Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
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Clin. Gastroenterol. Hepatol. · Jan 2017
Randomized Controlled Trial Multicenter StudyVigorous Periprocedural Hydration With Lactated Ringer's Solution Reduces the Risk of Pancreatitis After Retrograde Cholangiopancreatography in Hospitalized Patients.
Vigorous intravenous fluid resuscitation (IVFR) was reported to reduce post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in a pilot study. We performed a randomized, double-blind controlled trial to establish whether periprocedural vigorous IVFR reduces the risk of post-ERCP pancreatitis. ⋯ In a double-blind, randomized controlled trial, we found vigorous periprocedural intravenous hydration with lactated Ringer's solution to reduce the incidence and severity of post-ERCP pancreatitis in average-risk and high-risk cases. IVFR is not associated with increased adverse events. ClinicalTrials.gov number: NCT02308891.
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Clin. Gastroenterol. Hepatol. · Nov 2015
Randomized Controlled Trial Comparative StudyWater Exchange Is the Least Painful Colonoscope Insertion Technique and Increases Completion of Unsedated Colonoscopy.
Unsedated colonoscopy is acceptable for diagnostic, surveillance, and screening indications worldwide. However, insertion of the colonoscope can be painful; it is not clear which technique is least painful and thereby increases the likelihood of colonoscopy completion. We performed a head-to-head comparison of air insufflation (AI), carbon dioxide (CO2) insufflation, water immersion (WI), and water exchange (WE) to determine which combination of insertion techniques produces the least amount of pain. ⋯ In a prospective study of colonoscopy insertion methods, CO2 insufflation did not reduce real-time maximum insertion pain. Compared with AI or CO2, WI and WE reduced insertion pain. The least painful technique was WE, which significantly increased completion of unsedated colonoscopy and bowel cleanliness without prolonging insertion time. ClinicalTrials.gov number: NCT01954862.
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Clin. Gastroenterol. Hepatol. · Feb 2015
Randomized Controlled TrialLubiprostone increases spontaneous bowel movement frequency and quality of life in patients with chronic idiopathic constipation.
Lubiprostone is an activator of the type 2 chloride channel that facilitates spontaneous bowel movement (SBM). We performed phase 3 studies to determine whether lubiprostone increases the frequency of SBM in patients with chronic idiopathic constipation (CIC) in Japan, and whether long-term administration of lubiprostone increases the quality of life of patients with CIC. ⋯ In phase 3 studies in Japan, lubiprostone increased the weekly average number of SBMs and increased the quality of life of patients with CIC. Clinical Trial Notification of the Japanese Regulatory Authorities: 20-3296 and 20-3300.
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Clin. Gastroenterol. Hepatol. · Dec 2014
Randomized Controlled TrialResveratrol does not benefit patients with nonalcoholic fatty liver disease.
Nonalcoholic fatty liver disease (NAFLD), characterized by accumulation of hepatic triglycerides (steatosis), is associated with abdominal obesity, insulin resistance, and inflammation. Although weight loss via calorie restriction reduces features of NAFLD, there is no pharmacologic therapy. Resveratrol is a polyphenol that prevents high-energy diet-induced steatosis and insulin resistance in animals by up-regulating pathways that regulate energy metabolism. We performed a placebo-controlled trial to assess the effects of resveratrol in patients with NAFLD. ⋯ Eight weeks administration of resveratrol did not significantly improve any features of NAFLD, compared with placebo, but it increased hepatic stress, based on observed increases in levels of liver enzymes. Further studies are needed to determine whether agents that are purported to mimic calorie restriction, such as resveratrol, are safe and effective for complications of obesity. Clinical trials registration no: ACTRN12612001135808.
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Clin. Gastroenterol. Hepatol. · Dec 2014
Randomized Controlled TrialThe fatty acid-bile acid conjugate Aramchol reduces liver fat content in patients with nonalcoholic fatty liver disease.
We investigated the effects of the fatty acid-bile acid conjugate 3β-arachidyl-amido, 7α-12α-dihydroxy, 5β-cholan-24-oic acid (Aramchol; Trima Israel Pharmaceutical Products Ltd, Maabarot, Israel) in a phase 2 trial of patients with nonalcoholic fatty liver disease (NAFLD). ⋯ Three months' administration of the fatty acid-bile acid conjugate Aramchol is safe, tolerable, and significantly reduces liver fat content in patients with NAFLD. The reduction in liver fat content occurred in a dose-dependent manner and was associated with a trend of metabolic improvements, indicating that Aramchol might be used for the treatment of fatty liver disease. ClinicalTrials.gov number: NCT01094158.