Background & Aims Although the adenoma detection rate is used as a measure of colonoscopy quality, there are limited data on the quality of endoscopic resection of detected adenomas. We determined ...the rate of incompletely resected neoplastic polyps in clinical practice. Methods We performed a prospective study on 1427 patients who underwent colonoscopy at 2 medical centers and had at least 1 nonpedunculated polyp (5–20 mm). After polyp removal was considered complete macroscopically, biopsies were obtained from the resection margin. The main outcome was the percentage of incompletely resected neoplastic polyps (incomplete resection rate IRR) determined by the presence of neoplastic tissue in post-polypectomy biopsies. Associations between IRR and polyp size, morphology, histology, and endoscopist were assessed by regression analysis. Results Of 346 neoplastic polyps (269 patients; 84.0% men; mean age, 63.4 years) removed by 11 gastroenterologists, 10.1% were incompletely resected. IRR increased with polyp size and was significantly higher for large (10–20 mm) than small (5–9 mm) neoplastic polyps (17.3% vs 6.8%; relative risk = 2.1), and for sessile serrated adenomas/polyps than for conventional adenomas (31.0% vs 7.2%; relative risk = 3.7). The IRR for endoscopists with at least 20 polypectomies ranged from 6.5% to 22.7%; there was a 3.4-fold difference between the highest and lowest IRR after adjusting for size and sessile serrated histology. Conclusions Neoplastic polyps are often incompletely resected, and the rate of incomplete resection varies broadly among endoscopists. Incomplete resection might contribute to the development of colon cancers after colonoscopy (interval cancers). Efforts are needed to ensure complete resection, especially of larger lesions. ClinicalTrials.gov Number: NCT01224444.
Background Remote manipulation of wireless capsule endoscopes might improve diagnostic accuracy and facilitate therapy. Objective To test a new capsule-manipulation system. Setting University ...hospital. Design and Interventions A first-in-human study tested a new magnetic maneuverable wireless capsule in a volunteer. A wireless capsule endoscope was modified to include neodymium-iron-boron magnets. The capsule's magnetic switch was replaced with a thermal one and turned on by placing it in hot water. One imager was removed from the PillCam colon-based capsule, and the available space was used to house the magnets. A handheld external magnet was used to manipulate this capsule in the esophagus and stomach. The capsule was initiated by placing it in a mug of hot water. The capsule was swallowed and observed in the esophagus and stomach by using a gastroscope. Capsule images were viewed on a real-time viewer. Main Outcome Measurements The capsule was manipulated in the esophagus for 10 minutes. It was easy to make the capsule turn somersaults and to angulate at the cardioesophageal junction. In the stomach, it was easy to move the capsule back from the pylorus to the cardioesophageal junction and hold/spin the capsule at any position in the stomach. The capsule in the esophagus and stomach did not cause discomfort. Limitations Magnetic force varies with the fourth power of distance. Conclusions This study suggests that remote manipulation of a capsule in the esophagus and stomach of a human is feasible and might enhance diagnostic endoscopy as well as enable therapeutic wireless capsule endoscopy.
Secure and reliable endoscopic closure is of paramount importance before clinical introduction of transgastric natural orifice transluminal endoscopic surgery (NOTES). Gastrotomy closure in humans ...using standard endoclips has been reported. The aim of this study was to assess the safety of standard endoclip closure and to compare it to a new over-the-scope clip (OTSC) specifically designed for gastrotomy closure.
Gastric wall puncture and balloon dilation followed by peritoneoscopy was carried out in 20 female swine. After randomization, closure of the gastric incision was performed using a tissue approximation grasper and either endoclips or OTSCs.
Mean (+/- SD) time for gastrotomy closure using endoclips was 31.5 +/- 24.2 minutes (range 8 - 88 minutes) compared with 8.5 +/- 9.1 minutes (range 2 - 31 minutes) using OTSC (P = 0.002). No intraoperative complications occurred. Laparoscopic leak tests with insufflation and saline immersion demonstrated three minor leaks and one major leak in the endoclip closures. No leaks were observed in the OTSC group. At necropsy, complete sealing of the gastrotomy sites was found in all OTSC closures. Small, localized perigastric abscesses were observed in two animals in the OTSC group and in three animals in the endoclip group. One animal in the endoclip group was sacrificed prematurely due to signs of sepsis and was found to have gross peritonitis secondary to a leak. At necropsy, evidence of peritonitis was identified in two other animals in the endoclip group.
NOTES gastrotomy closure using standard endoclips, even with a tissue approximation grasper, is associated with an increased risk of leakage and intra-abdominal infection compared with OTSC. The significance of perigastric abscesses, which were seen in both groups, warrants further investigation.
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 .)
Bariatric surgery is associated with weight loss attributed to reduced caloric intake, mechanical changes, and alterations in gut hormones. However, some studies have suggested a heightened incidence ...of colorectal cancer (CRC) has been associated with bariatric surgery, emphasizing the importance of identifying mechanisms of risk. The objective of this study was to determine if bariatric surgery is associated with decreases in fecal short-chain fatty acids (SCFA), a group of bacterial metabolites of fiber. Fecal samples (n = 22) were collected pre- (~6 weeks) and post-bariatric surgery (~4 months) in patients undergoing Roux-en-Y gastric bypass and sleeve gastrectomy. SCFA levels were quantified using liquid chromatography/mass spectrometry. Dietary intake was quantified using 24-h dietary recalls. Using an aggregate variable, straight SCFAs significantly decreased by 27% from pre- to post-surgery, specifically acetate, propionate, butyrate, and valerate. Pre-surgery weight was inversely associated with butyrate, with no association remaining post-surgery. Multiple food groups were positively (sugars, milk, and red and orange vegetables) and inversely (animal protein) associated with SCFA levels. Our results suggest a potential mechanism linking dietary intake and SCFA levels with CRC risk post-bariatric surgery with implications for interventions to increase SCFA levels.
The Diagnosis of Gastroesophageal Reflux Disease Lacy, Brian E., PhD, MD; Weiser, Kirsten, MD, MPh; Chertoff, Jocelyn, MD, MS ...
The American journal of medicine,
07/2010, Letnik:
123, Številka:
7
Journal Article
Recenzirano
Abstract Background Gastroesophageal reflux disease is a highly prevalent condition that imposes a significant economic impact on the US health care system. The utility of commonly used tests for the ...diagnosis of gastroesophageal reflux disease has not been adequately reviewed. Methods A comprehensive review of the literature was undertaken to provide an evidence-based approach to the diagnosis of gastroesophageal reflux disease. EMBASE (1980-December 2008), OVID MEDLINE, and PubMed, (1966-December 2008) were searched using “gastroesophageal reflux” and “adults” with other terms, including medications, diagnostic tests, symptoms, and epidemiologic terms. Studies were limited to human trials, English language, and full articles. Results Heartburn is a reasonably sensitive symptom for the diagnosis of gastroesophageal reflux disease, although it does not reliably predict esophagitis. Standardized questionnaires have limited specificity, whereas the double-contrast barium swallow has a low sensitivity to diagnose gastroesophageal reflux. The role of esophageal manometry is limited to accurate placement of a pH-measuring device. pH testing has reasonable sensitivity and specificity for the diagnosis of gastroesophageal reflux disease. The sensitivity of upper endoscopy to diagnose gastroesophageal reflux is lower than that of pH tests. Conclusion The diagnosis of gastroesophageal reflux disease remains difficult. In the absence of alarm symptoms, empiric treatment with acid suppression is warranted. pH testing provides valuable information in many patients, although the clinical utility of newer tests needs to be determined. Endoscopy should not be the first test used to diagnose gastroesophageal reflux.
Background The Direct Drive Endoscopic System (DDES) is a multitasking platform developed to overcome the limitations of the currently available rigid and flexible endoscopic systems in application ...to natural orifice transluminal endoscopic surgery (NOTES), single-port laparoscopy, and advanced endoluminal procedures. The system consists of a 3-channel, steerable guide sheath accepting a 6-mm endoscope and two 4-mm articulating instruments. The system's overall design enables the interventionalist to operate instruments bimanually from a stable platform, conveying a laparoscopic paradigm to the functional working space at the distal end of the flexible guide sheath. Objective To assess the basic functionality of the DDES device in a series of defined exercises by using ex vivo porcine stomachs and 1 in vivo animal model. Design Ex vivo calibration and training exercises, including EMR, full-thickness suturing, and knot tying. Setting Animal laboratory. Interventions EMR, full-thickness suturing, and knot tying. Main Outcome Measurements Successful completion of specified tasks. Results Independent instrument movement with a wide range of motion allowed the interventionalist to perform several complex tasks efficiently. The DDES was able to (1) grasp tissue and hold it under tension, (2) cut through layers of porcine stomach in a controlled fashion, (3) suture, and (4) tie knots. Limitation Ex vivo study. Conclusions This novel multitasking platform demonstrated surgical functionality including triangulation, cutting, grasping, suturing, and knot tying. Preliminary results suggest that the DDES can perform complex endosurgical tasks that have traditionally been challenging or impossible with the standard endoscopic paradigm, and may enable NOTES, single-port laparoscopy, and complex endoluminal procedures.
Background The duodenojejunal bypass liner (DJBL) (EndoBarrier Gastrointestinal Liner) is an endoscopically placed and removable intestinal liner that creates a duodenojejunal bypass resulting in ...weight loss and improvement in type 2 diabetes mellitus. Objective Weight loss before bariatric surgery to decrease perioperative complications. Design Prospective, randomized, sham-controlled trial. Setting Multicenter, tertiary care, teaching hospitals. Patients Twenty-one obese subjects in the DJBL arm and 26 obese subjects in the sham arm composed the intent-to-treat population. Interventions The subjects in the sham arm underwent an EGD and mock implantation. Both groups received identical nutritional counseling. Main Outcome Measurements The primary endpoint was the difference in the percentage of excess weight loss (EWL) at week 12 between the 2 groups. Secondary endpoints were the percentage of subjects achieving 10% EWL, total weight change, and device safety. Results Thirteen DJBL arm subjects and 24 sham arm subjects completed the 12-week study. EWL was 11.9% ± 1.4% and 2.7% ± 2.0% for the DJBL and sham arms, respectively ( P < .05). In the DJBL arm, 62% achieved 10% or more EWL compared with 17% of the subjects in the sham arm ( P < .05). Total weight change in the DJBL arm was −8.2 ± 1.3 kg compared with −2.1 ± 1.1 kg in the sham arm ( P < .05). Eight DJBL subjects terminated early because of GI bleeding (n = 3), abdominal pain (n = 2), nausea and vomiting (n = 2), and an unrelated preexisting illness (n = 1). None had further clinical symptoms after DJBL explantation. Limitations Study personnel were not blinded. There was a lack of data on caloric intake. Conclusions The DJBL achieved endoscopic duodenal exclusion and promoted significant weight loss beyond a minimal sham effect in candidates for bariatric surgery. (Clinical trial registration number: NPT00469391 .)
Laboratory and epidemiological data suggest that folic acid may have an antineoplastic effect in the large intestine.
To assess the safety and efficacy of folic acid supplementation for preventing ...colorectal adenomas.
A double-blind, placebo-controlled, 2-factor, phase 3, randomized clinical trial conducted at 9 clinical centers between July 6, 1994, and October 1, 2004. Participants included 1021 men and women with a recent history of colorectal adenomas and no previous invasive large intestine carcinoma.
Participants were randomly assigned in a 1:1 ratio to receive 1 mg/d of folic acid (n = 516) or placebo (n = 505), and were separately randomized to receive aspirin (81 or 325 mg/d) or placebo. Follow-up consisted of 2 colonoscopic surveillance cycles (the first interval was at 3 years and the second at 3 or 5 years later).
The primary outcome measure was occurrence of at least 1 colorectal adenoma. Secondary outcomes were the occurrence of advanced lesions (> or =25% villous features, high-grade dysplasia, size > or =1 cm, or invasive cancer) and adenoma multiplicity (0, 1-2, or > or =3 adenomas).
During the first 3 years, 987 participants (96.7%) underwent colonoscopic follow-up, and the incidence of at least 1 colorectal adenoma was 44.1% for folic acid (n = 221) and 42.4% for placebo (n = 206) (unadjusted risk ratio RR, 1.04; 95% confidence interval CI, 0.90-1.20; P = .58). Incidence of at least 1 advanced lesion was 11.4% for folic acid (n = 57) and 8.6% for placebo (n = 42) (unadjusted RR, 1.32; 95% CI, 0.90-1.92; P = .15). A total of 607 participants (59.5%) underwent a second follow-up, and the incidence of at least 1 colorectal adenoma was 41.9% for folic acid (n = 127) and 37.2% for placebo (n = 113) (unadjusted RR, 1.13; 95% CI, 0.93-1.37; P = .23); and incidence of at least 1 advanced lesion was 11.6% for folic acid (n = 35) and 6.9% for placebo (n = 21) (unadjusted RR, 1.67; 95% CI, 1.00-2.80; P = .05). Folic acid was associated with higher risks of having 3 or more adenomas and of noncolorectal cancers. There was no significant effect modification by sex, age, smoking, alcohol use, body mass index, baseline plasma folate, or aspirin allocation.
Folic acid at 1 mg/d does not reduce colorectal adenoma risk. Further research is needed to investigate the possibility that folic acid supplementation might increase the risk of colorectal neoplasia.
clinicaltrials.gov Identifier: NCT00272324.
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