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.).

Effects of Glucagon-like Peptide-1 Receptor Agonists on Upper Endoscopy in Diabetic and Non-Diabetic Patients.

BACKGROUND AND AIMS: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) promote weight loss by suppressing appetite, enhancing satiety, regulating glucose metabolism and delaying gastric motility. We sought to determine whether GLP-1 RA use could impact sedated medical procedures like esophagogastroduodenoscopy (EGD). METHODS: We conducted a retrospective study on 35,183 patients who underwent EGD between 2019 and 2023, 922 of which were using a GLP-1-RA. Data were collected regarding demographics, diabetes status, retained gastric contents during EGD (RGC), incidence of aborted EGD, and necessity for repeat EGD. RESULTS: GLP-1 RA use was associated with a fourfold increase in the retention of gastric contents (p<0.0001), fourfold higher rates of aborted EGD (p<0.0001), and twice the likelihood of requiring repeat EGD (p=0.0001), even after stratifying for presence of diabetes. CONCLUSIONS: GLP-1 RA use can lead to delayed gastric emptying, affecting EGD adequacy regardless of the presence of diabetes, and may warrant dose adjustment to improve safety and efficacy of these procedures.

Efficacy of cap-assisted endoscopy for the visualization of the major duodenal papilla: a systematic review and meta-analysis.

BACKGROUND AND AIMS: The current standard of practice is to use a duodenoscope for the evaluation of the major duodenal papilla (MDP). Recently, cap-assisted endoscopy (CAE), which uses a transparent cap at the tip of a standard front-viewing endoscope, has emerged as an alternative. METHODS: A systematic literature search was performed in several databases from inception to January 2023 to identify studies evaluating the efficacy of CAE for the evaluation of the MDP. RESULTS: Nine studies including 806 patients met our inclusion criteria. The pooled rate of technical success for CAE was 93.2% (95% confidence interval, 85.6-96.9; I2 = 84.6%). A subgroup analysis comparing CAE with a standard endoscope showed higher odds for the evaluation of the MDP with CAE (but not a duodenoscope, which was better than CAE) with an odds ratio of 57.294 (95% confidence interval, 17.767-184.755; I2 = 45.303%). CONCLUSIONS: CAE offers a significant advantage with high rates of complete MDP evaluation compared with standard forward-viewing endoscopy. However, CAE is associated with lower rates of success when compared with side-viewing endoscopes.

Flexible endoscopic incisional therapy for Zenker's diverticulum (FEIT-Z) is an effective treatment for surgical failures or non-operative patients.

BACKGROUND: Symptomatic Zenker's diverticulum (ZD) occurs mostly in the elderly, who often have significant comorbidities, and poor neck hyperextension, putting them at high risk for surgical management while also increasing the potential of technical failure. Flexible endoscopic incisional therapy for Zenker's diverticulum (FEIT-Z) offers a safe approach to this problem with high technical and clinical success rates. There are limited data on its use following a failed surgical approach or in patients unfit for a surgical approach. The aim of this study was to assess clinical and technical outcomes of FEIT-Z in patients who were non-operative candidates or refused or failed surgical management. METHODS: Patients who underwent FEIT-Z from January 2015 to February 2019 at a tertiary referral center were included. Patient demographics, prior ZD surgical history, procedural data, dysphagia scores, clinical success, and adverse events (AE) were collected. Univariable analysis was performed to assess differences between pre- and post-FEIT-Z dysphagia scores. RESULTS: 30 patients undergoing FEIT-Z were included. Seven had a prior failed ZD surgical approach, 6 refused surgical management, and 17 were deemed to be non-operative candidates based on medical comorbidities. Mean age was 78.4 (± 12.1) and 36.7% were male. Technical success of FEIT-Z was 96.7%. There was a significant improvement in dysphagia scores after FEIT-Z: 2.3 (± 0.64) vs. before, 0.4 (± 0.76) (p < 0.001). Long-term clinical success was achieved in 73.3% of patients. Adverse events were seen in 23.3% of patients; however, these were graded as mild in 85.7% of patients. One microperforation was managed with antibiotics. CONCLUSION: FEIT-Z is a safe procedure with low adverse events and a high rate of technical and clinical success. FEIT-Z can be done in patients who fail previous surgical treatment, refuse a surgical approach, or are not surgical candidates due to medical comorbidity or other factors.

Safety and Efficacy of Endoscopic Retrograde Cholangiopancreatography in Nonagenarians: A Systematic Review and Meta-Analysis.

BACKGROUND: Recent advances in modern medicine have translated into increase in life expectancy in the USA and with that, a rise in the demand for invasive procedures in elderly patients. Endoscopic retrograde cholangiopancreatography (ERCP) is the procedure of choice for managing various benign and malignant pancreatobiliary conditions and can be associated with various adverse events. AIM: We performed a systematic review and meta-analysis to evaluate outcomes of ERCP in nonagenarians. METHODS: A comprehensive literature search was performed in Embase, MEDLINE, Web of Science, and Cochrane Review library until July 2020. Our primary outcomes were the rate of technical success and adverse events in nonagenarians. Secondary outcomes were comparison of technical success and adverse events compared with younger patients. RESULTS: The initial search revealed 4933 studies, of which 24 studies with 5521 patients met our inclusion criteria. Pooled technical success rate of ERCP in nonagenarians was 92%, and pooled adverse event rate was 7.8%. There was no significant difference in technical success rate and overall rate of adverse events comparing ERCP outcomes in nonagenarians with a relatively younger population. The risk of post-ERCP bleeding was significantly higher in nonagenarians compared to younger patients with OR = 1.986 [1.113-3.544], I2 = 0. ERCP-related mortality was also significantly higher in nonagenarians compared to younger patients with OR = 4.720 [1.368-16.289], I2 = 0. CONCLUSION: There was no significant difference in technical success rate and risk of adverse events related to ERCP in nonagenarians compared to younger patients. However, the risk of bleeding and procedure-related mortality was significantly higher.

Single-pass 1-needle actuation versus single-pass 3-needle actuation technique for EUS-guided liver biopsy sampling: a randomized prospective trial (with video).

BACKGROUND AND AIMS: Several reports have validated EUS-guided liver biopsy sampling (EUS-LB) as safe and effective. Nineteen-gauge EUS aspiration (FNA) or core (fine-needle biopsy [FNB]) needles are used, but different needle techniques can yield variable outcomes. Some data show that 1 pass (single liver puncture) with 1 actuation (1 to-and-fro needle movement) may be enough to obtain a satisfactory specimen. However, there has not been a head-to-head comparison of single versus multiple needle actuations for EUS-LB. METHODS: This was a prospective randomized trial of EUS-LB in 40 patients comparing tissue yields and adequacy using 1 pass, 1 actuation (1:1) versus 1 pass 3 actuations (1:3) of an FNB needle. The primary outcome was number of complete portal triads (CPTs). Secondary outcomes were length of the longest piece, aggregate specimen length, number of cores >9 mm, and adverse events (AEs). Computerized randomization determined selection (either 1:1 or 1:3 with fanning technique). Sample lengths were measured before pathologic processing. RESULTS: Both groups had similar demographics and indications for EUS-LB. All biopsy samples were adequate for pathologic interpretation. Compared with 1:1, biopsy sampling with 1:3 yielded more CPTs (mean [standard deviation], 17.25 [6.2] vs 24.5 [9.88]; P < .008) and longer aggregate specimen length (6.89 cm [1.86] vs 12.85 cm [4.02]; P < .001). AEs were not statistically different between the techniques. No severe AEs were noted. CONCLUSIONS: EUS-LB using the 1:3 technique produced longer liver cores with more CPTs than the 1:1 technique with an equivalent safety profile. Two needle passes are more likely to provide tissue adequacy according to the American Association for the Study of Liver Diseases guidelines. (Clinical trial registration number: UMIN 000040101.).

Maximizing success in single-session EUS-directed transgastric ERCP: a retrospective cohort study to identify predictive factors of stent migration.

BACKGROUND AND AIMS: EUS-directed transgastric ERCP (the EDGE procedure) is a simplified method of performing ERCP in Roux-en-Y gastric bypass patients. The EDGE procedure involves placement of a lumen-apposing metal stent (LAMS) into the excluded stomach to serve as a conduit for passage of the duodenoscope for pancreatobiliary intervention. Originally a multistep process, urgent indications for ERCP have led to the development of single-session EDGE (SS-EDGE) with LAMS placement and ERCP performed in the same session. The goal of this study was to identify predictive factors of intraprocedural LAMS migration in SS-EDGE. METHODS: We conducted a multicenter retrospective review that included 9 tertiary medical centers across the United States. Data were collected and analyzed from 128 SS-EDGE procedures. The primary outcome was intraprocedural LAMS migration. Secondary outcomes were other procedural adverse events such as bleeding and perforation. RESULTS: Eleven LAMS migrations were observed in 128 procedures (8.6%). Univariate analysis of clinically relevant variables was performed, as was a binary logistic regression analysis of stent diameter and stent dilation. This revealed that use of a smaller (15 mm) diameter LAMS was an independent predictor of intraprocedural stent migration (odds ratio, 5.36; 95% confidence interval, 1.29-22.24; P = .021). Adverse events included 3 patients who required surgery and 2 who experienced intraprocedural bleeding. CONCLUSIONS: Use of a larger-diameter LAMS is a predictive factor for a nonmigrated stent and improved procedural success in SS-EDGE. Although larger patient cohorts are needed to adequately assess these findings, performance of LAMS dilation and fixation may also decrease risk of intraprocedural LAMS migration and improve procedural success.

Endoscopic ultrasound-directed transgastric ERCP (EDGE): a retrospective multicenter study.

BACKGROUND: Endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) is an alternative to enteroscopy- and laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy. Although short-term results are promising, the long-term outcomes are not known. The aims of this study were: (1) to determine the rates of long-term adverse events after EDGE, with a focus on rates of persistent gastrogastric or jejunogastric fistula; (2) to identify predictors of persistent fistula; (3) to assess the outcomes of endoscopic closure when persistent fistula is encountered. METHODS: This was a multicenter retrospective study involving 13 centers between February 2015 and March 2019. Adverse events were defined according to the ASGE lexicon. Persistent fistula was defined as an upper gastrointestinal series or esophagogastroduodenoscopy showing evidence of fistula. RESULTS: 178 patients (mean age 58 years, 79 % women) underwent EDGE. Technical success was achieved in 98 % of cases (175/178), with a mean procedure time of 92 minutes. Periprocedural adverse events occurred in 28 patients (15.7 %; mild 10.1 %, moderate 3.4 %, severe 2.2 %). The four severe adverse events were managed laparoscopically. Persistent fistula was diagnosed in 10 % of those sent for objective testing (9/90). Following identification of a fistula, 5 /9 patients underwent endoscopic closure procedures, which were successful in all cases. CONCLUSIONS: The EDGE procedure is associated with high clinical success rates and an acceptable risk profile. Persistent fistulas after lumen-apposing stent removal are uncommon, but objective testing is recommended to identify their presence. When persistent fistulas are identified, endoscopic treatment is warranted, and should be successful in closing the fistula.

Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography, From Training Through Independent Practice.

BACKGROUND & AIMS: It is unclear whether participation in competency-based fellowship programs for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) results in high-quality care in independent practice. We measured quality indicator (QI) adherence during the first year of independent practice among physicians who completed endoscopic training with a systematic assessment of competence. METHODS: We performed a prospective multicenter cohort study of invited participants from 62 training programs. In phase 1, 24 advanced endoscopy trainees (AETs), from 20 programs, were assessed using a validated competence assessment tool. We used a comprehensive data collection and reporting system to create learning curves using cumulative sum analysis that were shared with AETs and trainers quarterly. In phase 2, participating AETs entered data into a database pertaining to every EUS and ERCP examination during their first year of independent practice, anchored by key QIs. RESULTS: By the end of training, most AETs had achieved overall technical competence (EUS 91.7%, ERCP 73.9%) and cognitive competence (EUS 91.7%, ERCP 94.1%). In phase 2 of the study, 22 AETs (91.6%) participated and completed a median of 136 EUS examinations per AET and 116 ERCP examinations per AET. Most AETs met the performance thresholds for QIs in EUS (including 94.4% diagnostic rate of adequate samples and 83.8% diagnostic yield of malignancy in pancreatic masses) and ERCP (94.9% overall cannulation rate). CONCLUSIONS: In this prospective multicenter study, we found that although competence cannot be confirmed for all AETs at the end of training, most meet QI thresholds for EUS and ERCP at the end of their first year of independent practice. This finding affirms the effectiveness of training programs. Clinicaltrials.gov ID NCT02509416.

Setting minimum standards for training in EUS and ERCP: results from a prospective multicenter study evaluating learning curves and competence among advanced endoscopy trainees.

BACKGROUND AND AIMS: Minimum EUS and ERCP volumes that should be offered per trainee in "high quality" advanced endoscopy training programs (AETPs) are not established. We aimed to define the number of procedures required by an "average" advanced endoscopy trainee (AET) to achieve competence in technical and cognitive EUS and ERCP tasks to help structure AETPs. METHODS: American Society for Gastrointestinal Endoscopy (ASGE)-recognized AETPs were invited to participate; AETs were graded on every fifth EUS and ERCP examination using a validated tool. Grading for each skill was done using a 4-point scoring system, and learning curves using cumulative sum analysis for overall, technical, and cognitive components of EUS and ERCP were shared with AETs and trainers quarterly. Generalized linear mixed-effects models with a random intercept for each AET were used to generate aggregate learning curves, allowing us to use data from all AETs to estimate the average learning experience for trainees. RESULTS: Among 62 invited AETPs, 37 AETs from 32 AETPs participated. Most AETs reported hands-on EUS (52%, median 20 cases) and ERCP (68%, median 50 cases) experience before starting an AETP. The median number of EUS and ERCPs performed per AET was 400 (range, 200-750) and 361 (range, 250-650), respectively. Overall, 2616 examinations were graded (EUS, 1277; ERCP-biliary, 1143; pancreatic, 196). Most graded EUS examinations were performed for pancreatobiliary indications (69.9%) and ERCP examinations for ASGE biliary grade of difficulty 1 (72.1%). The average AET achieved competence in core EUS and ERCP skills at approximately 225 and 250 cases, respectively. However, overall technical competence was achieved for grade 2 ERCP at about 300 cases. CONCLUSION: The thresholds provided for an average AET to achieve competence in EUS and ERCP may be used by the ASGE and AETPs in establishing the minimal standards for case volume exposure for AETs during their training. (Clinical trial registration number: NCT02509416.).

19 G aspiration needle versus 19 G core biopsy needle for endoscopic ultrasound-guided liver biopsy: a prospective randomized trial.

BACKGROUND: Endoscopic ultrasound-guided liver biopsy (EUS-LB) is a safe and effective method for accomplishing parenchymal liver biopsy. The aim of this study was to compare a 19 G aspiration needle (FNA) with a 19 G Franseen-tip core biopsy needle (FNB) for EUS-LB. METHODS: This was a prospective, parallel group, randomized trial comparing the tissue yields and adequacy of a 19 G FNA needle vs. a 19 G FNB needle for EUS-LB. The primary outcome was length of the longest piece of liver core specimen. Secondary outcomes were aggregate specimen length, number of complete portal triads (CPTs), and adverse events. One transgastric pass and one transduodenal pass were performed with the same needle in each patient. Specimen lengths were measured before and after histological processing. RESULTS: 40 patients referred for EUS-LB were randomized to either the FNA group (n = 20) or the FNB group (n = 20). Both groups had similar patient characteristics. FNB biopsies yielded longer mean (standard deviation) specimen lengths (pre-processing mean 2.09 cm [0.41] vs. mean 1.47 cm [0.46], and post-processing mean 1.78 cm [0.66] vs. mean 1.05 cm [0.42]; both P < 0.001), a longer aggregate specimen length (pre-processing mean 15.78 cm [5.19] vs. 10.89 cm [4.38]; P = 0.003), and more CPTs (mean 42.6 25 vs 18.1 [9.3]; P < 0.001) compared with the FNA needle. There were no severe adverse events or difference in adverse event rate between the two needles. Post-biopsy pain was noted in 37.5 %. CONCLUSION: EUS-LB using the FNB needle delivered longer liver biopsy specimens with more CPTs than the regular (non-core) needle.

A prospective pilot comparison of wet and dry heparinized suction for EUS-guided liver biopsy (with videos).

BACKGROUND AND AIMS: As EUS-guided liver biopsy sampling (EUS-LB) becomes more widely used, further studies have investigated ways to improve tissue yields. Use of a heparin-primed needle may lead to less clotting of blood within the needle, improve tissue recovery, and decrease fragmentation. The purpose of this study was to prospectively evaluate wet suction using a heparin-primed needle for EUS-LB. METHODS: This was a prospective crossover study evaluating wet suction for EUS-LB in parenchymal liver disease. The primary outcome was specimen adequacy, defined by an aggregate specimen length ≥15 mm and ≥5 complete portal tracts (CPTs). Secondary outcomes included number of CPTs, length of the longest piece, aggregate specimen length, and number of small (≤4 mm), medium (5-8 mm), and large (≥9 mm) fragments. Adverse events were tracked at 7 and 30 days. RESULTS: One hundred twenty biopsy specimens were collected from 40 participants (3 specimens per patient). Specimen adequacy occurred in 39 wet heparin (98%), 37 dry heparin (93%), and 30 dry needle biopsy samples (80%; 95% confidence interval [CI], .14-.18; P = .01). There was no difference between dry needle techniques. Length of the longest piece was 8.9 mm for wet heparin and 5.8 mm for dry techniques (95% CI, .33-1.53; P = .003). Aggregate specimen length was 49.2 mm for wet heparin and 23.9 mm for dry heparin (95% CI, -46.34 to 44.94; P = .003). Mean CPT count was 7.0 for wet heparin versus 4.0 for dry (95% CI, .74-6.26; P = .01). There were more medium (2.0 vs 1.0; 95% CI, .06-1.24; P = .03) and large (1.0 versus 0.0; 95% CI, .33-1.53; P = .003) fragments with wet suction with no difference in small fragments between groups. CONCLUSIONS: The use of wet suction EUS-LB demonstrated improved tissue adequacy compared with dry needle techniques. (Clinical trial registration number: NCT03103997.).

EUS-guided drainage of postsurgical fluid collections using lumen-apposing metal stents: a multicenter study.

BACKGROUND AND AIMS: Postsurgical fluid collections (PSFCs) are traditionally drained either percutaneously or surgically. Endoscopic drainage offers several advantages compared with either percutaneous or surgical approaches, including avoiding repeat surgery or the need to have a percutaneous drain in place for weeks. There are very little data regarding the use of lumen-apposing metal stents (LAMSs) in the drainage of PSFCs. We aim to study the technical and clinical success and adverse events (AEs) of using LAMSs in the drainage of PSFCs. METHODS: Collaborators from 8 centers retrospectively reviewed their endoscopic databases to find procedures using LAMSs for drainage of PSFCs. Technical success (successful placement of LAMSs into the fluid collection), clinical success (complete resolution of the fluid collection on repeat imaging or endoscopy), and intraprocedure and postprocedure AEs were measured. RESULTS: Forty-seven patients were identified with PSFCs after various surgeries. Thirteen patients had failed previous percutaneous or surgical drainage attempts. Fluid collections averaged 78.6 mm (range, 47-150 mm) in size. The most common site of stent placement was transgastric, followed by rectum and duodenum. Technical success rate was 93.6% and clinical success rate 89.3%. The intraprocedural AE rate was 4.25% and postprocedural AE rate 6.4%. There was 1 death unrelated to the procedure. CONCLUSIONS: The use of LAMSs to drain PSFCs has a high technical and clinical success rate with low AEs. For collections that are favorably located adjacent to the stomach, duodenum, or rectum, LAMS placement is a viable alternative to repeat surgery or percutaneous drainage.