- Email: [email protected]
Sa1420 A Randomized Control Study of Audio Versus Visual Distraction to Reduce Patient Discomfort During Colonoscopy
Abstracts
leakage and identify predictors associated with successful stent therapy. Methods: All patients undergoing SEMS placement for benign esophageal leakage were identified by a systematic search in the electronic endoscopic database from January 2004 to October 2014. All patients with active malignant esophageal disease were excluded. Clinical success was defined as no need for further interventions (including tube feeding) after final stent removal, or as successful sealing without further symptoms of leakage in case the stent was permanent. Results: 56 patients were treated with SEMS placement for benign esophageal leakage. Baseline characteristics are presented in table 1. A total of 109 SEMS, fully covered (50%) and partially covered (48%), were used. The median follow-up after stent placement was 232 (range 103103) days. The median period of stent therapy per patient was 46.5 (range 1-835) days. In 44 (79%) patients the stent was finally removed, including 6 (11%) during surgery, 8 (14%) patients died with the stent in situ and in 4 (7%) patients the stent was permanent. Clinical success was achieved in 25 (45%) patients. Stent therapy was most successful in patients with iatrogenic perforations (10/12; 83%) followed by Boerhaave syndrome (5/7; 71%), but was less successful in post-surgical leaks (7/21; 33%) and fistulae (3/16; 19%). Patients with a history of radiation therapy had a clinical success rate of 36% (8/22) compared with 50% (17/34) when patients had not been subjected to radiation. Clinical success according to location in the esophagus was proximal 38% (9/24), mid 33% (4/12) and 56% (10/18) for leakage in the distal esophagus. The highest CRP level measured before stent placement was on average 266 (range 11-496) mg/L in the clinical failure group and 195 (range 4-369) mg/L in the group with clinical success. Patients who received a stent within 7 days after diagnosis did much better than patients with a delay of more than 7 days before stent placement, with clinical success rates of 57% (21/37) and 24% (4/17), respectively. Conclusions: The success of SEMS placement appears to depend on multiple factors, including etiology, a history of radiation therapy, location in esophagus, septic state and time from diagnosis to stent placement. Early stent placement after diagnosis seems to be crucial. Patients with an iatrogenic perforation and Boerhaave syndrome respond well to stent therapy, while clinical success is modest in patients with fistulae and post-surgical leaks.
controlled pilot study on the use of antibiotics in pancreatic cyst aspiration. Patients referred for pancreatic cyst evaluation within a large integrated health care setting between January to November 2014 were screened. Those who met inclusion criteria (patients 18-90 years old) & not excluded (e.g. prior antibiotic use within 6 weeks of EUS, pancreatitis in past 6 months, underlying immunosuppression, imaging evidence of cyst cavity debris or necrotic debris) were invited to participate. At time of EUS-guided cyst aspiration, a single dose of IV ciprofloxacin was administered. After completion of EUS exam, patients were randomized in a 1:1 fashion to receive either 3 days of oral ciprofloxacin 500 mg twice a day versus 3 days of placebo. Patients were followed for 6 weeks. The primary outcome of interest was cyst infection. Secondary outcomes of interest were procedure- or antibiotic-related complications. Feasibility parameters assessed included patient accrual rate and lossto-follow up. We also determined sample size estimates for a projected non-inferiority trial. Results: 117 patients were screened over an 11-month period. 71 (61%) were excluded based on eligibility. Of the 46 patients invited to participate, 3 (2.5%) were no shows to their appointment, 12 (10%) declined, and 5 (4.3%) did not have their EUS scheduled within the study period. A total of 26 study participants (22% of screened patients) were randomized & analyzed in intention to treat analysis. Following randomization, there was a high rate of study completion (85% attendance to 3 telephone follow-up visits, 15% EMR chart review only)Demographics & further trial findings are presented in table 1.Sample size estimates were calculated based on the currently described infection rate in the literature (less than 1%), onesided alpha 5%, 80% power, non-inferiority limit of 1-2%. An adequately powered non-inferiority trial using these parameters would require 614-2450 patients. Conclusions: We were able to enroll 22% of screened patients, & implement a study protocol evaluating a single dose of IV antibiotics versus full course of antibiotics for cyst aspiration. The observed primary event rate (cyst infection) was zero. An adequately powered study to test non-inferiority of withholding antibiotics in this setting would likely be logistically challenging. (clinicaltrials.gov identifier NCT01929460)
Demographics / Trial Results Table 1. Baseline characteristics No. (%) Patients Male Mean age std. dev. (years) Medical history Esophageal cancer Radiation therapy Etiology of esophageal leakage Post-surgical leak Fistula Iatrogenic perforation Boerhaave syndrome Location in the esophagus Proximal (! 25 cm from the incisors) Mid (25-30 cm from the incisors) Distal (O 30 cm from the incisors) Unknown Highest measured CRP level (N[38) Mean (mg/L) Highest measured leukocyte count (N[33) Mean (10E9/L) Time from diagnosis to stent placement 0-1 days 2-7 days 8-14 days O 14 days Unknown
36 (64.3) 63.7 12.0 (range 9-84) 30 (53.6) 22 (39.3) 21 (37.5) 16 (28.6) 12 (21.4) 7 (12.5) 24 (42.9) 12 (21.4) 18 (32.1) 2 (3.6) 236 (range 4-496) 17.9 (range 7.9-41.9)
24 (42.9) 13 (23.2) 8 (14.3) 9 (16.1) 2 (3.6)
Sa1419 A Pilot Study on the Use of Prophylactic Antibiotics for EUSGuided Pancreatic Cyst Aspiration Karl Kwok*1, Joseph C. Chang1, Brian S. Lim2, Kevin T. Kao3, Andrew Q. Giap2, Bechien U. Wu1 1 Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA; 2 Gastroenterology, Kaiser Permanente, Riverside, CA; 3Gastroenterology, Kaiser Permanente, Downey, CA Background: Currently antibiotics are recommended for endoscopic ultrasound (EUS)-guided pancreatic cyst aspiration. However, emerging data suggest that patients may not benefit from prophylactic antibiotics in this setting. To date, there has been no prospective trial to investigate this topic. Aims: To evaluate the feasibility of a prospective trial on the use of prophylactic antibiotics for EUS-guided pancreatic cyst aspiration. Methods: We performed a randomized, double-blind, placebo-
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Demographic / Procedural Characteristics Participants 26 (intention to treat) Mean age 68.3 years (IQR 65,77) Sex 13 (50%) female Mean number of passes 1.4 Number of cysts fully aspirated 19 (73%) Antibiotic: Placebo allocation 1:1 blinded allocation via pharmacy Cyst characteristics Location 31% uncinate, 19% head, 12% neck, 31% body, 8% tail Mean long axis cyst size 21.4 mm (IQR 15,27.5) Cyst type 15% IPMN, 12% MCN, 23% SCA, 23% pseudocyst, 23% indeterminate, 4% other Septation 8 (31%) Median CEA 16.9 ng/mL Median Amylase 282 Unit/L Adverse Events Infections 0 0 Antibiotic-associated adverse events (e.g. diarrhea, rash, allergy) Procedure-related adverse events 1 (pancreatitis admission) Unrelated events 2 (nephrolithiasis and dyspepsia) Protocol Violation Number and reason 1 (patient took antibiotics for dental work, discovered after randomization)
Sa1420 A Randomized Control Study of Audio Versus Visual Distraction to Reduce Patient Discomfort During Colonoscopy Arjuna P. De Silva*1, Yasodha Nandamuni1, Sunali Nanayakkara1, Kuranage R. Perera2, Senarath K. Kodisinghe2, Subasin Kattadige C. Subasinghe2, Madunil A. Niriella1, Anuradha S. Dassanayake1, Arunasalam Pathmeswaran1, H. J. De Silva1 1 Medicine, University of Kelaniya, Ragama, Sri Lanka; 2Professorial Medical Unit, Colombo North Teaching Hospital, Ragama, Sri Lanka Introduction: Colonoscopy can cause discomfort and anxiety in patients who undergo the procedure. Heavy sedation as premedication can lead to complications in the elderly and those with co-morbidities. This has led to an interest in investigating the use of audio-visual distraction during the procedure. Our aim was to compare effects of audio versus visual distraction in reducing discomfort during colonoscopy. Methods: Seventy seven consecutive patients who were undergoing colonoscopy were randomized into three groups. One group was told to listen to
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Abstracts
the music of their choice during colonoscopy (AD), the second group was allowed to watch a film of their choice (VD) using (SONY head mounted display: HMZ-T3WH) and the third group acted as a control (C). Patient controlled sedation (PCS) was administered to all three groups; we used 25 mg pethidine 5 mg aliquots and 2.5 mg midazolam in 0.5 mg aliquots. All patients were assessed for pain, number of ‘topups’ of sedation, total dose of pethidine and midazolam and patient cooperation and willingness to repeat the procedure. Results: There were 77 patients (AD, nZ25 ,16 males, median age 57 years; VD, nZ26 , 18 males, median age 58 years; C, nZ26, 10 males, median age 59 years).The AD group had significantly less pain (pZ0.048), number of ‘top-ups’ of sedation (pZ0.03),total doses of pethidine(pZ0.03) and midazolam (pZ0.032), and better patient cooperation (pZ0.001) compared with controls. There was no difference between the AD(72%) and VD (73%) groups in willingness to undergo a repeat procedure. Conclusions: Audio distraction reduces pain and discomfort and the, requirement for sedation and seems a useful and simple tool for use during colonoscopy.
Sa1421 Effect of Functional Relaxation on Patients Undergoing Colonoscopy: A Prospective Randomized Controlled Trial Jeong Seon Ji*1, Young-Seok Cho2 1 Division of Gastroenterology, Departments of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea (the Republic of); 2Division of Gastroenterology, Departments of Internal Medicine, Uijeongbu St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea (the Republic of) Background: Several methods have been reported to reduce patient discomfort during colonoscopy, including use of pediatric colonoscope, variable stiffness colonoscope, gastroscope, insufflation of carbon dioxide, and music. Although a potential benefit from some of these methods has been suggested, none are currently recommended by clinical practice. For functional relaxation, there was no study assessing the efficacy in the reducing discomfort during colonoscopy. The aim of this randomized controlled trial was to evaluate the effectiveness of functional relaxation on patients undergoing colonoscopy. Methods: A total 61 patients were randomized to functional relaxation group (30 patients) or control group (31 patients). In the study group, functional relaxation was carried out by listening and following recorded functional relaxation education tape before and during colonoscopy. In control group, no education was carried out. All colonoscopies were performed by two experienced endoscopists. Patients were given analgesics (50 mg of meperidine) before colonoscopy. Additional meperidine and midazolam were given on demand. Primary outcome measure was pain measured on linear analogue scale from 0 to 10. Secondary endpoints were the overall patient satisfaction, willingness to repeat the procedure, and need of sedation. Results: Mean pain score was significantly reduced by functional relaxation from 5.12.7 to 3.02.1 (PZ0.013). Overall satisfaction (6.72.3 vs. 8.91.4, PZ0.011) and willingness to repeat the procedure (71.0% vs. 96.7%, PZ0.012) were significantly improved by fuctional relaxation. Also, therewas a significant reduction of the proportion of patients requiring additional analgesics and sedation in the relaxation group (25.8% vs. 3.3%, P Z 0.026). A multivariable analysis to adjust treatment effect for potential confounding factors confirmed the significant beneficial effect of functional relaxation (PZ0.021). On a subgroup analysis, functional relaxation was more effective in the highly educated and female patients. Conclusions: Functional relaxation significantly reduces abdominal pain and could be offered to patients undergoing colonoscopy.
Sa1422 Evaluation of the Proximal Serrated Polyp Detection Rate As a Valuable Colonoscopy Quality Parameter Joep E. Ijspeert*1, Sascha C. Van Doorn1, Barbara A. Bastiaansen1,2, Paul Fockens1,2, Evelien Dekker1,2 1 gastroenterology and hepatology, Academic Medical Centre, Amsterdam, Netherlands; 2Procolo center for colonoscopy, Bergman Clinics, Amsterdam, Netherlands Background: The adenoma detection rate (ADR) is currently the most important surrogate quality parameter in the context of CRC prevention. However, also serrated polyps (SPs) are precursors of CRC. Large prospective studies comparing the detection rate of SPs among endoscopists in an era of awareness about the malignant potential of SPs have not yet been performed. Aim: To compare the proximal SP detection rate (PSPDR) and the detection rate of clinically relevant SPs (RSPDR) among endoscopists and to analyze the association between these parameters and the ADR. Methods: Colonoscopy data were retrieved in one expert center between January 2011 and June 2014 using a structured reporting system, enabling prospective and automatic quality assessment. Endoscopists were instructed to resect all lesions, irrespective of predicted histology. Endoscopists who performed at least 50 colonoscopies within the timeframe were included for analysis. Multivariate
AB208 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
logistic regression, adjusted for patient age, gender, quality of bowel preparation and colonoscopy indication, was used to compare the ADR, PSPDR and RSPDR among endoscopists. The association between these parameters was calculated using the Pearson’s r correlation coefficient. Proximal colon was defined as proximal to the descending colon. Clinically relevant SPs were defined as all SPs, except for hyperplastic polyps (HPs) %5mm in the rectosigmoid. All lesions were assessed by an expert pathologist. Results: In total 1485 adenomas and 841 SPs (582 HPs, 253 sessile serrated adenomas/polyps (SSA/Ps) and 6 traditional serrated adenomas) were retrieved in 2123 colonoscopies. Of all SPs, 304 (36.1%) were located in the proximal colon and 452 (53.7%) were regarded clinically relevant. Sixteen endoscopists were included for analysis. The PSPDR ranged from 2.8-18.6% (median 9.7%) (Table 1). Corrected for confounders, the odds ratio for detecting at least one proximal SP compared to the highest detector ranged from 0.78 (95% CI 0.41-1.51) to 0.12 (CI 0.03-0.54) (table 2). The PSPDR was highly correlated with the RSPDR (0.871, p!0.001), ranging from 4.3-20.9% (median 12.9%). The PSPDR moderately correlated with the ADR (0.526, pZ0.036), ranging from 23.9-49.2% (median 36.2%). The 25% highest clinically relevant SP detectors showed a significant higher detection rate for all SP subcategories. Most pronounced difference was found for the detection rate of at least one large SSA/P (2.2% vs 0.6%, OR 3.84 (p!0.01, CI 1.61-9.18)). Discussion: The PSPDR is widely variable among endoscopists, strongly correlated to the RSPDR and moderately correlated to the ADR. The most pronounced difference was seen in the detection rate of non-diminutive SPs. Measurement of the PSPDR, alongside the ADR, seems valuable and future research should determine the association between endoscopists’ PSPDR and the risk of interval cancer. Table 1. Colonoscopy performance per endoscopist
Endoscopist
Colonoscopies (n)
Age patient (SD)
1 2 3 4 5 6 7 8 9 10 11
86 243 170 50 65 186 88 101 63 65 106
56.1 56.1 59.3 55.1 58.3 58.6 57.6 59.2 59.8 58.0 56.8
(12.8) (12.9) (11.5) (11.7) (11.5) (12.8) (12.8) (11.0) (12.7) (12.2) (12.3)
12 13 14 15 16 Overall
127 561 61 80 71 2123
58.0 58.7 56.2 56.7 58.0 57.9
(14.8) (12.4) (13.0) (13.5) (13.0) (12,6)
BBPS (IQR) 9 (8-9) 8 (7-9) 9 (8-9) 9 (8-9) 9 (8-9) 9 (7-9) 8 (7-9) 9 (8-9) 8 (7-9) 9 (9-9) 7.5 (68) 8 (6-9) 6 (5-7) 9 (7-9) 7 (7-8) 9 (6-9) 8 (6-9)
Male patient (%)
ADR (%)
PSPDR (%)
RSPDR (%)
38.4 46.9 44.7 44.0 49.2 49.5 44.3 42.6 54.0 41.5 50.0
36.0 34.2 41.2 46.0 49.2 39.2 36.4 29.7 42.9 38.5 26.4
18.6 15.2 14.1 14.0 13.9 13.4 12.5 9.9 9.5 9.2 8.5
20.9 19.3 17.7 16.0 15.4 18.3 14.8 11.9 12.7 12.3 9.4
52.8 47.4 37.7 48.7 60.6 47.2
32.3 33.9 29.5 38.8 23.9 36.2
7.9 7.7 6.5 5.0 2.8 9.7
12.6 12.1 13.1 6.3 4.3 12.9
SD Z standard deviation, IQR Z interquartile range, ADR Z adenoma detection rate, PSPDR Z proximal serrated polyp detection rate, RSPDR Z clinically relevant serrated polyp detection rate, BBPS Z Boston Bowel preparation score
Table 2. Odds for the detection of at least one proximal SP and one
relevant SP compared to the endoscopist with the highest detection rate Endoscopist 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
OR for detection of at least one proximal SP (95% CI)
OR for detection of at least one clinically relevant SP (95% CI)
1 0.78 (0.41-1.51) 0.67 (0.33-1.36) 0.54 (0.18-1.60) 0.67 (0.27-1.64) 0.63 (0.32-1.27) 0.60 (0.26-1.39) 0.44 (0.19-1.00) 0.41 (0.15-1.14) 0.42 (0.15-1.15) 0.41 (0.17-0.99) 0.35 (0.15-0.82) 0.35 (0.18-0.68) 0.30 (0.10-0.97) 0.22 (0.07-0.69) 0.12 (0.03-0.54)
1 0.87 (0.47-1.62) 0.79 (0.41-1.52) 0.56 (0.20-1.53) 0.65 (0.27-1.53) 0.78 (0.41-1.50) 0.61 (0.27-1.35) 0.48 (0.22-1.08) 0.50 (0.20-1.24) 0.52 (0.21-1.28) 0.39 (0.17-0.90) 0.50 (0.24-1.06) 0.48 (0.26-0.90) 0.56 (0.22-1.39) 0.22 (0.08-0.64) 0.15 (0.04-0.53)
CI Z confidence interval, OR Z odds ratio, SP Z serrated polyp
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leakage and identify predictors associated with successful stent therapy. Methods: All patients undergoing SEMS placement for benign esophageal leakage were identified by a systematic search in the electronic endoscopic database from January 2004 to October 2014. All patients with active malignant esophageal disease were excluded. Clinical success was defined as no need for further interventions (including tube feeding) after final stent removal, or as successful sealing without further symptoms of leakage in case the stent was permanent. Results: 56 patients were treated with SEMS placement for benign esophageal leakage. Baseline characteristics are presented in table 1. A total of 109 SEMS, fully covered (50%) and partially covered (48%), were used. The median follow-up after stent placement was 232 (range 103103) days. The median period of stent therapy per patient was 46.5 (range 1-835) days. In 44 (79%) patients the stent was finally removed, including 6 (11%) during surgery, 8 (14%) patients died with the stent in situ and in 4 (7%) patients the stent was permanent. Clinical success was achieved in 25 (45%) patients. Stent therapy was most successful in patients with iatrogenic perforations (10/12; 83%) followed by Boerhaave syndrome (5/7; 71%), but was less successful in post-surgical leaks (7/21; 33%) and fistulae (3/16; 19%). Patients with a history of radiation therapy had a clinical success rate of 36% (8/22) compared with 50% (17/34) when patients had not been subjected to radiation. Clinical success according to location in the esophagus was proximal 38% (9/24), mid 33% (4/12) and 56% (10/18) for leakage in the distal esophagus. The highest CRP level measured before stent placement was on average 266 (range 11-496) mg/L in the clinical failure group and 195 (range 4-369) mg/L in the group with clinical success. Patients who received a stent within 7 days after diagnosis did much better than patients with a delay of more than 7 days before stent placement, with clinical success rates of 57% (21/37) and 24% (4/17), respectively. Conclusions: The success of SEMS placement appears to depend on multiple factors, including etiology, a history of radiation therapy, location in esophagus, septic state and time from diagnosis to stent placement. Early stent placement after diagnosis seems to be crucial. Patients with an iatrogenic perforation and Boerhaave syndrome respond well to stent therapy, while clinical success is modest in patients with fistulae and post-surgical leaks.
controlled pilot study on the use of antibiotics in pancreatic cyst aspiration. Patients referred for pancreatic cyst evaluation within a large integrated health care setting between January to November 2014 were screened. Those who met inclusion criteria (patients 18-90 years old) & not excluded (e.g. prior antibiotic use within 6 weeks of EUS, pancreatitis in past 6 months, underlying immunosuppression, imaging evidence of cyst cavity debris or necrotic debris) were invited to participate. At time of EUS-guided cyst aspiration, a single dose of IV ciprofloxacin was administered. After completion of EUS exam, patients were randomized in a 1:1 fashion to receive either 3 days of oral ciprofloxacin 500 mg twice a day versus 3 days of placebo. Patients were followed for 6 weeks. The primary outcome of interest was cyst infection. Secondary outcomes of interest were procedure- or antibiotic-related complications. Feasibility parameters assessed included patient accrual rate and lossto-follow up. We also determined sample size estimates for a projected non-inferiority trial. Results: 117 patients were screened over an 11-month period. 71 (61%) were excluded based on eligibility. Of the 46 patients invited to participate, 3 (2.5%) were no shows to their appointment, 12 (10%) declined, and 5 (4.3%) did not have their EUS scheduled within the study period. A total of 26 study participants (22% of screened patients) were randomized & analyzed in intention to treat analysis. Following randomization, there was a high rate of study completion (85% attendance to 3 telephone follow-up visits, 15% EMR chart review only)Demographics & further trial findings are presented in table 1.Sample size estimates were calculated based on the currently described infection rate in the literature (less than 1%), onesided alpha 5%, 80% power, non-inferiority limit of 1-2%. An adequately powered non-inferiority trial using these parameters would require 614-2450 patients. Conclusions: We were able to enroll 22% of screened patients, & implement a study protocol evaluating a single dose of IV antibiotics versus full course of antibiotics for cyst aspiration. The observed primary event rate (cyst infection) was zero. An adequately powered study to test non-inferiority of withholding antibiotics in this setting would likely be logistically challenging. (clinicaltrials.gov identifier NCT01929460)
Demographics / Trial Results Table 1. Baseline characteristics No. (%) Patients Male Mean age std. dev. (years) Medical history Esophageal cancer Radiation therapy Etiology of esophageal leakage Post-surgical leak Fistula Iatrogenic perforation Boerhaave syndrome Location in the esophagus Proximal (! 25 cm from the incisors) Mid (25-30 cm from the incisors) Distal (O 30 cm from the incisors) Unknown Highest measured CRP level (N[38) Mean (mg/L) Highest measured leukocyte count (N[33) Mean (10E9/L) Time from diagnosis to stent placement 0-1 days 2-7 days 8-14 days O 14 days Unknown
36 (64.3) 63.7 12.0 (range 9-84) 30 (53.6) 22 (39.3) 21 (37.5) 16 (28.6) 12 (21.4) 7 (12.5) 24 (42.9) 12 (21.4) 18 (32.1) 2 (3.6) 236 (range 4-496) 17.9 (range 7.9-41.9)
24 (42.9) 13 (23.2) 8 (14.3) 9 (16.1) 2 (3.6)
Sa1419 A Pilot Study on the Use of Prophylactic Antibiotics for EUSGuided Pancreatic Cyst Aspiration Karl Kwok*1, Joseph C. Chang1, Brian S. Lim2, Kevin T. Kao3, Andrew Q. Giap2, Bechien U. Wu1 1 Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA; 2 Gastroenterology, Kaiser Permanente, Riverside, CA; 3Gastroenterology, Kaiser Permanente, Downey, CA Background: Currently antibiotics are recommended for endoscopic ultrasound (EUS)-guided pancreatic cyst aspiration. However, emerging data suggest that patients may not benefit from prophylactic antibiotics in this setting. To date, there has been no prospective trial to investigate this topic. Aims: To evaluate the feasibility of a prospective trial on the use of prophylactic antibiotics for EUS-guided pancreatic cyst aspiration. Methods: We performed a randomized, double-blind, placebo-
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Demographic / Procedural Characteristics Participants 26 (intention to treat) Mean age 68.3 years (IQR 65,77) Sex 13 (50%) female Mean number of passes 1.4 Number of cysts fully aspirated 19 (73%) Antibiotic: Placebo allocation 1:1 blinded allocation via pharmacy Cyst characteristics Location 31% uncinate, 19% head, 12% neck, 31% body, 8% tail Mean long axis cyst size 21.4 mm (IQR 15,27.5) Cyst type 15% IPMN, 12% MCN, 23% SCA, 23% pseudocyst, 23% indeterminate, 4% other Septation 8 (31%) Median CEA 16.9 ng/mL Median Amylase 282 Unit/L Adverse Events Infections 0 0 Antibiotic-associated adverse events (e.g. diarrhea, rash, allergy) Procedure-related adverse events 1 (pancreatitis admission) Unrelated events 2 (nephrolithiasis and dyspepsia) Protocol Violation Number and reason 1 (patient took antibiotics for dental work, discovered after randomization)
Sa1420 A Randomized Control Study of Audio Versus Visual Distraction to Reduce Patient Discomfort During Colonoscopy Arjuna P. De Silva*1, Yasodha Nandamuni1, Sunali Nanayakkara1, Kuranage R. Perera2, Senarath K. Kodisinghe2, Subasin Kattadige C. Subasinghe2, Madunil A. Niriella1, Anuradha S. Dassanayake1, Arunasalam Pathmeswaran1, H. J. De Silva1 1 Medicine, University of Kelaniya, Ragama, Sri Lanka; 2Professorial Medical Unit, Colombo North Teaching Hospital, Ragama, Sri Lanka Introduction: Colonoscopy can cause discomfort and anxiety in patients who undergo the procedure. Heavy sedation as premedication can lead to complications in the elderly and those with co-morbidities. This has led to an interest in investigating the use of audio-visual distraction during the procedure. Our aim was to compare effects of audio versus visual distraction in reducing discomfort during colonoscopy. Methods: Seventy seven consecutive patients who were undergoing colonoscopy were randomized into three groups. One group was told to listen to
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Abstracts
the music of their choice during colonoscopy (AD), the second group was allowed to watch a film of their choice (VD) using (SONY head mounted display: HMZ-T3WH) and the third group acted as a control (C). Patient controlled sedation (PCS) was administered to all three groups; we used 25 mg pethidine 5 mg aliquots and 2.5 mg midazolam in 0.5 mg aliquots. All patients were assessed for pain, number of ‘topups’ of sedation, total dose of pethidine and midazolam and patient cooperation and willingness to repeat the procedure. Results: There were 77 patients (AD, nZ25 ,16 males, median age 57 years; VD, nZ26 , 18 males, median age 58 years; C, nZ26, 10 males, median age 59 years).The AD group had significantly less pain (pZ0.048), number of ‘top-ups’ of sedation (pZ0.03),total doses of pethidine(pZ0.03) and midazolam (pZ0.032), and better patient cooperation (pZ0.001) compared with controls. There was no difference between the AD(72%) and VD (73%) groups in willingness to undergo a repeat procedure. Conclusions: Audio distraction reduces pain and discomfort and the, requirement for sedation and seems a useful and simple tool for use during colonoscopy.
Sa1421 Effect of Functional Relaxation on Patients Undergoing Colonoscopy: A Prospective Randomized Controlled Trial Jeong Seon Ji*1, Young-Seok Cho2 1 Division of Gastroenterology, Departments of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea (the Republic of); 2Division of Gastroenterology, Departments of Internal Medicine, Uijeongbu St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea (the Republic of) Background: Several methods have been reported to reduce patient discomfort during colonoscopy, including use of pediatric colonoscope, variable stiffness colonoscope, gastroscope, insufflation of carbon dioxide, and music. Although a potential benefit from some of these methods has been suggested, none are currently recommended by clinical practice. For functional relaxation, there was no study assessing the efficacy in the reducing discomfort during colonoscopy. The aim of this randomized controlled trial was to evaluate the effectiveness of functional relaxation on patients undergoing colonoscopy. Methods: A total 61 patients were randomized to functional relaxation group (30 patients) or control group (31 patients). In the study group, functional relaxation was carried out by listening and following recorded functional relaxation education tape before and during colonoscopy. In control group, no education was carried out. All colonoscopies were performed by two experienced endoscopists. Patients were given analgesics (50 mg of meperidine) before colonoscopy. Additional meperidine and midazolam were given on demand. Primary outcome measure was pain measured on linear analogue scale from 0 to 10. Secondary endpoints were the overall patient satisfaction, willingness to repeat the procedure, and need of sedation. Results: Mean pain score was significantly reduced by functional relaxation from 5.12.7 to 3.02.1 (PZ0.013). Overall satisfaction (6.72.3 vs. 8.91.4, PZ0.011) and willingness to repeat the procedure (71.0% vs. 96.7%, PZ0.012) were significantly improved by fuctional relaxation. Also, therewas a significant reduction of the proportion of patients requiring additional analgesics and sedation in the relaxation group (25.8% vs. 3.3%, P Z 0.026). A multivariable analysis to adjust treatment effect for potential confounding factors confirmed the significant beneficial effect of functional relaxation (PZ0.021). On a subgroup analysis, functional relaxation was more effective in the highly educated and female patients. Conclusions: Functional relaxation significantly reduces abdominal pain and could be offered to patients undergoing colonoscopy.
Sa1422 Evaluation of the Proximal Serrated Polyp Detection Rate As a Valuable Colonoscopy Quality Parameter Joep E. Ijspeert*1, Sascha C. Van Doorn1, Barbara A. Bastiaansen1,2, Paul Fockens1,2, Evelien Dekker1,2 1 gastroenterology and hepatology, Academic Medical Centre, Amsterdam, Netherlands; 2Procolo center for colonoscopy, Bergman Clinics, Amsterdam, Netherlands Background: The adenoma detection rate (ADR) is currently the most important surrogate quality parameter in the context of CRC prevention. However, also serrated polyps (SPs) are precursors of CRC. Large prospective studies comparing the detection rate of SPs among endoscopists in an era of awareness about the malignant potential of SPs have not yet been performed. Aim: To compare the proximal SP detection rate (PSPDR) and the detection rate of clinically relevant SPs (RSPDR) among endoscopists and to analyze the association between these parameters and the ADR. Methods: Colonoscopy data were retrieved in one expert center between January 2011 and June 2014 using a structured reporting system, enabling prospective and automatic quality assessment. Endoscopists were instructed to resect all lesions, irrespective of predicted histology. Endoscopists who performed at least 50 colonoscopies within the timeframe were included for analysis. Multivariate
AB208 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
logistic regression, adjusted for patient age, gender, quality of bowel preparation and colonoscopy indication, was used to compare the ADR, PSPDR and RSPDR among endoscopists. The association between these parameters was calculated using the Pearson’s r correlation coefficient. Proximal colon was defined as proximal to the descending colon. Clinically relevant SPs were defined as all SPs, except for hyperplastic polyps (HPs) %5mm in the rectosigmoid. All lesions were assessed by an expert pathologist. Results: In total 1485 adenomas and 841 SPs (582 HPs, 253 sessile serrated adenomas/polyps (SSA/Ps) and 6 traditional serrated adenomas) were retrieved in 2123 colonoscopies. Of all SPs, 304 (36.1%) were located in the proximal colon and 452 (53.7%) were regarded clinically relevant. Sixteen endoscopists were included for analysis. The PSPDR ranged from 2.8-18.6% (median 9.7%) (Table 1). Corrected for confounders, the odds ratio for detecting at least one proximal SP compared to the highest detector ranged from 0.78 (95% CI 0.41-1.51) to 0.12 (CI 0.03-0.54) (table 2). The PSPDR was highly correlated with the RSPDR (0.871, p!0.001), ranging from 4.3-20.9% (median 12.9%). The PSPDR moderately correlated with the ADR (0.526, pZ0.036), ranging from 23.9-49.2% (median 36.2%). The 25% highest clinically relevant SP detectors showed a significant higher detection rate for all SP subcategories. Most pronounced difference was found for the detection rate of at least one large SSA/P (2.2% vs 0.6%, OR 3.84 (p!0.01, CI 1.61-9.18)). Discussion: The PSPDR is widely variable among endoscopists, strongly correlated to the RSPDR and moderately correlated to the ADR. The most pronounced difference was seen in the detection rate of non-diminutive SPs. Measurement of the PSPDR, alongside the ADR, seems valuable and future research should determine the association between endoscopists’ PSPDR and the risk of interval cancer. Table 1. Colonoscopy performance per endoscopist
Endoscopist
Colonoscopies (n)
Age patient (SD)
1 2 3 4 5 6 7 8 9 10 11
86 243 170 50 65 186 88 101 63 65 106
56.1 56.1 59.3 55.1 58.3 58.6 57.6 59.2 59.8 58.0 56.8
(12.8) (12.9) (11.5) (11.7) (11.5) (12.8) (12.8) (11.0) (12.7) (12.2) (12.3)
12 13 14 15 16 Overall
127 561 61 80 71 2123
58.0 58.7 56.2 56.7 58.0 57.9
(14.8) (12.4) (13.0) (13.5) (13.0) (12,6)
BBPS (IQR) 9 (8-9) 8 (7-9) 9 (8-9) 9 (8-9) 9 (8-9) 9 (7-9) 8 (7-9) 9 (8-9) 8 (7-9) 9 (9-9) 7.5 (68) 8 (6-9) 6 (5-7) 9 (7-9) 7 (7-8) 9 (6-9) 8 (6-9)
Male patient (%)
ADR (%)
PSPDR (%)
RSPDR (%)
38.4 46.9 44.7 44.0 49.2 49.5 44.3 42.6 54.0 41.5 50.0
36.0 34.2 41.2 46.0 49.2 39.2 36.4 29.7 42.9 38.5 26.4
18.6 15.2 14.1 14.0 13.9 13.4 12.5 9.9 9.5 9.2 8.5
20.9 19.3 17.7 16.0 15.4 18.3 14.8 11.9 12.7 12.3 9.4
52.8 47.4 37.7 48.7 60.6 47.2
32.3 33.9 29.5 38.8 23.9 36.2
7.9 7.7 6.5 5.0 2.8 9.7
12.6 12.1 13.1 6.3 4.3 12.9
SD Z standard deviation, IQR Z interquartile range, ADR Z adenoma detection rate, PSPDR Z proximal serrated polyp detection rate, RSPDR Z clinically relevant serrated polyp detection rate, BBPS Z Boston Bowel preparation score
Table 2. Odds for the detection of at least one proximal SP and one
relevant SP compared to the endoscopist with the highest detection rate Endoscopist 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
OR for detection of at least one proximal SP (95% CI)
OR for detection of at least one clinically relevant SP (95% CI)
1 0.78 (0.41-1.51) 0.67 (0.33-1.36) 0.54 (0.18-1.60) 0.67 (0.27-1.64) 0.63 (0.32-1.27) 0.60 (0.26-1.39) 0.44 (0.19-1.00) 0.41 (0.15-1.14) 0.42 (0.15-1.15) 0.41 (0.17-0.99) 0.35 (0.15-0.82) 0.35 (0.18-0.68) 0.30 (0.10-0.97) 0.22 (0.07-0.69) 0.12 (0.03-0.54)
1 0.87 (0.47-1.62) 0.79 (0.41-1.52) 0.56 (0.20-1.53) 0.65 (0.27-1.53) 0.78 (0.41-1.50) 0.61 (0.27-1.35) 0.48 (0.22-1.08) 0.50 (0.20-1.24) 0.52 (0.21-1.28) 0.39 (0.17-0.90) 0.50 (0.24-1.06) 0.48 (0.26-0.90) 0.56 (0.22-1.39) 0.22 (0.08-0.64) 0.15 (0.04-0.53)
CI Z confidence interval, OR Z odds ratio, SP Z serrated polyp
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