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WATER II (80-150 mL) procedural outcomes.
Desai, M, Bidair, M, Bhojani, N, Trainer, A, Arther, A, Kramolowsky, E, Doumanian, L, Elterman, D, Kaufman, RP, Lingeman, J, et al
BJU international. 2019;(1):106-112
Abstract
OBJECTIVES To present early safety and feasibility data from a multicentre prospective study (WATER II) of aquablation in the treatment of symptomatic men with large-volume benign prostatic hyperplasia (BPH). METHODS Between September and December 2017, 101 men with moderate-to-severe BPH symptoms and prostate volume of 80-150 mL underwent aquablation in a prospective multicentre international clinical trial. Baseline demographics and standardized postoperative management variables were carefully recorded in a central independently monitored database. Surgeons answered analogue scale questionnaires on intra-operative technical factors and postoperative management. Adverse events up to 1 month were adjudicated by an independent clinical events committee. RESULTS The mean (range) prostate volume was 107 (80-150) mL. The mean (range) operating time was 37 (15-97) min and aquablation resection time was 8 (3-15) min. Adequate adenoma resection was achieved with a single pass in 34 patients and with additional passes in 67 patients (mean 1.8 treatment passes), all in a single operating session. Haemostasis was achieved using either a Foley balloon catheter placed in the bladder under traction (n = 98, mean duration 18 h) or direct tamponade using a balloon inflated in the prostate fossa (n = 3, mean duration 15 h). No patient required electrocautery for haemostasis at the time of the primary procedure. The mean length of stay after the procedure was 1.6 days (range same day to 6 days). The Clavien-Dindo grade ≥2 event rate observed at 1 month was 29.7%. Bleeding complications were recorded in 10 patients (9.9%) during the index procedure hospitalization prior to discharge, and included six (5.9%) peri-operative transfusions. CONCLUSIONS Aquablation is feasible and safe in treating men with men with large prostates (80-150 mL). The 6-month efficacy data are being accrued and will be presented in future publications (ClinicalTrials.gov number, NCT03123250).
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Water exchange for screening colonoscopy increases adenoma detection rate: a multicenter, double-blinded, randomized controlled trial.
Cadoni, S, Falt, P, Rondonotti, E, Radaelli, F, Fojtik, P, Gallittu, P, Liggi, M, Amato, A, Paggi, S, Smajstrla, V, et al
Endoscopy. 2017;(5):456-467
Abstract
Background and study aims Single-center studies, which were retrospective and/or involved unblinded colonoscopists, have suggested that water exchange, but not water immersion, compared with air insufflation significantly increases the adenoma detection rate (ADR), particularly in the proximal and right colon. Head-to-head comparison of the three techniques with ADR as primary outcome and blinded colonoscopists has not been reported to date. In a randomized controlled trial with blinded colonoscopists, we aimed to evaluate the impact of the three insertion techniques on ADR. Patients and methods A total of 1224 patients aged 50 - 70 years (672 males) and undergoing screening colonoscopy were randomized 1:1:1 to water exchange, water immersion, or air insufflation. Split-dose bowel preparation was adopted to optimize colon cleansing. After the cecum had been reached, a second colonoscopist who was blinded to the insertion technique performed the withdrawal. The primary outcome was overall ADR according to the three insertion techniques (water exchange, water immersion, and air insufflation). Secondary outcomes were other pertinent overall and right colon procedure-related measures. Results Baseline characteristics of the three groups were comparable. Compared with air insufflation, water exchange achieved a significantly higher overall ADR (49.3 %, 95 % confidence interval [CI] 44.3 % - 54.2 % vs. 40.4 % 95 %CI 35.6 % - 45.3 %; P = 0.03); water exchange showed comparable overall ADR vs. water immersion (43.4 %, 95 %CI 38.5 % - 48.3 %; P = 0.28). In the right colon, water exchange achieved a higher ADR than air insufflation (24.0 %, 95 %CI 20.0 % - 28.5 % vs. 16.9 %, 95 %CI 13.4 % - 20.9 %; P = 0.04) and a higher advanced ADR (6.1 %, 95 %CI 4.0 % - 9.0 % vs. 2.5 %, 95 %CI 1.2 % - 4.6 %; P = 0.03). Compared with air insufflation, the mean number of adenomas per procedure was significantly higher with water exchange (P = 0.04). Water exchange achieved the highest cleanliness scores (overall and in the right colon). These variables were comparable between water immersion and air insufflation. Conclusions The design with blinded observers strengthens the validity of the observation that water exchange, but not water immersion, can achieve significantly higher adenoma detection than air insufflation. Based on this evidence, the use of water exchange should be encouraged.Trial registered at ClinicalTrials.gov (NCT02041507).
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Water Exchange Method Significantly Improves Adenoma Detection Rate: A Multicenter, Randomized Controlled Trial.
Jia, H, Pan, Y, Guo, X, Zhao, L, Wang, X, Zhang, L, Dong, T, Luo, H, Ge, Z, Liu, J, et al
The American journal of gastroenterology. 2017;(4):568-576
Abstract
OBJECTIVES Adenoma detection rate (ADR) is a key colonoscopy quality indicator in Western clinical literature. Our low ADR prompted us to assess novel methods to improve performance. Western retrospective reports suggested that water exchange (WE) could increase ADR. However, most of these studies used pain score or intubation rate as the primary outcome. Here we test the hypothesis that WE significantly increases ADR among Chinese colonoscopists and design a prospective randomized controlled trial using ADR as our primary outcome. METHODS This prospective, randomized controlled trial was performed at six centers in China. Screening, surveillance, and diagnostic cases were randomized to be examined by WE or traditional air insufflation (AI) method. The primary outcome was ADR. RESULTS From April 2014 to July 2015, 3,303 patients were randomized to WE (n=1,653) and AI (n=1,650). The baseline characteristics were comparable. Overall ADR was 18.3% (WE) and 13.4% (AI) (relative risk 1.45, 95% confidential interval: 1.20-1.75, P<0.001). ADR in screening patients using AI was 25.8% (male) and 15.7% (female). ADR in screening patients aged >50 years old was 29.4% (WE) and 22.9% (AI) (relative risk 1.09, 95% confidential interval: 1.00-1.19, P=0.040). The increase by WE was reproducibly observed in all indication categories, and significant in screening and diagnostic cases. The limitation imposed by the unblinded investigators was mitigated by comparable inspection times in cases without polyps, similar adenoma per positive colonoscopy, and reproducible enhancement of ADR and adenoma per colonoscopy by WE across all eight investigators. CONCLUSIONS This prospective study confirms Western retrospective data that WE significantly improves ADR among Chinese colonoscopists. WE may be superior to AI for screening colonoscopy in China. Colonoscopists elsewhere with low ADR might consider evaluating WE for performance improvement.
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Adenoma detection with blue-water infusion colonoscopy: a randomized trial.
Lesne, A, Rouquette, O, Touzet, S, Petit-Laurent, F, Tourlonias, G, Pasquion, A, Rivory, J, Aguero Garcete, G, Scanzi, J, Chalumeau, S, et al
Endoscopy. 2017;(8):765-775
Abstract
UNLABELLED Background and aims Colonoscopy is currently the reference method to detect colorectal neoplasia, yet some adenomas remain undetected. The water infusion technique and dying with indigo carmine has shown interesting results for reducing this miss rate. The aim of this study was to compare the adenoma detection rate (adenoma and adenocarcinoma; ADR) and the mean number of adenomas per patient (MAP) for blue-water infusion colonoscopy (BWIC) versus standard colonoscopy. Methods We performed a multicenter, randomized controlled trial in eight units, including patients with a validated indication for colonoscopy (symptoms, familial or personal history, fecal occult blood test positive). Consenting patients were randomized 1:1 to BWIC or standard colonoscopy. All colonoscopies were performed by experienced colonoscopists. All colonoscopy quality indicators were prospectively recorded. Results Among the 1065 patients included, colonoscopies were performed completely for 983 patients (514 men; mean age 59.1). The ADR was not significantly different between the groups; 40.4 % in the BWIC group versus 37.5 % in the standard colonoscopy group (odds ratio [OR] 1.13; 95 % confidence interval [CI] 0.87 - 1.48; P = 0.35). MAP was significantly greater in the BWIC group (0.79) than in the standard colonoscopy group (0.64; P = 0.005). For advanced adenomas, the results were 50 (10.2 %) and 36 (7.3 %), respectively (P = 0.10). The cecal intubation rate was not different but the time to cecal intubation was significantly longer in BWIC group (9.9 versus 6.2 minutes; P < 0.001). Conclusion Despite the higher MAP with BWIC, the routine use of BWIC does not translate to a higher ADR. Whether increased detection ultimately results in a lower rate of interval carcinoma is not yet known. CLINICAL TRIALS REGISTRATION EudraCT 2012-A00548 - 35; NCT01937429.
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Patient-reported outcomes of parenteral somatostatin analogue injections in 195 patients with acromegaly.
Strasburger, CJ, Karavitaki, N, Störmann, S, Trainer, PJ, Kreitschmann-Andermahr, I, Droste, M, Korbonits, M, Feldmann, B, Zopf, K, Sanderson, VF, et al
European journal of endocrinology. 2016;(3):355-62
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Abstract
BACKGROUND Long-acting somatostatin analogues delivered parenterally are the most widely used medical treatment in acromegaly. This patient-reported outcomes survey was designed to assess the impact of chronic injections on subjects with acromegaly. METHODS The survey was conducted in nine pituitary centres in Germany, UK and The Netherlands. The questionnaire was developed by endocrinologists and covered aspects of acromegaly symptoms, injection-related manifestations, emotional and daily life impact, treatment satisfaction and unmet medical needs. RESULTS In total, 195 patients participated, of which 112 (57%) were on octreotide (Sandostatin LAR) and 83 (43%) on lanreotide (Somatuline Depot). The majority (>70%) of patients reported acromegaly symptoms despite treatment. A total of 52% of patients reported that their symptoms worsen towards the end of the dosing interval. Administration site pain lasting up to a week following injection was the most frequently reported injection-related symptom (70% of patients). Other injection site reactions included nodules (38%), swelling (28%), bruising (16%), scar tissue (8%) and inflammation (7%). Injection burden was similar between octreotide and lanreotide. Only a minority of patients received injections at home (17%) and 5% were self-injecting. Over a third of patients indicated a feeling of loss of independence due to the injections, and 16% reported repeated work loss days. Despite the physical, emotional and daily life impact of injections, patients were satisfied with their treatment, yet reported that modifications that would offer major improvement over current care would be 'avoiding injections' and 'better symptom control'. CONCLUSION Lifelong injections of long-acting somatostatin analogues have significant burden on the functioning, well-being and daily lives of patients with acromegaly.
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Insertion water exchange increases right colon adenoma and hyperplastic polyp detection rates during withdrawal.
Cadoni, S, Falt, P, Sanna, S, Argiolas, M, Fanari, V, Gallittu, P, Liggi, M, Mura, D, Porcedda, ML, Smajstrla, V, et al
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2016;(6):638-43
Abstract
BACKGROUND Single site studies in male Veterans in the U.S. reported increased detection of presumptive cancer precursors (adenomas, hyperplastic polyps) in the proximal colon (cecum-splenic flexure) by water exchange. AIMS Assess the reproducibility of the observation. METHODS Analysis of secondary outcomes collected prospectively in 3 similarly designed randomized controlled trials using water exchange, water immersion and insufflation (air or carbon dioxide). MAIN OUTCOME detection rates of adenomas and hyperplastic polyps in proximal, transverse and right colon (cecum-ascending). RESULTS 704 males (173 screening) were evaluated. In the proximal colon, WE showed increased detection of small adenomas (p=0.009) and adenomas plus hyperplastic polyps (p=0.015) (vs insufflation); increased detection of adenomas plus hyperplastic polyps of any size (p=0.045) and of small size (p=0.04) (vs water immersion). In the right colon water exchange increased detection of small adenomas (19% vs 12.1%, p=0.04) (vs insufflation); small adenomas (19% vs 12%, p=0.038), adenomas plus hyperplastic polyps of any size (25% vs 16.7%, p=0.028) and of small size (23.7% vs 14.6%, p=0.012) (vs water immersion). Water exchange significantly improved bowel cleanliness. Sedation had no impact on lesion detection. CONCLUSIONS Water exchange is a superior insertion technique for detection of adenomas and hyperplastic polyps primarily in the right colon, especially those of small size.
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Fruit and vegetable intakes and risk of colorectal cancer and incident and recurrent adenomas in the PLCO cancer screening trial.
Kunzmann, AT, Coleman, HG, Huang, WY, Cantwell, MM, Kitahara, CM, Berndt, SI
International journal of cancer. 2016;(8):1851-61
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The roles of fruits and vegetables in colorectal cancer development are unclear. Few prospective studies have assessed the association with adenoma, a known precursor to colorectal cancer. Our aim was to evaluate the association between fruit and vegetable intake and colorectal cancer development by evaluating the risk of incident and recurrent colorectal adenoma and colorectal cancer. Study participants were identified from the intervention arm of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Fruit and vegetable intake was measured using a self-reported dietary questionnaire. Total fruit and vegetable intake was not associated with reduced incident or recurrent adenoma risk overall, but a protective association was observed for multiple adenomas (Odds ratio 3rd tertile vs. 1st tertile = 0.61, 95% confidence interval (CI): 0.38, 1.00). Higher fruit and vegetable intakes were associated with a borderline reduced risk of colorectal cancer (Hazard ratio (HR) 3rd tertile vs. 1st tertile = 0.82, 95% CI: 0.67, 1.01), which reached significance amongst individuals with high processed meat intakes (HR = 0.74, 95% CI: 0.55, 0.99). Our results suggest that increased fruit and vegetable intake may protect against multiple adenoma development and may reduce the detrimental effects of high processed meat intakes on colorectal cancer risk.
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Conventional vs. waterjet-assisted endoscopic submucosal dissection in early gastric cancer: a randomized controlled trial.
Zhou, PH, Schumacher, B, Yao, LQ, Xu, MD, Nordmann, T, Cai, MY, Charton, JP, Vieth, M, Neuhaus, H
Endoscopy. 2014;(10):836-43
Abstract
BACKGROUND AND STUDY AIMS A hybrid knife was recently developed to allow waterjet-assisted endoscopic submucosal dissection, which aims to speed up and simplify the procedure. This technique has been shown to be effective and safe for the treatment of early gastric cancer (EGC) but it has not yet been compared with conventional ESD. PATIENTS AND METHODS In this two-center study, patients with an endoscopic and histopathological diagnosis of gastric adenoma or early gastric adenocarcinoma (meeting the extended Japanese criteria for local resection) were randomized to either conventional or waterjet-assisted ESD. The choice of knife was left to the endoscopist in the conventional group whereas the hybrid knife was used in the waterjet group. The primary end point was procedure time, and secondary outcomes included rates of en bloc resection, R0 resection, and complications. RESULTS A total of 117 patients (mean age 63.0 ± 10.6 years, 76 men) were randomized to either conventional ESD (n = 59; control group) or waterjet-assisted ESD (n = 58). There were no significant differences in patient demographics or lesion features between the groups. The mean procedure time was significantly shorter in the waterjet group compared with the conventional group (27.5 ± 30.6 vs. 35.0 ± 22.5 minutes; P = 0.0008), and a change of accessories was less frequently required (mean number of changes 1.4 ± 2.0 vs. 23.0 ± 15.4; P < 0.0001). There was no significant difference between the groups in the size of resected specimen, R0 resection rates, number of perforations, major delayed bleedings, or rates of complete remission of neoplasia after 3 months. CONCLUSIONS Waterjet-assisted ESD and conventional ESD are comparably effective and safe techniques for the local treatment of EGC. The waterjet-assisted technique is a faster and simpler procedure and requires fewer accessory changes compared with conventional ESD.
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A two-center randomized controlled trial of water-aided colonoscopy versus air insufflation colonoscopy.
Cadoni, S, Gallittu, P, Sanna, S, Fanari, V, Porcedda, ML, Erriu, M, Leung, FW
Endoscopy. 2014;(3):212-8
Abstract
BACKGROUND AND STUDY AIM Water-aided colonoscopy includes water immersion and water exchange. Several small single-center studies have suggested that the use of water rather than air insufflation during colonoscopy reduces pain on insertion. The aim of this study was to investigate whether water-aided colonoscopy is less painful than air insufflation in a large cohort of patients. PATIENTS AND METHODS This was a two-center, randomized controlled trial. Consecutive patients who agreed to start colonoscopy without premedication were included. Sedation was administered on demand. Water-aided colonoscopy was performed using water immersion in the early phase of the study, and subsequently water exchange was used. The primary endpoint was cecal intubation with pain scores of ≤ 2 and sedation with no or ≤ 2 mg midazolam. Secondary outcomes were pain score at discharge, cecal intubation rate and time, and adenoma detection rate (ADR). RESULTS A total of 672 patients were randomized to water exchange (n = 338) or air insufflation (n = 334). The primary endpoint was achieved in more patients in the water exchange group (83.8 % vs. 62 %; P < 0.0005). On-demand sedation was also required less (11.5 % vs. 26.0 %; P < 0.0005) and mean pain score was lower (1.3 vs. 2.3; P < 0.0005) in the water exchange group. The cecal intubation rates were comparable. Water exchange had a significantly higher overall ADR (25.8 % vs. 19.1 %; P = 0.041), proximal ADR (10.1 % vs. 4.8 %; P = 0.014), and proximal < 10 mm ADR (7.7 % vs. 3.9 %; P = 0.046); proximal ADR was also higher in screening-only patients in the water exchange group (18.9 % vs. 7.4 %; P = 0.015). No detailed analysis was possible for the air insufflation vs. water immersion comparison. CONCLUSION The current results confirmed that water exchange minimized the requirement for sedation and increased the ADR.
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The preventive effects of low-dose enteric-coated aspirin tablets on the development of colorectal tumours in Asian patients: a randomised trial.
Ishikawa, H, Mutoh, M, Suzuki, S, Tokudome, S, Saida, Y, Abe, T, Okamura, S, Tajika, M, Joh, T, Tanaka, S, et al
Gut. 2014;(11):1755-9
Abstract
OBJECTIVE To evaluate the influence of low-dose, enteric-coated aspirin tablets (100 mg/day for 2 years) on colorectal tumour recurrence in Asian patients with single/multiple colorectal tumours excised by endoscopy. DESIGN A double-blinded, randomised, placebo-controlled multicentre clinical trial was conducted. PARTICIPANTS 311 subjects with single/multiple colorectal adenomas and adenocarcinomas excised by endoscopy were enrolled in the study (152 patients in the aspirin group and 159 patients in the placebo group). Enrolment began at the hospitals (n=19) in 2007 and was completed in 2009. RESULTS The subjects treated with aspirin displayed reduced colorectal tumourigenesis and primary endpoints with an adjusted OR of 0.60 (95% CI 0.36 to 0.98) compared with the subjects in the placebo group. Subgroup analysis revealed that subjects who were non-smokers, defined as those who had smoked in the past or who had never smoked, had a marked reduction in the number of recurrent tumours in the aspirin-treated group. The adjusted OR for aspirin treatment in non-smokers was 0.37 (CI 0.21 to 0.68, p<0.05). Interestingly, the use of aspirin in smokers resulted in an increased risk, with an OR of 3.44. In addition, no severe adverse effects were observed in either group. CONCLUSIONS Low-dose, enteric-coated aspirin tablets reduced colorectal tumour recurrence in an Asian population. The results are consistent with those obtained from other randomised controlled trials in Western countries. THE CLINICAL TRIAL REGISTRY WEBSITE AND THE CLINICAL TRIAL NUMBER http://www.umin.ac.jp (number UMIN000000697).