedures are necessary to achieve competence to perform ERCP. The majority of graduating fellows do not achieve an acceptable success rate during training, yet still intend to perform ERCP after training.

Targeted cyst wall puncture and aspiration during EUS-FNA increases the diagnostic yield of premalignant and malignant pancreatic cysts

BACKGROUND Characterization of pancreatic cysts by using EUS-FNA includes chemical and cytologic analysis. OBJECTIVE To evaluate whether material obtained from FNA of the cyst wall increases diagnostic yield. DESIGN Prospective series. SETTING Tertiary referral center. PATIENTS Consecutive patients with pancreatic cysts referred for EUS-FNA between March 2010 and March 2011. INTERVENTION FNA was performed with aspiration of cyst fluid for carcinoembryonic antigen (CEA) and cytology, followed by cyst wall puncture (CWP). CWP is defined as puncturing the far wall of the cyst and moving the needle back and forth through the wall to sample the wall epithelium. MAIN OUTCOME MEASUREMENTS The diagnostic yield for mucinous cystic pancreatic neoplasms by CEA and cytology obtained from cyst fluid compared with cytology obtained from CWP. CEA ≥192 ng/mL was considered mucinous. RESULTS A total of 69 pancreatic cysts from 66 patients were included. Adequate amounts of fluid were aspirated for CEA, amylase, and cytology in 60 cysts (81%). Cellular material adequate for cytologic assessment from CWP was obtained in 56 cysts (81%). Ten (30%) of 33 cysts with CEA <192 ng/mL and negative results of cyst fluid cytology had a mucinous diagnosis from CWP; 6 of 9 (67%) cysts with an insufficient amount of fluid for CEA analysis and cyst fluid cytology had a mucinous diagnosis from CWP. Furthermore, 4 malignant cysts were independently diagnosed by CWP cytology. The incremental diagnostic yield of CWP for mucinous or malignant cysts was therefore 29% (20 of 69 cysts, P = .0001). An episode of pancreatitis (1.45%) occurred. LIMITATION Lack of surgical criterion standard. CONCLUSIONS CWP during EUS-FNA is a safe and effective technique for improving the diagnostic yield for premalignant and malignant pancreatic cysts.

Functional magnetic resonance cholangiography (fMRC) of the gallbladder and biliary tree with contrast-enhanced magnetic resonance cholangiography

To determine the diagnostic performance of functional magnetic resonance cholangiography (fMRC) for the evaluation of anatomic and functional biliary disorders.

Placement of fully covered self-expandable metal stents in patients with locally advanced esophageal cancer before neoadjuvant therapy

BACKGROUND Most patients with locally advanced esophageal cancer requiring neoadjuvant therapy have significant dysphagia. OBJECTIVE To report our experience in using a fully covered self-expandable metal stent (FCSEMS) to treat malignant dysphagia and for maintenance of nutritional support during neoadjuvant therapy. DESIGN Retrospective study. SETTING Two tertiary-care referral centers. PATIENTS This study involved 55 patients with locally advanced esophageal cancer (50 adenocarcinoma, 5 squamous cell carcinoma). Forty-three patients were men, and the mean age was 65.8 years. INTERVENTION EUS followed by FCSEMS placement. MAIN OUTCOME MEASUREMENTS Procedural success, dysphagia scores, patient weights, stent migration, and stent-related complications. RESULTS All stents were successfully placed. Tumors were located in the middle esophagus (n = 10) and distal esophagus (n = 45). The mean dysphagia score obtained at 1 week after stent placement had improved significantly from baseline (2.4 and 1, respectively; P < .001). Patients maintained their weights at 1 month follow-up when compared with baseline (153 and 149 pounds, respectively; P = .58). Immediate complications included chest discomfort in 13 patients; 2 patients required stent removal because of intractable pain. One patient had stent removal because of significant acid reflux. Stent migration occurred at some point in 17 of 55 patients (31%). There was a delayed perforation in 1 patient. Because of disease progression or the discovery of metastasis after neoadjuvant therapy, only 8 of 55 patients underwent curative surgery. LIMITATIONS Retrospective study. CONCLUSION Placement of FCSEMSs in patients with locally advanced esophageal cancer significantly improves dysphagia and allows for oral nutrition during neoadjuvant therapy. FCSEMSs appear to be effective for palliating dysphagia. Migration was not associated with injury or harm to the patient and usually represented a positive response to neoadjuvant therapy. Few patients undergoing stenting in this situation ultimately undergo surgery because of disease progression or poor operative candidacy.

Expandable Polyester Silicon-Covered Stent for Malignant Esophageal Structures before Neoadjuvant Chemoradiation: A Pilot Study

Patients with resectable esophageal cancer often require placement of a surgical jejunostomy tube prior to receiving chemoradiation so as to maintain adequate nutrition due to their inability to swallow and eat. This study reports a single institutional experience with the Polyflex self-expanding silicone stent (Rüsch; Kernen. Germany) in patients with malignant stenosis receiving chemoradiation prior to esophagectomy. This was a retrospective, nonrandomized study of 6 patients who underwent Polyflex esophageal stent placement across a malignant stricture prior to receiving neoadjuvant chemoradiation. The study assessed procedural success, restoration of oral nutrition, migration, and removal of the Polyflex stent. The outcomes measured were the efficacy of treatment, stent-related complications, and changes in the nutritional status of the patient after stent placement. Stent placement was successful in 5 of 6 patients (83%). Restoration of oral nutrition after stent placement occurred in 5 of 5 patients (100%). Migration of the stent into the stomach occurred in 3 patients (60%) without occurrence of gastric outlet obstruction; there was no proximal migration. Stents were successfully removed endoscopically or at the time of esophagectomy. This early experience suggests that the removable silicone Polyflex stent is an effective alternative to a surgical jejunostomy tube for the management of malignant esophageal stenosis in patients for whom neoadjuvant chemoradiation is planned prior to esophagectomy.

Multicenter trial evaluating the use of covered self-expanding metal stents in benign biliary strictures: time to revisit our therapeutic options?

Background: Covered self-expanding metal stents are being used more frequently in benign biliary strictures (BBS). We report the results of a multicenter study with fully covered self-expanding metal stent (FCSEMS) placement for the management of BBS. Aim: To prospectively evaluate the efficacy and safety of FCSEMS in the management of BBS. Patients and Methods: Patients with BBS from 6 tertiary care centers who received FCSEMS with flared ends between April 2009 and October 2010 were included in this retrospective study. Efficacy was measured after removal of FCSEMS by evaluating stricture resolution on the basis of symptom resolution, imaging, laboratory studies, and/or choledochoscopy at removal. Safety profile was evaluated by assessing postprocedural complications. Results: A total of 133 patients (78, 58.6% males) with a mean age of 59.2±14.8 years with BBS received stents. Of the 133 stents placed, 97 (72.9%) were removed after a mean stent duration of 95.5±48.7 days. Stricture resolution after FCSEMS removal was as follows: postsurgical, 11/12 (91.6%); gallstone-related disease, 16/19 (84.2%); chronic pancreatitis, 26/31 (80.7%); other etiology, 4/5 (80.0%); and anastomotic strictures, 19/31(61.2%). Ninety-four patients were included in the logistic regression analyses. Patients who had indwelling stents for >90 days were 4.3 times more likely to have resolved strictures [odds ratio, 4.3 (95% confidence interval, 1.24-15.09)] and patients with nonmigrated stents were 5.4 times more likely to have resolved strictures [odds ratio, 5.4 (95% confidence interval, 1.001-29.29)]. Conclusions: FCSEMS for BBS had an acceptable rate of stricture resolution for postsurgical strictures, gallstone-related strictures, and those due to chronic pancreatitis. Predictors for stricture resolution include longer indwell time and absence of migration. Further study is warranted to assess long-term efficacy in a prospective manner with longer than 3-month time of stent indwelling time.

Identification of Cholangiocarcinoma by Using the Spyglass Spyscope System for Peroral Cholangioscopy and Biopsy Collection

BACKGROUND & AIMS It is a challenge to collect samples from bile duct strictures to diagnose patients with cholangiocarcinoma. We investigated the utility of the Spyglass Spyscope, a single-operator endoscope that is used to perform cholangiopancreatoscopy, to identify extrahepatic cholangiocarcinoma in patients who were not diagnosed with this disorder by endoscopic retrograde cholangiopancreatography (ERCP) cytology or endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) analyses. METHODS We conducted a retrospective analysis of data from 30 patients (median age, 67 years; 67% male) with indeterminate extrahepatic biliary strictures who were ultimately diagnosed with cholangiocarcinoma but had inconclusive results from initial biliary ductal brush cytology and EUS-FNA analyses. Patients then underwent cholangioscopy by using the Spyglass Spyscope and intraductal biopsy analysis. None of the patients had a definitive mass in abdominal imaging or EUS analyses. RESULTS The biliary stricture was located in the common bile duct in 13 patients and in the common hepatic duct in 17 patients. The Spyglass Spyscope system had 77% accuracy (23 of 30) in the diagnosis of malignancies that were inconclusive on the basis of ERCP-guided brush or EUS-FNA analyses. CONCLUSIONS The Spyglass Spyscope for cholangioscopy and biopsy collection identified malignancies with 77% accuracy in patients with suspected cholangiocarcinoma.

Cyst wall puncture and aspiration during EUS-guided fine needle aspiration may increase the diagnostic yield of mucinous cysts of the pancreas.

Background Pancreatic cysts are common, however, their diagnosis and classification remains a challenge despite advances in cross-sectional imaging and endoscopic ultrasound with fine needle aspiration (EUS-FNA). Objective To determine the incremental yield of cytologic examination of material obtained from targeted fine needle aspiration (“puncture”) of the cyst wall after aspiration of fluid for CEA. Design Retrospective consecutive series. Patients and Setting Consecutive patients undergoing EUS-FNA of a pancreatic cyst by 2 expert endoscopists at a single tertiary care center between January 2006 and June 2008. Intervention Standard EUS-FNA of pancreatic cysts was carried out, and after cyst fluid aspiration the cyst wall was punctured and aspirated (CWP) to obtain epithelium for cytologic analysis. Main Outcome Measurements The diagnostic yields of carcinoembryonic antigen (CEA) obtained from cyst fluid and of cytology obtained from CWP. CEA greater than192 ng/mL was considered diagnostic of a mucinous cyst. Results One hundred seven patients underwent EUS-FNA with CWP. Sixteen (31%) of 52 patients with CEA <192 ng/mL had cytology positive for mucinous epithelium, whereas 15 (47%) of 32 cysts with an insufficient amount of fluid for CEA analysis had positive cytology from CWP. The additional, cumulative diagnostic yield for mucinous cysts was therefore, 37%. Of 55 cysts diagnosed as mucinous, more (56%) were diagnosed by CWP cytology alone than by CEA (P<0.05). Limitations Retrospective design and limited surgical pathology. Conclusions Cyst wall puncture and aspiration during routine EUS-FNA may be a safe, easily applied, and inexpensive technique for improving the diagnostic yield for mucinous cysts of the pancreas.

Self-expanding plastic esophageal stents versus jejunostomy tubes for the maintenance of nutrition during neoadjuvant chemoradiation therapy in patients with esophageal cancer: a retrospective study

In patients undergoing chemoradiotherapy for esophageal cancer, the inability to eat may severely impair nutritional status. We conducted a retrospective study to compare the efficacy of the Polyflex self-expanding silicone stent (PS) versus a jejunostomy tube (JT) for maintaining nutrition during neoadjuvant chemoradiation therapy in patients with esophageal cancer who were scheduled for resectional surgery. Thirty-six patients were treated either with PS placement (12 patients) or JT placement (24 patients) prior to receiving an 8-week course of chemoradiation therapy. Patients were interviewed weekly until cessation of therapy. Patient data were collected on procedural success and complication rates, nutritional status, and dysphagia scores. PS placement was successful in 11 of 12 patients (92%), and those 11 patients were able to resume oral nutrition. Dysphagia scores improved from a mean of 3 to 1 in the PS group (P < 0.005) but did not change significantly in the JT group. PS were removed endoscopically without complications prior to the esophagectomies. Albumin levels and weight increased significantly in both the PS and JT groups. There were no significant differences between groups in the procedural success rates (PS 92% vs. JT 100%, P = 0.33), complication rates (PS 22% vs. JT 4%, P = 0.11), mean increase in weight (PS 4.4 kg vs. JT 4.2 kg, P = 0.59), and mean increase in serum albumin (PS 0.62 g/dL vs. JT 0.44 g/dL, P = 0.05). PS is a safe and effective alternative to a surgical JT for maintaining nutrition in this subset of patients.