Abstracts
endoscope. During the procedures, CO2 was constantly set at 1.0 l/min. Abdominal girth were recorded at pre-examination, 0minutes and 15minutes after examination. Abdominal girth were measured by nurse blinded about insufflation whether CO2 or air. Pain evaluation using written questionnaire of 100mm visual analogue scale (VAS) was measured at 0minutes and 15minutes after examination. Results: 81 and 80 patients were evaluated as the patients of CO2 and air group, respectively. Mean age, body mass index and examination times did not differ in both groups. There was no significant difference about VAS scores at 0 minutes after examination in both groups (31 in CO2 group and 36 in air group). VAS scores 15 minutes after procedures were significantly lower in CO2 group (17) than air group (26, p⬍0.05). Mean abdominal girth at preexamination, 0 and 15minutes after examination between CO2 and air group were 78.9:81.0:79.5 and 80.5:83.1:82.7cm, respectively. Distention ratio of abdominal girth at 15minutes after colonoscopy was significantly better in CO2 group (1.008) than air group (1.028, p⬍0.001). Conclusion: CO2 insufflation improves patient abdominal distention and abdominal pain after colonoscopy without sedation rather than air insufflation colonoscopy.
Su1295 Randomized Prospective Trial of TransNasal Versus Standard Upper Diagnostic Endoscopy Under Local Anaesthetic: Interim Analysis of Endoscopy Quality, Patient Acceptability and Tolerability Efstratios G. Alexandridis*, Ken Trimble, Peter Hayes, John N. Plevris Centre of Liver and Digestive Disorders, Royal Infirmary of Edinburgh, University of Edinburgh, Edinburgh, United Kingdom Introduction: Transnasal upper gastrointestinal endoscopy (TNE) using ultrathin endoscopes is considered less invasive, thus an attractive alternative, if not a first choice option, for diagnostic upper endoscopy. Aim: This is the first prospective, randomised study, in a UK population to assess tolerability, acceptability and quality of TNE, in comparison with standard upper endoscopy (SOGD) under local anaesthetic (throat spray). Material and Methods: We prospectively recruited up to date 125 patients [59 male/ 66 female] mean age 57 years. To avoid bias, a single experienced endoscopist performed all endoscopies. The Fujinon EG530N (5.9mm) and EG530WR (9.4mm) endoscopes were used. The endoscopist and all patients completed detailed questionnaires regarding tolerability, acceptance and quality of each endoscopy using standard visual analogue scales (VAS). Oxygen saturation [SaO2], heart rate [HR] and systolic blood pressure [SBP] were recorded during procedure. SOGD group received O2 2lt/min. Quality of biopsies was evaluated blindly by the reporting pathologists. Results: Trial interim analysis included 129 endoscopies in 125 patients [TNE⫽65, SOGD⫽64]. In all patients intubation of D2 was achieved. VAS scores for patient comfort (higher score⫽greater comfort) were significantly better in the TNE compared to SOGD group (7 vs 5.6, respectively, p⫽0.0013). 40 patients had previous experience of standard endoscopy, and 22(55%) reported gagging as main reason of discomfort. 22/40 were randomised to TNE. 21 of these 22 patients [95.5%] stated preference to transnasal endoscopy in the future. Gagging score (higher score⫽more gagging) was significantly less in the TNE compared with SOGD group (0.05 vs 3.22 respectively, p⬍0.001). Panendoscopy was achieved in all TNE patients with the hypopharynx, epiglottis and vocal cords significantly better visualised compared with SOGD group (VAS: 10 vs 4.1 respectively, p⬍0.001). Double product reverse [a marker of cardiac stress, DPR⫽(HR x SBP at middle of procedure)] was significantly lower in the TNE group (11049 vs 13536, p⬍0.001). DPR increased only in 8% of TNE vs 32.5% of SOGD patients. There was no difference in procedure time (8.5 vs 7.3 min, respectively, p⫽0.54), quality of images (9.93 vs 9.88, respectively, p⫽0.55) or SaO2 (98 % vs 98.3%, respectively, p⫽0.22). Only 2 (5.4%) of TNE biopsies did not permit a definite diagnosis, but when standard biopsies were later taken, also failed to confirm diagnosis. Conclusions: TNE is equal to SOGD in image quality, endoscope handling and length of procedure. It is superior to SOGD in the ability to perform a panendoscopy and in terms of comfort and patient acceptance. Importantly it induced significantly less stress to the heart, thus should be considered as the endoscopic diagnostic method of choice in patients with significant cardio-respiratory problems.
Su1296 The Use of an Ultra-Thin Instrument for Difficult Colonoscopy in Unsedated Patients Kazutomo Togashi*1, Daiki Nemoto1, David G. Hewett2, Keijiro Sunada3, Hironori Yamamoto3 1 Coloproctology, Fukushima Medical University, Aizu Medical Center, Aizuwakamatsu, Japan; 2University of Queensland School of Medicine, Brisbane, QLD, Australia; 3Endoscopy, Jichi Medical University, Shimotsuke, Japan Background and study aims: Pediatric colonoscopes with 11 mm diameter are used by many colonoscopists to negotiate the female colon and after previously
incomplete colonoscopy. Gastroscopes are occasionally required to negotiate angulated sigmoid colons. However, the use of ultra-thin colonoscopes for such difficult cases has not been studied. In this study, we report our experience of unsedated colonoscopy with an ultra-thin instrument for elderly female patients and for those with previously difficult examinations. Methods: Between September 2011 and November 2011 in a single center, one expert physician (colonoscopy experience ⬎20,000) performed unsedated colonoscopy on 20 patients with an ultra-thin instrument (EC-530XP, 6.8 mm diameter, standard length). Carbon dioxide insufflation was used, without fluoroscopic guidance. Conventional insertion techniques, including clockwise torque shortening technique, were used with position change and abdominal pressure when necessary. Patients did not receive any sedation. The patients comprised 14 female patients older than 70 years (EF group) and 6 patients with previously difficult colonoscopy (DC group). Patient age ranged from 42 to 87 years (median 72 years) in the DC group and from 72 to 84 years (median 77.5 years) in the EF group. Only one patient in the DC group was male. The reported reasons for previously difficult colonoscopy were adhesions in 4, severe pain during the procedure in 1 and severe diverticular disease in 1. Cecal intubation had been unsuccessful in two patients in the DC group during previous colonoscopy. Cecal intubation rate, ileal intubation rate, time to cecum, adenoma detection rate and additional sedation dose were measured; degree of pain experienced was measured using a visual analogue scale (VAS). We used the Mann-Whitney test to compare between groups. Results: Cecal intubation was achieved in 100% of patients, with an ileal intubation rate of 85%. Time to cecum ranged from 13.4 minutes to 25.4 minutes (median 15.6 minutes) in the DC group, and from 7.1 minutes to 52.4 minutes (median 18.0 minutes) in the EF group. There was no significant difference in insertion time between 2 groups. Adenoma detection rate was 50% in both groups. No patients required sedation. Visual analogue pain scores ranged from 0/10 to 1/10 (median score 0.5/10) in the DC group and from 0/10 to 5/10 (median score 2/10) in the EF group. Conclusions: Unsedated ultra-thin colonoscopy is a useful technique for elderly females and patients with previously difficult examinations, and is an effective alternative to conventional colonoscopes or gastroscopes for difficult cases.
Su1297 Quality Assessment of Colonoscopies Performed by Nurse and Physician Endoscopists Reveals High Safety and Good Quality in Nurse Endoscopists Renate Massl1, Paul G. Van Putten*1, Ewout W Steyerberg2, Antonie J.P.Van Tilburg3, Jonathan Lai4, Rogier J. De Ridder5, Johannes T. Brouwer6, Robert Verburg7, Joyce Alderliesten8, Erik J. Schoon9, Ernst J. Kuipers1,10, Monique Van Leerdam1 1 Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, Netherlands; 2Department of Public Health, Erasmus University Medical Center, Rotterdam, Netherlands; 3 Department of Gastroenterology and Hepatology, Sint Franciscus Gasthuis, Rotterdam, Netherlands; 4Department of Gastroenterology, Groene Hart Ziekenhuis, Gouda, Netherlands; 5Division of Gastroenterology-Hepatology, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, Netherlands; 6 Department of Gastroenterology and Hepatology, Reinier de Graaf Medical Center, Delft, Netherlands; 7Department of Gastroenterology, Medisch Centrum Haaglanden, Den Haag, Netherlands; 8Department of Gastroenterology, Albert Schweitzer Hospital, Dordrecht, Netherlands; 9Department of Gastroenterology, Catharina Hospital, Eindhoven, Netherlands; 10Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, Netherlands Background: The introduction of colorectal cancer screening leads to an increasing demand for endoscopists. A resulting shortage in physicianendoscopists could be compensated by nurse endoscopists (NE), but the quality and safety of NE has been insufficiently investigated. The aim of this study was to compare the quality and safety of colonoscopies performed by either NE or physicians in a large cohort. Methods: NE and GI fellows both without any endoscopic experience at baseline were evaluated in this prospective multicenter cohort study (Sept 2008-today). After having finished a 2-day background and simulator-training (Olympus and Symbionix), and a training period (part I) of 100 supervised colonoscopies, the endoscopists started to perform colonoscopies independently (part II) with supervision immediately available on request. The first 135 colonoscopies of part II of each endoscopist were used to assess endoscopic quality. Colonoscopies in patients ⬍18 and in those referred for therapeutic procedures were excluded. Evaluation was done using a portfolio in which the following procedure characteristics were assessed: extent of procedure, cecal intubation time, withdrawal time, performance of polypectomy, and use of supervision. Information on adenoma detection rate (ADR) and complications was also collected. Results: A total of 6 NE and 8 GI fellows participated in this study. Five out of 6 NE (83%) were female compared to 4 out of 8 (50%) GI fellows (p⫽0.30). Median age was 32 years in both groups. A total of 1229 diagnostic colonoscopies were performed in 1229 patients. Mean patient
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Abstracts
age was 56.1 years (SD⫾15.7). The unassisted cecal intubation rate was lower in NE (81.6%) than in GI fellows (87.2%), p⫽0.01. The overall cecal intubation rate was 95.9% and 93% resp. (p⫽0.03) including supervisor-assisted colonoscopies. The mean unassisted cecal intubation time was 11 minutes both for NE and GI fellows, p⫽0.33. Mean withdrawal time in colonoscopies without intervention was 11.7 minutes in both groups, p⫽0.99. ADR was 24.0% in NE colonoscopies and 28.6% in colonoscopies performed by GI fellows (p⫽0.07). The need for assistance of a supervisor was more likely among NE than among GI fellows (unadjusted OR⫽2.73; 95%CI 2.00-3.72). These findings remained significant after adjusting for endoscopists’ sex (OR⫽1.47; 95%CI 1.03-2.09). NE required assistance in 29.9% of colonoscopies while GI fellows needed assistance in 13.5% (p⬍0.01). Overall numbers of complications were small. Results are summarized in Table 1. Conclusion: NE can learn to perform diagnostic colonoscopy as effectively and safely as GI fellows with a low rate of complications. During the learning period, they do however require more assistance of a supervising physician and have lower unassisted cecal intubation rates. Future studies are needed to evaluate the cost-effectiveness of NE.
Cecal intubation rate - Un-assisted - assisted Cecal intubation time (unassisted) - Mean, min (SD) Mean withdrawal time in min (SD)* Polyp detection rate, % Adenoma detection rate, % Assistance supervisor required Yes - No Complications: - Bleeding Perforation - Cardiorespiratory complication
NE (nⴝ6) 641 colonoscopies
GI fellows (nⴝ8) 588 colonoscopies
p-Value**
n⫽576 470 (81.6%) n⫽628 602 (95.9%) 11.3 (4.9)
n⫽545 475 (87.2%) n⫽573 533 (93.0%) 11.0 (5.8)
0.01 0.03 0.33
11.7 (4.5)
11.7 (5.5)
0.99
42.1 24.0 n⫽559 167 (29.9%) 392 (70.1%) n⫽630 3 (0.5%) 0 (0%) 1 (0.2%)
46.4 28.6 n⫽518 70 (13.5%) 448 (86.5%) n⫽588 0 (0%) 0 (0%) 1 (0.2%)
0.21 0.07 ⬍0.01 0.25
*Only colonoscopies without intervention included in calculation. **p-Values were calculated using the 2-test and t-test.
Su1298 QVAPolyp: Quantitative, Video-Based Assessment of Celecoxib Effects on Colorectal Polyp Burden in Familial Adenomatous Polyposis Using Web-Based Tool Patrick M. Lynch*, Jeffrey Morris, William A. Ross, Miguel Rodriguez-Bigas, Juan F. Posadas Ruiz, Diane Weber, Valerie Sepeda, Bernard Levin, Imad Shureiqi University of Texas MD Anderson Cancer Center, Houston, TX Background & Aim: Measures of adenoma burden/ treatment response in FAP are crude. We develop and validate a scoring method that quantifies the totality of endoscopic video data. We conducted a 6-month drug trial in patients with a clinical diagnosis of FAP, ⫹/⫺ prior colectomy. 47 subjects had baseline and offstudy endoscopy with evaluable video pairs in 27.Videos were captured by colon segment, edited to remove extraneous material. Coded videos were posted to intranet site for scoring. 3 scorers (2 endoscopists, 1 surgeon) cumulated adenomas by an on-screen tabulation field while reviewing videos. Counts were in “bins” by polyp diameter: ⬍2mm, 2-4mm, ⬎4mm. 5 methods summarized polyp burden: total counts, total counts ⬎/⫽2mm, counts weighted (WC) by mid-range (MRWC), bottom-range (BRWC), or equal-step (ESWC). For each, correlations were computed between reviewer pairs, variability partitioned among rater, video, and video rater, and replicates (intra-observer variation). Results: All measures showed high levels of interobserver agreement, with the highest being the so-called mid-range weighted count {MRWC ⫽ 1.0 (# polyps ⬍2mm) ⫹ 3 (# polyps 2-4mm) ⫹ 5 (# polyps ⬎4mm). For this measure, we observed a Pearson correlation of 0.978 between the two endoscopists, and correlations of 0.876 and 0.848 between the surgical scorer and the respective endocopists. Other summary measures had similar correlations, with the weighted measures incorporating both polyp count and size slightly higher than those only based on counts. Polyp burden, as measured by this quantitative, video-based method, achieved a greater treatment-related reduction than was seen in the original celecoxib trial (Steinbach NEJM 2000), with 53-85% of subjects experiencing a 25% or greater adenoma burden decrease. We found a vast majority of the variability in polyp burden (81%) was from video-to-video, with only 1% in systematic rater-to-rater variability and 18% in video-by-rater interaction. Conclusions: State-of-the-art video capturing of total colonic adenoma burden enables a potentially more accurate measure of polyp. This method, which we call QVApolyp, is not time-consuming for the scorer and is computationally straight-forward. Its appeal is that it is quantitative, covers the entire colon, and takes both polyp number and size into account. A head-tohead comparison with older methods (quantitation of limited fields captured in still-color photo of “representative” polyp clusters or qualitative video comparisons: better-worse-same) will be required. Video-based staging of colon
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burden could provide a more accurate and convenient outcome measurement tool for trials undertaking to demonstrate “clinical benefit” of new chemopreventive agents and combinations.
Su1299 Interim Report of a Randomized Cross-Over Study Comparing Clinical Performance of Novice Trainee Endoscopists Using Conventional Air Insufflation Versus Warm Water Infusion Colonoscopy Catherine Ngo*1, Joseph W. Leung1,2, Surinder K. Mann1, Cecilia Terrado1, Christopher L. Bowlus1, Drew Ingram1, Felix W. Leung3 1 Division of Gastroenterology, UC Davis Medical Center, Sacramento, CA; 2Division of Gastroenterology, Sacramento VA Medical Center, Mather, CA; 3Division of Gastroenterology, Sepulveda ACC and David Geffen School of Medicine at UCLA, North Hills, CA Background: Experienced colonoscopists reported that use of the water method for colonoscopy significantly increased adenoma detection rate (ADR) compared to traditional colonoscopy using only air insufflation. Whether trainees learning to perform colonoscopy can reproduce the observation is unknown. Aim: To compare the water method vs. usual air method in teaching novice trainee colonoscopy. This interim analysis is undertaken because trainees have reported anecdotally ease of learning colonoscopy with the water method. Confirmation by the interim data, even with all other outcome measures being comparable, may prompt other training programs to consider similar evaluations. Method: An IRB approved prospective randomized cross-over study (NCT01482546) in a university setting with diverse patient population. Design: Three first year GI fellows consented to participate in the study. Trainees were randomized to learn with either usual air method or the water method in performing colonoscopy with a dedicated endoscopy attending during their weekly outpatient endoscopy clinics for the initial six months of training and then cross-over to the other method for the remaining six months. The attending was familiar with the teaching technique and provided verbal instructions during the colonoscopy. Attending took over scope insertion if the trainee failed to advance the scope after 5 minutes or failed to get to the cecum in 20 minutes. The details of each procedure were documented by the nurse (e.g. medications, cecal intubation time, volume of water infused), the trainee (e.g. ease of learning colonoscopy, confidence) and the instructor (e.g. assessment of trainee competence). Procedure-related variables included ADR (primary outcome) and unassisted cecal intubation success rate. In recovery, a satisfaction survey was administered to the patient. Analysis was done by intention-to-treat. Results: The interim data (Table 1) revealed no significant difference in age, gender, and body mass index (BMI). ADR was significantly higher (p⫽0.035) and cecal intubation time was almost significantly lower (p⫽0.05) in the water method group. The unassisted cecal intubation rate (water 57.9% vs. air 42.1%, p⫽0.12), though in favor of the water method, did not reach statistical significance, likely because of the small sample size at this stage. Trainees rated the water method colonoscopy as significantly easier to learn compared to the air method (p⫽0.007). Conclusions: The interim data favor the water method with a significantly higher ADR and a shorter cecal intubation time that was nearly significant. The analysis also showed ease of learning colonoscopy with the water method by novice trainees. Fellowship programs are encouraged to consider evaluation of the water method in the education of novice trainees. Table 1. Patient demographics and procedure-related outcomes
Number of cases Average age (years) Gender (Male/Female) BMI (kg/m2) Adenoma detection rate (%) Trainee unassisted cecal intubation rate (%) Cecal intubation time (minutes) Total procedure time (minutes) Average volume water in (mL) Trainee ease of learning technique Trainee confidence Instructor assessment of trainee Patient experience score Patient satisfaction score
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Air Fellow
Water Fellow
P-Value
19 57 6/13 31 5.3 42.1
39 60 14/25 27 28.2 57.9
0.41 0.75 0.06 0.035* 0.12
22 38 — 4.1
17 32 939 2.9
0.05 0.07 — 0.007**
2.1 2.4 1.5 9.1
2.2 2.7 1.9 8.9
0.33 0.38 0.20 0.75
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