Disposable duodenoscopes. Is healthcare system affordability the main hindrance?

The performance of an endoscopic procedure involves introducing an endoscope through the mouth or the anus, which may potentially lead to lethal infection. The risk increases when complex and difficult-to-clean scopes are used, as in the case of duodenoscopes. Side-viewing duodenoscopes are complex in design, with the camera and working channel exit located on one side of the endoscope's distal end, and with an elevator nail also located at this point for catheter redirection. This complex design may facilitate the presence of blind areas not easy to access for cleaning, resulting in suboptimal disinfection of the duodenoscope and therefore a higher risk of bacterial infection. This is of particular importance in particularly vulnerable patients like those who are immunosuppressed (e.g., transplanted patients) or have a malignant disease and are receiving chemotherapy. Moreover, in the era of ¨superbugs¨, like carbapenem-resistant Enterobacteriaceae, infection outbreaks related to endoscopic retrograde cholangiopancreatography (ERCP) have been reported with a significant mortality rate.

Two novel protocols for cleaning residual simethicone and fluid in patient-ready duodenoscopes.

BACKGROUND AND AIM: Approximately 42-95% of working channels have been reported to show the presence of residual fluid despite endoscope reprocessing. The aim of this study was to design two novel protocols for cleaning residual simethicone and demonstrate its efficiency by evaluating the residual fluid and cleanliness in the working channels of patient-ready duodenoscopes. METHODS: The designed protocol for cleaning residual simethicone was implemented in manual cleaning and/or high-level disinfection (HLD). The residual fluid inside the working channels was estimated by visual inspection. Adenosine triphosphate (ATP) values were evaluated to determine cleanliness after manual cleaning. RESULTS: Manual cleaning with novel simethicone cleaning protocol demonstrated a significant decrease in fluid droplets (14.6 ± 29.9 vs 0 ± 0, P < 0.001) and ATP values (157 ± 196 relative light units [RLUs] vs 52 ± 41 RLUs, P = 0.031). HLD with simethicone cleaning protocol, using either enzymatic detergent with effective for cleaning simethicone or cleaning time set in the automatic endoscope reprocessor program for 8 min, demonstrated significant decrease in the number of fluid droplets. Follow-up after the implementation of the simethicone cleaning protocol showed a significant decrease in fluid droplets (37.4 ± 41.0 vs 2.1 ± 5.5, P = 0.003) and ATP values (271 ± 268 RLUs vs 82 ± 136 RLUs, P = 0.021). CONCLUSIONS: Simethicone cleaning protocol is advantageous for significantly decreasing fluid droplets and ATP values within endoscope working channels. After manual cleaning with the simethicone cleaning protocol, in particular, no retained fluid droplet was observed in patient-ready duodenoscopes.

Initial performance profile of a new 6F self-expanding metal stent for palliation of malignant hilar biliary obstruction.

BACKGROUND: A 6F endoscopic biliary self-expanding metal stent (SEMS) has been newly introduced for intended simultaneous side-by-side bilateral deployment in hilar malignant obstruction. OBJECTIVE: To report our initial experience with the Zilver 635 biliary SEMS. DESIGN: Retrospective chart review. SETTING: Tertiary referral medical center. PATIENTS: Sixteen consecutive malignant hilar biliary obstruction patients. INTERVENTIONS: Endoscopic palliative treatment of malignant biliary obstruction with the Zilver 635 SEMS from December 2008 to January 2010. MAIN OUTCOME MEASUREMENTS: Technical/functional success rates, early complications (within 30 days of stent placement), early/late stent occlusion, and biliary reintervention rates. RESULTS: A total of 49 Zilver SEMSs were placed in 16 patients (mean age 61 years, 6 men) for Bismuth type II (n = 4), III (n = 5), and IV (n = 7) lesions. Twelve had cholangiocarcinoma, 2 had metastatic colon cancer, 1 had lung cancer, and 1 had pancreatic cancer. The technical success rate was 100%. Side-by-side simultaneous bilateral stent deployment was required and was achieved successfully in 10 cases. Additional transpapillary stents were placed for potential future biliary access. The 30-day mortality rate was 0%. There were 1 early (6%) and 3 late (19%) stent occlusions. Successful overall biliary drainage was 75%. LIMITATIONS: Small sample size, uncontrolled retrospective study. CONCLUSIONS: Malignant hilar biliary obstruction endoscopic palliation with the Zilver 635 SEMS offers acceptable initial feasibility, safety, and efficacy profiles. The current design facilitates smaller bile duct negotiation and more precise intrahepatic placement. Expanding available lengths would allow transpapillary bridged bilateral SEMS placement for future reobstructed biliary access. Further long-term studies are required for comparative outcomes with other current SEMS technology.

Endoscopic resection of ampullary adenoma after a new insulated plastic pancreatic stent placement: a pilot study.

BACKGROUND AND AIM: Although pancreatic stent insertion is recommended for the prevention of post-procedure pancreatitis during endoscopic papillectomy, insertion of the stent after the procedure can be technically difficult. The aim of the present study was to determine the feasibility and safety of inserting a newly developed insulated pancreatic stent before endoscopic papillectomy. METHODS: We conducted a prospective pilot study involving 11 consecutive patients with adenomas of the major duodenal papilla. After a 5F polytetrafluoroethylene-insulated pancreatic stent was inserted through the tumor, the stent and tumor were simultaneously grasped with a snare. After resection of the tumor with the stent in place, the tumor was incised perpendicularly along the edge of the stent for retrieval of the specimen. RESULTS: In all patients, the insulated pancreatic stents were successfully inserted before endoscopic papillectomy and were resistant to electrical current; retrieval of the specimen was technically feasible and successful without stent migration. There were no stent-related complications, but five papillectomy-related complications (including mild bleeding [n = 4] and late papillary stenosis [n = 1]) occurred without any episodes of acute pancreatitis or perforation. CONCLUSIONS: Pre-resection stenting with a polytetrafluoroethylene-insulated stent in patients with adenomas of the major duodenal papilla is a feasible and useful technique to prevent pancreatitis.

Endoscopic management of unresectable malignant gastroduodenal obstruction with a nitinol uncovered metal stent: A prospective Japanese multicenter study.

AIM: To determine the safety and efficacy of endoscopic duodenal stent placement in patients with malignant gastric outlet obstruction. METHODS: This prospective, observational, multicenter study included 39 consecutive patients with malignant gastric outlet obstruction. All patients underwent endoscopic placement of a nitinol, uncovered, self-expandable metal stent. The primary outcome was clinical success at 2 wk after stent placement that was defined as improvement in the Gastric Outlet Obstruction Scoring System score relative to the baseline. RESULTS: Technical success was achieved in all duodenal stent procedures. Procedure-related complications occurred in 4 patients (10.3%) in the form of mild pneumonitis. No other morbidities or mortalities were observed. The clinical success rate was 92.3%. The mean survival period after stent placement was 103 d. The mean period of stent patency was 149 d and the patency remained acceptable for the survival period. Stent dysfunction occurred in 3 patients (7.7%) on account of tumor growth. CONCLUSION: Endoscopic management using duodenal stents for patients with incurable malignant gastric outlet obstruction is safe and improved patients' quality of life.

A simple device for disinfecting endoscopes.

A method for disinfecting fibreoptic endoscopes with povidone-iodine and a simple cleaning device, consisting of a curved glass pipe and a peristaltic pump is described. If properly employed the system produces satisfactory results.

The first transendoscopic plastic to self-expandable metal stent replacement in Serbia and Montenegro using a diagnostic duodenoscope.

Studies have shown that SEMS remain patient longer with fewer associated complications compared with conventional plastic strents. Zilver stent, a nitinol zig-zag mash SEMS has a special advantage, having a thin introducer diameter of 7 Fr with a fully deployed span of 10mm. For a 48-year-old woman presented with obstructive jaundice and a diagnosis of unresectable pancreatic carcinoma with consequent stenosis of common bile duct (CBD), infiltration of local blood vessels and life expectancy longer than six months, it was decided that an endoscopic palliative drainage procedure should be performed. The technique of transendoscopic plastic to metal stent exchange is described, using a diagnostic duodenoscope. The patient lived 7 months after implementation of Zilver stent and died anicteric due to progression of a primary disease. The transendoscopic plastic to metal stent exchange is feasible palliative method which requires a basic endoscopic equipment and experienced staff and therefore is applicable in developing countries as well.

Endoscopic evaluation of the defunctionalized stomach by using ShapeLock technology (with video).

BACKGROUND: Patients with Roux-en-Y gastric bypass (RYGB) present a unique problem if they require diagnostic or therapeutic interventions for which the pancreatobiliary limb or the defunctionalized stomach must be accessed. Novel shape-locking guides have been reported in the literature to reduce looping during colonoscopy, and a new guide is now available to assist with enteroscopy. OBJECTIVE: To use ShapeLock technology to permit evaluation of the defunctionalized stomach. DESIGN: Observational case series. SETTING: Tertiary-care center. PATIENTS: Nine patients with a history of RYGB referred for repeat endoscopic evaluation after initial enteroscopy failed to reach the excluded stomach. INTERVENTIONS: After achieving appropriate levels of sedation, a standard enteroscope was back-loaded with the ShapeLock enteroscopy guide and was inserted through the mouth. The device was moved through the gastrojejunal (GJ) anastomosis, along the Roux limb, and into the distal pancreatobiliary limb. The device was then locked, which allowed the enteroscope to be advanced to the defunctionalized stomach. RESULTS: The ShapeLock guide was able to be advanced to the excluded stomach and perform a thorough examination of the pancreatobiliary limb in 8 of 9 patients, without complications. In 1 patient, the diameter of the GJ anastomosis prevented passage of the device. CONCLUSIONS: The ShapeLock enteroscopy guide can allow access to the upper-GI tract in patients after RYGB, provided the GJ anastomosis is of adequate diameter. This study suggested that the technique is safe and has the potential to allow therapeutic interventions in the defunctionalized stomach and duodenum, including ERCP.

Endoscopic removal of biliary self-expandable metallic stents: a prospective study.

BACKGROUND AND STUDY AIMS: The transpapillary endoscopic insertion of self-expandable metallic stents (SEMSs) has been widely used for the palliation of unresectable malignant biliary obstruction. We attempted the endoscopic removal of malfunctioning SEMSs. The aim of this study was to assess the feasibility and safety of the endoscopic removal of SEMSs by comparing the results between removal of covered and uncovered SEMSs. PATIENTS AND METHODS: 30 patients with a malfunctioning biliary SEMS prospectively underwent an attempt at endoscopic removal of the biliary SEMS over a 2-year period. Removal of the malfunctioning SEMS was done with a therapeutic duodenoscope (ED-450XT5 or TJF-240), using a rat-tooth forceps. Of the 30 SEMS used, 22 were silicone-covered Wallstents, while eight were uncovered SEMSs including five uncovered Wallstents and three Zilver stents. The time for an attempt at each endoscopic removal was limited to 15 minutes in a single endoscopic procedure session. RESULTS: The covered SEMSs were easily removed in 19 out of 22 patients (86.4 %), whereas none of the eight uncovered SEMSs (0 %) could be removed. The only factor predicting successful stent removal was the presence of a stent covering ( P = 0.000). There was no morbidity or mortality related to endoscopic removal of malfunctioning stents. CONCLUSIONS: In contrast to uncovered biliary SEMSs, in most cases malfunctioning covered biliary SEMSs can be easily and safely removed endoscopically using a rat-tooth forceps.