Summary Background Although colonoscopy is the accepted standard for detection of colorectal adenomas and cancers, many adenomas and some cancers are missed. To avoid interval colorectal cancer, the ...adenoma miss rate of colonoscopy needs to be reduced by improvement of colonoscopy technique and imaging capability. We aimed to compare the adenoma miss rates of full-spectrum endoscopy colonoscopy with those of standard forward-viewing colonoscopy. Methods We did an international, multicentre, randomised trial at three sites in Israel, one site in the Netherlands, and two sites in the USA between Feb 1, 2012, and March 31, 2013. Patients aged 18–70 years referred for colorectal cancer screening, polyp surveillance, or diagnostic assessment underwent same-day, back-to-back tandem colonoscopy with standard forward-viewing colonoscope and the full-spectrum endoscopy colonoscope. The patients were randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure was done first. The endoscopist was masked to group allocation until immediately before the start of colonoscopy examinations; patients were not masked. The primary endpoint was adenoma miss rates. We did per-protocol analyses. This trial is registered with ClinicalTrials.gov , number NCT01549535. Findings 197 participants were enrolled. 185 participants were included in the per-protocol analyses: 88 (48%) were randomly assigned to receive standard forward-viewing colonoscopy first, and 97 (52%) to receive full-spectrum endoscopy colonoscopy first. By per-lesion analysis, the adenoma miss rate was significantly lower in patients in the full-spectrum endoscopy group than in those in the standard forward-viewing procedure group: five (7%) of 67 vs 20 (41%) of 49 adenomas were missed (p<0·0001). Standard forward-viewing colonoscopy missed 20 adenomas in 15 patients; of those, three (15%) were advanced adenomas. Full-spectrum endoscopy missed five adenomas in five patients in whom an adenoma had already been detected with first-pass standard forward-viewing colonoscopy; none of these missed adenomas were advanced. One patient was admitted to hospital for colitis detected at colonoscopy, whereas five minor adverse events were reported including vomiting, diarrhoea, cystitis, gastroenteritis, and bleeding. Interpretation Full-spectrum endoscopy represents a technology advancement for colonoscopy and could improve the efficacy of colorectal cancer screening and surveillance. Funding EndoChoice.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Although colonoscopy is currently the optimal method for detecting colorectal polyps, some are missed. The Third Eye Retroscope provides an additional retrograde view that may detect ...polyps behind folds. Objective To determine whether the addition of the Third Eye Retroscope to colonoscopy improves the adenoma detection rate. Design Prospective, multicenter, randomized, controlled trial. Setting Nine European and U.S. centers. Patients Of 448 enrolled subjects, 395 had data for 2 procedures. Interventions Subjects underwent same-day tandem examinations with standard colonoscopy (SC) and Third Eye colonoscopy (TEC). Subjects were randomized to SC followed by TEC or TEC followed by SC. Main Outcome Measurements Detection rates for all polyps and adenomas with each method. Results In the per-protocol population, 173 subjects underwent SC and then TEC, and TEC yielded 78 additional polyps (48.8%), including 49 adenomas (45.8%). In 176 subjects undergoing TEC and then SC, SC yielded 31 additional polyps (19.0%), including 26 adenomas (22.6%). Net additional detection rates with TEC were 29.8% for polyps and 23.2% for adenomas. The relative risk of missing with SC compared with TEC was 2.56 for polyps ( P < .001) and 1.92 for adenomas ( P = .029). Mean withdrawal times for SC and TEC were 7.58 and 9.52 minutes, respectively ( P < .001). The median difference in withdrawal times was 1 minute ( P < .001). The mean total procedure times for SC and TEC were 16.97 and 20.87 minutes, respectively ( P < .001). Limitations Despite randomization and a large cohort, there was disparity in polyp prevalence between the 2 groups of subjects. Conclusion The Third Eye Retroscope increases adenoma detection rate by visualizing areas behind folds. (Clinical trial registration number: NCT01044732 .)
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background and Aims Accurate determination of residual cancer status after neoadjuvant chemoradiotherapy (nCRT) for esophageal cancer could assist in selecting the optimal treatment strategy. The aim ...of this study was to review the evidence on the diagnostic accuracy of endoscopic biopsy and EUS after nCRT for detecting residual cancer at the primary tumor site (ypT+) and regional lymph nodes (ypN+) as opposed to a pathologic complete response (ypT0 and ypN0). Methods PubMed/Medline, Embase, and the Cochrane library were systematically searched. The analysis included diagnostic studies reporting on the accuracy of endoscopic biopsy or EUS in detecting residual cancer versus complete response after nCRT for esophageal cancer with histopathology as the reference standard. Bivariate random-effects models were used to estimate pooled sensitivities and specificities and examine sources of heterogeneity. Results Twenty-three studies comprising 12 endoscopic biopsy studies (1281 patients), 11 EUS studies reporting on ypT status (593 patients), and 10 EUS studies reporting on ypN status (602 patients), were included. Pooled estimates for sensitivity of endoscopic biopsy after nCRT for predicting ypT+ were 34.5% (95% confidence interval CI, 26.0%-44.1%) and for specificity 91.0% (95% CI, 85.6%-94.5%). Pooled estimates for sensitivity of EUS after nCRT were 96.4% (95% CI, 91.7%-98.5%) and for specificity were 10.9% (95% CI, 3.5%-29.0%) for detecting ypT+, and 62.0% (95% CI, 46.0%-75.7%) and 56.7% (95% CI, 41.8%-70.5%) for detecting ypN+, respectively. Conclusions Endoscopic biopsy after nCRT is a specific but not sensitive method for detecting residual esophageal cancer. Although EUS after nCRT yields a high sensitivity, only a limited number of patients will have negative findings at EUS with still a substantial false-negative rate. Furthermore, EUS provides only moderate accuracy for detecting residual lymph node involvement. Based on these findings, these endoscopic modalities cannot be used to withhold surgical treatment in test-negative patients after nCRT. (Clinical trial registration number: CRD42015016527.)
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Benign esophageal strictures refractory to standard dilation therapy present a challenging problem. Temporary plastic and metal stents have been proposed with inconclusive results. ...Objective To evaluate the efficacy and safety of a new biodegradable stent for the treatment of refractory benign esophageal strictures (RBESs). Design and Setting Prospective study from 2 European endoscopy centers. Patients and Intervention Twenty-one patients (11 men/10 women, mean age 60.2 ± 17.6 years) with RBESs defined according to the Kochman criteria treated by placement of a biodegradable stent (Ella stent). Main Outcome Measurements Clinical and endoscopic follow-up was scheduled at 1, 2, 3, and 6 months and later only in case of dysphagia recurrence. Pre- and poststenting dysphagia status was graded according to a 5-point scale. Minor and major complication rates were prospectively assessed. Results Stent insertion was technically successful in all of the patients. At 4 and 7 weeks, stent migration occurred in 2 patients (9.5%). At 3-month endoscopy, the stent appeared to be almost completely fragmented in all remaining patients. The median pre- and poststenting dysphagia scores were 3 (range 3-4) and 1 (range 0-2), respectively ( P < .01), with a median follow-up of 53 weeks (range 25-88 weeks). In detail, 9 of 20 patients (45%) were dysphagia free at the end of the follow-up. No major complications occurred. Severe poststenting pain requiring analgesics developed in 3 patients, and minor bleeding was observed in 1 patient. Limitations Limited follow-up; nonrandomized study. Conclusions In this preliminary study, the biodegradable stent showed a favorable risk/benefit ratio, achieving complete relief of dysphagia in nearly 50% of RBES patients without the occurrence of major complications. The use of this stent may be a valuable alternative to repeat endoscopic dilation. Larger studies with longer follow-up are needed.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Adequate bowel preparation is important for optimal colonoscopy. It is important to identify patients at risk for inadequate bowel preparation because this allows taking precautions in ...this specific group. Objective To develop a prediction score to identify patients at risk for inadequate bowel preparation who may benefit from an intensified bowel cleansing regimen. Design Patient and colonoscopy data were prospectively collected, whereas clinical data were retrospectively collected for a total of 1996 colonoscopies in participants who received split-dose bowel preparation. Multivariate logistic regression analyses were conducted in a random two-thirds of the cohort to develop a prediction model. Validation and evaluation of the discriminative power of the prediction model were performed within the remaining one-third of the cohort. Setting Four centers, including one academic and three medium-to-large size nonacademic centers. Patients Consecutive colonoscopies in November and December 2012. Mean age was 57.3 ± 15.9 years, 45.8% were male and indications for colonoscopy were screening and/or surveillance (27%), abdominal symptoms and/or blood loss and/or anemia (60%), inflammatory bowel disease (9%), and others (4%). Interventions Colonoscopy. Main Outcome Measurements Inadequate bowel preparation defined as Boston Bowel Preparation Scale score <6. Results A total of 1331 colonoscopies were included in the development cohort, of which 172 (12.9%) had an inadequate bowel preparation. Independent factors included in the prediction model were American Society of Anesthesiologists Physical Status Classification System score ≥3, use of tricyclic antidepressants, use of opioids, diabetes, chronic constipation, history of abdominal and/or pelvic surgery, history of inadequate bowel preparation, and current hospitalization. The discriminative ability of the scale was good, with an area under the curve of 0.77 in the validation cohort. Limitations Study design partially retrospective, no data on patient compliance. Conclusion We developed a validated, easy-to-use prediction scale that can be used to identify subjects with an increased risk of inadequate bowel preparation with good accuracy.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Background and Aims There is little evidence that structures targeted during EUS-guided celiac ganglia neurolysis (EUS-CGN) are celiac ganglia and that selective ethanol injection into ...ganglia is feasible. We aimed to visualize celiac ganglia, confirm that these structures are ganglia, and visualize ethanol spread after EUS-CGN and EUS-guided celiac plexus neurolysis (EUS-CPN). Methods First, celiac ganglia were sought during 97 consecutive EUS procedures. Second, ganglia were identified in a prosected human cadaver by placing a linear echo-endoscope next to the celiac trunk and the underlying tissue was removed for histology. Finally, various EUS-CGN and EUS-CPN techniques were performed in human cadavers; EUS-CGN was performed with 1 mL ethanol in one ganglion, 1 mL per ganglion (both “low volume”), and 4 mL per ganglion (“high volume”). EUS-CPN was performed with a central (20 mL) and a bilateral (2*10 mL) approach. Transverse sections (75 μm) were obtained and photographed to visualize the spread of ethanol. Results 204 ganglia were detected in 83 patients. Mean size of the long axis was 8.1 (±7.4) mm. Histology of the removed region in the cadaver showed only nerve cell bodies. After low volume EUS-CGN in cadavers, ethanol spread well beyond the targeted ganglion. After high-volume EUS-CGN in cadavers, a larger ethanol spread was seen, which also reached unidentified ganglia; the spread was comparable with spread after EUS-CPN. Conclusions Specific EUS-CGN is not feasible because ethanol spreads well beyond the targeted ganglion. Unidentified celiac ganglia are better reached with high-volume EUS-CGN, and this would likely result in a more thorough neurolysis. High-volume EUS-CGN should be preferred to low-volume EUS-CGN.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Although colonoscopy is the criterion standard for detecting colorectal adenomas and cancers, a significant percentage of adenomas are missed. Objective To compare forward-viewing with ...ultrawide-viewing colonoscopy in the detection of simulated colon polyps in an in vitro colon model. Design Prospective, multicenter. Setting Six endoscopy units (3 in the United States and 3 in Israel). Patients In vitro colon model with simulated colon polyps (n = 21 metallic beads). Interventions Detection of simulated colon polyps on colonoscope withdrawal. Main Outcome Measurements Incremental detection of simulated colon polyps and endoscopist evaluation of the usability, visibility, and maneuverability of ultrawide-viewing colonoscopy. Results On forward-viewing colonoscopy, the number of simulated polyps (mean ± standard deviation) detected per endoscopist was 11.1 ± 2.3 polyps, a 52.9% detection rate. Simulated polyp detection rates per colon segment were 3.0 ± 0.93 (60.0%) right colon, 2.4 ± 0.87 (48.0%) transverse colon, and 5.7 ± 1.5 (51.8%) left colon. On ultrawide-viewing colonoscopy, the simulated polyp detection rate per endoscopist significantly increased to 18.0 ± 1.98 polyps, an overall 85.7% polyp detection rate ( P < .001). Simulated polyp detection rates were also significantly higher by using the ultrawide-viewing mode in each colon segment, 4.5 ± 0.65 polyps (90.0%) right colon, 4.0 ± 0.87 (80.0%) polyps transverse colon, and 9.6 ± 1.28 polyps (87.3%) left colon (all comparisons, P < .001). Importantly, the ultrawide-viewing mode detected significantly more “hidden” simulated polyps (81.9% vs 31.9%, P < .0001). Limitations Nonrandomized design, use of a colon model, and “simulated” colon polyps. Conclusions Ultrawide-view colonoscopy significantly improved simulated polyp detection in a colon model. Clinical studies in human subjects should be pursued to further evaluate this new endoscopic technology.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Gastric outlet obstruction (GOO) is most commonly a complication of advanced distal gastric, periampullary, or duodenal malignancy. Palliation of obstruction is the primary aim of ...treatment in most of these patients. Self-expandable metal stents have emerged as an effective treatment option. Objective Our purpose was to investigate the efficacy and safety of a newly developed enteral metal stent (WallFlex). Design Prospective multicenter cohort study. Setting Three tertiary referral centers (2 academic). Patients Fifty-one consecutive patients with symptomatic malignant GOO from January 2005 to February 2006. Intervention Placement of a self-expandable metallic stent (WallFlex). Main Outcome Measurements The primary end point was defined as improvement of the GOO scoring system for the remainder of the patients' lives. Secondary end points focused on efficacy and safety and global quality of life. Results The Gastric Outlet Obstruction Scoring System score improved ( P < .001), the body mass index decreased ( P < .001), and the World Health Organization performance score improved ( P = .002) when the score before stenting was compared with the mean score until death. Global quality of life did not improve. Technical and clinical success was achieved in 98% and 84% of the patients. Median survival was 62 days (75% alive at 35 days, 25% alive at 156 days). Median stent patency was 307 days (75% functional at 135 days, 25% functional at 470 days). Stent dysfunction was proved in 7 patients (14%), migration in 1 (2%), and tumor overgrowth or ingrowth in 6 (12%). Limitations Lack of a control group. Conclusion Placement of a WallFlex enteral stent in patients with nonresectable malignant GOO is safe and provides a statistically significant and clinically relevant relief of obstructive symptoms with a low need for reintervention.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background and Aims Electromagnetic-guided placement (EMP) of a nasoduodenal feeding tube by trained nurses is an attractive alternative to EGD-guided placement (EGDP). We aimed to compare EMP and ...EGDP in outpatients, ward patients, and critically ill patients with normal upper GI anatomy. Methods In 3 centers with no prior experience in EMP, patients were randomized to placement of a single-lumen nasoduodenal feeding tube either with EGDP or EMP. The primary endpoint was post-pyloric position of the tube on abdominal radiography. Patients were followed for 10 days to assess patency and adverse events. The analyses were performed according to the intention-to-treat principle. Results In total, 160 patients were randomized to EGDP (N = 76) or EMP (N = 84). Three patients withdrew informed consent, and no abdominal radiography was performed in 2 patients. Thus, 155 patients (59 intensive care unit, 38%) were included in the analyses. Rates of post-pyloric tube position between EGDP and EMP were comparable (79% vs 82%, odds ratio 1.16; 90% confidence interval, 0.58-2.38; P = .72). Adverse events were observed in 4 patients after EMP (hypoxia, GI blood loss, atrial fibrillation, abdominal pain) and in 4 after EGDP (epistaxis N = 2, GI blood loss, hypoxia). Costs of tube placements were lower for EMP compared with EGDP: $519 versus $623, respectively ( P = .04). Conclusions Success rates and safety of EMP and EGDP in patients with normal upper GI anatomy were comparable. Lower costs and potential logistic advantages may drive centers to adopt EMP as their new standard of care. (Clinical trial registration number: NTR4286.)
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Palliation of malignant gastric outlet obstruction remains challenging. Although there are 2 established treatment options, ie, surgical gastrojejunostomy and endoscopic duodenal stent ...insertion, there is an ongoing search for a technique that would combine the safety and rapid effect of duodenal stent placement with the long-term efficacy and low reintervention rate of a surgical gastrojejunostomy. Objective To investigate the safety and success rate of endoscopic creation of a gastroenteric anastomosis formed by magnetic compression and stent placement. Design Prospective, multicenter cohort study. Setting Four referral centers. Patients The expected number of patients with symptomatic malignant gastric outlet obstruction to be included at the participating hospitals during a year was 40. Because of a serious adverse device event, the study was terminated after inclusion of 18 patients. Intervention Creation of an endoscopic gastroenteric anastomosis by using the Cook Magnetic Anastomosis Device with transanastomotic deployment of a self-expandable stent. Main Outcome Measurements Primary endpoints were safety and success rate associated with the creation of an endoscopic gastrojejunostomy by using a magnetic anastomotic device with transanastomotic deployment of a self-expandable stent. Results Because of a serious adverse event, the study was terminated prematurely. A success rate of 66.7% (12 of 18 patients) was achieved; 1 serious adverse event (stent perforation) occurred leading to the death of the patient. Three patients (25%) experienced an adverse device effect (stent migration). Limitations Small sample size, lack of a control group. Conclusion Endoscopic creation of a gastroenteric anastomosis by magnetic compression is feasible and safe; however, the necessity of a stent led to serious morbidity and even mortality in this study. The current system can therefore not be recommended for clinical use.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
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