Safety and efficacy of EsoFLIP dilation in patients with esophageal dysmotility: a systematic review.

Esophageal manometry is utilized for the evaluation and classification of esophageal motility disorders. EndoFlip has been introduced as an adjunctive test to evaluate esophagogastric junction (EGJ) distensibility. Treatment options for achalasia and EGJ outflow obstruction (EGJOO) include pneumatic dilation, myotomy, and botulinum toxin. Recently, a therapeutic 30 mm hydrostatic balloon dilator (EsoFLIP, Medtronic, Minneapolis, MN, USA) has been introduced, which uses impedance planimetry technology like EndoFlip. We performed a systematic review to evaluate the safety and efficacy of EsoFLIP in the management of esophageal motility disorders. A systematic literature search was performed with Medline, Embase, Web of science, and Cochrane library databases from inception to November 2022 to identify studies utilizing EsoFLIP for management of esophageal motility disorders. Our primary outcome was clinical success, and secondary outcomes were adverse events. Eight observational studies including 222 patients met inclusion criteria. Diagnoses included achalasia (158), EGJOO (48), post-reflux surgery dysphagia (8), and achalasia-like disorder (8). All studies used 30 mm maximum balloon dilation except one which used 25 mm. The clinical success rate was 68.7%. Follow-up duration ranged from 1 week to a mean of 5.7 months. Perforation or tear occurred in four patients. EsoFLIP is a new therapeutic option for the management of achalasia and EGJOO and appears to be effective and safe. Future comparative studies with other therapeutic modalities are needed to understand its role in the management of esophageal motility disorders.

Adverse Events of the Single Operator Cholangioscopy System: A MAUDE Database Analysis.

BACKGROUND AND AIMS: SpyGlass single operator cholangioscopy (SOC) system is generally considered safe but adds additional risks to those associated with standard endoscopic retrograde cholangiopancreatography. METHODS: We evaluated adverse events (AEs) with the SpyGlass System reported in the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2016 & August 2023. RESULTS: A total of 2331 device problems (SpyGlass DS:1301, SpyGlass DS II:1010) were reported. An optical problem was the most reported issue with 83 for the SpyGlass DS and 457 for the SpyGlass DS II. Patient related events were found in 62 (3.5%) of 1743 reports: 33 with SpyGlass DS, and 29 with SpyGlass DSII. The most common AEs were bleeding/hemorrhage followed by perforation, infection, fever, or sepsis and pancreatitis. CONCLUSIONS: Our findings add to the existing literature and provides a fuller picture of potential problems associated with SpyGlass™ SOC.

A Delphi Method for Development of a Barrett's Esophagus Question Prompt List as a Communication Tool for Optimal Patient-physician Communication.

BACKGROUND METHODS: The question prompt list content was derived through a modified Delphi process consisting of 3 rounds. In round 1, experts provided 5 answers to the prompts "What general questions should patients ask when given a new diagnosis of Barrett's esophagus" and "What questions do I not hear patients asking, but given my expertise, I believe they should be asking?" Questions were reviewed and categorized into themes. In round 2, experts rated questions on a 5-point Likert scale. In round 3, experts rerated questions modified or reduced after the previous rounds. Only questions rated as "essential" or "important" were included in Barrett's esophagus question prompt list (BE-QPL). To improve usability, questions were reduced to minimize redundancy and simplified to use language at an eighth-grade level (Fig. 1). RESULTS: Twenty-one esophageal medical and surgical experts participated in both rounds (91% males; median age 52 years). The expert panel comprised of 33% esophagologists, 24% foregut surgeons, and 24% advanced endoscopists, with a median of 15 years in clinical practice. Most (81%), worked in an academic tertiary referral hospital. In this 3-round Delphi technique, 220 questions were proposed in round 1, 122 (55.5%) were accepted into the BE-QPL and reduced down to 76 questions (round 2), and 67 questions (round 3). These 67 questions reached a Flesch Reading Ease of 68.8, interpreted as easily understood by 13 to 15 years olds. CONCLUSIONS: With multidisciplinary input, we have developed a physician-derived BE-QPL to optimize patient-physician communication. Future directions will seek patient feedback to distill the questions further to a smaller number and then assess their usability.

Endoscopic Powered Resection Device for Residual Colonic Lesions: The First Multicenter, Prospective, International Clinical Study.

BACKGROUND AND AIMS: Endoscopic resection is standard treatment for adenomatous colorectal lesions. Depending on lesion morphology and resection technique, recurrence can occur. Scarred adenomas are challenging to resect and may require surgical management. This study evaluated safety and effectiveness of an endoscopic powered resection (EPR) system for scarred adenomatous colorectal lesions. METHODS: Single-arm, prospective, multicenter, study conducted from January 2018 to January 2021 at 12 sites. Patients with persistent flat or sessile colorectal lesions were enrolled. Primary endpoints were technical success (the ability of the device to resect the lesion(s) without use of other resection devices without device-related serious adverse events (SAE)) and safety (the occurrence of adverse events (AE) through 90 days). Secondary endpoints included endoscopic confirmation of resection completeness, occurrence of colon stenosis, disease persistence, and diagnostic value of resected specimens. RESULTS: Sixty-five patients were in the intent-to-treat / safety analysis population. Primary analysis was performed on 45 per-protocol (PP) patients with 48 lesions. All PP-patients were solely treated by the EndoRotor device. Technical success was achieved in 44 (98%) patients. Three (5%) SAEs occurred: 2 delayed self-limited bleeds and 1 perforation. Non-serious AEs included 4 (6%) cases of mild intraprocedural bleeding. Completeness of resection and histopathological diagnosis of tissue specimens were achieved in all patients, 21 (46.7%) patients had disease persistence after the first treatment, and there was no colon stenosis. CONCLUSIONS: EPR is a safe and effective for benign, persistent, large (>20mm) scarred, colorectal adenomas and should be considered as an alternative treatment in lieu of surgery. Persistence rate of 46.7% show that more than one treatment are necessary for effective endoscopic treatment.

Comparing a 19-gauge fine-needle biopsy needle with a 22-gauge fine-needle biopsy needle for EUS-guided liver biopsy sampling: a prospective randomized study.

BACKGROUND AND AIMS: EUS-guided liver biopsy (EUS-LB) sampling is being increasingly used. We performed a prospective randomized trial to compare specimen adequacy of a 19-gauge fine-needle biopsy (FNB) needle with a 22-gauge FNB Franseen tip needle for EUS-LB sampling. METHODS: Forty-two consecutive patients referred for EUS-LB sampling were prospectively randomized to a 19-gauge or 22-gauge FNB needle. When the specimen with the 22-gauge needle was macroscopically inadequate, an additional pass with the 19-gauge needle was done. Bilobar EUS-LB sampling was performed with heparinized wet suction using 1 pass and 3 actuations per lobe. Descriptive statistics were computed for all variables. RESULTS: Biopsy sampling was performed for abnormal liver enzymes in 95.5% of patients (57% women; average age, 51 years). Five patients undergoing sampling with the 22-gauge FNB needle had macroscopically inadequate specimens and required additional biopsy sampling with the 19-gauge FNB needle. Mean preprocessing length of the longest tissue core was 21.5 ± 6.3 mm with a 19-gauge FNB needle compared with 9.4 ± 5.5 mm with the 22-gauge FNB needle (P < .001). Postprocessing specimens were significantly longer with 19-gauge than with 22-gauge FNB needles (17.4 mm vs 6.8, P < .001). There were no adverse events, and postprocedure pain and discomfort was similar in both groups (14% for 19-gauge vs 10% for 22-gauge, P = .99). CONCLUSIONS: Liver core biopsy sampling using the 19-gauge FNB needle is superior to the 22-gauge FNB needle in terms of length of longest core and aggregate specimen length. Considerably more fragmentation of the 22-gauge cores occurs during tissue processing. No increased postprocedure pain or AEs were found with the 19-gauge needle. A 19-gauge FNB needle is preferred to the 22-gauge FNB needle for EUS-LB. (Clinical trial registration number: NCT04806607.).

Changing Trends in Liver Biopsy Practices: A Single-Center Analysis.

Introduction To assess the trends for liver biopsy (LB) indications, technique, and histopathologic diagnosis, we retrospectively evaluated liver biopsies in two one-year periods, separated by a decade. Methods A pathology database query was performed for all parenchymal LB in patients over 18 years (11/2017 to 10/2018) and compared to those performed over a one-year period, a decade ago. We identified 427 parenchymal liver biopsies in the recent group and 166 in the decade-old group. Results Elevated liver enzymes are the most common indication for LB. Non-alcoholic fatty liver disease (NAFLD) has become the most common diagnosis compared to 10 years ago, when it was viral hepatitis. Routes of LB were significantly different between the two groups, endoscopic ultrasound-guided liver biopsy (EUS-LB) (80.3% vs 0; p<0.0001), computed tomography-guided (0 vs 42.8%, p<0.0001), percutaneous by gastroenterologists (0% vs 29.5%, p<0.0001), and transjugular-LB (15.1% vs 17.6%, p<0.0001). The adequacy of the tissue for pathological diagnosis was similar, and there was no difference in adverse events. Conclusion At our institution, practice patterns have changed significantly for liver biopsy. There has been an increase in liver biopsy volume, and EUS guidance has become the most common approach for liver biopsy.

Safety and Efficacy of Powered Non-Thermal Endoscopic Resection Device for Removal of Colonic Polyps: A Systematic Review and Meta-Analysis.

Background: Endoscopic mucosal resection is a frequently employed method for removing colonic polyps. Nonetheless, the recurrence of these polyps over a healed submucosal base can complicate the extraction of leftover lesions through standard procedures. EndoRotor®, a non-thermal device specifically designed for endoscopic mucosal resection, has recently been assessed for its utility in removing colonic polyps, non-dysplastic Barrett's esophagus, and pancreatic necrosis. We conducted a systematic review and meta-analysis to ascertain the safety and efficacy of EndoRotor® in resecting scared or recurrence colonic polyps. Methods: We conducted an exhaustive review of existing literature using databases such as Medline, Embase, Web of Science, and the Cochrane Library until January 2023. Our aim was to find all studies that assessed the safety of non-thermal endoscopic resection devices in removing colonic polyps. The primary outcome we focused on was the rate of technical success. Secondary outcomes that we considered included the frequency of remaining lesions and instances of adverse events. To analyze these data, we used comprehensive meta-analysis software. Results: Our analysis incorporated three studies comprising 54 patients who underwent resection of 60 lesions. The combined technical success rate was 93.9% (95% confidence interval (CI): 77.7-98.6%, I2 = 25.5%). In patients who had another endoscopic examination, 20 were found to have a residual lesion. After the initial session, the combined rate of remaining lesions was 39.8% (95% CI: 15.3-70.8%, I2 = 74.5%). There were eight occurrences of intraoperative bleeding and four instances of bleeding post-procedure. The combined rate of intraoperative bleeding was 13.2% (95% CI: 6.7-24.3%, I2 = 0%), and post-procedure bleeding stood at 8.5% (95% CI: 3.4-19.8%, I2 = 0%). Only one major bleeding event was recorded, and no cases of perforation were reported. Conclusion: Our research indicates that the EndoRotor® effectively removes scarred colonic polyps, though the rate of remaining lesions is significant, potentially necessitating several sessions for a thorough removal. There is a need for broader prospective studies, mainly randomized controlled trials, to further assess EndoRotor®'s efficiency and safety in eliminating colonic polyps.

Endoscopically guided sutured gastropexy: a novel treatment of gastric volvulus.

Video 1An overview of the case, background information on gastric volvulus, 3-dimensional models of the different types of gastric volvuli, and novel endoscopic and surgical techniques.

A Tissue Systems Pathology Test Outperforms the Standard-of-Care Variables in Predicting Progression in Patients With Barrett's Esophagus.

INTRODUCTION: Objective risk stratification is needed for patients with Barrett's esophagus (BE) to enable risk-aligned management to improve health outcomes. This study evaluated the predictive performance of a tissue systems pathology [TSP-9] test (TissueCypher) vs current clinicopathologic variables in a multicenter cohort of patients with BE. METHODS: Data from 699 patients with BE from 5 published studies on the TSP-9 test were evaluated. Five hundred nine patients did not progress during surveillance, 40 were diagnosed with high-grade dysplasia/esophageal adenocarcinoma (HGD/EAC) within 12 months, and 150 progressed to HGD/EAC after 12 months. Age, sex, segment length, hiatal hernia, original and expert pathology review diagnoses, and TSP-9 risk classes were collected. The predictive performance of clinicopathologic variables and the TSP-9 test was compared, and the TSP-9 test was evaluated in clinically relevant patient subsets. RESULTS: The sensitivity of the TSP-9 test in detecting progressors was 62.3% compared with 28.3% for expert-confirmed low-grade dysplasia (LGD), while the original diagnosis abstracted from medical records did not provide any significant risk stratification. The TSP-9 test identified 57% of progressors with nondysplastic Barrett's esophagus (NDBE) ( P < 0.0001). Patients with NDBE who scored TSP-9 high risk progressed at a similar rate (3.2%/yr) to patients with expert-confirmed LGD (3.7%/yr). The TSP-9 test provided significant risk stratification in clinically low-risk patients (NDBE, female, short-segment BE) and clinically high-risk patients (IND/LGD, male, long-segment BE) ( P < 0.0001 for comparison of high-risk classes vs low-risk classes). DISCUSSION: The TSP-9 test predicts risk of progression to HGD/EAC independently of current clinicopathologic variables in patients with BE. The test provides objective risk stratification results that may guide management decisions to improve health outcomes for patients with BE.

Low adenoma burden in unselected patients with a pathogenic APC variant.

PURPOSE: Genomic screening can improve clinical outcomes, but presentation of individuals with risk for polyposis identified via genomic screening is unknown. To inform assessment of clinical utility of genomic screening for polyposis risk, clinical presentation of individuals in an unselected health care system cohort with an APC pathogenic or likely pathogenic (P/LP) variant causative of familial adenomatous polyposis are described. METHODS: Electronic health records of individuals with an APC P/LP variant identified via the MyCode program (MyCode APC+) were reviewed to assess adenoma burden and compare it among individuals with a clinical diagnosis of familial adenomatous polyposis and matched variant-negative controls. RESULTS: The prevalence of APC P/LP variants in this health care cohort is estimated to be 1 in 2800. Twenty-four MyCode APC+ individuals were identified during the study period. Median age at result disclosure was 53 years. Rate of clinical polyposis was 8%. Two of six participants with a classic region variant and none of those with an attenuated region variant had polyposis. MyCode APC+ participants did not differ from controls in cumulative adenoma count. CONCLUSION: APC P/LP variant prevalence estimate in the MyCode cohort is higher than prior published prevalence rates. Individuals with APC P/LP variants identified via genomic screening had a low adenoma burden.

Multicenter prospective evaluation of an overtube endoluminal interventional platform for colorectal polypectomy.

Background and study aims Endoscopic removal of complex colorectal polyps (≥ 2 cm) can be technically challenging. A dual balloon endoluminal overtube platform (DBEP) was developed to facilitate colonoscopic polypectomy. The study purpose was to evaluate clinical outcomes with the DBEP for complex polypectomy. Patients and methods This was an observational, prospective, multicenter Institutional Review Board-approved study. Between January 2018 and December 2020, safety and performance data were collected intra-procedurally and at 1 month post-procedure in patients undergoing intervention with the DBEP at three US centers. The primary endpoint was device safety and technical success of the procedure. Secondary endpoints included navigation time, total procedure time, and user feedback assessment post-procedure. Results A total of 162 patients underwent colonoscopy with the DBEP. Of these, 144 (89 %) underwent 156 interventions successfully with DBEP (44.5 % endoscopic mucosal resection, 53.2 % hybrid endoscopic submucosal dissection (ESD)/ESD, 1.3 % other). In 13 patients (8 %), device challenges contributed to unsuccessful intervention. One mild device-related adverse event (AE) occurred. Procedural AE rate was 8.3 %. Median lesion size was 2.6 cm [range 0.5-12]. The investigators felt that navigating the device was easy/somewhat easy in 78.5 % of successful cases. Median total procedure time was 69 minutes [range, 19-213], median navigation time to lesion was 8 minutes [range, 1-80], And median polypectomy time was 33.5 minutes [range, 2-143]. Conclusions Endoscopic colon polyp resection with the DBEP was safe with a high technical success rate. The DBEP has the potential to provide enhanced scope stability and visualization, traction, and a conduit for scope exchange. Further prospective randomized studies are warranted.

Utility of endoscopic ultrasound for assessment of locoregional recurrence of pancreatic adenocarcinoma after surgical resection.

Background and study aims Up to 80 % of patients with pancreatic adenocarcinoma develop locoregional recurrence after primary resection. However, the detection of recurrent pancreatic ductal adenocarcinoma (RPDAC) after pancreatic surgery can be challenging because of difficulty distinguishing locoregional recurrence from normal postoperative or post-radiation changes. We sought to evaluate the utility of endoscopic ultrasound (EUS), in detecting pancreatic adenocarcinoma recurrence after surgical resection and its impact on the clinical management of patients. Patients and methods This was a retrospective study of all pancreatic cancer patients who underwent EUS post-resection at two tertiary care centers between January 2004 and June 2019. Results Sixty-seven patients were identified. Of these, 57 (85 %) were diagnosed with RPDAC, resulting in change in clinical management of 46 (72 %) patients. EUS identified masses not seen on computed tomography, magnetic resonance imaging, or positron emission tomography in seven (14 %). Conclusions EUS is useful in detecting RPDAC after pancreatic surgery and can lead to significant impact on clinical management.

Gastrointestinal Bleeding Secondary to Splenic Artery Pseudoaneurysm: A Delayed Complication of a Lumen-Apposing Metal Stent.

Lumen-apposing metal stents (LAMSs) have been widely used for drainage of peripancreatic collections. A 71-year-old woman with a history of necrotizing pancreatitis who underwent LAMS placement 3 months ago for symptomatic pancreatic fluid collection presented with hematochezia and hemodynamic instability. Computed tomographic angiography of the abdomen showed concerns for stent erosion into the splenic artery. Esophagogastroduodenoscopy revealed a large pulsating nonbleeding vessel within the LAMS. She underwent a mesenteric angiogram, which showed splenic artery pseudoaneurysm, and coil embolization was performed. Gastrointestinal bleeding secondary to pseudoaneurysm should be considered in patients with recent LAMS placement who present with signs of gastrointestinal bleeding.

Clinical and financial outcomes of per-oral endoscopic myotomy compared to laparoscopic heller myotomy for treatment of achalasia.

BACKGROUND: Previous studies analyzing short-term outcomes for per-oral endoscopic myotomy (POEM) have shown excellent clinical response rates and shorter operative times compared to laparoscopic Heller myotomy (LHM). Despite this, many payors have been slow to recognize POEM as a valid treatment option. Furthermore, comparative studies analyzing long-term outcomes are limited. This study compares perioperative and long-term outcomes, cost-effectiveness, and reimbursement for POEM and LHM at a single institution. METHODS: Adult patients who underwent POEM or LHM between 2014 and 2021 and had complete preoperative data with at least one complete follow up, were retrospectively analyzed. Demographic data, success rate, operative time, myotomy length, length of stay, pre- and postoperative symptom scores, anti-reflux medication use, cost and reimbursement were compared. RESULTS: 58 patients met inclusion with 25 undergoing LHM and 33 undergoing POEM. There were no significant differences in preoperative characteristics. Treatment success (Eckardt ≤ 3) for POEM and LHM was achieved by 88% and 76% of patients, respectively (p = 0.302). POEM patients had a shorter median operative time (106 min. vs. 145 min., p = 0.003) and longer median myotomy length (11 cm vs. 8 cm, p < 0.001). All LHM patients had a length of stay (LOS) ≥ 1 day vs. 51.5% for POEM patients (p < 0.001). Both groups showed improvements in dysphagia, heartburn, regurgitation, Eckardt score, GERD HRQL, RSI, and anti-reflux medication use. The improvement in dysphagia score was greater in patients undergoing POEM (2.30 vs 1.12, p = 0.003). Median hospital reimbursement was dramatically less for POEM ($3,658 vs. $14,152, p = 0.002), despite median hospital costs being significantly lower compared to LHM ($2,420 vs. $3,132, p = 0.029). RESULTS: POEM is associated with a shorter operative time and LOS, longer myotomy length, and greater resolution of dysphagia compared to LHM. POEM costs are significantly less than LHM but is poorly reimbursed.

First interobserver agreement of optical coherence tomography in the bile duct: A multicenter collaborative study.

Background and study aims Optical coherence tomography (OCT) is a new technology available for evaluation of indeterminate biliary strictures. It allows under-the-surface visualization and preliminary studies have confirmed standardized characteristics associated with malignancy. The aim of this study is to evaluate the first interobserver agreement in identifying previously agreed upon OCT criteria and diagnosing of malignant versus benign disease. Patients and methods Fourteen endoscopists were asked to review an atlas of reference clips and images of eight criteria derived from expert consensus A total of 35 de-identified video clips were then evaluated for presence of the eight criteria and for final diagnosis of malignant versus benign using the atlas as reference Intraclass correlation (ICC) analysis was done to evaluate interrater agreement. Results Clips of 23 malignant lesions and 12 benign lesions were scored. Excellent interobserver agreement was seen with dilated hypo-reflective structures (0.85) and layering effacement (0.89); hyper-glandular mucosa (0.76), intact layering (0.81), and onion-skin layering (0.77); fair agreement was seen with scalloping (0.58), and thickened epithelium (0.4); poor agreement was seen with hyper-reflective surface (0.36). The diagnostic ICC for both neoplastic (0.8) and non-neoplastic (0.8) was excellent interobserver agreement. The overall diagnostic accuracy was 51 %, ranging from 43 % to 60 %. Conclusions Biliary OCT is a promising new modality for evaluation of indeterminate biliary strictures. Interobserver agreement ranged from fair to almost perfect on eight previously identified criteria. Interobserver agreement for malignancy diagnosis was substantial (0.8). Further studies are needed to validate this data.