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Effect of Different Modalities of Purgative Preparation on the Diagnostic Yield of Small Bowel Capsule for the Exploration of Suspected Small Bowel Bleeding: A Multicenter Randomized Controlled Trial.
Rahmi, G, Cholet, F, Gaudric, M, Filippi, J, Duburque, C, Bramli, S, Quentin, V, Alavi, Z, Nowak, E, Saurin, JC, et al
The American journal of gastroenterology. 2022;(2):327-335
Abstract
INTRODUCTION The aim of our study was to compare clear liquid diet with 2 different polyethylene glycol (PEG)-based bowel preparation methods regarding diagnostic yield of small bowel capsule endoscopy (SBCE) in patients with suspected small bowel bleeding (SBB). METHODS In this prospective multicenter randomized controlled trial, consecutive patients undergoing SBCE for suspected SBB between September 2010 and February 2016 were considered. Patients were randomly assigned to standard regimen, that is, clear fluids only (prep 1), standard regimen plus 500 mL PEG after SBCE ingestion (prep 2), or standard regimen plus 2 L PEG plus 500 mL PEG after SBCE ingestion (prep 3). The primary outcome was the detection of at least one clinically significant lesion in the small bowel. The quality of small bowel cleansing was assessed. A questionnaire on the clinical tolerance was filled by the patients. RESULTS We analyzed 834 patients. No significant difference was observed for detection of P1 or P2 small bowel lesions between prep1 group (40.5%), prep 2 group (40.2%), and prep 3 group (38.5%). Small bowel cleansing was improved in prep 2 and 3 groups compared with that in prep 1 group. Compliance to the preparation and tolerance was better in prep 2 group than in prep 3 group. DISCUSSION Small bowel purgative before SBCE allowed better quality of cleansing. However, it did not improve diagnostic yield of SBCE for suspected SBB.
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The Use of a PEG/Ascorbate Booster Following Standard Bowel Preparation Improves Visualization for Capsule Endoscopy in a Randomized, Controlled Study.
Mascarenhas-Saraiva, MJ, Oliveira, E, Mascarenhas-Saraiva, MN
The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology. 2021;(5):437-442
Abstract
BACKGROUND/AIMS: The increasing use of capsule endoscopy (CE) to examine the gastrointestinal tract highlights the need to establish intestinal preparations that ensure optimal visualization while maximizing patient adherence. Thus, we assessed whether bowel preparation involving dietary restriction and a booster regimen produces adequate CE visualization in a real-world clinical setting. METHODS We conducted a randomized, double-blind, prospective study of CE procedures at 2 tertiary-care centers. Patients were allocated to 3 groups: group 1 followed a clear liquid diet and fasting-based bowel preparation for the exploration (n = 55); group 2 followed the same procedure as group 1 and then ingested 1 L of a polyethylene glycol (PEG)/ascorbic acid booster solution when the capsule reached the small intestine (n = 55); and group 3 followed the same procedure but ingesting only 0.5 L of the booster solution (n = 56). The quality of visualization and the average gastric, orocecal and small-bowel transit times were evaluated. RESULTS A total of 166 patients participated in the study. Significantly higher quality of visualization (Park score) was obtained in group 3 (2.28 ± 0.59) than in group 1 (1.84 ± 0.54, P < .001), while there were no significant differences in the average gastric (range: 36.58- 48.32 min, P = .277), orocecal (range: 322.58-289.45 min, P = .072), and small-bowel transit time (range: 280.71-249.95 min, P = .286) between the 3 groups. CONCLUSIONS Following a clear liquid diet and fasting-based bowel preparation for CE exploration, administering a booster solution of PEG/ascorbic acid after the capsule had reached the small intestine improves mucosal visualization and cleansing without affecting capsule transit times.
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Daprodustat Compared with Epoetin Beta Pegol for Anemia in Japanese Patients Not on Dialysis: A 52-Week Randomized Open-Label Phase 3 Trial.
Nangaku, M, Hamano, T, Akizawa, T, Tsubakihara, Y, Nagai, R, Okuda, N, Kurata, K, Nagakubo, T, Jones, NP, Endo, Y, et al
American journal of nephrology. 2021;(1):26-35
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Abstract
BACKGROUND Daprodustat is an oral agent that stimulates erythropoiesis by inhibiting the prolyl hydroxylases which mark hypoxia-inducible factor for degradation through hydroxylation. Its safety and efficacy (noninferiority) were assessed in this 52-week, open-label study. METHODS Japanese patients not on dialysis (ND) (N = 299) with anemia of CKD (stages G3, G4, and G5) with iron parameters of ferritin >100 ng/mL or transferrin saturation >20% at screening were randomized to daprodustat or epoetin beta pegol (continuous erythropoietin receptor activator [CERA], also known as methoxy polyethylene glycol-epoetin beta). After initiation of the study, the daprodustat starting dose for erythropoiesis-stimulating agent (ESA)-naïve participants was revised, and daprodustat was started at 2 or 4 mg once daily depending on baseline hemoglobin. ESA users switched to daprodustat 4 mg once daily. CERA was started at 25 μg every 2 weeks for ESA-naïve patients and 25-250 μg every 4 weeks for ESA users based on previous ESA dose. In both treatment groups, dose was adjusted every 4 weeks based on hemoglobin level and changed according to a prespecified algorithm. The primary endpoint was mean hemoglobin level during weeks 40-52 in the intention-to-treat (ITT) population. ESA-naïve patients who entered before the protocol amendment revising the daprodustat starting dose were excluded from the ITT population. RESULTS Mean hemoglobin levels during weeks 40-52 were 12.0 g/dL in the daprodustat group (n = 108; 95% confidence interval [CI], 11.8-12.1) and 11.9 g/dL for CERA (n = 109; 95% CI 11.7-12.0); the difference between the groups was 0.1 g/dL (95% CI -0.1 to 0.3 g/dL). The lower limit of the 95% CI of the difference was greater than the prespecified margin of -1.0 g/dL. The mean hemoglobin level was within the target range (11.0-13.0 g/dL) during weeks 40-52 for 92% of participants in both groups. There was no meaningful difference in the frequencies of adverse events. CONCLUSIONS Oral daprodustat was noninferior to CERA in achieving and maintaining target hemoglobin levels in Japanese ND patients. Daprodustat was well tolerated, with no new safety concerns identified.
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A Randomized Trial Comparing the Bowel Cleansing Efficacy of Sodium Picosulfate/Magnesium Citrate and Polyethylene Glycol/Bisacodyl (The Bowklean Study).
Hung, SY, Chen, HC, Chen, WT
Scientific reports. 2020;(1):5604
Abstract
Bowel cleansing is essential for a successful colonoscopy, but the ideal clearing agent and the volume have yet to be determined. A small-volume cleanser is important for patient compliance. This study aimed to compare the bowel cleansing efficacy, safety, tolerability, and acceptability of a 300-mL small-volume sodium picosulfate/magnesium citrate (PSMC) preparation-Bowklean with one 2-L polyethylene glycol (PEG)/bisacodyl-Klean-Prep/Dulcolax preparation under identical dietary recommendations. This multicenter, randomized, parallel-group, pre-specified noninferiority study enrolled 631 outpatients scheduled to undergo colonoscopy (Bowklean = 316 and Klean-Prep/Dulcolax = 315). After bowel preparation, an independent evaluator blinded to the subject's treatment allocation rated the quality of the colon cleansing. Efficacy was evaluated using the Aronchick Scale and Ottawa Bowel Preparation Scale (OPBS). Safety was assessed by monitoring adverse events. Tolerability and acceptability were measured via a patient questionnaire. Bowklean was non-interior to Klean-Prep/Dulcolax in overall colon cleansing but was associated with significantly better preparation quality. Notably, Bowklean was associated with significantly greater tolerability and acceptability of bowel preparations than Klean-Prep/Dulcolax. Safety profiles did not differ significantly between the groups. Our data indicate that Bowklean is a more effective and better-tolerated bowel cleansing preparation before colonoscopy than Klean-Prep/Dulcolax. Bowklean may therefore increase positive attitudes toward colonoscopies and participation rates.
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The Titanium-coated PEEK Cage Maintains Better Bone Fusion With the Endplate Than the PEEK Cage 6 Months After PLIF Surgery: A Multicenter, Prospective, Randomized Study.
Hasegawa, T, Ushirozako, H, Shigeto, E, Ohba, T, Oba, H, Mukaiyama, K, Shimizu, S, Yamato, Y, Ide, K, Shibata, Y, et al
Spine. 2020;(15):E892-E902
Abstract
STUDY DESIGN A multicenter, randomized, open-label, parallel-group trial. OBJECTIVE To investigate interbody bone fusion rates in titanium-coated polyetheretherketone (TiPEEK) and polyetheretherketone (PEEK) cages after posterior lumbar interbody fusion (PLIF) surgery. SUMMARY OF BACKGROUND DATA Previous clinical studies have not revealed any significant difference in bone fusion rates between TiPEEK and PEEK cages. METHODS During one-level PLIF surgery, 149 patients (84 men, 65 women, mean age 67 yr) were randomly allocated to use either a TiPEEK cage (n = 69) or PEEK cage (n = 80). Blinded radiographic evaluations were performed using computed tomography and assessed by modified intention-to-treat analysis in 149 cases and per-protocol analysis in 143 cases who were followed for 12 months. Clinical outcomes were assessed using the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and the Oswestry Disability Index. RESULTS The interbody union rate at 12 months after surgery was 45% owing to a very strict definition of bone fusion. The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted modified intention-to-treat analysis and were significantly higher at 6 months in the unadjusted per-protocol analysis. Binary logistic regression analysis adjusted for sex, age, body mass index, bone mineral density, and surgical level showed that using a TiPEEK cage (odds ratio, 2.27; 95% confidence interval: 1.09-4.74; P = 0.03) was independently associated with bone fusion at 6 months after surgery. Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and Oswestry Disability Index results improved postoperatively in both groups. CONCLUSION Using the TiPEEK cage for PLIF enabled the maintenance of better bone fusion to the endplate than using the PEEK cage at 6 months after the surgery. Our findings suggest the possibility of an earlier return to rigorous work or sports by the use of TiPEEK cage. LEVEL OF EVIDENCE 1.
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The advantage of polyethylene glycol electrolyte solution combined with lactulose in patients with long interval preparation-to-colonoscopy.
Yuanchao, H, Xueping, L, Tao, L, Jianping, N, Man, M
The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology. 2020;(1):23-29
Abstract
BACKGROUND/AIMS: The main aim of the present study was to assess the efficacy of polyethylene glycol electrolyte (PEG) solution combined with lactulose in bowel preparation to find a new method for colonoscopy preparation to improve the quality of colonoscopy in patients with long interval preparation-to-colonoscopy (P-C). MATERIALS AND METHODS A prospective, randomized, endoscopist-blinded and placebo-controlled study was conducted. Three hundred sixty patients who were scheduled for colonoscopy were enrolled in the study. They were randomly divided into the PEG-lactulose group and the PEG-placebo group with 180 patients per arm. Two of the most common methods for estimating the quality of bowel preparation were the use of the Boston Bowel Preparation Scale and the measurement of the Bubble Scale and adenoma detection rate (ADR) as a secondary outcome of observation. RESULTS The PEG-lactulose group had a significant improvement in the quality of bowel preparation compared with the PEG-placebo group including colon cleanliness in interval P-C at 8 and 9 h (p<0.05) and bubble elimination in interval P-C at 5, 6, 7, 8, and 9 h (p<0.05). Compared with the PEG-placebo group, the ADR (23.3% vs. 15.0%, p<0.05) and the size (≤5 mm) of the adenoma (45.2% vs. 18.5%, p<0.05) increased in the PEG-lactulose group, and there were significant differences between the two groups. CONCLUSION PEG solution combined with lactulose can improve the quality of colonoscopy in patients with long interval P-C to allow the patients to select more flexible colonoscopy time. It is worth further popularizing in clinical practice.
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Can a 1-day clear liquid diet with a split -dose polyethylene glycol overcome conventional practice patterns during the preparation for screening colonoscopy?
Özer Etik, D, Suna, N, Gündüz, C, Bostan, A, Özdemir, A, Gürel, BY, Yenişekerci, E, Boyacıoğlu, AS
The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology. 2019;(9):817-825
Abstract
BACKGROUND/AIMS: A successful screening colonoscopy is closely linked to the quality of a bowel preparation. In this study, we aimed to determine the impact of a 1-day clear liquid diet (CLD) compared to a 3-day combined diet (CMD) accompanied by a split-dose regimen of polyethylene glycol and electrolyte lavage solution (PEG-ELS) for screening colonoscopy. MATERIALS AND METHODS This was a prospective, randomized, endoscopist-blinded study. Patients referred for screening colonoscopy were randomized to four groups as a 1-day CLD+PEG-ELS vs. a 1-day CLD+sulfate free (SF)-PEG-ELS and a 3-day CMD+PEG-ELS vs. a 3-day CMD+SF-PEG-ELS. An assessment of the quality of colon cleaning, tolerability to the preparation, and symptoms related to the preparation were recorded. RESULTS A total of 506 patients were enrolled in this study. The quality of bowel preparation was significantly inferior in the CMD+PEG-ELS group than CLD+PEG-ELS (p=0.004) and CMD+SF-PEG-ELS groups (p=0.007). There were no statistical differences among the groups in terms of the polyp detection rate. With respect to an easy rating of diet following and the consumption of laxative, there were no significant differences among the four groups. Gastric fullness and nausea/vomiting were pointed out much more, especially in the SF-PEG-ELS users (p=0.008 and p=0.004, respectively). CONCLUSION A 1-day CLD was not inferior to a 3-day CMD for colonoscopy preparation in terms of bowel cleaning, the polyp detection rate, and patient tolerance.
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Plasma asparaginase activity and asparagine depletion in acute lymphoblastic leukemia patients treated with pegaspargase on Children's Oncology Group AALL07P4.
Schore, RJ, Devidas, M, Bleyer, A, Reaman, GH, Winick, N, Loh, ML, Raetz, EA, Carroll, WL, Hunger, SP, Angiolillo, AL
Leukemia & lymphoma. 2019;(7):1740-1748
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Abstract
The efficacy of asparaginase in acute lymphoblastic leukemia (ALL) is dependent on depletion of asparagine, an essential amino acid for ALL cells. The target level of plasma asparaginase activity to achieve asparagine depletion has been between 0.05 and 0.4 IU/mL. COG AALL07P4 examined the asparaginase activity and plasma and CSF asparagine concentration of pegaspargase when given intravenously in the treatment of NCI high risk ALL. Matched plasma asparaginase/asparagine levels of the clearance of 54 doses of pegaspargase given in induction or consolidation demonstrated that all patients who had a plasma asparaginase level >0.02 IU/mL had undetectable plasma asparagine. No difference was observed in CSF asparagine levels associated with matched plasma asparaginase levels of 0.02-0.049 versus 0.05-0.22 IU/mL (p = .25). Our data suggest that a plasma asparaginase activity level of 0.02 IU/mL can effectively deplete plasma asparagine. The data also indicate that the 95% CI for plasma asparagine depletion after a pegaspargase dose is 22-29 days. Clinical trial registration: clinicaltrials.gov identifier NCT00671034.
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Impact of a 1-day versus 3-day low-residue diet on bowel cleansing quality before colonoscopy: a randomized controlled trial.
Gimeno-García, AZ, de la Barreda Heuser, R, Reygosa, C, Hernandez, A, Mascareño, I, Nicolás-Pérez, D, Jiménez, A, Lara, AJ, Alarcon-Fernández, O, Hernandez-Guerra, M, et al
Endoscopy. 2019;(7):628-636
Abstract
BACKGROUND The aim of this study was to assess whether a 3-day low-residue diet (LRD) improved bowel cleansing quality compared with a 1-day LRD regimen. METHODS Consecutive patients scheduled for outpatient colonoscopy were randomized to the 1-day LRD or 3-day LRD groups. All patients received a 2-L split-dose of polyethylene glycol plus ascorbic acid. The primary outcome was bowel cleansing quality as evaluated using the Boston Bowel Preparation Scale (BBPS) (adequate cleansing ≥ 2 points per segment). Secondary outcomes were adherence to and level of satisfaction with the LRD, difficulty following the dietary recommendations, and willingness to repeat the same LRD in the future. Intention-to-treat (ITT) and per-protocol (PP) analyses were conducted for the primary outcome. A superiority analysis was performed to demonstrate that a 3-day LRD regimen was superior to a 1-day LRD regimen with a margin of 10 %. RESULTS 390 patients (1-day LRD group = 196, 3-day LRD = 194) were included. The cleansing quality was not significantly different between the groups: ITT analysis 82.7 % (95 % confidence interval [CI] 77.4 to 88.0) vs. 85.6 % (95 %CI 80.7 to 90.5), with odds ratio (OR) 1.2 (95 %CI 0.72 to 2.15); PP analysis 85.0 % (95 %CI 79.9 to 90.1) vs. 88.6 % (95 %CI 84.0 to 93.2), with OR 1.4 (95 %CI 0.88 to 2.52). No differences were found regarding adherence to the diet or cleansing solution, satisfaction or difficulty with the LRD, and the polyp/adenoma detection rates. CONCLUSION 3-day LRD did not offer advantages over 1-day LRD in preparation for colonoscopy.
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Bowel preparation for small bowel capsule endoscopy - The later, the better!
Xavier, S, Rosa, B, Monteiro, S, Arieira, C, Magalhães, R, Cúrdia Gonçalves, T, Boal Carvalho, P, Magalhães, J, Moreira, MJ, Cotter, J
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2019;(10):1388-1391
Abstract
BACKGROUND In small bowel capsule endoscopy (SBCE), the presence of residue may compromise diagnostic accuracy. AIMS To assess differences in quality of visualisation and diagnostic yield of SBCE using 3 different preparation protocols. METHODS Prospective, randomized, blind, pilot study. Protocol A:Clear liquids diet the day before the examination with fasting from 8p.m.; Protocol B:Protocol A + 2 pouches of Moviprep®(polyethylene glycol electrolyte solution + sodium ascorbate) in 1 L of water from 8p.m. of the day before the examination; Protocol C: Protocol A + 2 pouches of Moviprep® in 1 L of water consumed after real-time confirmation of capsule arrival at small bowel. Small bowel preparation was classified by two experienced physicians, considering the percentage of the examination during which mucosal observation was adequate: Excellent(>90%); Good(90-75%); Fair(75-50%); Poor(<50%). RESULTS 101 patients randomized to the 3 protocols (A 37, B 31, C 33 patients). Protocol C had an excellent/good small bowel preparation in a higher percentage of examinations for both readers(Reader 1-A:37.8% vs B:45.2% vs C:78.8%, p = 0.002 and Reader 2 -A:37.8% vs B:41.9% vs C:75.8%, p = 0.003). Also, protocol C had a higher detection of angioectasia (A:5.4% vs B:9.7% vs C:27.3%, p = 0.022). CONCLUSIONS The administration of Moviprep® after the capsule had reached the small bowel was associated with a better small bowel preparation and a higher detection of angioectasia.