Endoscopic sleeve gastroplasty: the identification of the key procedural steps through a modified Delphi method.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an innovative, minimally invasive bariatric procedure with an excellent safety and efficacy profile in adults with obesity. The purpose of the procedure is to shorten and tubularize the stomach along its greater curvature. Nevertheless, there are some heterogeneities in the approach to ESG, which will be important to address as the procedure sees increasingly widespread clinical adoption. Here, an expert consensus on standardized ESG techniques is presented. METHODS: The modified Delphi method was used to establish the key procedural steps of an ESG. A panel of 8 experts was selected, of which 6 participated. The panel was selected based on their experience with performing the procedure and consisted of 1 bariatric surgeon and 5 interventional gastroenterologists. A neutral facilitator was designated and produced a skeletonized initial version of the key steps that was sent to each expert. Each survey began with the experts rating the given steps on a Likert scale of 1 to 5, with 1 being the most inaccurate and 5 being the most accurate. Furthermore, the final product was rated. The survey continued with open-ended questions designed to revise and polish the key steps. Areas of discrepancy were addressed using binary questions and a majority vote. The respondents were given 10 days to complete each survey. At the end of each round, the survey was redistributed with updated key steps and questions. This process was continued for a predesignated 3 rounds. RESULTS: Of the 8 experts who were queried, 6/8, 5/8, and 5/8 replied to each round. The given ratings for the accuracy of the steps in each round were 4.2, 4.6, and 4.4. The final rating was 4.8. Although expert opinion varied around smaller portions of the procedure, such as the placement of an overtube and the shape of each suture line, there was consensus on the need for full-thickness bites and appropriate swirling of the tissue with the helix device. Whether or not to include the fundus in the gastroplasty was an additional area of discrepancy. Of note, 4 of 5 experts agreed that the fundus should remain intact. The final protocol consisted of 21 steps curated from the summarized responses of the experts. CONCLUSION: Using the modified Delphi method, 21 key steps have been described for a safe and effective ESG. This rubric will be standardized across institutions and practitioners. Furthermore, these findings allow for the generation of educational assessment tools to facilitate training and increase the adoption of ESG by endoscopists.

Curative Resection of T1a Inlet Patch Adenocarcinoma With Traction-Assisted Endoscopic Submucosal Dissection.

Esophageal inlet patch (EIP) adenocarcinoma is extremely rare. We present a case of a 58-year-old man who underwent a diagnostic esophagogastroduodenoscopy for dysphagia and found to have a 2 cm polypoid mass arising from an EIP. Biopsies and staging were consistent with T1aN0M0 EIP adenocarcinoma. While surgical resection was the main method of treatment of these lesions, very few case reports have shown that endoscopic resection can successfully remove these lesions. After multidisciplinary discussion, the patient underwent curative traction-assisted endoscopic submucosal dissection-which is the first known case report to highlight the success of this technique.

Threshold evaluation for optimal number of endoscopic treatment sessions to achieve complete eradication of Barrett's metaplasia.

BACKGROUND: Endoscopic eradication therapy (EET) is the standard of care for Barrett's esophagus (BE)-associated neoplasia. Previous data suggest the mean number of EET sessions required to achieve complete eradication of intestinal metaplasia (CE-IM) is 3. This study aimed to define the threshold of EET sessions required to achieve CE-IM. METHODS: The TREAT-BE Consortium is a multicenter outcomes cohort including prospectively enrolled patients with BE undergoing EET. All patients achieving CE-IM were included. Demographic, endoscopic, and histologic data were recorded at treatment onset along with treatment details and surveillance data. Kaplan-Meier analysis was performed to define a threshold of EET sessions, with 95 %CI, required to achieve CE-IM. A secondary analysis examined predictors of incomplete response to EET using multiple logistic regression and recurrence rates. RESULTS: 623 patients (mean age 65.2 [SD 11.6], 79.6 % male, 86.5 % Caucasian) achieved CE-IM in a mean of 2.9 (SD 1.7) EET sessions (median 2) and a median total observation period of 2.7 years (interquartile range 1.4-5.0). After three sessions, 73 % of patients achieved CE-IM (95 %CI 70 %-77 %). Age (odds ratio [OR] 1.25, 95 %CI 1.05-1.50) and length of BE (OR 1.24, 95 %CI 1.17-1.31) were significant predictors of incomplete response. CONCLUSION: The current study found that a threshold of three EET sessions would achieve CE-IM in the majority of patients. Alternative therapies and further diagnostic testing should be considered for patients who do not have significant response to EET after three sessions.

Economic burden of enhanced practices of duodenoscopes reprocessing and surveillance: balancing risk and cost containment.

Background and study aims Recent outbreaks attributed to contaminated duodenoscopes have led to the development of enhanced surveillance and reprocessing techniques (enhanced-SRT) aimed at minimizing cross-contamination. Common enhanced-SRT include double high-level disinfection (HLD), ethylene oxide (EtO) gas sterilization, and culture-based monitoring of reprocessed scopes. Adoption of these methods adds to the operational costs and we aimed to assess its economic impact to an institution. Methods We compared the estimated costs of three enhanced-SRT versus single-HLD using data from two institutions. We examined the cost of capital measured as scope inventory and frequency of scope use per unit time, the constituent reprocessing costs required on a per-cycle basis, and labor & staffing needs. The economic impact attributable to enhanced-SRT was defined as the difference between the total cost of enhanced-SRT and single HLD. Results Compared to single HLD, adoption of double HLD increased the costs approximately by 47 % ($80 vs $118). Similarly, culture and quarantine and EtO sterilization increased costs by 160 % and 270 %, respectively ($80 vs $208 and $296). Enhanced-SRT introduced significant scope downtime due to prolonged techniques, necessitating a 3.4-fold increase in the number of scopes needed to maintain procedural volume. The additional annual budget required to implement enhanced-SRT approached $406,000 per year in high-volume centers. Conclusions While enhanced-SRT may reduce patient risk of exposure to contaminated duodenoscopes, it significantly increases the cost of performing ERCP. Future innovation should focus on approaches that can ensure patient safety while maintaining the ability to perform ERCP in a cost-effective manner.

Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity.

BACKGROUND AND AIMS: Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience. METHODS: Fourteen "expert" (>2000 lifetime ERCPs) and 5 "less-expert" endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events. RESULTS: Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P = .131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P = .999), median ERCP completion time (25.0 vs 28.5 minutes, P = .130), mean cannulation attempts (2.8 vs 2.8, P = .954), and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0 [range, 1.0-10.0], P = .840) were similar for expert versus less-expert endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grades 1 to 2 versus grades 3 to 4 (P < .001). Serious adverse events were reported in 13 patients (6.5%). CONCLUSIONS: In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinical trial registration number: NCT04223830.).

Use of a novel single-use disposable duodenoscope for ERCP: selected clips from a real-world case series.

BACKGROUND AND AIMS: Single-use/disposable duodenoscopes represent one strategy to decrease the risk of patient infection related to ERCP. A preliminary case series was performed to demonstrate the feasibility and performance of a new single-use duodenoscope in a real-world clinical setting. METHODS: A single expert endoscopist performed ERCP for standard indications using a single-use duodenoscope. RESULTS: Videos of several key steps of ERCP obtained from 4 patients are shown to demonstrate that these steps can successfully be performed using the new single-use device. Clip 1 shows a patient with a large pancreatic duct stone in whom the image quality and maneuverability are demonstrated. Clip 2 shows a patient with choledocholithiasis and demonstrates bile duct cannulation, cholangiography, and sphincterotomy. Clip 3 shows a patient with acute cholecystitis and choledocholithiasis who underwent bile duct cannulation, sphincterotomy, and balloon sweeps. Clip 4 shows a patient with a history of liver transplant and refractory biliary anastomotic stricture who presented with abnormal liver tests and fever and underwent removal of a metal stent and placement of plastic stents. CONCLUSIONS: A single-use duodenoscope can successfully accomplish fundamental steps of ERCP. This device can potentially eliminate the risk of patient-to-patient infections linked to contaminated instruments. Larger studies are required to assess device performance.

Cholangioscopy-guided retrieval basket and snare for the removal of biliary stones and retained prostheses.

BACKGROUND AND AIMS: Certain pancreaticobiliary conditions remain challenging to treat using standard endoscopic techniques. Examples include difficult-to-remove gallstones and foreign objects in the bile ducts. Two tools designed for these purposes are the SpyGlass retrieval basket and the SpyGlass retrieval snare, which are passed through the cholangioscope channel for use under direct visualization. We present 3 cases in which these tools were used successfully. METHODS: Three cases using the SpyGlass retrieval basket and retrieval snare were reviewed for efficacy. RESULTS: Patient 1 had hepatitis C cirrhosis and underwent liver transplantation with T tube placement at the site of biliary anastomosis. Image-guided T tube removal by interventional radiology was unsuccessful. Endoscopic removal with the SpyGlass retrieval snare was completed. Patient 2 presented with cholangitis from an impacted common bile duct stone. Fragmentation with electrohydraulic lithotripsy was performed, and the fragments were removed with the SpyGlass retrieval basket. Patient 3 presented for removal of a migrated biliary stent. The stent was placed a year prior during an ERCP for treatment of choledocholithiasis. Initial removal attempt at an area hospital failed, so the patient was referred to our center, where the Spyglass retrieval snare was used to remove the biliary stent. CONCLUSIONS: This case series demonstrates initial successes treating biliary pathologic conditions with the SpyGlass retrieval basket and retrieval snare, 2 tools designed for use under direct visualization with the cholangioscope.

Anatomic location of Barrett's esophagus recurrence after endoscopic eradication therapy: development of a simplified surveillance biopsy strategy.

BACKGROUND AND AIMS: Surveillance endoscopy is recommended after endoscopic eradication therapy (EET) for Barrett's esophagus (BE) because of the risk of recurrence. Currently recommended biopsy protocols are based on expert opinion and consist of sampling visible lesions followed by random 4-quadrant biopsy sampling throughout the length of the original BE segment. Despite this protocol, some recurrences are not visibly identified. We aimed to identify the anatomic location and histology of recurrences after successful EET with the goal of developing a more efficient and evidence-based surveillance biopsy protocol. METHODS: We performed an analysis of a large multicenter database of 443 patients who underwent EET and achieved complete eradication of intestinal metaplasia (CE-IM) from 2005 to 2015. The endoscopic location of recurrence relative to the squamocolumnar junction (SCJ), visible recurrence identified during surveillance endoscopy, and time to recurrence after CE-IM were assessed. RESULTS: Fifty patients with BE recurrence were studied in the final analysis. Seventeen patients (34%) had nonvisible recurrences. In this group, biopsy specimens demonstrating recurrence were taken from within 2 cm of the SCJ in 16 of these 17 patients (94%). Overall, 49 of 50 recurrences (98%) occurred either within 2 cm of the SCJ or at the site of a visible lesion. Late recurrences (>1 year) were more likely to be visible than early (<1 year) recurrences (P = .006). CONCLUSIONS: Recurrence after EET detected by random biopsy sampling is identified predominately in the distal esophagus and occurs earlier than visible recurrences. As such, we suggest a modified biopsy protocol with targeted sampling of visible lesions followed by random biopsy sampling within 2 cm of the SCJ to optimize detection of recurrence after EET. (Clinical trial registration number: NCT02634645.).

Safely reprocessing duodenoscopes: current evidence and future directions.

Highly publicised outbreaks of various infections related to the use of duodenoscopes have increased public awareness of the once arcane and largely ignored subject of endoscope reprocessing. Since 2015, national professional societies, multiple federal agencies, and even the US Senate have written reports and guidelines on duodenoscope reprocessing. However, their recommendations are sometimes contradictory and difficult to implement, and new research on the topic is published regularly which further complicates the situation. With this flood of new and sometimes contradictory information, clinicians can feel confused about how to assure the safety of their patients undergoing duodenosocopy. This Review summarises the most salient current research on duodenoscope-associated outbreaks and reprocessing, and aims to provide clinicians with practical information applicable to their practice.

Inspection of endoscope instrument channels after reprocessing using a prototype borescope.

BACKGROUND AND AIMS: Visual inspection of the instrument channel has been proposed as a quality assurance step during endoscope reprocessing. However, the nature and severity of findings in a broad array of endoscopes (gastroscopes, colonoscopes, duodenoscopes, and echoendoscopes) after systemic implementation of an inspection protocol remain unknown. In addition, a study using borescope inspection in upper endoscopes and colonoscopes raised concerns about persistent simethicone residue despite full reprocessing. METHODS: A pilot inspection study using a prototype borescope (SteriCam Inspection Scope; SteriView Inc, San Rafael, Calif) was performed on routinely used endoscopes after high-level disinfection, manual forced-air dry of the instrument channel, and overnight vertical storage. Video recordings 1.5 to 2 minutes in duration were reviewed for visible moisture, debris, discoloration, scratches, channel shredding (scratches that result in strips or filaments of the channel lining protruding into the lumen), and visible evidence of biofilm or simethicone residue. RESULTS: A total of 97 inspections of 59 endoscopes were reviewed. The most common finding was scratches, seen in 51 devices (86%). Channel shredding was found in 35 devices (59%). Intrachannel debris was identified in 22 (23%) of the 97 inspections. No moisture was seen (0%) in the 74 inspections performed after forced-air dry and overnight vertical storage compared with moisture in 5 of 18 inspections (28%) performed after storage alone. No visual evidence of biofilm or simethicone residue was discovered despite its frequent use in our unit. CONCLUSION: Internal defects of the instrument channel appear to occur frequently. Manual forced-air drying of the channel appears to be highly effective in eliminating moisture compared with overnight hang drying alone. Video inspection of the endoscope channel may be useful to audit reprocessing performance and to identify damaged endoscopes.

Duodenoscope reprocessing practice patterns in U.S. endoscopy centers: a survey study.

BACKGROUND AND AIMS: After recent outbreaks of duodenoscope-related infections from multidrug-resistant organisms (MDRO), the United States Food and Drug Administration (FDA) recommended implementing 1 or more of 4 enhanced reprocessing measures in addition to updated manual cleaning methods and high-level disinfection (HLD). The implementation of these techniques in endoscopy facilities and provider opinions regarding reprocessing priorities remain unknown. METHODS: Physicians, nurse managers, nurses, and infection control staff at endoscopy units performing ERCP in the United States were surveyed to assess current institutional practices and individual opinions regarding future reprocessing solutions. RESULTS: A total of 249 distinct institutions participated in the survey. Of these, 223 (89.6%) implemented at least 1 of the 4 supplemental reprocessing methods after MDRO outbreaks. Overall, 63% of centers used repeat HLD, 53% performed surveillance microbiological culturing, 35% used liquid chemical sterilization, and 12% used ethylene oxide sterilization. Thirty-seven centers (15%) routinely screened patients for MDRO. Forced-air drying after reprocessing was used by 47.8% of centers. Fifty percent of individual respondents, including 58.6% of physicians, believed that redesign of the duodenoscope is the best long-term reprocessing solution. The majority (55.1%) identified efficacy to be the single most important factor in selecting a reprocessing technique. CONCLUSIONS: Although most endoscopy centers have implemented enhanced duodenoscope reprocessing techniques, there is a large variation in practice. Most providers believe that duodenoscope redesign and identifying reprocessing techniques with maximal efficacy are the long-term priorities. Improved adherence to forced-air drying in duodenoscope reprocessing is needed.

Multicenter evaluation of the clinical utility of laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass.

BACKGROUND AND AIMS: The obesity epidemic has led to increased use of Roux-en-Y gastric bypass (RYGB). These patients have an increased incidence of pancreaticobiliary diseases, yet standard ERCP is not possible because of surgically altered gastroduodenal anatomy. Laparoscopy-assisted ERCP (LA-ERCP) has been proposed as an option, but supporting data are derived from single-center small case series. Therefore, we conducted a large multicenter study to evaluate the feasibility, safety, and outcomes of LA-ERCP. METHODS: This is a retrospective cohort study of adult patients with RYGB who underwent LA-ERCP in 34 centers. Data on demographics, indications, procedure success, and adverse events were collected. Procedure success was defined when all the following were achieved: reaching the papilla, cannulating the desired duct, and providing endoscopic therapy as clinically indicated. RESULTS: A total of 579 patients (median age, 51; 84% women) were included. Indication for LA-ERCP was biliary in 89%, pancreatic in 8%, and both in 3%. Procedure success was achieved in 98%. Median total procedure time was 152 minutes (interquartile range [IQR], 109-210), with a median ERCP time of 40 minutes (IQR, 28-56). Median hospital stay was 2 days (IQR, 1-3). Adverse events were 18% (laparoscopy related, 10%; ERCP related, 7%; both, 1%) with the clear majority (92%) classified as mild/moderate, whereas 8% were severe and 1 death occurred. CONCLUSIONS: Our large multicenter study indicates that LA-ERCP in patients with RYGB is feasible with a high procedure success rate comparable with that of standard ERCP in patients with normal anatomy. The ERCP-related adverse events rate is comparable with conventional ERCP, but the overall adverse event rate was higher because of the added laparoscopy-related events.

Transhiatal Herniation of the Pancreas: A Rare Cause of Acute Pancreatitis.

Transhiatal herniation of the pancreas is rare. Acute pancreatitis secondary to this phenomenon is particularly unusual. A 102-year-old woman presented with 1 day of severe chest pain, vomiting, dyspnea, and diaphoresis. Serum lipase was elevated, and computed tomography angiogram of the chest and magnetic resonance cholangiopancreatography revealed a hiatal hernia containing the pancreas, with associated findings of pancreatitis. Pancreatitis in this setting may be due to repetitive trauma or ischemia from sliding, intermittent folding of the pancreatic duct, or pancreatic incarceration. Mild cases can be managed supportively, with surgery being reserved for severe cases or for younger patients with low surgical risk.

Advanced Imaging Techniques in Gastrointestinal Endoscopy.

The fundamental approach to endoscopy is to identify concerning and potentially premalignant lesions in the gastrointestinal tract, sample or resect the area of interest, await histologic results, and subsequently formulate a treatment and/or surveillance strategy. Detecting subtle lesions and deciding whether they are clinically significant are challenges that rely on the endoscopist's observation skills and experience. Enhanced imaging technologies have been developed to aid in lesion identification and classification, enabling better visualization of the lumen from a wide-field view while also enabling real-time near-field, including cellular level, imaging of the tissue. These innovations can potentially help reduce the rate of missed lesions, the need for extensive surveillance biopsies, and the frequency of surveillance. Several of these advanced imaging technologies are discussed in this review.