Faculty Bibliography

EUS and ERCP are widely used for the evaluation and management of various pancreatobiliary conditions. They are generally regarded as safe procedures. Perforation is a rare but life-threatening adverse event of EUS and ERCP. Here we present 3 cases of ERCP- and EUS-related perforations that were successfully managed with over-the-scope clips (OTSCs). This work highlights the importance of early recognition and management of post-ERCP and -EUS perforations to ensure the best outcome possible. OTSCs have expanded the ability to close larger perforations and fistulas and could be considered a first-line tool for endoscopic closure of ERCP- and EUS-related perforations.

Introduction: Menetrier disease (MD) is a rare protein-losing hypertrophic gastropathy usually confined to the gastric fundus and body. Involvement of the esophageal inlet patch is extremely rare. We report a case of symptomatic MD involving the inlet patch that was managed with endoscopic submucosal dissection (ESD). Case Description/Methods: A 27-year-old woman with a history of MD was referred to our clinic for further evaluation of dysphagia and globus sensation. She had a family history of MD and gastric adenocarcinoma in her maternal grandmother who passed away at the age of 56. Outside upper endoscopy (EGD) revealed two proximal esophageal lesions, biopsies of which revealed gastric heterotopia. We performed an EGD with endoscopic ultrasound. Two 15 and 20-mm subepithelial lesions were found in the proximal esophagus at 18 cm from the incisors (Figure, panel A), and the lesions appeared to arise from the superficial submucosa. Biopsies revealed hyperplastic gastric foveolar epithelium, consistent with MD involving the esophageal inlet patch. We proceeded with ESD of the two lesions in two separate sessions. First, ESD of the 20 mm lesion was successful, and histologic examination showed MD with negative margins and no evidence of intestinal metaplasia or dysplasia (Figure, panel B). One month later, she underwent ESD of the 15 mm lesion (Figure, panel C). Histologic examination showed MD with negative margins and no evidence of intestinal metaplasia or dysplasia. The patient continued to report dysphagia and underwent EGD 3 weeks later which showed a benign-appearing esophageal stricture at the ESD site (Figure, panel D). This was dilated to 12mm. She then underwent three more dilations to 12, 13, and 15mm at 6, 10, and 22 weeks later, respectively (Figure, panels E and F). There was no evidence of residual or recurrent disease on any of the repeat endoscopies. The patient has remained symptom-free for 3 months now.
Discussion(s): To our knowledge, this is the first report of symptomatic MD involving the esophageal inlet patch that was managed with ESD for two reasons. First, the lesions appeared to arise from the superficial submucosa. Second, underlying malignancy could not be ruled out in either lesion given family history of gastric adenocarcinoma. In patients with symptomatic MD at high-risk of gastric adenocarcinoma, ESD, when compared with mucosal resection, has the advantage of en-bloc resection which in the setting of malignancy can provide staging data and can be potentially curative

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

BACKGROUND AND AIMS/OBJECTIVE:The full-thickness resection device (FTRD) offers a safe and effective approach for resection of complex colorectal lesions, but is limited to lesions under 2 cm in size. A hybrid approach-combining endoscopic mucosal resection (EMR) with FTRD-significantly expands the pool of lesions amenable to this technique; however, its safety and efficacy has not been well established. METHODS:We report a single-center retrospective study of consecutive patients who underwent full-thickness resection of colorectal lesions, either via standalone FTRD or hybrid (EMR+FTRD) approaches. Outcomes of technical success, clinical success (macroscopically complete resection), R0 resection, and adverse events were evaluated. RESULTS:Sixty-nine FTR procedures (38 stand-alone FTR and 31 hybrid EMR + FTR) were performed on 65 patients. The most common indications were nonlifting polyp (43%), or suspected high-grade dysplasia or carcinoma (38%). Hybrid EMR + FTR permitted resection of significantly larger lesions (mean 39 mm, range 15-70 mm) compared with stand-alone FTR (mean 17 mm, range 7-25 mm, p<0.01). Clinical success (91%), technical success (83%), and R0 resection (81%) rates did not differ between standalone and hybrid groups. 96% of patients were discharged home on the day of the procedure. Three adverse events occurred, including 2 patients who developed acute appendicitis. CONCLUSIONS:A hybrid approach combining use of EMR and FTRD maintains safety and efficacy while permitting resection of significantly larger lesions than FTRD alone.