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).

EUS-guided Gastroenterostomy: A Multicenter International Study Comparing Benign and Malignant Diseases.

BACKGROUND: Endoscopic ultrasound (EUS)-guided gastroenterostomy (EUS-GE) is a minimally invasive therapy for patients with gastric outlet obstruction without the risks of surgical bypass and the limited long-term efficacy of enteral self-expanding metal stent placement. However, due to its novelty, there is a lack of significant data comparing long-term outcomes of patients with EUS-GE, based on the underlying disease. In this study, we compare outcomes of EUS-GE on benign versus malignant indications. METHODS: Consecutive patients from 12 international, tertiary care centers who underwent EUS-GE over 3 years were extracted in a retrospective registry. Demographic characteristics, procedure-related information and follow-up data was collected. Primary outcome was the rate of adverse events associated with EUS-GE and the comparison of the rate of adverse events in benign versus malignant diseases. Secondary outcomes included technical and clinical success as well as hospitalization admission. RESULTS: A total of 103 patients were included: 72 malignant and 31 benign. The characteristics of the patients undergoing EUS-GE is shown in Table 1. The mean age of the cohort was 68 years and 58 years for malignant and benign etiology. Gender distribution was 57% and 39% being females in malignant and benign etiology group, respectively. Clinical success, technical success, average procedure time, and hospital length of stay were similar in both groups. Patients with benign underlying etiology had significantly higher number of surgically altered midgut anatomy (P=0.0379). CONCLUSION: EUS-GE is equally efficient regardless of the underlying etiology (malignant vs. benign), and the adverse events both groups were comparable.

Endoscopic Ultrasound-Guided Gallbladder Drainage Versus Percutaneous Drainage in Patients With Acute Cholecystitis Undergoing Elective Cholecystectomy.

INTRODUCTION: Cholecystectomy (CCY) is the gold standard treatment of acute cholecystitis (AC). Nonsurgical management of AC includes percutaneous transhepatic gallbladder drainage (PT-GBD) and endoscopic ultrasound-guided gallbladder drainage (EUS-GBD). This study aims to compare outcomes of patients who undergo CCY after having received EUS-GBD vs PT-GBD. METHODS: A multicenter international study was conducted in patients with AC who underwent EUS-GBD or PT-GBD, followed by an attempted CCY, between January 2018 and October 2021. Demographics, clinical characteristics, procedural details, postprocedure outcomes, and surgical details and outcomes were compared. RESULTS: One hundred thirty-nine patients were included: EUS-GBD in 46 patients (27% male, mean age 74 years) and PT-GBD in 93 patients (50% male, mean age 72 years). Surgical technical success was not significantly different between the 2 groups. In the EUS-GBD group, there was decreased operative time (84.2 vs 165.4 minutes, P < 0.00001), time to symptom resolution (4.2 vs 6.3 days, P = 0.005), and length of stay (5.4 vs 12.3 days, P = 0.001) compared with the PT-GBD group. There was no difference in the rate of conversion from laparoscopic to open CCY: 5 of 46 (11%) in the EUS-GBD arm and 18 of 93 (19%) in the PT-GBD group ( P value 0.2324). DISCUSSION: Patients who received EUS-GBD had a significantly shorter interval between gallbladder drainage and CCY, shorter surgical procedure times, and shorter length of stay for the CCY compared with those who received PT-GBD. EUS-GBD should be considered an acceptable modality for gallbladder drainage and should not preclude patients from eventual CCY.

Invasive CO 2 monitoring with arterial line compared to end tidal CO 2 during peroral endoscopic myotomy.

Background and study aims Peroral endoscopic myotomy (POEM) has become a recognized treatment for achalasia. The technique requires CO 2 insufflation. It is estimated that the partial pressure of CO 2 (PaCO 2 ) is 2 to 5 mm Hg higher than the end tidal CO 2 (etCO 2 ), and etCO 2 is used as a surrogate for PaCO 2 because PaCO 2 requires an arterial line. However, no study has compared invasive and noninvasive CO 2 monitoring during POEM. Patients and methods Seventy-one patients who underwent POEM were included in a prospective comparative study. PaCO 2 plus etCO 2 was measured in 32 patients (invasive group) and etCO 2 only in 39 matched patients (noninvasive group). Pearson correlation coefficient (PCC) and Spearman's Rho were used to calculate the correlation between PaCO 2 and ETCO 2 . Results PaCO 2 and ETCO 2 were strongly correlated: PCC R value: 0.8787 P  ≤ 0.00001, Spearman's Rho R value: 0.8775, P  ≤ 0.00001. Within the invasive group, the average difference between PaCO 2 and ETCO 2 was 3.39 mm Hg (median 3, standard deviation 3.5), within the 2- to 5-mm Hg range. The average procedure time (scope in to scope out) was increased 17.7 minutes ( P  = 0.044) and anesthesia duration was 46.3 minutes. Adverse events (AEs) included three hematomas and one nerve injury in the invasive group and one pneumothorax in the noninvasive group. There were no differences in AE rates between the groups (13 % vs 3 % P  = 0.24). Conclusions Universal PaCO 2 monitoring contributes to increased procedure and anesthesia times without any decrease in AEs in patients undergoing POEM. CO 2 monitoring with an arterial line should only be performed in patients with major cardiovascular comorbidities; in all other patients, ETCO 2 is an appropriate tool.

EUS-Guided Biliary Drainage Versus ERCP in Malignant Biliary Obstruction Before Hepatobiliary Surgery: An International Multicenter Comparative Study.

INTRODUCTION: Endoscopic ultrasound-guided biliary drainage (EUS-BD) is the procedure of choice for patients who cannot undergo endoscopic retrograde cholangiopancreatography (ERCP). The outcomes of patients undergoing surgery after EUS-BD for malignancy are unknown. METHODS: We conducted an international, multicenter retrospective comparative study of patients who underwent hepatobiliary surgery after having undergone EUS-BD or ERCP from 6 tertiary care centers. Patient demographics, procedural data, and follow-up care were collected in a registry. RESULTS: One hundred forty-five patients were included: EUS-BD n=58 (mean age 66, 45% male), ERCP n=87 (mean age 68, 53% male). The majority of patients had pancreatic cancer, cholangiocarcinoma, or gallbladder malignancy. In the EUS-BD group, 29 patients had hepaticogastrostomy, 24 had choledochoduodenostomy, and 5 had rendezvous technique done. The most common surgery was Whipple in both groups (n=41 EUS-BD, n=56 ERCP) followed by partial hepatectomy (n=7 EUS-BD, n=14 ERCP) and cholecystectomy (n=2 EUS-BD, n=2 ERCP). Endoscopy clinical success was comparable in both groups (98% EUS-BD, 94% ERCP). Adverse event rates were similar in both groups: EUS-BD (n=10, 17%) and ERCP (n=23, 26%). Surgery technical success and clinical success were significantly higher in the EUS-BD group compared with the ERCP group (97% vs. 83%, 97% vs. 75%). Total Hospital stay from surgery to discharge was significantly higher in the ERCP group (19 d vs. 10 d, P =0.0082). DISCUSSION: Undergoing EUS-BD versus ERCP before hepatobiliary surgery is associated with fewer repeat endoscopic interventions, shorter duration between endoscopy and surgical intervention, higher rates of surgical clinical success, and shorter length of hospital stay after surgery.

Endoscopic Ultrasound-Directed Transgastric ERCP (EDGE) Utilization of Trends Among Interventional Endoscopists.

BACKGROUND: Endoscopic ultrasound-directed transgastric ERCP (EDGE) has become standard-of-care therapy at many centers for pancreaticobiliary disease in patients with Roux-en-Y Gastric Bypass. In this study, we aimed to evaluate the opinions and practices of endoscopists who perform EDGE. METHODS: A 22-question utilization of EDGE survey was sent to 36 advanced endoscopists at tertiary care centers in the United States. The two-section survey included questions regarding advanced endoscopy volume and training at the respective facilities, and questions on specific details of EDGE utilization. RESULTS: Among 36 interventional endoscopists (IE) surveyed, 14 (39%) reported performing > 1000 ERCPs annually. Thirty (83%) offered EDGE as an option for Roux-en-Y gastric bypass patients with previous cholecystectomy. Other options offered included: 19 (53%) offered Laparoscopy-assisted ERCP (LA-ERCP), 7 (19%) offered Single-Balloon ERCP (SBE), and 10 (28%) offered percutaneous drainage (PTC). Twenty (56%) IE performed 10 or less EDGE procedures, while 16 (44%) performed 11 or more. Single-session EDGE was performed by 7 (19%) IE, while 15 (42%) performed dual session, and 13 (36%) performed both. 19 (53%) actively closed fistulas while 17 (47%) let them close spontaneously. Thirty one (86%) reported a technical success rate of 91% to 100%. The most frequently reported immediate adverse event post-procedurally was abdominal pain, reported by 17 IE (47%). Weight gain was reported by 2 IE (6%). CONCLUSION: EDGE continues to gain in popularity as an option for Roux-en-Y gastric bypass patients requiring pancreaticobiliary interventions, with 24/36 IE (67%) believing that it should be the new standard. In addition, most report a low frequency of post-procedural weight gain. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT05041608.

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.

Subepithelial tumors: How does endoscopic full-thickness resection & submucosal tunneling with endoscopic resection compare with laparoscopic endoscopic cooperative surgery?

Background and study aims Endoscopic techniques are rapidly emerging for resection of subepithelial tumors (SETs). Submucosal tunneling for endoscopic resection (STER), endoscopic full-thickness resection (EFTR) and laparoscopic endoscopic cooperative surgery (LECS) are current alternatives to open surgery. In this study, we aimed to compare the three endoscopic techniques. Patients and methods Consecutive patients who underwent resection of a submucosal esophageal or gastric lesion at several tertiary care centers were included in a dedicated registry over 3 years. Demographics, size and location of resected lesion, histology of specimen, length of procedure, adverse events (AEs), duration of hospital stay, and follow-up data were collected. Results Ninety-six patients were included (47.7 % male, mean age 62): STER n = 34, EFTR n = 34, LECS n = 280. The lesions included leiomyoma, gastrointestinal stromal tumors (GISTs) and other. The mean lesion size was 28 mm (STD 16, range 20-72 mm). The majority of lesions in the EFTR and laparoscopic-assisted resection group were GISTs. There was no significant difference in clear resection margins, post-procedure complication rates, recurrence rate and total follow-up duration between the groups. However, the LECS group had a procedure time at least 30 minutes longer than STER or EFTR ( P  < 0.01). Total hospital stay for the laparoscopic-assisted resection group was also longer when compared to STER (1.5) and EFTR (1.8) ( P  < 0.01). Conclusions STER, EFTR, and laparoscopic-assisted resection are efficacious approaches for resection of SETs with similar R0 resection rates, complication rates, and AE rates. Laparoscopic assisted resection appears more time-consuming and is associated with a longer hospital stay.

Safety and efficacy of endoscopic sleeve gastroplasty for obesity management in new bariatric endoscopy programs: a multicenter international study.

Background: Endoscopic sleeve gastroplasty (ESG) is an incisionless procedure that reduces the size of the gastric cavity. In prior studies, it has been proven to be a safe and effective treatment for obesity. In this study, we performed a collaborative study to evaluate the effectiveness of ESG among new endobariatric programs. Methods: This was an international, multicenter study reviewing the outcomes of ESG in centers starting ESG programs. Total body weight loss, change of body mass index (BMI), excess body weight loss (EBWL), technical success, duration of hospitalization, and immediate and delayed adverse events and complications at 24 h, 1 week, and 1, 3, and 6 months post-procedure were evaluated. Results: A total of 91 patients (35 males) from six centers were included. The patients' mean BMI before the procedure was 38.7 kg/m2. BMI reduction at 3 months was 7.3 (p < 0.000), at 6 months 9.3 (p < 0.000), and at 12 months 8.6 (p < 0.000) from baseline. EBWL was 17.3% at 1 month (p < 0.000), 29.2% at 3 months (p < 0.000), and 35.6% at 6 months (p < 0.000). The mean procedure duration was 85.1 min. The mean length of hospital stay post-procedure was 27 h. Conclusion: ESG provides EBWL percentage sustained up to 12 months. These results are equivalent among the new ESG centers compared to previous studies by expert centers. Lay title: Endoscopic sleeve gastroplasty in new bariatric endoscopy programs. Plain Language Summary: This article is the result of a collaborative international study on new endoscopic programs offering endoscopic sleeve gastroplasty.The minimally invasiveness and increasing accessibility of this technique makes it very attractive for patients with obesity while being poor candidate for surgery or refusing surgery.This study will also provide valuable information regarding this rising technique of endobariatric treatment.

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.

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.