Impact of COVID-19 Infection on Pancreato-Biliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography.

BACKGROUND: Viral infections are known to impact the pancreato-biliary system; however, there are limited data showing that the same is true of COVID-19. Endoscopic retrograde cholangiopancreatography (ERCP) can safely be performed in patients with COVID-19 infection, but outcomes of patients with COVID-19 infections and concomitant pancreatic and biliary disease requiring endoscopic intervention are unknown. AIMS: This study aims to evaluate the severity of pancreaticobiliary diseases and post-ERCP outcomes in COVID-19 patients. METHODS: Patients with pancreato-biliary disease that required inpatient ERCP from five centers in the United States and South America between January 1, 2020, and October 31, 2020 were included. A representative cohort of patients from each month were randomly selected from each site. Disease severity and post-ERCP outcomes were compared between COVID-19 positive and COVID-19 negative patients. RESULTS: A total of 175 patients were included: 95 COVID positive and 80 COVID negative. Mean CTSI score for the patients who had pancreatitis was higher in COVID-positive cohort by 3.2 points (p < .00001). The COVID-positive group had more cases with severe disease (n = 41) versus the COVID-negative group (n = 2) (p < .00001). Mortality was higher in the COVID-19 positive group (19%) compared to COVID-negative group (7.5%) even though the COVID-19-negative group had higher incidence of malignancy (n = 17, 21% vs n = 7, 7.3%) (p = 0.0455). CONCLUSIONS: This study shows that patients with COVID infection have more severe pancreato-biliary disease and worse post-ERCP outcomes, including longer length of stay and higher mortality rate. These are important considerations when planning for endoscopic intervention. CLINICALTRIALS: gov: (NCT05051358).

Endoscopic vacuum therapy: 2 methods of successful endosponge placement for treatment of anastomotic leak in the upper GI tract.

Video 1Presentation of 2 methods of successful endosponge placement for treatment of anastomotic leak in the upper GI tract.

Endoscopic Submucosal Dissection (ESD) Offers a Safer and More Cost-effective Alternative to Transanal Endoscopic Microsurgery (TEM): An International Collaborative Study.

BACKGROUND: Endoscopic submucosal dissection (ESD) and transanal endoscopic microsurgery (TEM) are minimally invasive procedures that treat early rectal cancer (ERC). Both are effective treatments, yet there are very few studies comparing them. The aim of our study was to identify ideal candidates for each procedure. MATERIALS AND METHODS: Between January 2016 and November 2019, 204 ERC patients were managed with either ESD (n=101) or TEM (n=103) at 7 international centers. Data analyzed included clinical success, tumor characteristics, procedure info, and recurrence rates. RESULTS: Median tumor size was 40 mm±23.9 in the ESD group and 56 mm±27.9 in the TEM group, significantly larger in the latter ( P <0.00001). Average procedure time was 131.5±67.9 minutes in ESD group and 104.9±28.4 minutes in TEM group ( P =0.000347). Average hospital stay was 3.3±2.6 days in the ESD group and 4.7±0.7 days in the TEM group ( P <0.00001). Adverse event rate was 6.8% in the ESD group and 24% in the TEM group. There were no significant difference in the rate of en bloc resection, technical success, tumor location, necessity of additional procedures, and tumor recurrence rates. CONCLUSION: Compared with TEM, ESD is a safer procedure with shorter hospital stay and should be offered for patients who have ERC.

Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes: A Multicenter Study.

INTRODUCTION: Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the safety and efficacy of the two available SDDs in the United States. METHODS: We conducted a comparative study of 2 SDD in consecutive ERCP procedures performed by expert endoscopists from 9 academic centers. Performance ratings, procedure details, and adverse events were collected. RESULTS: A total of 201 patients were included: 129 patients underwent ERCP with Exalt (mean age 63, Males- 66 (51%), 72 with aScope Duodeno (mean age 65, males=30 (42%). A majority of endoscopists had performed >2000 ERCPs in both groups (71% Exalt, 93% aScope Duodeno). Technical success was 92% in both groups (n=119 Exalt-group, n=66 aScope-Duodeno-group). The procedural complexity for the ERCP cases performed were: Grade 1: 35 cases (18%), Grade 2: 83 cases (41%), Grade 3: 65 cases (32%), and Grade 4: 18 cases (9%). Thirteen patients (10%) from the Exalt group and 16 patients (22%) from the aScope Duodeno group required conversion to a reusable duodenoscope. On a scale of 1 to 5, Exalt and aScope Duodeno, respectively, were rated: 2.31 versus 2.60 for location and visualization quality, 1.38 versus 1.57 for maneuverability based on papillary orientation, 1.48 versus 1.15 for suction/air control, and 2.31 versus 2.34 for elevator efficiency. None of the adverse events were related to the SDDs. CONCLUSIONS: The 2 SDDs were comparable. Further ongoing enhancements to these devices will improve maneuverability and clinical effectiveness.

Digital single-operator cholangioscopy interobserver study using a new classification: the Mendoza Classification (with video).

BACKGROUND AND AIMS: Digital single-operator cholangioscopy (DSOC) allows direct visualization of the biliary tree for evaluation of biliary strictures. Our objective was to assess the interobserver agreement (IOA) of DSOC interpretation for indeterminate biliary strictures using newly refined criteria. METHODS: Fourteen endoscopists were asked to review an atlas of reference clips and images of 5 criteria derived from expert consensus. They then proceeded to score 50 deidentified DSOC video clips based on the visualization of tortuous and dilated vessels, irregular nodulations, raised intraductal lesions, irregular surface with or without ulcerations, and friability. The endoscopists then diagnosed the clips as neoplastic or non-neoplastic. Intraclass correlation (ICC) analysis was done to evaluate inter-rater agreement for both criteria sets and final diagnosis. RESULTS: Clips of 41 malignant lesions and 9 benign lesions were scored. Three of 5 revised criteria had almost perfect agreement. ICC was almost perfect for presence of tortuous and dilated vessels (.86), raised intraductal lesions (.90), and presence of friability (.83); substantial agreement for presence of irregular nodulations (.71); and moderate agreement for presence of irregular surface with or without ulcerations (.44). The diagnostic ICC was almost perfect for neoplastic (.90) and non-neoplastic (.90) diagnoses. The overall diagnostic accuracy using the revised criteria was 77%, ranging from 64% to 88%. CONCLUSIONS: The IOA and accuracy rate of DSOC using the new Mendoza criteria shows a significant increase of 16% and 20% compared with previous criteria. The reference atlas helps with formal training and may improve diagnostic accuracy. (Clinical trial registration number: NCT02166099.).

Per Oral Endoscopic Myotomy for Zenker's Diverticulum: A Novel and Superior Technique Compared With Septotomy?

INTRODUCTION: Endoscopic management of Zenker diverticuli (ZD) has traditionally been via septotomy technique. The recent development of tunneling technique has shown to be both efficacious and safe. The aim of this study is to evaluate the tunneling technique using per oral endoscopic myotomy (Z-POEM) versus septotomy. METHODS: Patients who underwent endoscopic management of ZD either by Z-POEM or septotomy from March 2017 until November 2020 from 9 international academic centers were included. Demographics, clinical data preprocedure and postprocedure, procedure time, adverse events, and hospital length of stay were analyzed. RESULTS: A total of 101 patients (mean age 74.9 y old, 55.4% male) were included: septotomy (n=49), Z-POEM (n=52). Preprocedure Functional Oral Intake Scale score and Eckardt score was 5.3 and 5.4 for the septotomy group and 5.9 and 5.15 for the Z-POEM group. Technical success was achieved in 98% of the Z-POEM group and 100% of the septotomy group. Clinical success was achieved in 84% and 92% in the septotomy versus Z-POEM groups. Adverse events occurred in 30.6% (n=15) in septotomy group versus 9.6% (n=5) in the Z-POEM group (P=0.017). Reintervention for ongoing symptoms occurred in 7 patients in the septotomy group and 3 patients in the Z-POEM group. Mean hospital length of stay was shorter for the Z-POEM group, at 1.5 versus 1.9 days. CONCLUSIONS: A tunneling technique via the Z-POEM procedure is an efficacious and safe endoscopic treatment for ZD. Z-POEM is a safer procedure with a statistically significant reduction in adverse events compared with traditional septotomy technique.

Impact of the SARS-CoV-2 pandemic on turnover time and revenue in the endoscopy unit: single-center experience.

Background and study aims The SARS-CoV-2 pandemic heavily impacted the New York metro area causing most institutions to either reduce case volume or fully close remaining open units incorporated specific guidelines for procedures lockdown potentially leading to a greater turn-over time. We analyzed the quantitative and financial impact of this lost time on our tertiary care center's endoscopy unit. Patients and methods This single-center, retrospective study included demographics, procedure details and turn-over times (TOT) from all endoscopic procedures between December 1, 2019 to June 30, 2020. Cases were categorized as pre-COVID-19 group from December 1, 2019 to March 15, 2020 and during COVID-19 (lockdown) group from March 16, 2020 to June 30, 2020. The financial impact was assessed using national averages for reimbursement of outpatient endoscopic procedures provided by Center for Medicare and Medicaid Services. Results A total of 3622 procedures were performed during the study period: 2297 in the pre-COVID-19 period, 1325 in the COVID-19 period, representing a 42.32 % decrease. In the COVID-19 lockdown group, there was a significant increase in TOT in both the general endoscopy cases (18.11 minutes, P  = 0.000) and advanced endoscopy cases (17.7 minutes, P  = 0.000). The 42.3 % decrease in volume equated to at least $1.6 million USD in lost revenue during the lockdown. Conclusions COVID-19 pandemic led to an increase in TOT with overall reduced procedure volume and a negative effect on revenue. Providing continued endoscopic management during a pandemic avoids delays in reopening the endoscopy unit and hampers the post-pandemic surge of delayed cases and its financial impact.

Gastric per-oral endoscopic myotomy versus pyloromyotomy for gastroparesis: An international comparative study.

BACKGROUND AND AIM: Gastroparesis is a potentially debilitating gastric motility disorder with limited treatment options. Highest efficacy treatments include gastric per-oral endoscopic myotomy (GPOEM) and surgical pyloromyotomy. This study compares the efficacy and safety of GPOEM versus laparoscopic pyloromyotomy for refractory gastroparesis. METHODS: Patients who underwent GPOEM or laparoscopic pyloromyotomy for refractory gastroparesis from four centers across the USA and Latin America were included in a dedicated registry. Data collected included patient demographics, imaging, laboratory values, clinical success, gastroparesis cardinal symptom index, procedure time, pre-op and post-op gastric emptying times, adverse events, and hospital length of stay. RESULTS: A total of 102 patients were included (mean age 47; 32.4% male): GPOEM n = 39, surgical pyloromyotomy n = 63.Technical success was 100% in both groups. Clinical success was 92.3% in the GPOEM group and 82.5% in the surgery group (P = 0.164). The GPOEM group had a significantly higher post-op GSCI score reduction by 1.3 units (P < 0.00001), post-op retention reduction at 2 h by 18% (P < 0.00001), post-op retention reduction at 4 h by 25% (P < 0.00001) and a lower procedure time by 20 min (P < 0.00001) as compared with surgery. GPOEM also had a lower hospital length of stay by 2.8 days (P < 0.00001). Adverse events were significantly fewer in the GPOEM group (13%) compared with surgery group (33.3%; P = 0.021). Mean blood loss in the GPOEM group was only 3.6 mL compared with 866 mL in the surgery group. CONCLUSIONS: The GPOEM may be a less invasive, safer, and more efficacious procedural treatment for refractory gastroparesis as compared with surgical pyloromyotomy.

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.

Analysis of robotic-assisted laparoscopic pyleloplasty for primary versus secondary repair in 119 consecutive cases.

OBJECTIVE: To analyze the outcomes of our robotic-assisted pyeloplasty series for primary ureteropelvic junction obstruction (UPJO) and compare them with our series of robotic-assisted pyeloplasty for secondary UPJO. The repair of secondary UPJO can pose additional challenges to surgeons. Robotic assistance could aid in these repairs. METHODS: Using an institutional review board-approved database, we reviewed 119 consecutive patients who had undergone robotic-assisted laparoscopic pyeloplasty at our institution during an 8-year period (May 2002 to February 2010). Data were collected in a combined retrospective and prospective manner. The patients were stratified into primary repair and secondary repair for the primary analysis. The patients were also stratified into those with stones and those without stones for the secondary analysis. We compared the demographic, operative, postoperative, and radiographic outcomes. Student's t test and Pearson's chi-square correlation were used for statistical analysis of continuous and categorical variables, respectively. RESULTS: Of the original 119 patients, data were available for 117. Of the 117 patients, 97 had undergone primary pyeloplasty repair and 20 had undergone secondary pyleloplasty repair. Radiographic data were available for 84 patients with primary repair and 17 patients with secondary repair. The radiographic success rate was 96.1% and 94.1%, respectively. No statistically significant differences were found in the patient demographics, operative data, or postoperative or radiographic outcomes for the primary analysis. Additionally, no differences were found in the outcomes for patients with concomitant stone disease. CONCLUSION: These data represent the largest single-center report of its kind. These data strongly suggest that robotic-assisted laparoscopic pyeloplasty is a safe and durable option for secondary UPJO repair.