Sa1077 Validation of a Novel Ercp Simulator

Abstracts

Sa1075 A Virtual Reality Curriculum in Non-Technical Skills Improves Colonoscopic Performance: A Randomized Trial Samir C. Grover1, Michael A. Scaffidi*1, Rishad Khan1, Barinder Chana1, Soha Iqbal1, Peter (Chien-feng) Lin1, Sivaruben Kalaichandran1, Cindy Tsui1, Mark Zasowski1, Ahmed Al-Mazroui1, Suraj Sharma1, Catharine M. Walsh2 1 Gastroenterology, St. Michael’s Hospital, Toronto, ON, Canada; 2 Gastroenterology, Hepatology & Nutrition, Hospital for Sick Children, Toronto, ON, Canada Background: Non-technical skills (NTS), such as communication and professionalism, contribute to safe and effective completion of procedures. Studies in the surgical literature show that NTS can be taught using simulation-based training (SBT). The impact of dedicated instruction in NTS as applied to endoscopy has yet to be evaluated. Aims: To evaluate the effectiveness of a curriculum of NTS on novice endoscopists’ performance of simulated colonoscopy, compared to a progressivelearning curriculum. Methods: Novice endoscopists (<25 procedures) were randomized to two groups. The progressive learning-based curriculum (PLC) group received 6 hours of interactive didactic sessions on colonoscopy theory, and 6 hours of SBT that started on bench-top simulators and progressed to virtual reality (VR) simulators. Hours 5 and 6 of SBT were integrated scenarios, wherein participants interacted with a standardized patient and nurse, while performing a colonoscopy on the VR simulator. The non-technical skills curriculum (NTC) group received the same teaching sessions and SBT; this group additionally received a didactic session on NTS, reviewed a checklist of tasks relevant to NTS concepts prior to each integrated scenario case and were provided with dedicated feedback on their NTS performance during the integrated scenario practice. All participants were assessed at baseline, immediately after training, and 4-6 weeks post-training. The primary outcome measure was NTS-specific performance in the simulated setting, as measured by the Objective Structured Assessment of Nontechnical Skills (OSANTS), an assessment tool for NTS in surgery, modified for endoscopy. Secondary outcome measures included: (1) colonoscopy-specific performance in the simulated setting, measured by the Joint Advisory Group Direct Observational of Procedures (JAG DOPS); (2) global performance and communication during the integrated scenario, assessed by the ISGRF and ISCRF, two previously validated global rating scales, respectively; and (3) attitudes towards NTS, measured by TEAMSTEPPS, a validated questionnaire of NTS perception. Results: Forty-two novice endoscopists completed the study. The NTC group had superior performance compared to the PLC group on the integrated scenarios immediately after training and 4-6 weeks after training, in terms of NTS-specific performance (P <0.05), colonoscopy-specific performance (p<0.05), global performance (P <0.05) and communication (P <0.05). Moreover, the NTS group regarded NTS more positively as compared to the conventional training group (P <0.05). Conclusions: Training in NTS in colonoscopy leads to superior NTS performance, communication, and global performance during simulated colonoscopy, as well as attitudes regarding NTS, compared to a traditional curriculum. Additional research should investigate the transfer of NTS to the clinical setting.

Sa1076 Endoscopic Skills Training Through Adaptation of the Fundamentals of Laparoscopic Surgery Box, Measuring Inter-Rater Reliability of the Scoring System Sultan Alhabdan*1, Ilay habaz1, Andrea Kwong1, Ethan Weiss1, Lee L. Swanstrom1, Silvana Perretta2, Allan Okrainec1, Eran Shlomovitz1 1 Minimally Invasive Surgery, University of Toronto, Toronto, ON, Canada; 2IRCAD, Strasbourg, France Background: We have previously described the adaptation of the Fundamentals of Laparoscopic Surgery (FLS) training box for the practice and evaluation of flexible endoscopic skills. This is intended to provide a low cost option for simulating common therapeutic endoscopic skills through six separate modules. As a part of ongoing validation efforts, the purpose of this study was to measure the inter-rater reliability of each module’s scoring system and assess their internal consistency. Methods: Two trained observers scored 63 trainees, either live or retrospectively through recorded videos. Kappa and percent of exact agreement indices were computed for all categorical variables and intraclass correlations were computed for continuous variables. A score of at least 0.7 for Kappa, 80% for percent agreement and 0.9 for intraclass correlation indicates sufficient inter-rater reliability. Results: All tasks measured showed intraclass correlation above 0.98 for tasks times. Sufficient level of inter-rater reliability was achieved for all variables (81% to 95%) except for puncturing accuracy (71%). Although the Kappa coefficient was below 0.70 for the number of clips completed, the percent agreement is very high (95%). Conclusion: The scoring system of the adopted endoscopic training box showed satisfactory inter-rater reliability, which is above the expected 80 % for a high-stakes assessment tool. Our findings further contribute to the existing validation of this training and evaluation simulator for flexible endoscopic skills.

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Table 1. Summary of the Inter-rater reliability assessment results Task

Intraclass Correlation (for time)

Forward Peg Transfer

1.00

Retroflexion Peg Transfer Puncturing Snaring Clipping Cannulation

1.00 0.98 1.00 0.98 1.00

Kappa

Percent of exact agreement %

Dropped 0.84 Completed 0.76 Dropped 0.72 Completed 0.75 0.42 0.84 0.68 N/A

Dropped 92% Completed 83% Dropped 84% Completed 81% 71% 92% 95% N/A

Sa1077 Validation of a Novel Ercp Simulator Pichamol Jirapinyo*, Andrew C. Thompson, Hiroyuki Aihara, Marvin Ryou, Christopher C. Thompson Brigham & Women’s Hospital, Boston, MA Background: Endoscopic Retrograde Cholangiopancreatography (ERCP) requires a unique skill set. Currently, there is no objective methodology to assess and train ERCP. Aim: To assess the validity evidence for a newly developed ERCP simulator. Methods: A prospective validation study. Participants: 15 subjects: 6 novices (<10 ERCPs), 3 intermediates (11-100 ERCPs) and 6 experts (>500 ERCPs). Simulator and scoring system: The simulator consists of silicone papilla with a pancreatic and bile duct. Different anatomy (normal vs surgically altered) and location (proximal vs distal 2nd duodenum) were represented. Deep cannulation of the pancreatic duct followed by the bile duct is performed at each papilla. Time allotted is 5 minutes. Successful cannulation is worth 10 points. Validity evidence based on content: Experts independently rated the simulator based on realism, relevance and representiveness. All participants completed a questionnaire. Validity evidence based on other variables: A correlation between level of ERCP experience and simulator score was determined. Additionally, workload demand associated with the simulator experience was assessed using NASA task load index (NASA-TLX). ANOVA was used to compare means among groups, p-value <0.05 was significant. Results: 15 participants completed the simulator. Baseline characteristics are shown in Table 1. Overall, experts had more experience performing all procedures than intermediates and novices (p<0.05). Validity evidence based on content: Realism ratings: orientation of the duodenoscope to papilla for cannulation (100%), angulation of papillotome to achieve selective cannulation (75%). Relevance ratings: the use of the elevator (100%), wheels to achieve en face orientation (100%), papillotome to apply tension for selective cannulation (100%). Representativeness ratings: basic cannulation (80%), different papilla locations (80%), different papilla anatomy (75%). Overall, participants thought the simulator was able to differentiate level of cannulation experience (92%) and improve clinical ERCP skill (92%). The majority thought the simulator should be used prior to first human ERCP (92%). Validity evidence based on other variables: Simulator scores differed significantly among experience levels (p < 0.05). Specifically, novices, intermediates and experts scored 35, 3017, and 7748, respectively (pZ0.006). NASA-TLX: Mental demand, effort and technical difficulty were higher in novices compared to experts (p<0.05). There was no difference in physical demand, temporal demand, performance and frustration level between groups. Conclusion: The ERCP simulator is able to objectively assess basic ERCP skills by differentiating scores based on clinical experience. A multicenter study to further validate this simulator and scoring system is ongoing.

Table 1. Baseline characteristics and ERCP simulator scores among the novice, intermediate expert

Baseline Characteristics Endoscopy experience (years) ERCP/EUS experience (years) Number of EGD (procedures) Number of colonoscopy (procedures) Number of ERCP (procedures) Number of EUS (procedures) Number of ERCP performed per year (procedures) Previous ERCP simulator (yes) (%) Previous experience with other advanced endoscopic procedures such as ESD, EUS-guided biliopancreatic drainage, endoscopic necrosectomy, endoscopic suturing (yes) (%) Primary outcome ERCP simulator score

Novice (n[6)

Intermediate (n[3)

Expert (n[6)

Pvalue

1.60.5 0 31768 24249 0.50.8 0 0

2.50.9 1.00.5 1433603 700436 5329 167289 4741

0 0

0 0

60 100

0.032 <0.001

35

3017

7748

0.006

13.88.4 0.005 11.39.1 0.014 2265031876 0.162 101009850 0.036 25191668 0.003 20541367 0.004 20649 <0.001

Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB181

Abstracts

Figure 1. ERCP training simulator

Sa1078 Prospective Study to Reduce the Postoperative Bleeding After Gastric Endoscopic Submucosal Dissection in Patients With High-Risk for Bleeding Daisuke Maruoka*1,2, Shingo Kasamatsu1, Hideaki Ishigami1, Kenichiro Okimoto1, Tomoaki Matsumura1, Tomoo Nakagawa1, Makoto Arai1 1 Dept. of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba Univ., Chiba, Japan; 2Clinical Research Center, Chiba Univ. Hospital, Chiba, Japan Aims: There is an elevated rate of postoperative bleeding (PB) after gastric endoscopic submucosal dissection (ESD) in patients with a high risk for bleeding. A scheduled second-look endoscopy (2nd-look) is not recommended after gastric ESD in patients without a risk for bleeding [1], but the efficacy of this procedure for patients with a high-risk for bleeding is unclear. Most patients without a risk for bleeding experienced PB within five days after gastric ESD. Meanwhile, PB occurred more than five days after gastric ESD at a high rate in patients with a high risk for bleeding [2]. Therefore, we hypothesized that the rate of PB after gastric ESD in patients with a high risk for bleeding may be reduced when the 2nd-look was delayed. Methods: Patients with a high risk for bleeding who underwent gastric ESD between November 2013 and September 2016 underwent 2nd-look one day or four day after gastric ESD as a randomized clinical trial (UMIN 000016104). Patients with a high risk for bleeding were those who were continuously administered low-dose aspirin (LDA) during the perioperative period of gastric ESD, heparin replacement (HR) from warfarin, or direct oral anticoagulants (DOAC), or those who underwent hemodialysis (HD) [2-4]. We followed guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment [5]. Results: Fifty-five lesions from 51 patients were resected. PB occurred in 15.5% (nine lesions from nine patients). There was no significant difference in subject characteristics between subjects with PB and without PB, but there were significant differences in risk for bleeding (LDA/ HR/HD/LDA+HR/LDA+HD Z 3/2/0/2/2 vs. 35/9/2/3/0, p Z 0.012). The rates of PB were 8/18/0/40/10% in patients with LDA/HR/HD/LDA+HR/LDA+HD, respectively. The rate of PB is significantly higher in patients who experienced two indications of a risk for bleeding than that in patients with only one indication of a risk for bleeding (57% vs. 10%, p Z 0.001). In patients with only one indication of a risk for bleeding, the rate of PB in patients with HR from warfarin tended to be higher than in patients with HR from DOAC (28% vs. 0%, p Z 0.237). There was no significant difference in patient characteristics between patients who underwent a 2nd-look one day after ESD and four days after ESD (12.9% vs. 18.5%). Conclusions: The rate of PB after gastric ESD was higher in patients who had multiple indications of a risk for bleeding than in patients who had only one indication of a risk for bleeding. HR from DOAC may be safer than HR from warfarin regarding PB. It is necessary to further study the significance of the 2nd-look after gastric ESD. References: 1. Mochiuki S, et al. Gut. 2015; 2. Matsumura T, et al. BMC Gastroenterol. 2014; 3. Cho SJ, et al. Endoscopy. 2012; 4. Numata N, et al. J Gastroenterol Hepatol; 5. Fujimoto K, et al. Dig Endosc. 2014

Sa1079 Safety of Percutaneous Endoscopic Gastrostomy (PEG) Tubes in Centenarian Patients Zain A. Sobani*1, Kevin Tin2, Yuriy Tsirlin2 1 Internal Medicine, Maimonides Medical Center, Brooklyn, NY; 2 Gastroenterology, Maimonides Medical Center, Brooklyn, NY Background: Although a relatively safe procedure, percutaneous gastrostomy (PEG) carries its inherent set of complications. Procedure-related mortality ranges between 0.8-1%, with major complication rates ranging between 1-10%, and minor compli-

AB182 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S : 2017

cation rates between 11-13%. Increasingly older patients are undergoing the procedure; however data regarding complications in the geriatric population is sparse. To date no study has looked into the safety of PEG tube placement in centenarian patients (aged 100 and older). We performed a retrospective audit to evaluate the success rate, complications and procedure related mortality of PEG tube placement in this subset of the population at our institution. Methods: A retrospective chart review of patients aged 100 years and older having undergone PEG tube placement at our institution between April 1, 2011 and March 31, 2016 was conducted. All patients that underwent PEG regardless of the indication were included in the study. Data was recorded in a predesigned database. Complications were grouped into major and minor. All PEG tubes were performed by an attending gastroenterologist with assistance from gastroenterology fellows. Sedation and airway were managed by an anesthesiologist. Results: Thirty patients that met the inclusion criteria were identified. The patient population was predominantly female (80%, nZ24) with a mean age of 100.5  0.938. Dysphagia and aspiration were the primary indications for 70 % of the procedures. The overall procedural success rate was 93.3%. There were no major procedure related complications. Minor complications were noted in 13.3% (nZ4) of the patients. Two patients passed away of unrelated causes within the index hospitalization. Conclusion: PEG tube placement is a relatively safe procedure in patients aged 100 years or older. Success and complication rates appear to be comparable to those reported in literature. Age alone should not be an absolute contraindication to PEG placement. However, thoughtful patient selection and appropriate indication should always be practiced.

Table 1. Indications and outcomes of patients in the study. (Percentage). Primary Indications CVA Dysphagia and Aspiration Failure to thrive Replacement

5 (16.7) 21 (70) 2 (6.7) 2 (6.7)

Procedure Plan Inpatient Outpatient Outpatient converted to inpatient

25 (83.3) 4 (13.3) 1 (3.3)

American Society of Anesthesiologists (ASA) Physical Status ASA 3 ASA 4 Unknown

6 (20) 22 (73) 2 (6.7)

Complications Mucosal injury Minor bleeding Inadvertent dislodgement of tube

2 (6.7) 1 (3.3) 1 (3.3)

Sa1080 Double Stents Placement Rescue Type II Perforation: A Single-Center Retrospective Study Ping Yue*1,2, Wenbo Meng1,2, Wence Zhou3,2, Lei Zhang4,2, Kexiang Zhu5,2, Xiaoliang Zhu4,2, Hui Zhang3,2, Long Miao3,2, Haiping Wang6, Zhengfeng Wang3,2, Xun Li3,2 1 Special Minimally Invasive Surgery Department, The First Hospital of LanZhou University, Lanzhou, Gansu, China; 2Hepatopancreatobiliary Surgery Institute of Gansu Province, Lanzhou, Gansu, China; 3The Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, Gansu, China; 4The Fifth Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, Gansu, China; 5The General Surgery Department, Donggang Branch of The First Hospital of Lanzhou University, Lanzhou, Gansu, China; 6Key Laboratory of Biological Therapy And Regenerative Medicine Transformation Gansu Province, Lanzhou, Gansu, China Background: Traditionally, surgical operation remains the primary treatment for iatrogenic endoscopic retrograde cholangiopancreatography (ERCP) related perforations. Non-surgical management with endoscopic treatment of perforation, however, is increasingly being reported. Aim: To evaluate the impact of remedial ERCP treatment of double biliary stents placement for ERCP-induced Stapfer type II perforation. Methods: Between December 2010 and September 2016, fourteen out of 7,059 patients underwent therapeutic ERCP developed perforations. Of these, 7 patients had a Stapfer type II perforation and underwent salvage ERCP and nonsurgical management. We retrospectively analyzed factors including pre-ERCP diagnosis, ERCP procedure, post-ERCP signs and symptoms, systemic inflammatory response syndrome (SIRS) score, pain score and partial pressure of arterial oxygen (PaO2) (Table 1). We compared the SIRS score, pain score, PaO2, procalcitonin (PCT)

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