Faculty Bibliography

Introduction: Pancreatic cystic lesions (PCL) are increasingly identified on cross-sectional imaging. Types include intraductal papillary mucinous neoplasms (IPMN), mucinous cystic neoplasms (MCN), serous cystadenoma (SCA), solid pseudopapillary tumors (SPT) and pseudocysts. Given the risk of malignancy associated with MCN and IPMN with high risk features, accurate PCL diagnosis is essential. Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) of cyst fluid for cytology remains important for the classification of PCL, but is limited by the ability to obtain a sufficient sample and cellularity of fluid. The specificity for malignant cytology is 94%, but sensitivity remains low at 51%. Recently, introduction of a novel microforceps biopsy (MFB) device (Moray Micro Forceps, US Endoscopy, Mentor, OH) has enabled EUS-guided through-the-needle biopsies of PCL through a 19-gauge needle. The aim of this study is to compare the technical success and diagnostic yield for PCL using MFB versus cyst fluid studies alone, along with identifying adverse events associated with MFB.
Method(s): We conducted a retrospective chart review of adult patients with PCL diagnosed by cross sectional imaging undergoing EUS-guided FNA with MFB at 2 tertiary academic centers from November 2016 to November 2019. FNA of PCL was performed and cyst fluid was sent for cytology, carcinoembryonic antigen (CEA) levels, and mutational analysis. Cyst biopsy was performed using MFB.
Result(s): 14 patients were included. 71% were female. Median age was 60 years. Location of cysts in pancreas were head (4), body (6), and tail (4). MFB was technically successful in 12 of 14 cases (yield 86%) including 1 case where no cyst fluid was able to be obtained. There were no reported adverse outcomes (bleeding, pancreatitis, perforation, infection, abdominal pain). MFB diagnosed IPMN in 2 patients, neither of which were identified by cytology but were identified by fluid mutational analysis; MCN in 2 patients, 1 of which was identified by cytology; and SCA in 1 patient where cytology was concerning for a mucinous lesion. Both MFB and cytology were concerning for pseudocyst in 1 patient who ultimately was found to have MCN.
Discussion(s): The technical success of MFB is high and is associated with increased overall diagnostic yield without significant adverse events. For distinguishing PCL types, MFB provided additive diagnostic information to fluid cytology in 4 of 14 patients in our study. Including mutational analysis which identified IPMN in 2 patients where cytology was negative, MFB still provided further diagnostic information in 2 additional patients. This study suggests that the addition of MFB to EUS-guided sampling for cytology, CEA and mutational analysis further augments PCL diagnosis. Future studies should elucidate the role of MFB in combination with mutational analysis. [Formula presented]
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The full thickness resection device (FTRD) has become a safe and effective alternative to endoscopic submucosal dissection (ESD) in select cases.One obvious limitation of the FTRD is lesion size, generally less than 20mm.But because polyp size is one of the strongest predictors of advanced histology, many larger lesions may be amenable to a combined approach involving endoscopic mucosal resection (EMR) of the laterally spreading components and full-thickness resection (FTR) of the invasive, non-lifting portion.To our knowledge, a comparison of FTR alone to hybrid EMR + FTR has not been previously published in North America.We report our initial experience using the FTRD alone compared to a hybrid technique combining EMR and FTR in consecutive patients with lesions unresectable by conventional EMR alone. This is a single-center retrospective analysis of prospectively-collected data on consecutive patients who underwent attempted FTR alone or hybrid EMR/FTR.All consecutive patients in whom FTR was attempted during the study were included in this analysis, whether or not FTR was successful.Primary outcomes included technical success, clinical success, R0 resection, and adverse events.Secondary outcomes included procedure duration, adverse events, and subsequent need for surgery.ariataes collected included patient demographics, anticoagulant use, and lesion characteristics. A total of 62 patients underwent either FTR alone (33 patients) or hybrid EMR + FTR(29 patients).The mean lesion size was larger for the hybrid group (36 mm, range 15-60 mm) as compared to FTR alone (19 mm, range 7-40 mm, p<0.01).The FTR procedure was technically successful in 55 of 62 patients (89%).Of these 55 patients, 53 (96%) had R0 resection margins.There was no difference in R0 resection rate among those who underwent hybrid FTR + EMR, (23/24, 96%) versus those who underwent underwent FTR alone (30/31, 97%).In cases of technical failure, R0 resection was not assessed. Two significant adverse events occurred that were directly related to FTR.One patient developed acute appendicitis following FTR of a 15 mm polyp at the appendiceal orifice.One patient suffered an inadvertent perforation.This was immediately identified and successfully closed endoscopically.No bleeding-related adverse events were noted. We demonstrate high rates of technical success, clinical success, R0 resection, and safety.While this is the first study to compare hybrid EMR + FTR to FTR alone from North America, several groups have demonstrated its efficacy and safety elsewhere.In conclusion, our study shows FTR is a safe and effective method to resect large and complex colorectal lesions, and that a hybrid EMR + FTR technique can expand the pool of resectable lesions.Further multi-center prospective studies with the device are needed to assess its long-term safety, efficacy, and curative resection rates. [Formula presented] [Formula presented]
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BACKGROUND AND AIMS/OBJECTIVE:Large colon polyps removed by endoscopic mucosal resection (EMR) can be complicated by delayed bleeding. Prophylactic defect clip closure can reduce post-EMR bleeding. Larger defects can be challenging to close using through-the-scope clips (TTSCs) and proximal defects are difficult to reach using over-the-scope techniques. A novel, through-the-scope suture (TTSS) device allows direct closure of mucosal defects without scope withdrawal. We aim to evaluate the rate of delayed bleeding following the closure of large colon polyp EMR sites with TTSS. METHODS:A multi-center retrospective cohort study was performed involving 13 centers. All defect closure by TTSS following EMR of colon polyps ≥2 cm from January 2021 to February 2022 were included. The primary outcome was rate of delayed bleeding. RESULTS:A total of 94 patients (F= 52%, mean age 65 years) underwent EMR of predominantly right sided (n=62, 66%) colon polyps (median size 35 mm, IQR 30-40) followed by defect closure with TTSS during the study period. All defects were successfully closed with TTSS alone (n=62, 66%) or with TTSS and TTSC (n=32, 34%), using a median of 1 (IQR 1-1) TTSS systems. Delayed bleeding occurred in three patients (3.2%) with two requiring repeat endoscopic evaluation/treatment (moderate). CONCLUSION/CONCLUSIONS:TTSS alone or with TTSC was effective in achieving complete closure of all post-EMR defects, despite a large lesion size. Following TTSS closure with or without adjunctive devices, delayed bleeding was seen in 3.2% of cases. Further prospective studies are needed to validate these findings before wider adoption of TTSS for large polypectomy closure.

INTRODUCTION/BACKGROUND:The development of non-anastomotic biliary strictures (NAS) following orthotopic adult liver transplantation (OLT) is associated with significant morbidity. We performed a systematic review and meta-analysis to identify all prognostic factors for the development of NAS. METHODS:A systematic review was conducted following preferred reporting items for systematic reviews and meta-analyses (PRISMA) and the meta-analysis of observational studies in epidemiology (MOOSE) guidelines. We used the Newcastle-Ottawa scale to assess the quality of the included studies. Using the random-effects model, we calculated the weighted pooled odds ratios (OR), mean differences (MD), hazard ratios (HR), and 95% confidence intervals (CI) of the risk factors. RESULTS:Based on 19 international studies that included a total of 8269 adult LT patients, we calculated an 8% overall incidence of NAS. In this study, 7 potential prognostic factors were associated with a statistically significant hazard ratio for NAS in pooled analyses including (1) DCD donors compared to DBD donors (2) PSC as an indication for a liver transplant (3) Roux-en-Y bile duct reconstruction compared to duct-to-duct reconstruction (4) hepatic artery thrombosis (5) longer cold ischemia time (6) longer warm ischemia time (7) and total operative times. CONCLUSION/CONCLUSIONS:In this systematic review and meta-analysis, we identified 7 prognostic factors for the development of NAS following OLT. These findings might lay the groundwork for development of diagnostic algorithms to better risk stratify patients at risk for development of NAS.

BACKGROUND AND AIMS/OBJECTIVE:Closure of endoscopic resection defects can be achieved with through-the-scope clips, over-the-scope clips or endoscopic suturing. However, these devices are often limited by their inability to close large, irregular, and difficult to reach defects. Thus, we aimed to assess the feasibility and safety of the novel through-the-scope suture-based closure system that was developed to overcome these limitations. METHODS:This is a retrospective multicenter study involving 8 centers in the United States. Primary outcomes included feasibility and safety of early use of the device. Secondary outcomes included assessment of need for additional closure devices, prolonged procedure time, and technical feasibility of performing the procedure with an alternative device(s). RESULTS:A total of 93 patients (48.4% female) with mean age 63.6 ± 13.1 years were included. Technical success was achieved in 83 patients (89.2%) and supplemental closure was required in 24.7% (n=23) of patients with a mean defect size of 41.6 ± 19.4 mm. Closure with an alternative device was determined to be impossible in 24.7% of patients due to location, size, or shape of the defect. The use of the tack and suture device prolonged the procedure in 8.6% of the cases but was considered acceptable. Adverse events occurred in 2 patients (2.2%) over a duration of follow-up of 34 days (interquartile range: 13-93.5 days) and were mild and moderate in severity. No serious adverse events or procedure-related deaths occurred. CONCLUSIONS:The novel endoscopic through-the-scope tack and suture system is safe, efficient, and permits closure of large, and irregularly shaped defects that were not possible with predicate devices.

Background and Aims: Endoscopic submucosal dissection (ESD) is a technically challenging and time-consuming procedure. A major limitation of ESD is the lack of a "second hand" to provide traction. We have developed a novel retraction device, a traction wire (TW), for ESD. This study was conducted to assess the efficacy, safety, and efficiency of TW-ESD. Methods: We initially evaluated TW-ESD in a randomized live pig study. After the device was approved for clinical use, we used it in patients undergoing ESD at 8 academic centers in the United States and Japan. Data on demographics, procedural performance, histopathology, and clinical follow-up were collected and analyzed retrospectively. Results: Porcine study: In total, 12 ESDs were performed in random order in 3 live pigs. ESDs performed with TW had significantly shorter submucosal dissection time (7.0 ± 1.9 minutes vs 18.3 ± 3.4 minutes; P < 0.001) and shorter total ESD time (21.5 ± 4.1 minutes vs 29.5 ± 7.7 minutes; P= 0.049). TW was successfully deployed in all 103 study patients. The median device deployment time was 2 minutes (2, 3.0), and the median procedure time was 100.5 (65.50, 175.75) minutes. En-bloc and R0 resection rates were 98.1% (101/103) and 90.29% (93/103), respectively. The median ease of deployment and retrieval of the device on a 100-mm visual analog scale was 100 (80, 100). The median degree to which the device improved ease of procedure was 90 (77.5, 100). No adverse events related to the TW were seen. Conclusion: The TW device was safe and efficient to use in ESD.

BACKGROUND AND AIM/OBJECTIVE:Recently, the BLI Adenoma Serrated International Classification (BASIC) system was developed by European experts to differentiate colorectal polyps. Our aim was to validate the BASIC classification system among the US-based endoscopy experts. METHODS:Participants utilized a web-based interactive learning system where the group was asked to characterize polyps using the BASIC criteria: polyp surface (presence of mucus, regular/irregular and [pseudo]depressed), pit appearance (featureless, round/non-round with/without dark spots; homogeneous/heterogeneous distribution with/without focal loss), and vessels (present/absent, lacy, peri-cryptal, irregular). The final testing consisted of reviewing BLI images/videos to determine whether the criteria accurately predicted the histology results. Confidence in adenoma identification (rated "1" to "5") and agreement in polyp (adenoma vs non-adenoma) identification and characterization per BASIC criteria were derived. Strength of interobserver agreement with kappa (k) value was reported for adenoma identification. RESULTS:Ten endoscopy experts from the United States identified conventional adenoma (vs non-adenoma) with 94.4% accuracy, 95.0% sensitivity, 93.8% specificity, 93.8% positive predictive value, and 94.9% negative predictive value using BASIC criteria. Overall strength of interobserver agreement was high: kappa 0.89 (0.82-0.96). Agreement for the individual criteria was as follows: surface mucus (93.8%), regularity (65.6%), type of pit (40.6%), pit visibility (66.9%), pit distribution (57%), vessel visibility (73%), and being lacy (46%) and peri-cryptal (61%). The confidence in diagnosis was rated at high ≥4 in 67% of the cases. CONCLUSIONS:A group of US-based endoscopy experts hsave validated a simple and easily reproducible BLI classification system to characterize colorectal polyps with >90% accuracy and a high level of interobserver agreement.

BACKGROUND AND AIMS/OBJECTIVE:Consensus regarding an optimal algorithm for endoscopic treatment of papillary adenomas has not been established. We aimed to assess the existing degree of consensus among international experts and develop further concordance by means of a Delphi process. METHODS:Fifty-two international experts in the field of endoscopic papillectomy were invited to participate. Data were collected between August and December 2019 using an online survey platform. Three rounds were conducted. Consensus was defined as ≥70% agreement. RESULTS:Sixteen experts (31%) completed the full process, and consensus was achieved on 47 of the final 79 statements (59%). Diagnostic workup should include at least an upper endoscopy using a duodenoscope (100%) and biopsy sampling (94%). There should be selected use of additional abdominal imaging (75%-81%). Patients with (suspected) papillary malignancy or over 1 cm intraductal extension should be referred for surgical resection (76%). To prevent pancreatitis, rectal nonsteroidal anti-inflammatory drugs should be administered before resection (82%) and a pancreatic stent should be placed (100%). A biliary stent is indicated in case of ongoing bleeding from the papillary region (76%) or concerns for a (micro)perforation after resection (88%). Follow-up should be started 3 to 6 months after initial papillectomy and repeated every 6 to 12 months for at least 5 years (75%). CONCLUSIONS:This is the first step in developing an international consensus-based algorithm for endoscopic management of papillary adenomas. Surprisingly, in many areas consensus could not be achieved. These aspects should be the focus of future studies.

Introduction: Multiple recent outbreaks of multidrug resistant organisms (MDRO) related to contaminated duodenoscopes have led to increased scrutiny of duodenoscope standard reprocessing methods. A key component of duodenoscope reprocessing is the cleaning step that occurs before high-level disinfection (HLD) or sterilization. Perfect adherence to manufacturer Instructions for Use (IFU) for manual cleaning can be difficult to achieve due to technical complexity and is open to human factor error. Adequate cleaning is measured against FDA and industry maximum allowed contaminants post cleaning of protein<6.4 ug/cm^2 and carbohydrates<2.2 ug/cm^2. Inadequate cleaning increases the risk for inadequate high-level disinfection and the possibility of procedures being performed with contaminated duodenoscopes. A new cleaning process has been developed to fully automate the cleaning step using turbulent flow technology.
Method(s): A total of 48 therapeutic ERCP procedures were performed utilizing Olympus TJF-Q180V duodenoscopes. After bedside point of use cleaning, 21 duodenoscopes were manually cleaned by trained technicians following the manufacturer IFU. 27 duodenoscopes were cleaned using the automated cleaning system. Duodenoscope instrument channels and distal elevator areas were sampled for residual protein and carbohydrates after cleaning.
Result(s): The automated cleaning process resulted in a lower average level of residual protein and carbohydrate compared to standard manual cleaning (Table 1). Using FDA and industry standards as a benchmark, the automated cleaning process reduced levels of protein and carbohydrate below safety threshold levels on all study duodenoscopes, while manual cleaning resulted in 4/21 (19%) duodenoscopes having protein or carbohydrate levels above FDA standards (p= 0.03).
Conclusion(s): Recent outbreaks of MDRO organisms transmitted after ERCP have brought to light the risk to patients when reusable duodenoscopes are not sufficiently reprocessed. The complex design of the device-involving multiple channels and an elevator mechanism at the distal tip-makes proper cleaning difficult. Without sufficient cleaning, subsequent HLD or sterilization can fail to adequately remove contaminants. As seen in this study, manual cleaning can be prone to error. With no incidents of elevated bioburden post cleaning, a fully automated cleaning technology appears to be a viable alternative for replacement of manual cleaning of duodenoscopes