Faculty Bibliography

Background: Factors associated with need for surgical intervention (SI)following endoscopic therapy for iatrogenic luminal perforations are not well known. We aim to identify predictors of need for SI amongst patients undergoing attempted endoscopic closure following iatrogenic luminal perforation.
Method(s): We conducted a retrospective review of iatrogenic perforations that underwent endoscopic closure attempts in 7 North American referral centers. Data was collected including patient demographics, index perforation procedure, attempted closure procedures and need for surgical repair. Univariate and multivariable logistic regression analyses were performed.
Result(s): A total of 144 iatrogenic perforation cases were reviewed. Only 22 patients (15.3%)required SI following endoscopic closure attempts. Perforations occurred after upper endoscopy (67), colonoscopy (35), surgical endoscopy (17), and ERCP (25)interventions as defined in Figure 1. Notably none of the surgical endoscopy cases required surgical intervention. The most common perforation locations included: duodenum (35; 24.3%), esophagus (32; 22.2%), colon (32; 22.2%), and stomach (20; 13.9%). Perforation was recognized during the index procedure in 128 patients (88.9%). Needle decompression was needed in 9 cases (6.3%). Twelve patients (8.3%)underwent more than one endoscopic closure session. Multiple endoscopic closure modalities were used in 24 cases (16.7%). Most common modalities used included: through-the-scope clips (TTS, 58; 40.3%), stents (42; 29.2%), over-the-scope clips (OTSC, 37; 25.7%), and endoscopic suturing (27; 18.8%). On univariate analysis, needle decompression was a significant predictor of need for SI (27.3% vs. 2.5%); while stent use (9.1% vs. 32.8%), technical (31.8% vs. 94.3%)and immediate clinical success (27.3% vs. 95.1%)were inversely associated (Table 1). On multivariable analysis, index colonoscopy-related perforation, needle decompression and need for multiple endoscopic closure modalities were significant predictors of need for SI; while use of TTS clips and immediate clinical success were inversely associated (Table 1). None of the other examined factors predicted the need for SI, outlined in Table 1.
Conclusion(s): The need for surgical intervention after attempted endoscopic closure of iatrogenic perforations is low. Needle decompression, index colonoscopy-related perforation, and use of multiple endoscopic closure modalities were predictors of need for surgical intervention. [Figure presented]Univariate and multivariable analyses of need for surgical intervention after attempted endoscopic closure of iatrogenic perforations
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Introduction: Many patients who undergo Roux-en-Y gastric bypass (RYGB)surgery experience weight regain after initial weight loss, particularly patients who develop dilation of the gastrojejunal (GJ)anastomosis. Transoral outlet reduction (TORe)is a minimally invasive endoscopic procedure which has demonstrated efficacy in inducing weight loss in patients who have experienced weight regain after RYGB. Prior literature has described total weight loss of 8.4-8.6kg or 25% excess weight loss. However, there is limited published information on patient reported experiences with the TORe procedure. We aimed to evaluate clinical and patient-reported experience outcomes in patients who have undergone TORe.
Result(s): A total of 18 patients who underwent TORe procedure within the last 1.5 years at a large, urban medical center were requested to participate in a survey-based study. A total of 7 subjects agreed to participate. All were older than age 18, had undergone RYGB, and had a mean GJ diameter prior to TORe of 27mm. All patients underwent TORe with reduction of the GJ to a diameter of 8mm sized by a CRE balloon, and 5 out of 7 received supporting sutures to reduce the gastric pouch. The average weight loss was 6.8kg, with average excess weight loss of 7.5% with median follow-up of 4 months after TORe. Metabolic parameters including hemoglobin A1c and lipid panels were evaluated pre- and post-TORe, and all were reduced, however the differences were not statistically significant (table 1). Survey results indicated that 4 out of 7 subjects were satisfied with their weight loss after TORe, and were notable for a higher perceived than actual weight loss after TORe (self-reported average 8.6kg or 9.6% excess weight loss). Only 1 patient reported significant adverse event following TORe, with epigastric pain requiring hospitalization for two days for pain control. Subjects, on average, reported high quality of life following TORe with use of Moorehead-Ardelt Quality of Life Questionnaire. 6 of 7 subjects stated they were willing to undergo repeat TORe for further weight loss.
Conclusion(s): Our study demonstrates that patients who have undergone TORe tolerated the procedure well and experienced excess weight loss. Most patients reported satisfaction with their weight loss following TORe, and we found that patients reported a higher perceived weight loss than objectively measured. Clinically our cohort demonstrated a reduction in metabolic parameters, but this was not statistically significant, likely given small sample size. Most patients reported high quality of life scores following TORe and were willing to undergo repeat TORe based on their experiences. These findings support the use of TORe given general positive patient-reported outcomes, however further evaluation is needed to predict which patients are most likely to clinically benefit from this procedure. [Figure presented]
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Background: Factors associated with successful endoscopic therapy for iatrogenic gastrointestinal luminal perforations are not well known. We aim to evaluate safety and efficacy outcomes of endoscopic closure of perforations and identify factors associated with successful closure.
Method(s): We conducted a multicenter retrospective study from 7 North American referral centers. All patients underwent attempted endoscopic closure of iatrogenic perforations. Primary outcomes evaluated were technical success and immediate clinical success (less than 14 days). Secondary outcomes were adverse events, length of hospital stay, and long term clinical success (more than 14 days). Cases were analyzed based on immediate clinical success status. Univariate and multivariable analyses were performed.
Result(s): A total of 144 iatrogenic perforation cases were reviewed. Collectively, a total of 163 endoscopic closure procedures were performed with median follow up 192 days. Technical and immediate clinical success were achieved in 122/144 cases (84.7%). Mean perforation size was 11.28 mm. Perforation occurrence: 67 during upper endoscopy (diagnostic, dilation, EMR, stent placement/removal and endoscopic US), 35 during colonoscopy (diagnostic, EMR, stent placement/removal, dilation and EUS), 17 during surgical endoscopy (ESD, POEM)and 25 during ERCP. Univariate analysis of patient demographics, index perforation procedure details, closure procedure details, and need for surgical intervention are reported in Table 1. Factors associated with immediate clinical success with respective (OR [95% CI], p<0.05)were morning timing (AM)of index procedure 3.34(1.23-9.09), fellow involvement in index procedure 0.37(0.14-0.97), antibiotic use 5.13(1.45-18.12), needle decompression 0.11(0.03-0.45), use of stent 4.63(1.02-20.88)and technical success of closure procedure 16.7(5.58-50.24). None of the perforations that occurred during surgical endoscopy cases had clinical failure of closure. Patients with immediate clinical success had shorter hospital stay (5.7 vs. 9.3 days)and achieved higher long term clinical success (96.2% vs. 7.7%)compared to those with immediate clinical failure. In the multivariable model, technical success 22.20(3.99-123.6)was the only positive predictor of immediate clinical success; while needle decompression 0.11(0.02-0.76)was the only negative predictor. The overall adverse event rate for endoscopic closure procedures was 13.9%, outlined in Table 1.
Conclusion(s): Endoscopic closure techniques are safe and effective for treatment of iatrogenic perforations. Technical success of the endoscopic closure procedure is a positive predictor of immediate clinical success. Needle decompression is negative predictor of successful closure. Patients that achieve immediate clinical success have shorter hospitalizations and higher rates of long term clinical success. [Figure presented]
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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.

Background: Pancreatic ERCP remains a cornerstone in the management of pancreatic disease but is technically complex. Limited data exist regarding current pancreatic ERCP training in advanced endoscopy training programs (AETPs).
Aim(s): Establish learning curves in pancreatic ERCP.Report practice patterns in pancreatic ERCP among advanced endoscopy trainees (AETs) during the 1st year of independent practice.
Method(s): In Phase I of this prospective multicenter study, AETs were graded on every 5th ERCP using the TEESAT; a validated tool that grades both technical and cognitive aspects. Learning curves were created using cumulative sum analysis for overall, technical and cognitive components. AETs with at least 20 evaluationswere included for final analysis. In Phase II, AETs logged performance data on all ERCPs completed during independent practice.
Result(s): 24 AETs were included in the final analysis (Phase I). Overall, 1339 ERCPexams received grading.Aminority (4.6%)were pancreatic ERCPs, with indications including pancreatic stricture (43.3%), stones (22.9%) and recurrent acute pancreatitis (17.9%). 45% of pancreatic ERCPs were ASGE grade of difficulty 3, compared to 7% in biliary ERCPs (P < 0.01). Only 4 AETs had enough data to generate meaningful learning curves. No AETs achieved overall technical competence or competence in individual endpoints such as cannulation or sphincterotomy. Aggregate learning curves demonstrated that the "average" trainee would achieve cognitive, but not technical, competence in pancreatic ERCP at the completion of training. 22 AETs participated in Phase II, performing 3620 ERCPs of which only 7.8%were performed for pancreatic indications. The overall cannulation rate was 92.2% and 85.7% in native papilla cases.
Conclusion(s): AETs receive minimal training in pancreatic ERCP during their AETP and continue to perform low volume pancreatic ERCP in independent practice, which have significant implications for AETs and AETPs as novel strategies are warranted to increase AET exposure to pancreatic ERCPs

BACKGROUND & AIMS/OBJECTIVE:It is not clear whether digital single-operator cholangioscopy (D-SOC) with electrohydraulic and laser lithotripsy is effective in removal of difficult biliary stones. We investigated the safety and efficacy of D-SOC with electrohydraulic and laser lithotripsy in an international, multicenter study of patients with difficult biliary stones. METHODS:We performed a retrospective analysis of 407 patients (60.4% female; mean age, 64.2 years) who underwent D-SOC for difficult biliary stones at 22 tertiary centers in the United States, United Kingdom, or Korea from February 2015 through December 2016; 306 patients underwent electrohydraulic lithotripsy and 101 (24.8%) underwent laser lithotripsy. Univariate and multivariable analyses were performed to identify factors associated with technical failure and the need for more than 1 D-SOC electrohydraulic or laser lithotripsy session to clear the bile duct. RESULTS:The mean procedure time was longer in the electrohydraulic lithotripsy group (73.9 minutes) than in the laser lithotripsy group (49.9 minutes; P < .001). Ducts were completely cleared (technical success) in 97.3% of patients (96.7% of patients with electrohydraulic lithotripsy vs 99% patients with laser lithotripsy; P = .31). Ducts were cleared in a single session in 77.4% of patients (74.5% by electrohydraulic lithotripsy and 86.1% by lithotripsy; P = .20). Electrohydraulic or laser lithotripsy failed in 11 patients (2.7%); 8 patients were treated by surgery. Adverse events occurred in 3.7% patients and the stone was incompletely removed from 6.6% of patients. On multivariable analysis, difficult anatomy or cannulation (duodenal diverticula or altered anatomy) correlated with technical failure (odds ratio, 5.18; 95% confidence interval, 1.26-21.2; P = .02). Procedure time increased odds of more than 1 session of D-SOC electrohydraulic or laser lithotripsy (odds ratio, 1.02; 95% confidence interval, 1.01-1.03; P < .001). CONCLUSIONS:In a multicenter, international, retrospective analysis, we found D-SOC with electrohydraulic or laser lithotripsy to be effective and safe in more than 95% of patients with difficult biliary stones. Fewer than 5% of patients require additional treatment with surgery and/or extracorporeal shockwave lithotripsy to clear the duct.

BACKGROUND AND AIMS/OBJECTIVE:Pancreatic cancer organoids are tumor models of individualized human pancreatic ductal adenocarcinoma (PDA), created from surgical specimens and used for personalized treatment strategies. Unfortunately the vast majority of patients with PDA are not operative candidates. Creation of human PDA organoids at the time of initial tumor diagnosis is therefore critical. Our aim was to assess the feasibility of creating human PDA organoids by EUS fine-needle biopsy (EUS-FNB) in patients with PDA. METHODS:Prospective clinical trial in patients referred to evaluate a pancreatic mass (ClincalTrials.gov: NCT01698190). EUS-FNA was performed for initial on-site diagnosis. Two additional needle passes were performed with a 22-gauge FNB needle for organoid creation. Primary outcome was successful isolation of organoids within 2 weeks of EUS-FNB (P0), confirmed by organoid morphology and positive genotyping. RESULTS:Thirty-seven patients with 38 PDA tumors were enrolled. Successful isolation of organoids (P0) was achieved in 33 of 38 tumors, or 87%. Establishment of PDA organoid lines for ≥5 passages of growth (P5) was reached in 25 of 38 tumors, or 66%. In the single patient with successful P5 FNB-derived and P5 surgically derived organoids, there was identical matching of specimens. There were no serious adverse events. Two patients developed bleeding at the EUS-FNB puncture site requiring hemostasis clips. CONCLUSIONS:Pancreatic cancer organoids can be successfully and rapidly created by means of EUS-FNB using a 22-gauge needle at the time of initial diagnosis. Successful organoid generation is essential for precision medicine in patients with pancreatic cancer, in whom the majority are not surgically resectable.

Background: We have shown that AETs achieve EUS and ERCP competence at varying rates, validating the shift from defining competence based on an absolute number of procedures to well-defined metrics. However, there are no data to confirm that advanced endoscopy trainees (AETs) who achieve competence during training subsequently perform high quality EUS and ERCP in their 1st year of independent practice. Aims: To report the outcomes of AETs during their 1st year of independent practice using ASGE established quality indicator (QI) thresholds To measure the relationship between achieving competence benchmarks during training and reported outcomes during independent practice. Methods: ASGE recognized advanced endoscopy training programs (AETPs) were invited to participate. In Phase I, AETs were graded on every 5th EUS and ERCP exam after completion of 25 hands-on EUS and ERCPs using the validated EUS and ERCP Skills Assessment Tool (TEESAT). Grading for each skill was done using a 4-point scoring system. A comprehensive data collection and reporting system was used to create learning curves using cumulative sum (CUSUM) analysis. Learning curves were created using CUSUM for overall and technical and cognitive components of EUS and ERCP and shared with AETs and trainers quarterly. Acceptable and unacceptable (Table presented) failures rates were set a priori and AETs with <20 evaluations were excluded. During Phase II, AETs provided QI performance data on all EUS and ERCP procedures during the 1st year of independent practice. Results: Of the 62 programs invited, 37 AETs from 32 AETPs participated in this study and 24 AETs were included in the final analysis (Phase I). At the end of training, median number of EUS and ERCPs performed/ AET was 400 (range 200-750) and 361 (250-650), respectively. Overall, 2616 exams were graded (EUS: 1277, ERCP-biliary 1143, pancreatic 196). Majority of graded EUS exams were performed for pancreatobiliary indications (70%) and ERCPs for ASGE biliary grade of difficulty 1 (72.1%). Majority of trainees achieved overall technical (EUS: 91.6%; ERCP: 73.9%) and cognitive (EUS: 91.6%, ERCP: 95.6%) competence at conclusion of training (Table 1). 22 of 24 AETs participated in (Phase II) and median EUS and ERCP procedures completed in independent practice/AET were 136 (IQR 102-204) and 116 (48-169), respectively. Table 2 highlights QI performance in EUS and ERCP during Phase II. Majority of AETs crossed the QI threshold for obtaining adequate samples (overall rate: 94.4%), diagnostic yield of malignancy (83.8%), and cannulation rates overall (94.9%) and native papilla cases (93.1%). Conclusions: Majority of AETs achieved EUS and ERCP competence by the end of training. Moreover, these AETs achieved QI thresholds for routine EUS and ERCP during their 1st year of independent practice, affirming the effectiveness of AETPs

BACKGROUND AND AIMS/OBJECTIVE:The obesity epidemic has led to increased use of Roux-en-Y gastric bypass (RYGB). These patients have an increased incidence of pancreaticobiliary diseases yet standard ERCP is not possible due to surgically altered gastroduodenal anatomy. Laparoscopic-ERCP (LA-ERCP) has been proposed as an option but supporting data are derived from single center small case-series. Therefore, we conducted a large multicenter study to evaluate the feasibility, safety, and outcomes of LA-ERCP. METHODS:This is retrospective cohort study of adult patients with RYGB who underwent LA-ERCP in 34 centers. Data on demographics, indications, procedure success, and adverse events were collected. Procedure success was defined when all of the following were achieved: reaching the papilla, cannulating the desired duct and providing endoscopic therapy as clinically indicated. RESULTS:A total of 579 patients (median age 51, 84% women) were included. Indication for LA-ERCP was biliary in 89%, pancreatic in 8%, and both in 3%. Procedure success was achieved in 98%. Median total procedure time was 152 minutes (IQR 109-210) with median ERCP time 40 minutes (IQR 28-56). Median hospital stay was 2 days (IQR 1-3). Adverse events were 18% (laparoscopy-related 10%, ERCP-related 7%, both 1%) with the clear majority (92%) classified as mild/moderate whereas 8% were severe and 1 death occurred. CONCLUSION/CONCLUSIONS:Our large multicenter study indicates that LA-ERCP in patients with RYGB is feasible with a high procedure success rate comparable with that of standard ERCP in patients with normal anatomy. ERCP-related adverse events rate is comparable with conventional ERCP, but the overall adverse event rate was higher due to the added laparoscopy-related events.