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Background: Safe esophageal closure remains a challenge in transesophageal Natural Orifice Transluminal Endoscopic Surgery (NOTES). Previously described methods, such as suturing devices, clips, or submucosal tunneling, all have weaknesses. In this survival animal series, we demonstrate safe esophageal closure with a prototype retrievable, antimigration stent.Methods: Nine Yorkshire swine underwent thoracic NOTES procedures. A double-channel gastroscope equipped with a mucosectomy device was used to create an esophageal mucosal defect. A 5-cm submucosal tunnel was created and the muscular esophageal wall was incised with a needle-knife. Mediastinoscopy and thoracoscopy were performed in all swine; lymphadenectomy was performed in seven swine. A prototype small intestinal submucosal (SurgiSIS(®)) covered stent was deployed over the mucosectomy site and tunnel. Three versions of the prototype stent were developed. Prenecropsy endoscopy confirmed stent location and permitted stent retrieval. Explanted esophagi were sent to pathology.Results: Esophageal stenting was successful in all animals. Stent placement took 15.8 ± 4.8 minuted and no stent migration occurred. Prenecropsy endoscopy revealed proximal ingrowth of esophageal mucosa and erosion with Stent A. Mucosal inflammation and erosion was observed proximally with Stent B. No esophageal erosion or pressure damage from proximal radial forces was seen with Stent C. On necropsy, swine 5 had a 0.5-cm periesophageal abscess. Histology revealed a localized inflammatory lesion at the esophageal exit site in swine 1, 3, and 9. The mucosectomy site was partially healed in three swine and poorly healed in six. All swine thrived clinically, except for a brief period of mild lethargy in swine 9 who improved with short-term antibiotic therapy. The submucosal tunnels were completely healed and no esophageal bleeding or stricture formation was observed. All swine survived 13.8 ± 0.4 days and gained weight in the postoperative period.Conclusions: Esophageal stenting provides safe closure for NOTES thoracic procedures but may impede healing of the mucosectomy site. [ABSTRACT FROM AUTHOR]

Background: The criterion standard for sampling mediastinal lymph nodes is cervical mediastinoscopy. Current methods that require transthoracic or cervical incisions can result in significant postoperative pain. Objective: To determine the feasibility of a novel, transesophageal endoscopic technique for mediastinal lymph node dissection and en bloc resection. Design: Nonsurvival and survival animal study. Setting: Animal trial at a tertiary-care academic center. Subjects: This study involved 12 Yorkshire swine. Intervention: An endoscopic cap band mucosectomy device was used to create an esophageal mucosal defect. By using the tip of the endoscope and biopsy forceps, a submucosal tunnel was fashioned, and, within the submucosal space, a hook-knife incised the muscular esophageal wall. The endoscope was then advanced into the mediastinum and chest. Mediastinoscopy and thoracoscopy were performed to identify lymph node stations. Prototype endoscopic devices permitted lymph node dissection prior to removal with an electrocautery snare. A covered prototype stent was placed over the mucosectomy site. Main Outcome Measurements: Feasibility of endoscopic transesophageal lymphadenectomy. Results: Three lymph nodes (1 para-aortic and 2 right paratracheal) were removed in the 3 nonsurvival swine. Nine swine were survived for 14 days (range 13-14 days) and had a total of 7 lymph nodes (2 para-aortic and 5 paratracheal) removed. Two swine had no endoscopically visible lymph nodes in the mediastinum or chest. Lymph node dissection and resection was successful in all cases where lymph nodes were identified. Lymphadenectomy was completed in a median time of 20.0 minutes (range 8-60 minutes); median total procedure time was 70.0 minutes (range 28-105 minutes). Median lymph node size was 1.1 cm (range 0.6-1.4 cm). Limitations: Animal study. Conclusion: An endoscopic transesophageal approach can accomplish mediastinal lymph node dissection and en bloc resection and provides architecturally intact lymph node specimens for histologic examination. [ABSTRACT FROM AUTHOR]

Background: EUS-guided FNA has been well documented to aid in the diagnosis of subepithelial lesions by providing cytologic material. Studies to date evaluating the sensitivity of EUS-FNA for the diagnosis of GI stromal cell tumors (GIST) have been small, and few have relied on surgical histologic diagnosis as the reference standard. Objective: Our purpose was to determine the diagnostic yield and sensitivity of EUS-FNA for the diagnosis of GIST and to identify EUS features of GIST that are predictive of the ability to obtain adequate tissue by EUS-FNA. Design: All patients with histologically confirmed, c-kitDSpositive GIST who underwent EUS-FNA from 1998 to 2006 were reviewed. EUS images were examined for mass size, shape, location, wall layer, heterogeneity, echogenicity, cystic spaces, lobulation, ulceration, and central umbilication. Needle gauge, number of needle passes, and presence of a cytologist during the EUS-FNA were recorded. Results: A total of 37 patients (29 with diagnostic FNA cytology; 8 with nondiagnostic cytology) met the inclusion criteria. The diagnostic yield and sensitivity of EUS-FNA cytology for the diagnosis of GIST was 78.4% (29/37). The sensitivity was 84.4% (27/32) for GISTs located in the stomach, but poor for lesions located in the duodenum because none of these tumors yielded diagnostic cytology (n = 3). An increase in size up to 10 cm, round/oval shape, and identification of the origin of GIST within a specific sonographic wall layer were statistically significant in their ability to predict adequate tissue yield. Conclusions: The sensitivity of EUS-FNA cytology for the diagnosis of GIST is 78.4% and is influenced by size, location, shape, and layer of origin. [ABSTRACT FROM AUTHOR]

BACKGROUND: With conventional EMR, specimens are fragmented, metaplasia may be left behind, and invasive lesions could be missed because of incomplete sampling. Concentric subtotal esophageal mucosectomy would address these limitations. OBJECTIVE: To examine en bloc esophageal mucosectomy (EEM). DESIGN: A prospective case series. SETTING: An academic hospital. SUBJECTS: Nine swine. INTERVENTIONS: Conventional EMR was performed in the proximal esophagus. The submucosal space was entered, and the distal two thirds of the esophageal mucosa was freed with blunt dissection. A snare was threaded over the column of mucosa to the gastroesophageal junction. The column was resected, and the mucosa was retrieved. MAIN OUTCOME AND MEASUREMENTS: Clinical examination, follow-up endoscopy, necropsy, and gross and histopathologic examination. RESULTS: EEM permitted subtotal esophageal mucosectomy in 9 of 9 swine (tissue specimens removed ranged 9-15 cm in length). The mean procedure duration was 110 minutes. In the survival series, 4 of 4 swine thrived after surgery, for 9 to 13 days. At 9 days, there was no evidence of a perforation, stricture, or leak. At 13 days, 2 swine had a mild proximal stricture, which was easily traversed with a 9.8-mm gastroscope. On necropsy, the mediastinal and thoracic cavities were unremarkable in 3 of 4 swine. One swine was found to have a contained abscess containing cellulose, presumably secondary to ingestion of wood-chip bedding material postoperatively. Reepithelialization was present on histologic examination. LIMITATIONS: An animal study. CONCLUSIONS: EEM is feasible and enabled concentric subtotal esophageal mucosal resection. The technique could completely and circumferentially excise intramucosal lesions. Longer follow-up and larger studies are needed to evaluate infection, stricture, and safety. [ABSTRACT FROM AUTHOR]

BACKGROUND: EUS-guided photodynamic therapy (PDT) with the photosensitizing agent porfimer sodium has been shown to be effective in ablation of pancreatic tissue. OBJECTIVE: The objective of this study was to determine the effectiveness and safety of EUS PDT with verteporfin, a photosensitizer associated with less photosensitivity. DESIGN: Prospective investigation of 6 swine that received an IV injection of 6 mg/m2 of verteporfin before EUS. SETTING: Hospital animal laboratory. INTERVENTIONS: The tail of the pancreas was located with EUS and was used to guide the placement of a light catheter. The pancreatic tail was exposed to 10, 15, or 20 minutes of laser light (689 nm). MAIN OUTCOME MEASUREMENTS: Follow-up abdominal CT, liver and renal function tests, and serum pancreatic enzymes levels were performed. Histology of the pancreas was obtained 7 days after the procedure on necropsy. RESULTS: Localized tissue necrosis within the pancreatic tail (range 6.6-30.5 mm in diameter) was seen in all animals. The diameter of the necrotic tissue was directly related to the dose of light. No post-procedural complications were observed. LIMITATIONS: Normal animal model (lack of malignant tissue). CONCLUSIONS: EUS-guided PDT of porcine pancreas with verteporfin achieved localized pancreatic tissue ablation in a dose-related fashion. [ABSTRACT FROM AUTHOR]

Background and Aims: Computer-aided detection (CADe) devices have been shown to increase adenoma detection rates and adenomas per colonoscopy compared to standard colonoscopies. Questions remain about whether CADe colonoscopies are mainly increasing the detection of small, nonneoplastic lesions or if they are detecting more pathologically meaningful polyps. In this analysis, we compare the true histology rate (defined as polyps with confirmation of clinically relevant histopathology) of CADe-identified polyps with polyps identified during standard colonoscopies., Methods: Using data from the SKOUT trial, we compared the true histology rate (THR) between CADe and standard colonoscopies. We also conducted a subgroup analysis by patient, procedural, and endoscopist factors. To account for multiple testing of comparisons, we used the false discovery rate., Results: A total of 1423 participants were included (CADe, n = 714; standard, n = 709). Overall, THR was similar between the CADe and standard colonoscopy arms for adenomas, sessile serrated lesions, and large hyperplastic polyps. Higher THR with CADe colonoscopy was observed in some subgroups for adenomas. Endoscopists with 11 to 20 years of experience and procedures occurring after 12 pm had significantly higher adenoma THRs in the CADe cohort. Patients younger than 65 years, male patients, and procedures with a withdrawal time of ≥8 minutes had borderline significance in the CADe device adenoma THR subgroup., Conclusions: CADe colonoscopies may hold the key to improving endoscopic quality measures, provided that the polyps identified by the CADe device are those of clinical relevance. Although the benefit and significance in the CADe group were demonstrated in this analysis, further research is warranted to ensure that the true histology is maintained when applied in real-world applications., Competing Interests: Disclosure The following authors disclosed financial relationships: A. Shaukat: Research funding to her institution for the current article from Iterative Health, Inc and consulting fees from Freenome Inc and Medtronic. D. R. Lichtenstein: Consulting fees from Ambu and Olympus America Inc and research funding to his institution for the current article from and unremunerated participation in an advisory board for Iterative Health, Inc. D. C. Chung: Research funding to his institution for the current article from Iterative Health. C. Seidl: Employee of and holds stock or stock options in Iterative Health. Y. Wang: Employee of and holds stock or stock options in Iterative Health. E. E. Navajas: Employee of and holds stock or stock options in Iterative Health. D. R. Colucci: Employee of and holds stock or stock options in Iterative Health. S. Baxi: Employee of and holds stock or stock options in Iterative Health. W. R. Brugge: Unremunerated participation on an advisory board for Iterative Health, Inc. All other others disclosed no financial relationships. Support for this analysis was provided to A. Shaukat, D. C. Chung and W. R. Brugge by Iterative Health, Inc, Cambridge, Massachusetts, USA., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Introduction: To investigate the impact of procedure-related and endoscopist-related factors on the effectiveness of a computer-aided detection (CADe) device in adenomas per colonoscopy (APC) detection., Methods: The SKOUT clinical trial was conducted at 5 US sites. We present prespecified analyses of procedure-related and endoscopist-related factors, and association with APC across treatment and control cohorts., Results: There were numeric increases in APC between SKOUT vs standard colonoscopy in community-based endoscopists, withdrawal time of ≥8 minutes, for endoscopists with >20 years of experience, and endoscopists with baseline adenoma detection rate <45%., Discussion: The application of CADe devices in clinical practice should be carefully evaluated. Larger studies should explore differences in endoscopist-related factors for CADe., (Copyright © 2023 by The American College of Gastroenterology.)

Objective: The aim of this study was to describe our institutional experience with resected cystic tumors of the pancreas with emphasis on changes in clinical presentation and accuracy of preoperative diagnosis., Summary Background Data: Incidental discovery of pancreatic cystic lesions has increased and has led to a rise in pancreatic resections. It is important to analyze surgical outcomes from these procedures, and the prevalence of malignancy, pre-malignancy and resections for purely benign lesions, some of which may be unintended., Methods: Retrospective review of a prospective database spanning 3 decades. Presence of symptoms, incidental discovery, diagnostic studies, type of surgery, postoperative outcomes, and concordance between presumptive diagnosis and final histopathology were recorded., Results: A total of 1290 patients were identified, 62% female with mean age of 60 years. Fifty-seven percent of tumors were incidentally discovered. Ninety-day operative mortality was 0.9% and major morbidity 14.4%. There were 23 different diagnosis, but IPMN, MCN, and serous cystadenoma comprised 80% of cases. Concordance between preoperative and final histopathological diagnosis increased by decade from 45%, to 68%, and is presently 80%, rising in parallel with the use of endoscopic ultrasound, cytology, and molecular analysis. The addition of molecular analysis improved accuracy to 91%. Of misdiagnosed cases, half were purely benign and taken to surgery with the presumption of malignancy or premalignancy. The majority of these were serous cystadenomas., Conclusions: Indications and diagnostic work-up of cystic tumors of the pancreas have changed over time. Surgical resection can be performed with very low mortality and acceptable morbidity and diagnostic accuracy is presently 80%. About 10% of patients are still undergoing surgery for purely benign lesions that were presumed to be malignant or premalignant. Further refinements in diagnostic tests are required to improve accuracy., Competing Interests: The authors report no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background & Aims: Colonoscopy for colorectal cancer screening is endoscopist dependent, and colonoscopy quality improvement programs aim to improve efficacy. This study evaluated the clinical benefit and safety of using a computer-aided detection (CADe) device in colonoscopy procedures., Methods: This randomized study prospectively evaluated the use of a CADe device at 5 academic and community centers by US board-certified gastroenterologists (n = 22). Participants aged ≥40 scheduled for screening or surveillance (≥3 years) colonoscopy were included; exclusion criteria included incomplete procedure, diagnostic indication, inflammatory bowel disease, and familial adenomatous polyposis. Patients were randomized by endoscopist to the standard or CADe colonoscopy arm using computer-generated, random-block method. The 2 primary endpoints were adenomas per colonoscopy (APC), the total number of adenomas resected divided by the total number of colonoscopies; and true histology rate (THR), the proportion of resections with clinically significant histology divided by the total number of polyp resections. The primary analysis used a modified intention-to-treat approach., Results: Between January and September 2021, 1440 participants were enrolled to be randomized. After exclusion of participants who did not meet the eligibility criteria, 677 in the standard arm and 682 in the CADe arm were included in a modified intention-to-treat analysis. APC increased significantly with use of the CADe device (standard vs CADe: 0.83 vs 1.05, P = .002; total number of adenomas, 562 vs 719). There was no decrease in THR with use of the CADe device (standard vs CADe: 71.7% vs 67.4%, P for noninferiority < .001; total number of non-neoplastic lesions, 284 vs 375). Adenoma detection rate was 43.9% and 47.8% in the standard and CADe arms, respectively (P = .065)., Conclusions: For experienced endoscopists performing screening and surveillance colonoscopies in the United States, the CADe device statistically improved overall adenoma detection (APC) without a concomitant increase in resection of non-neoplastic lesions (THR)., Clinicaltrials: gov registration: NCT04754347., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Early detection of high-risk pancreatic cystic lesions enables potentially curative surgical resection, and early detection of lesions without worrisome features may lead to appropriate surveillance. Regrettably, differentiating premalignant and malignant cysts from nonmalignant ones remains challenging. However, emerging additional diagnostic tools, including the needle biopsy with microforceps and needle-based confocal laser endomicroscopy, are of exciting potential along with cyst fluid analysis"., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background and study aims  The aim of thi systematic review and consensus report is to standardize the practice of endoscopic ultrasound (EUS-guided needle-based confocal laser endomicroscopy (nCLE) for pancreatic cystic lesion (PCL) evaluation. Methods  We performed an international, systematic, evidence-based review of the applications, outcomes, procedural processes, indications, training, and credentialing of EUS-nCLE in management of PCLs. Based on available clinical evidence, preliminary nCLE consensus statements (nCLE-CS) were developed by an international panel of 15 experts in pancreatic diseases. These statements were then voted and edited by using a modified Delphi approach. An a priori threshold of 80 % agreement was used to establish consensus for each statement. Results  Sixteen nCLE-CS were discussed. Thirteen (81 %) nCLE-CS reached consensus addressing indications (non-communication PCL meeting criteria for EUS-FNA or with prior non-diagnostic EUS-FNA), diagnostic outcomes (improved accuracy for mucinous PCLs and serous cystadenomas with substantial interobserver agreement of image patterns), low incidence of adverse events (fluorescein-associated and pancreatitis), procedural processes (nCLE duration, manipulation of needle with probe), and training (physician knowledge and competence). Conclusion  Based on a high level of agreement pertaining to expert consensus statements, this report standardizes the practice of EUS-nCLE. EUS-nCLE should be systematically considered when EUS-FNA is indicated for PCL evaluation., Competing Interests: Competing interests Dr. Napoleon has received honoraria and grants from Mauna Kea Technologies and Boston Scientific. Dr. Krishna is currently receiving a travel grant from Mauna Kea Technologies. Dr. Marco has received honoraria and grants from Boston Scientific, Cook Medical, Pentax Medical, 3 M, and Mylan. Dr. Carr-Lock has received honoraria and grants from Mauna Kea Technologies, Boston Scientific, and US Endoscopy. Dr. Chang has received honoraria and grants from Boston Scientific, Cook Medical, Pentax Medical, NinePoint, and Erbe. Dr. Sejpal has received grants from Boston Scientific, Cook Medical, and Olympus. Dr. Palazzo has received grants from Mauna Kea Technologies. Dr. Brugge has received honoraria and grants from US Endoscopy and NinePoint., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background and Objectives: Currently, pancreatic cystic lesions (PCLs) are recognized with increasing frequency and have become a more common finding in clinical practice. EUS is challenging in the diagnosis of PCLs and evidence-based decisions are lacking in its application. This study aimed to develop strong recommendations for the use of EUS in the diagnosis of PCLs, based on the experience of experts in the field., Methods: A survey regarding the practice of EUS in the evaluation of PCLs was drafted by the committee member of the International Society of EUS Task Force (ISEUS-TF). It was disseminated to experts of EUS who were also members of the ISEUS-TF. In some cases, percentage agreement with some statements was calculated; in others, the options with the greatest numbers of responses were summarized., Results: Fifteen questions were extracted and disseminated among 60 experts for the survey. Fifty-three experts completed the survey within the specified time frame. The average volume of EUS cases at the experts' institutions is 988.5 cases per year., Conclusion: Despite the limitations of EUS alone in the morphologic diagnosis of PCLs, the results of the survey indicate that EUS-guided fine-needle aspiration is widely expected to become a more valuable method., Competing Interests: None

Background and Objectives: EUS-guided biliary drainage (EUS-BD) is increasingly utilized to manage unresectable malignant biliary obstruction after a failed ERCP. However, there is no data on how endoscopists perceive EUS-BD. The aim of this study was to investigate the perception of endoscopists on EUS-BD., Patients and Methods: A survey questionnaire of six topics with 22 survey statements was developed. A total of 17 pancreatobiliary endoscopists (10 from East and 7 from West) were invited to survey. The participants were asked to answer the multiple choice questionnaire and give comments. The opinions of the participants for individual survey statements were assessed using 5-point Likert scale., Results: All participants completed the survey. The endoscopists had a trend to perceive EUS-BD as a procedure indicated after a failed ERCP. Various EUS-BD methods were regarded as having different efficacy and safety. The superiority of EUS-BD over percutaneous transhepatic BD (PTBD) with regard to efficacy, procedure-related adverse events, and unscheduled re-intervention was not in agreement., Conclusions: EUS-BD was not yet perceived as the initial procedure to relieve the unresectable malignant biliary obstruction. Various EUS-BD methods were regarded as having different efficacy and safety. The superiority of EUS-BD over PTBD was not in agreement. Refining the procedure, developing dedicated devices, and gaining expertise in the procedure are necessary to popularize EUS-BD., Competing Interests: None

Competing Interests: Dr Brugge serves as a consultant for Boston Scientific and US Endoscopy.

Background and Aims: The tissue acquisition and diagnostic yield of cyst fluid cytology is low-to-moderate and rarely provides a specific diagnosis. The aim of this study was to compare the tissue acquisition and diagnostic tissue yield of microforceps biopsy (MFB) with cyst fluid cytology., Methods: In this multicenter study, data of 42 patients who had cysts both aspirated by EUS-guided FNA (EUS-FNA) and biopsy specimens were then obtained with an MFB device, were collected. Cytology analysis of cyst fluid and histologic analysis of biopsy specimens were done. Acquisition yield was defined as percentage of patients with tissue present in the aspirate or biopsy. Diagnostic tissue yield was evaluated at 3 levels: the ability of differentiation between mucinous and/or nonmucinous cysts, detection of high risk for malignancy, and specific cyst type diagnosis., Results: The mean patient age was 69 years. Sixteen pancreatic cysts (38.1%) were located in the head, 17 (40.5%) in the body, and 9 (21.4%) in the tail. The mean cyst size was 28.2 mm (12-60 mm); 25 of 42 (60%) were septated. The EUS-FNA tissue (fluid) acquisition yield was 88.1% (37/42). The MFB tissue acquisition yield was 90.4% (38/42). The diagnostic cytology yield to differentiate between mucinous and/or nonmucinous cysts was 47.6% (20/42), and the MFB histologic yield to differentiate between mucinous and/or nonmucinous cysts was 61.9% (26/42) (P = .188). The percentage of cysts at high risk for malignancy by cytology was 54.7% (23/42), and MFB was 71.5% (30/42) (P = .113). However, the ability of MFB to provide a specific cyst type diagnosis was 35.7% (15/42), and that for cytology was 4.8% (2/42) (P = .001). Surgical histology was concordant with that of MFB in 6 of 7 patients (85%), and with that of cytology in 1 of 7 patients (15%)., Conclusion: The cyst tissue acquisition yield for MFBs was 90%. Although cytology of cyst fluid and MFB were comparable in distinguishing mucinous and nonmucinous cysts and detecting cysts at high risk for malignancy, MFB was far superior to cytology for providing a specific cyst diagnosis., (Published by Elsevier Inc.)

Background: Management of the primary and secondary tumors of the bile ducts still remains as a major clinical challenge. Radiofrequency (RF) ablation (RFA) of these tumors is feasible but the effect of RF energy on the human common bile duct (CBD) and surrounding tissues has not been investigated. This pilot study aimed to determine the relationship between RF energy and the depth of ablation in the normal human CBD., Methods: The study was performed on fresh ex vivo human biliary-pancreatic tissue which had been resected for a pancreatic cyst or mass. The study was conducted within 15 min after resection. A bipolar Habib RFA catheter was placed into the middle of the intact CBD, and three different (5, 7, 10 W) power settings were applied over a 90-s period by an RF generator. Gross and histological examinations were performed. The depth of coagulation necrosis in CBD and the effect of RFA on CBD wall and surrounding pancreas tissue were determined by microscopic examination., Results: The study included eight tissue samples. 5 W power was applied to three sites and RFA caused only focal epithelial necrosis limited to the CBD mucosa. 7 and 10 W were applied to five sites and coagulation necrosis occurred in all cases. Microscopically, necrosis was transmural, involved accessory bile duct glands, and extended to the surrounding pancreatic tissue in four of these cases. Macroscopically, RFA resulted in circumferential white-yellowish color change extending approximately 2 cm of the CBD., Conclusion: Bipolar RF energy application with 5 W resulted in limited ablation on CBD wall. However, 7 and 10 W generated tissue necrosis which extended through the CBD wall and into surrounding pancreas tissue. Endoscopic biliary RFA is an effective technique for local biliary tissue ablation but the use of high energy may injure surrounding tissue.

Background: Making a specific diagnosis of pancreatic cysts preoperatively is difficult. The new disposable Moray micro forceps biopsy (MFB) device allows tissue sampling from the pancreatic cyst wall/septum and aims to improve diagnosis. This study compares the diagnostic performance of the MFB with the current conventional analysis of pancreatic cyst fluid (PCF)., Methods: A total of 48 patients sampled with MFB were identified. Cysts were classified as mucinous on PCF based on extracellular mucin/mucinous epithelium, carcinoembryonic antigen (CEA) levels ≥192 ng/mL, or KRAS/GNAS mutation. A diagnosis of intraductal papillary mucinous neoplasm was supported by GNAS mutation; a diagnosis of serous cystadenoma was supported by Von Hippel-Lindau tumor suppressor (VHL) mutation. A diagnosis of mucinous cystic neoplasm required the presence of subepithelial ovarian-type stroma. A high-risk cyst was defined as a mucinous cyst with high-grade dysplasia or an adenocarcinoma. Comparisons in diagnostic performance between PCF and MFB were made., Results: The mean age of the patients was 69.6 years (range, 27-90 years); 25 of 48 patients (52.1%) were female. Cysts were in the pancreatic head (13 patients), neck (2 patients), body (20 patients), and tail (13 patients), averaging 3.1 cm (range, 1.2-6.0 cm). There was concordance with mucinous versus nonmucinous classification (60.4% for PCF vs 58.3% for MFB; P = .949). Three high-risk cysts were detected by PCF and 2 were detected by MFB (P = .670). However, MFB diagnosed significantly more specific cysts compared with PCF (50.0% for MFB vs 18.8% for PCF; P<.001)., Conclusions: PCF analysis and MFB have comparable performance in distinguishing between mucinous and nonmucinous cysts and for detecting high-risk cysts. However, MFB was found to be superior for diagnosing specific cyst subtypes, thus adding significant value to preoperative patient management. Cancer Cytopathol 2018;126:414-20. © 2018 American Cancer Society., (© 2018 American Cancer Society.)

Background and Aims: Patients with chronic constipation or motility disorders may be referred for rectal suction biopsy (RSB) to rule out Hirschsprung's disease (HD). RSB may not be successful beyond infancy because of the increased thickness of the rectal mucosa. EMR could improve the diagnostic yield for HD when compared with traditional RSB because larger and deeper samples are acquired for analysis., Methods: In this prospective, single-center study, patients referred for RSB were offered enrollment for concurrent EMR. Specimens were analyzed pathologically for size, submucosal ganglionic tissue, and acetylcholinesterase or calretinin staining. Biopsy results were compared with transit studies, anorectal manometry, and constipation severity through validated questionnaires., Results: Seventeen patients (2 male, 15 female; mean age, 35.8 years; range, 22-61 years) were enrolled in the study from 2008 to 2014. All patients underwent anorectal manometry (88% with anorectal dysfunction, 68% with outlet obstruction) and transit studies (41% with delayed transit). There were no reports of adverse events from the RSB and EMR procedures. The RSB sample volumes were significantly lower than the EMR sample volumes (0.023 cm 3 vs 0.26 cm 3 , P = .001). There was diagnostic tissue for submucosal visualization by RSB in 53% (9/17) of cases compared with 100% (17/17) with EMR (P = .003). No cases of HD were diagnosed by RSB; one patient had rare ganglions observed by EMR., Conclusions: EMR provides greater tissue volume and can improve the characterization of ganglion cells in rectal tissue compared with RSB in patients with moderate to severe constipation with suspected HD., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: The differential diagnosis of pancreatic cystic lesions (PCLs) is an increasingly common clinical challenge. Confocal laser endomicroscopy (CLE) may differentiate PCLs by imaging of the cyst wall. However, clinical experience is still limited, and better image definition and characterization of the cyst wall in a spectrum of cysts are needed. This experimental study aimed to expose detailed imaging characteristics of PCLs by CLE., Methods: Patients who underwent surgery of a PCL were enrolled. During surgery, intravenous fluorescein (2.5 ml of 10%) was injected just prior to the ligation of blood vessels supplying the pancreas. The freshly excised specimens were transected along the long axis to fully expose the luminal surface. A Gastroflex-UHD CLE probe (pCLE) was used manually to acquire images directly from the surface of cyst wall. The specimen subsequently underwent cross-sectional histology. All recorded data were analyzed by two investigators for predefined and original image findings of PCLs., Results: Ten cases were recruited into the study. All patients underwent surgery because of a mucinous cyst with worrisome features or a symptomatic PCL. Imaging was successful in all patients and differently shaped papillary projections (PP) were visualized in eight patients. Pathological examination of those patients confirmed 6 cases with Intraductal Papillary Mucinous Neoplasm (IPMN) and 2 cases with Mucinous Cystic Neoplasm (MCN). In two patients with serous cystadenoma, typical vascular network was visualized in one patient, and microcystic structures in the other. Three of the IPMNs were malignant. The loss of papillary margin integrity and significant fragmentation together with irregularity was detected in malignant IPMNs by CLE., Conclusions: Pancreatic cyst epithelial wall can be visualized successfully by pCLE in ex vivo surgical specimens. Different papillary projections have been seen in all cases of IPMNs and MCNs. CLE has potential for identifying IPMN subtypes and for grading dysplasia.

Background & Aims: Little is known about the development of branch duct intraductal papillary mucinous neoplasms (BD-IPMNs). We evaluated long-term outcomes of a large cohort of patients with BD-IPMNs to determine risk of malignancy and define a subset of low-risk BD-IPMNs., Methods: We performed a retrospective analysis of data from 577 patients with suspected or presumed BD-IPMN under surveillance at the Massachusetts General Hospital. Patients underwent cross-sectional imaging analysis at 3 months or later after their initial diagnosis. The diagnosis of BD-IPMN was based on the presence of unilocular or multilocular cysts of the pancreas and a non-dilated main pancreatic duct (<5 mm). We collected demographic, clinical, and pathology data. Cysts were characterized at the time of diagnosis and during the follow-up period. Follow-up duration was time between initial cyst diagnosis and date of last visit or death for patients without development of pancreatic cancer, date of surgery for patients with histologically confirmed malignancy, or date of first discovery of malignancy by imaging analysis for patients with unresectable tumors or who underwent neoadjuvant treatment before surgery. The primary outcome was risk of malignancy, with a focus on patients followed for 5 years or more, compared with that of the US population, based on standardized incidence ratio., Results: Of the 577 patients studied, 479 (83%) were asymptomatic at diagnosis and 363 (63%) underwent endoscopic ultrasound at least once. The median follow-up time was 82 months (range, 6-329 months) for the entire study cohort; 363 patients (63%) underwent surveillance for more than 5 years, and 121 (21%) for more than 10 years. Malignancies (high-grade dysplasia or invasive neoplasm) developed after 5 years in 20 of 363 patients (5.5%), and invasive cancer developed in 16 of 363 patients (4.4%). The standardized incidence ratio for patients with BD-IPMNs without worrisome features of malignancy at 5 years was 18.8 (95% confidence interval, 9.7-32.8; P < .001). One hundred and eight patients had cysts ≤1.5 cm for more than 5 years of follow-up; only 1 of these patients (0.9%) developed a distinct ductal adenocarcinoma. By contrast, among the 255 patients with cysts >1.5 cm, 19 (7.5%) developed malignancy (P = .01)., Conclusions: In a retrospective analysis of patients with BD-IPMNs under surveillance, their overall risk of malignancy, almost 8%, lasted for 10 years or more, supporting continued surveillance after 5 years. Cysts that remain ≤1.5 cm for more than 5 years might be considered low-risk for progression to malignancy., (Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.)

A workshop was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases to address the research gaps and opportunities in pancreatic EUS. The event occurred on July 26, 2017 in 4 sessions: (1) benign pancreatic diseases, (2) high-risk pancreatic diseases, (3) diagnostic and therapeutics, and (4) new technologies. The current state of knowledge was reviewed, with identification of numerous gaps in knowledge and research needs. Common themes included the need for large multicenter consortia of various pancreatic diseases to facilitate meaningful research of these entities; to standardize EUS features of different pancreatic disorders, the technique of sampling pancreatic lesions, and the performance of various therapeutic EUS procedures; and to identify high-risk disease early at the cellular level before macroscopic disease develops. The need for specialized tools and accessories to enable the safe and effective performance of therapeutic EUS procedures also was discussed., (Copyright © 2017 American Society for Gastrointestinal Endoscopy and Wolters Kluwer. All rights reserved.)

Our treatment approach for either symptomatic or incidentally found pancreatic cysts continues to improve. The true incidence of pancreatic cysts is not known, and pancreatic cystic neoplasms, especially intraductal papillary mucinous neoplasms, are currently most commonly diagnosed and resected. This is a result of increasing awareness, widespread availability of imaging, and better understanding of the nature of pancreatic cysts as well. Recent studies on molecular analysis and devices such as microbiopsy forceps help us better define and select the treatment approach to alleviate symptoms and to prevent malignant tumors while avoiding unnecessary surgery., (Published by Elsevier Inc.)

Endoscopic ultrasound (EUS) plays an important role as a diagnostic and therapeutic modality in gastroenterology. New developments have emerged, especially in the last decade, and are being introduced to endoscopists. The ability to readily visualize and access organs in the gastrointestinal tract has allowed endoscopists to perform new interventional procedures. EUS procedures have taken the place of conventional approaches for the treatment of various gastrointestinal diseases, including pancreatic cystic lesions. This article focuses on the advances and future of diagnostic and therapeutic EUS., (Published by Elsevier Inc.)

Background and Aims: EUS-guided needle-based confocal laser endomicroscopy (nCLE) characteristics of common types of pancreatic cystic lesions (PCLs) have been identified; however, surgical histopathology was available in a minority of cases. We sought to assess the performance characteristics of EUS nCLE for differentiating mucinous from non-mucinous PCLs in a larger series of patients with a definitive diagnosis., Methods: Six endosonographers (nCLE experience >30 cases each) blinded to all clinical data, reviewed nCLE images of PCLs from 29 patients with surgical (n = 23) or clinical (n = 6) correlation. After 2 weeks, the assessors reviewed the same images in a different sequence. A tutorial on available and novel nCLE image patterns was provided before each review. The performance characteristics of nCLE and the κ statistic for interobserver agreement (IOA, 95% confidence interval [CI]), and intraobserver reliability (IOR, mean ± standard deviation [SD]) for identification of nCLE image patterns were calculated. Landis and Koch interpretation of κ values was used., Results: A total of 29 (16 mucinous PCLs, 13 non-mucinous PCLs) nCLE patient videos were reviewed. The overall sensitivity, specificity, and accuracy for the diagnosis of mucinous PCLs were 95%, 94%, and 95%, respectively. The IOA and IOR (mean ± SD) were κ = 0.81 (almost perfect); 95% CI, 0.71-0.90; and κ = 0.86 ± 0.11 (almost perfect), respectively. The overall specificity, sensitivity, and accuracy for the diagnosis of serous cystadenomas (SCAs) were 99%, 98%, and 98%, respectively. The IOA and IOR (mean ± SD) for recognizing the characteristic image pattern of SCA were κ = 0.83 (almost perfect); 95% CI, 0.73-0.92; and κ = 0.85 ± 0.11 (almost perfect), respectively., Conclusions: EUS-guided nCLE can provide virtual histology of PCLs with a high degree of accuracy and inter- and intraobserver agreement in differentiating mucinous versus non-mucinous PCLs. These preliminary results support larger multicenter studies to evaluate EUS nCLE. (Clinical trial registration number: NCT02516488.)., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

The ACR Incidental Findings Committee (IFC) presents recommendations for managing pancreatic cysts that are incidentally detected on CT or MRI. These recommendations represent an update from the pancreatic component of the JACR 2010 white paper on managing incidental findings in the adrenal glands, kidneys, liver, and pancreas. The Pancreas Subcommittee-which included abdominal radiologists, a gastroenterologist, and a pancreatic surgeon-developed this algorithm. The recommendations draw from published evidence and expert opinion, and were finalized by informal iterative consensus. Algorithm branches successively categorize pancreatic cysts based on patient characteristics and imaging features. They terminate with an ascertainment of benignity and/or indolence (sufficient to discontinue follow-up), or a management recommendation. The algorithm addresses most, but not all, pathologies and clinical scenarios. Our goal is to improve quality of care by providing guidance on how to manage incidentally detected pancreatic cysts., (Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.)

Acinar cell cystadenoma is a rare, benign cystic lesion of the pancreas. There have been only a few retrospective reports on its cytological features. We present the first case of acinar cell cystadenoma in a 65-year-old woman, diagnosed pre-operatively by pancreatic cyst fluid cytology and Moray ® micro-forceps biopsy. We emphasize possible diagnostic pitfalls of acinar cell cystadenoma cyst fluid cytology and suggest useful morphologic, immunohistochemical, and other clues to aid in diagnosis. Diagn. Cytopathol. 2017;45:557-560. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)