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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OBJECTIVES/OBJECTIVE:Non-exposed endoscopic full-thickness resection (EFTR) using a dedicated full-thickness resection device (FTRD) can be used to perform en bloc resection of subepithelial lesions throughout the gastrointestinal tract. Here we aim to evaluate the safety and efficacy of EFTR for the management of duodenal neuroendocrine tumors (dNET). METHODS:International multicenter retrospective study of device assisted EFTR for dNET. Study outcomes included rates of technical success, R0 resection, and adverse events (AE). RESULTS:171 patients were included across 35 centers. Lesions had a median size of 10 mm and were in the duodenal bulb in 143 cases (83.6%). Technical success was achieved in 164 (95.9%) and R0 resection in 123 cases (71.9%). R0 resection rate for lesions located in the proximal third of the bulb was 62.0% compared to 83.9% for more distal locations (P = 0.002). R0 resection rate was not affected by lesion size or depth of invasion. On multivariable analysis, date of resection (2021 onwards) and location distal to the proximal third of the duodenal bulb were independent predictors of R0 resection, but not case volume per participating center. Follow-up information was available for 114 patients (66.7%), and demonstrated two recurrences over a median follow-up of 10 months. Severe AEs occurred in 3 patients (1.8%). CONCLUSIONS:EFTR of dNET showed high technical success and R0 resection rates and very low rate of severe AEs. It could become endoscopic treatment of choice for dNET, at least for lesions not within proximity of the pylorus.

INTRODUCTION/BACKGROUND:While piecemeal endoscopic mucosal resection (EMR) for T1a oesophageal adenocarcinoma is acceptable, enbloc-R0 excision is advocated for T1b disease as it may offer a potential cure and mitigate recurrence. Thus, distinguishing between T1a and T1b disease is imperative under current treatment paradigms. We sought to ascertain whether expert Barrett's endoscopists were able to make this distinction based on optical evaluation. METHODS:Sixty sets of endoscopic images of histologically confirmed high grade dysplasia (HGD), T1a and T1b disease (n=20 for each) were compiled from consecutive patients at a single institution. Each set contained four images, and were standardized to include an overview, a close-up in high-definition white light, a near-focus magnification image, and a narrow-band image. Experts were invited to predict histology for each set. RESULTS:19 experts from 8 countries (Australia, USA, Italy, Netherlands, Germany, Canada, Belgium, and Portugal) participated. The majority had been practicing for >20 years, with a median annual case volume for Barrett's EMR of 50 (IQR 18-75), and Barrett's ESD of 25 (IQR 10-45). Oesophageal adenocarcinoma (T1a/b) could be distinguished from HGD, with a pooled sensitivity of 89.1% (95% CI:84.7-93.4. When predicting T-stage for T1b adenocarcinoma cases, pooled sensitivity was 43.8% (95% CI:29.9-57.7). Fleiss' kappa was 0.421 (95% CI:0.399-0.442, P<0.001), indicating fair-to-moderate agreement. CONCLUSIONS:Expert Barrett's endoscopists can reliably differentiate T1a/T1b oesophageal adenocarcinoma from HGD. Although there is fair-to-moderate agreement for T-staging, T1b disease cannot be reliably distinguished from T1a disease. This may have implications on clinical decision making and selection of endoscopic treatment methods.

OBJECTIVES/OBJECTIVE:We sought to determine the yield of somatic mutational analysis from EUS-guided biopsies of pancreatic adenocarcinoma compared to that of surgical resection and to assess the impact of these results on oncologic treatment. METHODS:We determined the yield of EUS sampling and surgical resection. We evaluated the potential impact of mutational analysis by identifying actionable mutations and its direct impact by reviewing actual treatment decisions. RESULTS:Yield of EUS sampling was 89.5%, comparable to the 95.8% yield of surgical resection. Over a quarter in the EUS cohort carried actionable mutations, and of these, over one in six had treatment impacted by mutational analysis. CONCLUSIONS:EUS sampling is nearly always adequate for somatic testing and may have substantial potential and real impact on treatment decisions.

INTRODUCTION:Adenoma per colonoscopy (APC) has recently been proposed as a quality measure for colonoscopy. We evaluated the impact of a novel artificial intelligence (AI) system, compared with standard high-definition colonoscopy, for APC measurement. METHODS:This was a US-based, multicenter, prospective randomized trial examining a novel AI detection system (EW10-EC02) that enables a real-time colorectal polyp detection enabled with the colonoscope (CAD-EYE). Eligible average-risk subjects (45 years or older) undergoing screening or surveillance colonoscopy were randomized to undergo either CAD-EYE-assisted colonoscopy (CAC) or conventional colonoscopy (CC). Modified intention-to-treat analysis was performed for all patients who completed colonoscopy with the primary outcome of APC. Secondary outcomes included positive predictive value (total number of adenomas divided by total polyps removed) and adenoma detection rate. RESULTS:In modified intention-to-treat analysis, of 1,031 subjects (age: 59.1 ± 9.8 years; 49.9% male), 510 underwent CAC vs 523 underwent CC with no significant differences in age, gender, ethnicity, or colonoscopy indication between the 2 groups. CAC led to a significantly higher APC compared with CC: 0.99 ± 1.6 vs 0.85 ± 1.5, P = 0.02, incidence rate ratio 1.17 (1.03-1.33, P = 0.02) with no significant difference in the withdrawal time: 11.28 ± 4.59 minutes vs 10.8 ± 4.81 minutes; P = 0.11 between the 2 groups. Difference in positive predictive value of a polyp being an adenoma among CAC and CC was less than 10% threshold established: 48.6% vs 54%, 95% CI -9.56% to -1.48%. There were no significant differences in adenoma detection rate (46.9% vs 42.8%), advanced adenoma (6.5% vs 6.3%), sessile serrated lesion detection rate (12.9% vs 10.1%), and polyp detection rate (63.9% vs 59.3%) between the 2 groups. There was a higher polyp per colonoscopy with CAC compared with CC: 1.68 ± 2.1 vs 1.33 ± 1.8 (incidence rate ratio 1.27; 1.15-1.4; P < 0.01). DISCUSSION:Use of a novel AI detection system showed to a significantly higher number of adenomas per colonoscopy compared with conventional high-definition colonoscopy without any increase in colonoscopy withdrawal time, thus supporting the use of AI-assisted colonoscopy to improve colonoscopy quality ( ClinicalTrials.gov NCT04979962).

BACKGROUND & AIMS/OBJECTIVE:Thermal treatment of the defect margin after endoscopic mucosal resection (EMR) of large nonpedunculated colorectal lesions reduces the recurrence rate. Both snare tip soft coagulation (STSC) and argon plasma coagulation (APC) have been used for thermal margin treatment, but there are few data directly comparing STSC with APC for this indication. METHODS:We performed a randomized 3-arm trial in 9 US centers comparing STSC with APC with no margin treatment (control) of defects after EMR of colorectal nonpedunculated lesions ≥15 mm. The primary end point was the presence of residual lesion at first follow-up. RESULTS:There were 384 patients and 414 lesions randomized, and 308 patients (80.2%) with 328 lesions completed ≥1 follow-up. The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% with control subjects (no margin treatment). The odds of residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (P = .001 and P = .01, respectively). The difference in odds was not significant between STSC and APC. STSC took less time to apply than APC (median, 3.35 vs 4.08 minutes; P = .019). Adverse event rates were low, with no difference between arms. CONCLUSIONS:In a randomized trial STSC and APC were each superior to no thermal margin treatment after EMR. STSC was faster to apply than APC. Because STSC also results in lower cost and plastic waste than APC (APC requires an additional device), our study supports STSC as the preferred thermal margin treatment after colorectal EMR. (Clinicaltrials.gov, Number NCT03654209.).

BACKGROUND: Delayed bleeding is among the most common adverse events associated with endoscopic mucosal resection (EMR) of nonampullary duodenal polyps. We evaluated the rate of delayed bleeding and complete defect closure using a novel through-the-scope (TTS) suturing system for the closure of duodenal EMR defects. METHODS: We reviewed the electronic medical records of patients who underwent EMR for nonampullary duodenal polyps of ≥ 10 mm and prophylactic defect closure with TTS suturing between March 2021 and May 2022 at centers in the USA. We evaluated the rates of delayed bleeding and complete defect closure. RESULTS: 36 nonconsecutive patients (61 % women; mean [SD] age, 65 [12] years) underwent EMR of ≥ 10-mm duodenal polyps followed by attempted defect closure with TTS suturing. The mean (SD) lesion size was 29 (19) mm, defect size was 37 (25) mm; eight polyps (22 %) involved > 50 % of the lumen circumference. Complete closure was achieved in all cases (78 % with TTS suturing alone), using a median of one TTS suturing kit. There were no cases of delayed bleeding and no adverse events attributed to application of the TTS suturing device. CONCLUSION/CONCLUSIONS: Prophylactic closure of nonampullary duodenal EMR defects using TTS suturing resulted in a high rate of complete closure and no delayed bleeding events.