Endoscopic Gallbladder Stenting to Prevent Recurrent Cholecystitis in Deferred Cholecystectomy: A Randomized Trial.

BACKGROUND & AIMS: Endoscopic transpapillary gallbladder stenting (ETGS) has been proposed as one of the adjunctive treatments, apart from antibiotics, before surgery in patients with acute cholecystitis whose cholecystectomy could not be performed or was deferred. Currently, there are no comparative data on the outcomes of ETGS in those who receive and do not receive ETGS. We aimed to compare the rates of recurrent cholecystitis at 3 and 6 months in these 2 groups. METHODS: Between 2020 and 2023, eligible acute calculous cholecystitis patients with a high probability of common bile duct stone, who were surgical candidates but could not have an early cholecystectomy during COVID-19 surgical lockdown, were randomized into groups A (received ETGS) and B (did not receive ETGS). A definitive cholecystectomy was performed at 3 months or later in both groups. RESULTS: A total of 120 eligible patients were randomized into group A (n = 60) and group B (n = 60). In group A, technical and clinical success rates were 90% (54 of 60) and 100% (54 of 54), respectively. Based on intention-to-treat analysis, group A had a significantly lower rate of recurrence than group B at 3 months (0% [0 of 60] vs 18.3% [11 of 60]; P = .001). At 3-6 months, group A showed a nonsignificantly lower rate of recurrent cholecystitis compared to group B (0% [0 of 32] vs 10% [3 of 30]; P = .11). CONCLUSIONS: ETGS could prevent recurrent cholecystitis in acute cholecystitis patients with common bile duct stone whose cholecystectomy was deferred for 3 months. In those who did not receive ETGS, the majority of recurrences occurred within 3 months. (Thaiclinicaltrials.org, Number TCTR20200913001).

Efficacy of multi-hole self-expandable metal stent compared to fully covered and uncovered self-expandable metal stents in patients with unresectable malignant distal biliary obstruction: a propensity analysis.

BACKGROUND AND AIMS: Self-expandable metal stent (SEMS) insertion is the standard palliative treatment for unresectable malignant extrahepatic biliary obstruction (MBO). Drawbacks of conventional fully covered SEMS (FCSEMS) and uncovered SEMS (USEMS) include stent migration and tumor ingrowth, respectively. This study aimed to compare stent patency in MBO with the newly design multi-hole SEMS (MHSEMS), which has multiple small side holes in the stent membrane, with conventional FCSEMS and UCSEMS. PATIENTS AND METHODS: This retrospective study using a propensity score matching design and stent patency times of 40 patients with MHSEMS was compared to 40 and 34 patients with FCSEMS and UCSEMS during the same period, respectively. Secondary outcomes were procedure-related adverse events, clinical success rate, time to recurrent biliary obstruction (RBO), and etiology of RBO. RBO was compared using Kaplan-Meier analysis. RESULTS: Baseline characteristics after matching were comparable among the 3 groups. RBO rates were 21%, 37%, and 55% for MHSEMS, FCSEMS, and UCSEMS, respectively (p = 0.014), at a mean time of 479, 353, and 306 days, respectively (MHSEMS vs UCSEMS, p = 0.002). Rate of tumor ingrowth was highest in the UCSEMS group (42.4% vs 13.2% in MHSEMS; p = 0.005 and vs 0% in FCSEMS; p < 0.001). Stent migration rate was highest in the FCSEMS group at 15.8% vs 2.6% in MHSEMS (p = 0.047) and 0% in UCSEMS (p = 0.005). CONCLUSION: MHSEMS provided the longest stent patency time with lowest RBO rate compared to conventional SEMS by showing a lower stent migration rate than FCSEMS and a lower tumor ingrowth rate than UCSEMS.

Intermediate- to long-term outcomes of endoscopic transpapillary gallbladder stenting in patients with gallstone-related disease: a 10-year single-center experience.

BACKGROUND: Endoscopic transpapillary gallbladder stenting (ETGS) can be a bridging therapy to elective cholecystectomy or a permanent gallbladder drainage method in patients with symptomatic gallbladder disease who are awaiting cholecystectomy or are unfit for surgery, respectively. We evaluated the intermediate- to long-term outcomes of ETGS in these groups. METHODS: We retrospectively reviewed 234 patients (acute cholecystitis = 147), who were unfit for surgery (n = 50) or had deferred cholecystectomy (n = 184) and who underwent ETGS between 2012 and 2021. A 7-Fr, 15-cm, double-pigtail plastic stent was placed for ETGS without scheduled stent exchange. Biliary event-free rates (i. e. cholecystitis and cholangitis) were determined at 6 months, 1 year, and ≥ 2 years. RESULTS: Technical and clinical success rates were 84.6 % (198/234) and 97.4 % (193/198), respectively. Kaplan-Meier analysis (n = 193) showed a biliary event-free rate of 99 % (95 %CI 0.95-1.00) at 6 months, 92 % (95 %CI 0.87-0.97) at 1 year, and 76 % (95 %CI 0.65-0.93) at ≥ 2 years, during a median follow-up period of 564 days (range 200-3001 days). CONCLUSIONS: ETGS is an effective biliary drainage method that should be considered in selected cases with common bile duct stone where cholecystectomy could not be performed or was deferred. The biliary event-free rates of ≥ 76 % up to ≥ 2 years further support the use of ETGS in these patient groups.

Electrocautery-enhanced Lumen-apposing Metal Stents in the Management of Symptomatic Pancreatic Fluid Collections: Results From the Multicenter Prospective Pivotal Trial.

BACKGROUND AND AIMS: Endoscopic decompression is considered a first-line treatment for symptomatic pancreatic fluid collections (PFCs). A lumen-apposing metal stent (LAMS) with an electrocautery-enhanced delivery system [electrocautery-enhanced lumen-apposing metal stent (ELAMS)] may facilitate this procedure. This study evaluated the safety and efficacy of ELAMS in the management of symptomatic PFCs. PATIENTS AND METHODS: A multicenter, nonblinded, prospective, Food and Drug Administration (FDA)-approved, investigational device exemption clinical trial was conducted. Enrollment criteria included symptomatic PFCs ≥6 cm with ≥70% fluid fraction. Subjects were followed prospectively for safety, efficacy, and resolution of the collections. Primary endpoint success was defined as ≥50% reduction in PFC size. Clinical outcomes were compared with our previously published series of LAMS without the cautery-enhanced delivery system. RESULTS: The target enrollment of 30 patients was achieved in 7 US tertiary care centers. All patients underwent successful placement of the ELAMS. The mean procedure duration, stent placement time, and fluoroscopy exposures were 28.1±12.5, 5.8±2.6, and 1.8±1.6 minutes, respectively. Eight patients had no fluoroscopy. The primary endpoint was achieved in 83.3% of patients. Two adverse events were attributed to the ELAMS: 1 bleeding upon stent removal and 1 stent migration. Relative to the comparator noncautery LAMS multicenter trial (N=33, 8 tertiary centers), there was a significantly shorter procedure duration [36 min ( P <0.001)] with similar technical and clinical outcomes in the ELAMS cohort. CONCLUSION: LAMS placed using an electrocautery delivery system significantly reduce procedure duration and were safe and effective in the management of symptomatic PFCs.

Bacterial contamination and organic residue after reprocessing in duodenoscopes with disposable distal caps compared with duodenoscopes with fixed distal caps: a randomized trial.

BACKGROUND AND AIMS: Newly designed duodenoscopes with disposable distal caps have been developed for better cleaning and preprocessing to reduce the risk of bacterial contamination (BC). We compared BC and organic residue of duodenoscopes with disposable distal caps and duodenoscopes with fixed distal caps after manual cleaning and high-level disinfection (HLD). METHODS: Four hundred duodenoscopes were randomized into group A (fixed distal caps, n = 200) and group B (disposable distal caps, n = 200). After manual cleaning, samples from the elevator were submitted for culture. An adenosine triphosphate (ATP) test was performed for organic residue evaluation. Based on our previous data, ATP < 40 relative light units (RLUs) had 100% sensitivity with 100% negative predictive value to confirm no BC after reprocessing. RESULTS: After manual cleaning, group A had a higher BC rate (14% vs 7%, P = .02), a higher proportion of duodenoscopes with ATP ≥ 40 RLUs (73.5% vs 57%, P = .001), and a higher mean of ATP level (226.6 vs 82.0 RLUs, P < .001) compared with group B. After HLD, the proportion of potential BC (ATP ≥ 40 RLUs) in group A was 2.7 times higher than group B (4% vs 1.5%, P = .13). Mean ATP level after HLD in the 2 groups was significantly lower than before the HLD procedure (group A, 24.2 vs 226.6 RLUs [P < .001]; group B, 20.4 vs 82.0 RLUs [P < .001], respectively). CONCLUSIONS: After manual cleaning, duodenoscopes with disposable distal caps had significantly lower BC and organic residue than duodenoscopes with fixed distal caps. Only a few duodenoscopes from each group did not pass the ATP threshold after HLD.

Long-term Outcome of Gastric Per-Oral Endoscopic Pyloromyotomy in Treatment of Gastroparesis.

BACKGROUND & AIMS: Gastric per oral endoscopic pyloromyotomy (GPOEM) is a promising treatment for gastroparesis. There are few data on the long-term outcomes of this procedure. We investigated long-term outcomes of GPOEM treatment of patients with refractory gastroparesis. METHODS: We conducted a retrospective case-series study of all patients who underwent GPOEM for refractory gastroparesis at a single center (n = 97), from June 2015 through March 2019; 90 patients had more than 3 months follow-up data and were included in our final analysis. We collected data on gastroparesis cardinal symptom index (GCSI) scores (measurements of postprandial fullness or early satiety, nausea and vomiting, and bloating) and SF-36 questionnaire scores (measures quality of life). The primary outcome was clinical response to GPOEM, defined as a decrease of at least 1 point in the average total GCSI score with more than a 25% decrease in at least 2 subscales of cardinal symptoms. Recurrence was defined as a return to baseline GCSI or GCSI scores of 3 or more for at least 2 months after an initial complete response. The secondary outcome was the factors that predict GPOEM failure (no response or gastroparesis recurrence within 6 months). RESULTS: At initial follow-up (3 to 6 months after GPOEM), 73 patients (81.1%) had a clinical response and significant increases in SF-36 questionnaire scores (indicating increased quality of life) whereas 17 patients (18.9%) had no response. Six months after GPOEM, 7.1% had recurrence. At 12 months, 8.3% of patients remaining in the study had recurrence. At 24 months, 4.8% of patients remaining in the study had a recurrence. At 36 months, 14.3% of patients remaining in the study had recurrence. For patients who experienced an initial clinical response, the rate of loss of that response per year was 12.9%. In the univariate and multivariate regression analysis, a longer duration of gastroparesis reduced the odds of response to GPOEM (odds ratio [OR], 0.092; 95% CI, 1.04-1.3; P = .001). On multivariate logistic regression, patients with high BMIs had increased odds of GPOEM failure (OR, 1.097; 95% CI, 1.022-1.176; P = .010) and patients receiving psychiatric medications had a higher risk of GPOEM failure (OR, 1.33; 95% CI, 0.110-1.008; P = .052). CONCLUSIONS: In retrospective analysis of 90 patients who underwent GPOEM for refractory gastroparesis, 81.1% had a clinical response at initial follow-up of their procedure. 1 year after GPOEM, 69.1% of all patients had a clinical response and 85.2% of initial responders maintained a clinical response. Patients maintained a clinical response and improved quality of life for as long as 3 years after the procedure. High BMI and long duration gastroparesis were associated with failure of GPOEM.

Short-term outcomes of double versus single pyloromyotomy at peroral endoscopic pyloromyotomy in the treatment of gastroparesis (with video).

BACKGROUND AND AIMS: The prevalence of gastroparesis (Gp), a chronic debilitating disorder, and resulting hospitalizations are increasing. Gastric peroral endoscopic pyloromyotomy (POP or GPOEM) is a novel technique in the treatment of refractory Gp. Despite the initial promising results of GPOEM, one-third of patients do not exhibit any clinical response. Furthermore, loss of clinical response was reported in several studies. No response or loss of response after GPOEM may be related to inadequate myotomy. The aim of our study is to examine whether double pyloromyotomy at GPOEM is superior to single pyloromyotomy. METHOD: A retrospective case-controlled study of patients who underwent GPOEM for refractory Gp at our tertiary care institution between June 2015 and March 2018 was performed. Because the follow-up time for the single myotomy group was much longer than that of the double myotomy group, we matched the length of follow-up for the single myotomy group to that of the double myotomy group. The outcomes were measured by the changes in the Gastroparesis Cardinal Symptom Index (GCSI) before and 3 to 6 months after the procedure. Adverse events and other procedural and clinical parameters were also compared. RESULTS: Ninety patients underwent GPOEM (55 single and 35 double pyloromyotomy). The mean age was 47 ± 14 years, and the mean duration of symptoms was 5.3 ± 4.4 years. The average GCSI score was 3.8 before the GPOEM, and the average GCSI score 6 months after procedure was 1.8. Thirty-seven of 55 (67%) patients who underwent single pyloromyotomy achieved clinical response compared with 30 of 35 (86%) patients who underwent double pyloromyotomy. There were no significant differences for procedure time, postoperative pain, or length of hospital stay between the 2 groups. There was no difference in adverse events in the 2 pyloromyotomy groups. CONCLUSION: Double pyloromyotomy is a safe and feasible technique during GPOEM. Clinical success was higher in patients undergoing double pyloromyotomy compared with single pyloromyotomy in this nonrandomized, short-term follow-up study. Long-term studies are needed to further confirm our results.

A newly designed duodenoscope with detachable distal cap significantly reduces organic residue contamination after reprocessing.

BACKGROUND: A newly designed duodenoscope with detachable distal cap may reduce bacterial contamination by allowing better access to the elevator. We compared bacterial contamination and organic residue evaluated by rapid adenosine triphosphate (ATP) test and culture from duodenoscopes with detachable vs. fixed distal caps after high-level disinfection (HLD). METHODS: During December 2018-April 2019, 108 used newly designed duodenoscopes were enrolled. In group A (n = 54), the distal cap of the duodenoscope was detached before manual cleaning. In group B (n = 54), the distal cap was not detached. After HLD, samples were collected from the elevator, submitted for culture, and evaluated using the ATP test, using the cutoff value of 40 relative light units (RLUs). RESULTS: After HLD, the proportion of potential bacterial contamination and organic residue in group A was significantly lower than in group B (37.0 % vs. 75.9 %; P  < 0.001; relative risk 0.49, 95 % confidence interval 0.33-0.71), and also confirmed by median ATP values (45.2 vs. 141.0 RLU; P  < 0.001). In group B, one sample culture was positive for nonpathogenic bacteria. Pathogenic bacteria were not found in any culture from either group. CONCLUSIONS: The detachable distal cap was more effective at eliminating bacterial contamination and reducing organic residue than a fixed cap. Nonpathogenic bacteria were detected in the fixed cap group after reprocessing. The ATP test with 40 RLU cutoff is a practical method to ensure the cleanliness of duodenoscope reprocessing without the need to wait for bacterial culture results.

Gastric peroral endoscopic pyloromyotomy versus gastric electrical stimulation in the treatment of refractory gastroparesis: a propensity score-matched analysis of long term outcomes.

BACKGROUND : Gastric peroral endoscopic pyloromyotomy (G-POEM) and gastric electrical stimulation (GES) have been reported as treatment options for refractory gastroparesis. In this study, we compared the long term clinical outcomes of G-POEM versus GES in the treatment of such patients. METHODS : We retrospectively evaluated 111 consecutive patients with refractory gastroparesis between January 2009 and August 2018. To overcome selection bias, we used propensity score matching (1:1) between G-POEM and GES treatment. The primary outcome was the duration of clinical response. RESULTS : After propensity score matching, 23 patients were included in each group. After a median follow-up of 27.7 months, G-POEM had a significantly better and longer clinical response than GES (hazard ratio [HR] for clinical recurrence 0.39, 95 % confidence interval [CI] 0.16 - 0.95; P = 0.04). The median duration of response was 25.4 months (95 %CI 8.7 - 42.0) in the GES group and was not reached in the G-POEM group. The Kaplan - Meier estimate of 24-month clinical response rate was 76.6 % with G-POEM vs. 53.7 % with GES. GES appeared to have little effect on idiopathic gastroparesis (HR for recurrence with G-POEM vs. GES 0.35, 95 %CI 0.13 - 0.95; P = 0.05). The incidence of adverse events was higher in the GES group (26.1 % vs. 4.3 %; P = 0.10). CONCLUSION : Among patients with refractory gastroparesis, clinical response was better and lasted longer with G-POEM than with GES. The positive outcomes with G-POEM are likely to derive from the superior clinical response in patients with idiopathic gastroparesis. Further studies are needed to confirm these findings.

Retrospective Multicenter Matched Controlled Comparison of Endoscopic Retrograde Cholangiopancreatography in Pediatric Patients: A 10-year Experience.

INTRODUCTION: This study was designed to evaluate outcomes in pediatric patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) as compared with an American Society of Gastrointestinal Endoscopy (ASGE) complexity grade-matched adult cohort. METHOD: In this retrospective case-control study, ERCPs performed in pediatric patients from January 2008 to December 2018 in 2 tertiary referral hospitals were compared with a complexity-matched adult control group with similar procedural indications. Primary outcomes included the clinical success rate, technical success rate, and complication rate. Secondary outcomes included postprocedural admission rates, mode of sedation, procedure time, fluoroscopy time, hospitalization length, and the number of repeat procedures. RESULTS: Two hundred thirty-two ERCPs performed in 110 pediatric patients (average age 13.3) and 318 ERCPs performed in 160 ASGE grade-matched adult controls (average age 47.2 years) were analyzed. All procedures were therapeutic. There was no difference in the technical success rate (P = 0.2), clinical success rate (P = 0.5), complication rates (P = 0.1), and fluoroscopy time (P = 0.4), between the pediatric and adult cohorts. General anesthesia use and length of stay were significantly higher in the pediatric group (P = 0.0001). In subgroup analysis, technical (P = 0.2) and clinical success (P = 0.2) as well as complication rates (P = 0.6) were comparable between patients 10 years or less and patients 11 to 18 years within pediatric cohort. CONCLUSIONS: ERCP in pediatric cohorts appears to be safe and effective with equivalent outcomes relative to an ASGE complexity-matched adult cohort. Pediatric patients are more likely to require general anesthesia and have a longer average length of stay relative to adult controls.

Gastric Peroral Endoscopic Pyloromyotomy Reduces Symptoms, Increases Quality of Life, and Reduces Health Care Use For Patients With Gastroparesis.

BACKGROUND & AIMS: Gastric peroral endoscopic pyloromyotomy (GPOEM) is becoming a promising treatment option for patients with refractory gastroparesis. We aimed to systematically assess the efficacy of GPOEM and its effects on health care use. METHODS: We performed a retrospective study on 30 patients with refractory gastroparesis who underwent GPOEM from June 2015 through July 2017 at a tertiary center. We compared outcomes with those of 7 patients with refractory gastroparesis who did not undergo the procedure (controls). The primary outcomes were patient-reported reductions in symptoms, based on the gastroparesis cardinal symptom index (GCSI), and increases in 8 aspects of quality of life, based on Short Form 36 (SF-36) scores. Data were collected on the day of the procedure (baseline) and at 1 month, 6 months, 12 months, and 18 months afterward. Secondary outcomes included visits to the emergency department or hospitalization for gastroparesis-related symptoms. RESULTS: GPOEM was technically successful in all patients and significantly reduced GCSI scores in repeated-measure analysis of variance (F2.044, 38.838 = 22.319; P < .0005). The mean score at baseline was 3.5 ± 0.6, at 1 month after GPOEM was 1.8 ± 1.0 (P < .0005), at 6 months after was 1.9 ± 1.2 (P < .0005), at 12 months after was 2.6 ± 1.5 (P < .026), and at 18 months after was 2.1 ± 1.3 (P < .016). GPOEM was associated with improved quality of life: 77.8%, 76.5%, and 70% of patients had significant increases in SF-36 scores, compared with baseline, at 1 month, 6 months, and 12 months after GPOEM, respectively (F1.71,18.83 = 14.16; P < .0005). Compared with controls, patients who underwent GPOEM had significant reductions in GCSI, after we controlled for baseline score and duration of the disease (F1,31 = 9.001; P = .005). Patients who received GPOEM had significant reductions in number of emergency department visits (from 2.2 ± 3.1 times/mo at baseline to 0.3 ± 0.8 times/mo; P = .003) and hospitalizations (from 1.7 ± 2 times/mo at baseline to 0.2 ± 0.4 times/mo; P = .0002). CONCLUSIONS: In a retrospective study of patients who underwent GPOEM for refractory gastroparesis, we found the procedure significantly improved symptoms, increased quality of life, and reduced health care use related to gastroparesis.

Association between duration or etiology of gastroparesis and clinical response after gastric per-oral endoscopic pyloromyotomy.

BACKGROUND AND AIMS: Gastric per-oral endoscopic pyloromyotomy (GPOEM) is a novel procedure with promising potential for the treatment of gastroparesis but with limited data regarding predictors of clinical response. This study aims to evaluate the safety and efficacy of the procedure and explore the impact of duration and etiology (diabetic vs nondiabetic) of gastroparesis on clinical outcome as measured by the Gastroparesis Cardinal Symptom Index (GCSI). METHODS: A single-center retrospective longitudinal study at a tertiary care hospital was performed over an 18-month period. Forty patients with refractory gastroparesis (25 nondiabetic and 15 diabetic patients) were included. RESULTS: GCSI significantly improved throughout the study period (F[2.176, 17.405] = 10.152, P = .001). The nausea/vomiting subscale showed sustained improvement through 18 months (F[2.213, 17.704] = 15.863, P < .00001). There was no significant improvement in bloating (F[2.099, 16.791] = 1.576, P = .236). Gastric scintigraphy retention was significantly reduced by 41.7% (t = -7.90; P < .00001). Multivariate linear regression modeling revealed a significant correlation between the duration of disease and a GCSI improvement at 12 months (P = .02), with a longer duration of disease associated with a poorer long-term response. The etiology of gastroparesis was not associated with clinical improvement (P = .16). Adverse events (7.5%) included 1 capnoperitoneum, 1 periprocedure chronic obstructive pulmonary disease exacerbation, and 1 mucosotomy closure site disruption. CONCLUSIONS: GPOEM appears to be a safe and effective minimally invasive therapy for refractory gastroparesis, especially for patients with predominant nausea/vomiting and shorter duration of disease, regardless of the etiology. We propose the clinical criteria for undergoing GPOEM should be a GCSI of at least 2.0 and a gastric retention of greater than 20%.

Editorial: ERCP-Related Radiation Cataractogenesis: Is It Time to Be Concerned?

With the growing number of fluoroscopic guided endoscopic procedures, radiation-related risk needs to be further assessed. Recent evidence indicates that radiation cataractogenesis occurs at a lower dose threshold than previously believed. While body aprons and thyroid shields are well-established standard protection during fluoroscopy, ocular safety and the use of protective eyewear are not as well defined. This prospective study answered two important questions: Does the standard body dosimeter provide an accurate ocular dosimetry? And what is the time of fluoroscopy needed to warrant using lens protection? It also raises the question whether current guidelines need to be updated.

Outcomes and quality-of-life assessment after gastric per-oral endoscopic pyloromyotomy (with video).

BACKGROUND AND AIM: Gastric per-oral endoscopic pyloromyotomy (GPOEM) is emerging as a promising option for the treatment of gastroparesis. This study assessed outcomes and quality of life after GPOEM for gastroparesis, performed in an endoscopy unit at a major tertiary referral center. METHODS: We performed a retrospective review of patients who had undergone GPOEM from June 2015 to July 2016. Data were collected from electronic medical records and included patient demographics, endoscopy records, hospitalization records, clinic visits, and electronic messages. Scores for the Short Form 36 (SF36) and Gastroparesis Cardinal Symptom Index (GCSI) were obtained pre-procedure (16 patients), at 1 month (16 patients), at 6 months (13 patients), and at 12 months (6 patients) after the GPOEM procedure was performed. RESULTS: Sixteen consecutive patients, 13 women and 3 men (mean age, 44.76 ± 14.8 years), who underwent GPOEM were enrolled. GPOEM was technically successful in all cases. Thirteen of 16 (81%) patients had a significant improvement in the mean GCSI after GPOEM: 3.40 ± 0.50 before the procedure (16 patients) to 1.48 ± 0.95 (P = .0001) at 1 month (16 patients), 1.36 ± 0.9 (P < .01) at 6 months (13 patients), and 1.46 ± 1.4 (P < .01) at 12 months (6 patients) follow-up. Mean duration of the procedure was 49.7 ± 22.1 minutes. Mean myotomy length was 2.94 ± 0.1 cm. Mean length of hospital stay was 2.46 ± 0.7 days. No adverse events occurred with GPOEM. The SF36 questionnaire demonstrated a significant improvement in quality of life in several domains that was sustained through 6-months' follow-up. Mean 4-hour gastric retention on gastric emptying scans decreased from 62.9% ± 24.3% to 17.6% ± 16.7% (P = .007) after GPOEM. CONCLUSIONS: GPOEM results in improvement in the overall symptoms of gastroparesis measured by GCSI, objective assessment of improvement in gastric emptying, and improvement in multiple domains on validated quality-of-life inventories in SF36 over a follow-up period of 6 months.

Endoscopic management of pain in pancreatic cancer.

Pancreatic cancer is the fourth leading cause of cancer-related death in the United States and one of the leading causes of cancer mortality in the United States. Due to its aggressive behavior and lack of effective therapies, palliation plays a critical role in the management of the disease. Most patients with pancreatic cancer suffer from severe pain, which adversely predicts prognosis and significantly impacts the quality of life. Therefore pain management plays a central role in palliation. Non-steroidal anti-inflammatory drugs and opioid agents are often first line medications in pain management, but they do not target the underlying pathophysiology of pain and their use is limited by adverse effects and dependence. The proposed mechanisms of pain development in pancreatic cancer include neurogenic inflammation and ductal hypertension which may be targeted by endoscopic therapies. Endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) and pancreatic duct stent placement are the two primary endoscopic modalities for palliative management in pancreatic cancer patients with refractory pain.  Other endoscopic treatments such as biliary stent placement and enteral stent placement for biliary and duodenal obstruction may also help palliate pain in addition to their role in decompression. This article reviews the existing evidence for these endoscopic interventions for pain management in pancreatic cancer.

Performance comparison between two computer-aided detection colonoscopy models by trainees using different false positive thresholds: a cross-sectional study in Thailand.

BACKGROUND/AIMS: This study aims to compare polyp detection performance of "Deep-GI," a newly developed artificial intelligence (AI) model, to a previously validated AI model computer-aided polyp detection (CADe) using various false positive (FP) thresholds and determining the best threshold for each model. METHODS: Colonoscopy videos were collected prospectively and reviewed by three expert endoscopists (gold standard), trainees, CADe (CAD EYE; Fujifilm Corp.), and Deep-GI. Polyp detection sensitivity (PDS), polyp miss rates (PMR), and false-positive alarm rates (FPR) were compared among the three groups using different FP thresholds for the duration of bounding boxes appearing on the screen. RESULTS: In total, 170 colonoscopy videos were used in this study. Deep-GI showed the highest PDS (99.4% vs. 85.4% vs. 66.7%, p<0.01) and the lowest PMR (0.6% vs. 14.6% vs. 33.3%, p<0.01) when compared to CADe and trainees, respectively. Compared to CADe, Deep-GI demonstrated lower FPR at FP thresholds of ≥0.5 (12.1 vs. 22.4) and ≥1 second (4.4 vs. 6.8) (both p<0.05). However, when the threshold was raised to ≥1.5 seconds, the FPR became comparable (2 vs. 2.4, p=0.3), while the PMR increased from 2% to 10%. CONCLUSION: Compared to CADe, Deep-GI demonstrated a higher PDS with significantly lower FPR at ≥0.5- and ≥1-second thresholds. At the ≥1.5-second threshold, both systems showed comparable FPR with increased PMR.

The synergistic role of virtual coaching with simulation-based mastery learning for upper endoscopy.

Introduction: Our simulation-based mastery learning (SBML) curriculum, delivered in person, has been shown to successfully train novices in structured esophagogastroduodenoscopy (EGD). SBML with virtual coaching (VC) has the potential to improve the effectiveness and efficiency of endoscopy training and expand access to trainees from around the world. We share our observations conducting an EGD training course using SBML with VC. Methods: We conducted a 1-week virtual SBML course for novice trainees across seven academic centers in the USA and Asia. The cognitive component was delivered using an online learning platform. For technical skills, a virtual coach supervised hands-on training and local coaches provided assistance when needed. At the end of training, an independent rater assessed simulation-based performance using a validated assessment tool. We assessed the clinical performance of 30 EGDs using the ASGE Assessment of Competency in Endoscopy tool. We compared the trainees' scores to our cohort trained using in-person SBML training using non-inferiority t-tests. Results: We enrolled 21 novice trainees (mean age: 30.8 ± 3.6 years; female: 52%). For tip deflection, the trainees reached the minimum passing standard after 31 ± 29 runs and mastery after 52 ± 37 runs. For structured EGD, the average score for the overall exam was 4.6 ± 0.6, similar to the in-person cohort (4.7 ± 0.5, p = 0.49). The knowledge-based assessment was also comparable (virtual coaching: 81.9 ± 0.1; direct coaching: 78.3 ± 0.1; p = 0.385). Over time, our novice trainees reached clinical competence at a similar rate to our historical in-person control. Conclusions: VC appears feasible and effective for training novice gastroenterology trainees. VC allowed us to scale our SBML course, expand access to experts, and administer SBML simultaneously across different sites at the highest standards.

A New Paradigm Shift in Gastroparesis Management.

Gastroparesis, once regarded as a rare disease, is difficult to diagnose and challenging to treat; there were many breakthrough advances in the 2010s, shifting the paradigm of the understanding of this complex entity and its management. Similar to diabetes, its increasing prevalence reflects increased accessibility to diagnostic modalities and suggests that gastroparesis was underacknowledged in the past. Major developments in the three main aspects of the disease include the discovery of smooth muscle cells, interstitial cells of Cajal, PDGFRα+ cells syncytium, rather than interstitial cells of Cajal alone, as the main gastric pacemaker unit; the development of validated point-of-care diagnostic modalities such as a wireless motility capsule, the carbon 13-labeled breath test, and impedance planimetry; and the introduction of novel minimally invasive therapeutic options such as newer pharmacologic agents and gastric peroral endoscopic pyloromyotomy. All aspects of these advances will be discussed further in this review.