Summary Background The safety and short-term efficacy of laparoscopic surgery for rectal cancer after preoperative chemoradiotherapy has not been demonstrated. The aim of the randomised Comparison of ...Open versus laparoscopic surgery for mid and low REctal cancer After Neoadjuvant chemoradiotherapy (COREAN) trial was to compare open surgery with laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy. Methods Between April 4, 2006, and Aug 26, 2009, patients with cT3N0–2 mid or low rectal cancer without distant metastasis after preoperative chemoradiotherapy were enrolled at three tertiary-referral hospitals. Patients were randomised 1:1 to receive either open surgery (n=170) or laparoscopic surgery (n=170), stratified according to sex and preoperative chemotherapy regimen. Short-term outcomes assessed were involvement of the circumferential resection margin, macroscopic quality of the total mesorectal excision specimen, number of harvested lymph nodes, recovery of bowel function, perioperative morbidity, postoperative pain, and quality of life. Analyses were based on the intention-to-treat population. Patients continue to be followed up for the primary outcome (3-year disease-free survival). This study is registered with ClinicalTrials.gov , number NCT00470951. Findings Two patients (1·2%) in the laparoscopic group were converted to open surgery, but were included in the laparoscopic group for analyses. Estimated blood loss was less in the laparoscopic group than in the open group (median 217·5 mL 150·0–400·0 in the open group vs 200·0 mL 100·0–300·0 in the laparoscopic group, p=0·006), although surgery time was longer in the laparoscopic group (mean 244·9 min SD 75·4 vs 197·0 min 62·9, p<0·0001). Involvement of the circumferential resection margin, macroscopic quality of the total mesorectal excision specimen, number of harvested lymph nodes, and perioperative morbidity did not differ between the two groups. The laparoscopic surgery group showed earlier recovery of bowel function than the open surgery group (time to pass first flatus, median 38·5 h 23·0–53·0 vs 60·0 h 43·0–73·0, p<0·0001; time to resume a normal diet, 85·0 h 66·0–95·0 vs 93·0 h 86·0–121·0, p<0·0001; time to first defecation, 96·5 h 70·0–125·0 vs 123 h 94·0–156·0, p<0·0001). The total amount of morphine used was less in the laparoscopic group than in the open group (median 107·2 mg 80·0–150·0 vs 156·9 mg 117·0–185·2, p<0·0001). 3 months after proctectomy or ileostomy takedown, the laparoscopic group showed better physical functioning score than the open group (0·501 n=122 vs −4·970 n=128, p=0·0073), less fatigue (−5·659 n=122 vs 0·098 n=129, p=0·0206), and fewer micturition (−2·583 n=122 vs 4·725 n=129, p=0·0002), gastrointestinal (−0·400 n=122 vs 4·331 n=129, p=0·0102), and defecation problems (0·535 n=103 vs 5·327 n=99, p=0·0184) in repeated measures analysis of covariance, adjusted for baseline values. Interpretation Laparoscopic surgery after preoperative chemoradiotherapy for mid or low rectal cancer is safe and has short-term benefits compared with open surgery; the quality of oncological resection was equivalent. Funding The National Cancer Center, South Korea.
Objectives We performed this study to determine the optimal intravascular ultrasound (IVUS) criteria and to evaluate their accuracy for defining the functional significance of intermediate coronary ...stenoses in different locations of the coronary tree. Background Presence of myocardial ischemia is the most important prognostic factor in patients with coronary artery disease and is determined by both the lesion severity and the amount of myocardium supplied. Methods IVUS and fractional flow reserve (FFR) measurements were performed in 267 intermediate lesions located at the proximal or mid part of major epicardial coronary arteries. Optimal IVUS criteria and their diagnostic accuracy for functionally significant stenoses (FFR <0.8) were assessed. Results FFR was <0.8 in 88 lesions (33%). The determinants of FFR were minimum lumen area (MLA) and lesion location. The diagnostic accuracy of MLA was highly variable according to the location of lesions. The best cutoff value of MLA to define the functional significance was 3.0 mm2 (area under the curve AUC: 0.81, 95% confidence interval CI: 0.68 to 0.91) for proximal left anterior descending artery (LAD) lesions and 2.75 mm2 for mid-LAD lesions located before the second diagonal branch (AUC: 0.76, 95% CI: 0.66 to 0.84). However, the appropriate MLA to predict the functional significance of lesions could not be found in other segments. Conclusions When IVUS parameters are used to determine the functional significance of lesions in patients with intermediate coronary artery stenoses, different criteria should be used according to lesion location. In segments or vessels with anatomic variations, IVUS cannot be used for functional assessment of a stenosis. (Comparison of Fractional Flow Reserve and Intravascular Ultrasound; NCT01133015 )
Abstract Background context Superior vena cava (SVC) obstruction can cause the development of collateral vessels. During contrast-enhanced thoracic computed tomography (CT), contrast material may ...reflux into the collaterals such as paravertebral venous plexus. However, an unusual pseudopathologic vertebral body enhancement on CT in the presence of SVC obstruction has not been studied previously. Purpose To demonstrate clinical presentation and imaging findings of pseudopathologic vertebral body enhancement in patients with SVC obstruction. Study design Retrospective study of diagnostic CT images examined at our clinic. Patient sample From March, 2009 to September, 2012, a retrospective radiologic database review was performed to identify patients with obstruction of SVC causing contrast reflux into collateral vessels and presented with an unusual vertebral body enhancement on thoracic CT. Thirteen patients (11 men, mean age 51.4 years) with vertebral body enhancement were enrolled. Outcome measures Enhancement patterns of vertebral bodies were classified as nodular enhancement with round shape occupying less than one-third of vertebral body or polygonal enhancement occupying greater than or equal to one-third of vertebral body on axial image. The locations of enhanced areas within vertebral bodies were described using right lateral/central/left lateral, anterior/posterior, and upper/middle/lower in the x-, y-, or z-axis directions, respectively. Materials and methods Enhancement patterns, locations, and the presence of a connection between vertebral body enhancement and the paravertebral venous plexus were evaluated. Results A total of 39 vertebral body enhancements were found in the 13 patients, involving cervical (n=12), thoracic (n=25), or lumbar (n=2) vertebrae. Vertebral body enhancements showed a nodular (n=19) or a polygonal (n=20) pattern. The central portions of vertebral bodies were more frequently involved. The connection to the paravertebral venous plexus was observed in 34 lesions (87.2%). Conclusions Patients with SVC obstruction with extensive collateral vessels might exhibit a pseudopathologic vertebral enhancement. They tended to involve the central portion of the vertebral body, and most of them showed connection to the paravertebral venous plexus.
Objectives This study sought to determine whether computational modeling can be used to predict the functional outcome of coronary stenting by virtual stenting of ischemia-causing stenoses identified ...on the pre-treatment model. Background Computed tomography (CT)-derived fractional flow reserve (FFR) is a novel noninvasive technology that can provide computed (FFR ct ) using standard coronary CT angiography protocols. Methods We prospectively enrolled 44 patients (48 lesions) who had coronary CT angiography before angiography and stenting, and invasively measured FFR before and after stenting. FFR ct was computed in blinded fashion using coronary CT angiography and computational fluid dynamics before and after virtual coronary stenting. Virtual stenting was performed by modification of the computational model to restore the area of the target lesion according to the proximal and distal reference areas. Results Before intervention, invasive FFR was 0.70 ± 0.14 and noninvasive FFR ct was 0.70 ± 0.15. FFR after stenting and FFR ct after virtual stenting were 0.90 ± 0.05 and 0.88 ± 0.05, respectively (R = 0.55, p < 0.001). The mean difference between FFR ct and FFR was 0.006 for pre-intervention (95% limit of agreement: –0.27 to 0.28) and 0.024 for post-intervention (95% limit of agreement: –0.08 to 0.13). Diagnostic accuracy of FFR ct to predict ischemia (FFR ≤0.8) prior to stenting was 77% (sensitivity: 85.3%, specificity: 57.1%, positive predictive value: 83%, and negative predictive value: 62%) and after stenting was 96% (sensitivity: 100%, specificity: 96% positive predictive value: 50%, and negative predictive value: 100%). Conclusions Virtual coronary stenting of CT-derived computational models is feasible, and this novel noninvasive technology may be useful in predicting functional outcome after coronary stenting. (Virtual Coronary Intervention and Noninvasive Fractional Flow Reserve FFR; NCT01478100 )
Objectives The object of this study was to introduce the KORean Observational study Network for Arthritis (KORONA) registry with an emphasis on the design of the Korean rheumatoid arthritis (RA) ...national database, as well as to provide an overview of the RA patients who are currently registered in KORONA. Methods The KORONA was established in July 2009 by the Clinical Research Center for Rheumatoid Arthritis (CRCRA) in South Korea. KORONA is based on a prospective protocol and standard, defined data collection instruments. Demographic and clinical features, laboratory and radiologic data, health-related outcomes, treatment side effects, resource utilization, and health behaviors of the RA cohort patients are recorded in a database. Results A total of 23 institutions, which are about 38% of the rheumatologic departments at tertiary academic hospitals across South Korea, are part of KORONA. The quality control of data collection and management has been performed through annual monitoring and auditing, staff training, and providing standard operation protocol by the executive committee of CRCRA. As of 31 December 2010, 4721 patients with established RA were included in KORONA, because an annual survey had started to be performed in July 2010. Conclusions KORONA is the first nationwide Korean RA-specific cohort and it will provide valuable “real-world” information for Korean RA patients.
Summary Background Compared with open resection, laparoscopic resection of rectal cancers is associated with improved short-term outcomes, but high-level evidence showing similar long-term outcomes ...is scarce. We aimed to compare survival outcomes of laparoscopic surgery with open surgery for patients with mid-rectal or low-rectal cancer. Methods The Comparison of Open versus laparoscopic surgery for mid or low REctal cancer After Neoadjuvant chemoradiotherapy (COREAN) trial was an open-label, non-inferiority, randomised controlled trial done between April 4, 2006, and Aug 26, 2009, at three centres in Korea. Patients (aged 18–80 years) with cT3N0–2M0 mid-rectal or low-rectal cancer who had received preoperative chemoradiotherapy were randomly assigned (1:1) to receive either open or laparoscopic surgery. Randomisation was stratified by sex and preoperative chemotherapy regimen. Investigators were masked to the randomisation sequence; patients and clinicians were not masked to the treatment assignments. The primary endpoint was 3 year disease-free survival, with a non-inferiority margin of 15%. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00470951. Findings We randomly assigned 340 patients to receive either open surgery (n=170) or laparoscopic surgery (n=170). 3 year disease-free survival was 72·5% (95% CI 65·0–78·6) for the open surgery group and 79·2% (72·3–84·6) for the laparoscopic surgery group, with a difference that was lower than the prespecified non-inferiority margin (–6·7%, 95% CI −15·8 to 2·4; p<0·0001). 25 (15%) patients died in the open group and 20 (12%) died in the laparoscopic group. No deaths were treatment related. Interpretation Our results show that laparoscopic resection for locally advanced rectal cancer after preoperative chemoradiotherapy provides similar outcomes for disease-free survival as open resection, thus justifying its use. Funding National Cancer Center, South Korea.
Abstract Purpose The reported actual compliance for severe sepsis bundles was very low, suggesting the presence of barriers to their implementation. The purpose of this study was to assess the ...influence of full-time intensivist and nurse-to-patient ratio in Korean intensive care units (ICUs) on the implementation of the severe sepsis bundles and clinical outcome. Materials and Methods A total of 251 patients with severe sepsis were enrolled from 28 adult ICUs during the July, 2009. We recorded the organizational characteristics of ICUs, patients' characteristics and clinical outcomes, and the compliance for severe sepsis bundles. Results Complete compliance with the resuscitation bundle and totally complete compliance with all element targets for resuscitation and management bundles were significantly higher in the ICU with full-time intensivist and a nurse-to-patient ratio of 1:2 ( P < .05). The hazard ratio (HR) for hospital mortality was independently reduced by the presence of full-time intensivist (HR, 0.456; 95% confidence interval, 0.223-0.932), and a nurse-to-patient ratio of 1:2 was independently associated with a lower 28-day mortality (HR, 0.459; 95% confidence interval, 0.211-0.998). Conclusions The full-time intensivist and the nurse-to-patient ratio had a substantial influence on the implementation of severe sepsis bundles and the mortalities of patients with severe sepsis.
This study was designed to assess the treatment of patients in whom a second primary lung cancer developed after the resection of primary lung cancer.
Between January 1990 and December 2008, 1852 ...patients underwent complete resection for primary lung cancer in our institution. Of these individuals, patients who had been identified as having a second primary lung cancer by December 2009 were selected for this study using the criteria proposed by Martini and Melamed.
Of 1852 patients, a second primary lung cancer developed in 40 (2.2%) during the follow-up period. The overall 5-year and 10-year survival rates after the resection of the first tumor were 78.3% and 39.9%, respectively. The overall 5-year survival rate from the time of detection of the second primary lung cancer was 47.8%, and the 5-year survival rate of the patients who underwent resection of the second tumor was 77.0%. The patients who underwent sublobar resection had comparable overall survival and disease-free survival compared with the patients who underwent anatomic resection. Additionally, the patients who underwent sublobar resection had a better operative outcome.
Surgical resection is feasible and effective in the management of second primary lung cancer, and sublobar resection may be adequate. Long-term surveillance of more than 5 years is essential for early detection to increase the chance of resection of a second primary lung cancer.
Background and Aims Capsule endoscopy for visualization of the upper GI tract has thus far been experimental and potentially expensive. Our aim was to demonstrate the maneuverability and evaluate the ...ability to completely visualize and maintain views in the upper GI tract by using a simple magnetic-assisted capsule endoscopy (MACE) system. Methods Twenty-six volunteers were recruited. The hand-held magnet was placed at strategic points on the body surface and rotated to hold and maneuver the capsule. The ability to view the upper GI tract landmarks was noted: esophagogastric junction (EGJ), cardia, fundus, body, incisura, antrum, and pylorus. Control was assessed by the ability to hold the capsule for 1 minute at 5 positions: the lower esophagus and 4 designated positions in the proximal and distal stomach and also traversing the stomach and through the pylorus. Volunteers subsequently underwent a standard gastroscopy. Results The median data are as follows: age, 38 years (range 26-45 years); BMI, 24 (range 19–38); and procedure time, 24 minutes (range 12-39 minutes). Successful visualization of each landmark was EGJ, 92%; cardia, 88%; fundus, 96%; body, 100%; incisura, 96%; antrum, 96%; and pylorus, 100%; with fewer clear views of the EGJ and fundus. The capsule could be held in 88% of designated positions for 1 minute, moved from the fundus to the antrum in all cases, and traversed the pylorus in 50% (n = 13). An age of 40 years and older was associated with successful pyloric traversing ( P = .04). There was positive concordance for 8 of 9 minor pathological findings on standard gastroscopy. Conclusion MACE in the upper GI tract is feasible. There is a high degree of visualization and control, with some improvement required for optimizing proximal gastric views and traversing the pylorus.
Background Recent evidence suggests that prenatal maternal distress increases the risk of allergic diseases in offspring. However, the effect of prenatal maternal depression and anxiety on atopic ...dermatitis (AD) risk remains poorly understood. Objective We investigated whether prenatal maternal distress is associated with AD risk in offspring and whether the mechanism is mediated by reactive oxygen species. Methods Two general population-based birth cohorts formed the study. One cohort (Cohort for Childhood Origin of Asthma and Allergic Diseases COCOA) consisted of 973 mother-baby dyads, and the other (Panel Study on Korean Children PSKC) consisted of 1531 mother-baby dyads. The association between prenatal distress and AD was assessed by using Cox proportional hazards and logistic regression models. In COCOA placental 11β-hydroxysteroid dehydrogenase type 2 and glutathione levels and serum IgE levels in 1-year-old children were measured. Results In COCOA and PSKC AD occurred in 30.6% (lifetime prevalence) and 11.6% (1 year prevalence) of offspring, respectively. Prenatal maternal distress increased the risk of AD in offspring, both in COCOA (hazard ratio for depression, 1.31 95% CI, 1.02-1.69; hazard ratio for anxiety, 1.41 95% CI, 1.06-1.89) and PSKC (odds ratio for distress, 1.85 95% CI, 1.06-3.25). In COCOA both prenatal maternal depression and anxiety scores were positively related to the predicted probability of AD ( P < .001 in both). Prenatal distress decreased placental glutathione to glutathione disulfide ratios ( P = .037) and, especially in those who later had AD, decreased placental 11β-hydroxysteroid dehydrogenase type 2 levels ( P = .010) and increased IgE levels at 1 year of age ( P = .005). Conclusion Prenatal maternal depression and anxiety promote risk of AD in offspring. Maternal distress increases the predicted probability of AD. The mechanism might involve chronic stress, abnormal steroid levels, and reactive oxygen species.
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