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PubMed1987

Idiopathic multicentric osteolysis with facial anomalies and nephropathy.

Idiopathic osteolysis denotes a group of rare bone disorders differentiated on the basis of clinical, radiological, and genetic criteria. Idiopathic multicentric osteolysis (IMO) is one form of osteolysis that can occur as an autosomal dominant condition. In childhood, affected individuals have arthritic-like episodes, followed by progressive deformities, radiological osteolytic changes, and variable degrees of disability. A peculiar face and variable renal involvement have been described as associated manifestations. We report on a family with three members affected by IMO in two generations showing variable bone changes and persistent proteinuria. A sporadic case with severe renal damage is also described in which a de novo dominant mutation is suggested. All patients had peculiar facial manifestations including triangular shape, protruding eyes, and micrognathia. These manifestations may be part of the syndrome of IMO.

Arthritis↗
PubMed1988

Idiopathic multicentric osteolysis: report of two new cases and a review of the literature.

Idiopathic multicentric osteolysis is a rare skeletal disorder, usually presenting in early childhood with a clinical picture mimicking juvenile rheumatoid arthritis. Progressive destruction of the carpal and tarsal bones usually occurs and other bones may also be involved. Chronic renal failure is a frequent component of this syndrome. Mental retardation and minor facial abnormalities have been noted in some patients. We report on 2 unrelated, sporadic cases, one with facial anomalies and the other with nephropathy. Our second patient is the first black child to be diagnosed with this disease. The mode of presentation, differential diagnosis, and natural history of this disorder are briefly reviewed.

Child↗
PubMed2006

Apolipoprotein E and alpha brain rhythms in mild cognitive impairment: a multicentric electroencephalogram study.

OBJECTIVE: Relationships between the apolipoprotein E epsilon4 allele and electroencephalographic (EEG) rhythmicity have been demonstrated in Alzheimer's disease (AD) patients but not in the preclinical stage prodromic to it, namely, mild cognitive impairment (MCI). The present multicentric EEG study tested the hypothesis that presence of epsilon4 affects sources of resting EEG rhythms in both MCI and AD subjects. METHODS: We enrolled 89 MCI subjects (34.8% with epsilon4) and 103 AD patients (50.4% with epsilon4). Resting eyes-closed EEG data were recorded for all subjects. EEG rhythms of interest were delta (2-4 Hz), theta (4-8 Hz), alpha 1 (8-10.5 Hz), alpha 2 (10.5-13Hz), beta 1 (13-20 Hz), and beta 2 (20-30 Hz). EEG cortical sources were estimated by low-resolution brain electromagnetic tomography. RESULTS: Results showed that amplitude of alpha 1 and 2 sources in occipital, temporal, and limbic areas was lower in subjects carrying the epsilon4 allele than in those not carrying the epsilon4 allele (p < 0.01). This was true for both MCI and AD. For the first time to our knowledge, a relationship was shown between ApoE genotype and global neurophysiological phenotype (ie, cortical alpha rhythmicity) in a preclinical AD condition, MCI, in addition to clinically manifest AD. INTERPRETATION: Such a demonstration motivates future genotype-EEG phenotype studies for the early prediction of AD conversion in individual MCI subjects.

Aged↗
PubMed1978

Idiopathic multicentric osteolysis. Report of an affected father and son.

Genetic, rheumatologic, immunologic, metabolic, and renal studies of a father and son with idiopathic multicentric osteolysis are reported. The disorder appeared through mutation. The father developed symptoms as an infant, his son at age 4 years and 9 months. Both have micrognathia and hypotelorism and were exceptionally tall during the symptomatic phase of their disease. Biopsies of the son's wrist showed normal synovium, encroachment on cartilage by fibrocellular tissue, and both osteoclastic resorption and repair of affected bone. Hydroxyproline in his urine was increased. No immunologic, renal, or other metabolic abnormalities were identified.

Adult↗
PubMed1997

A case of spontaneous femoral neck fracture associated with multicentric reticulohistiocytosis: oversecretion of interleukin-1beta, interleukin-6, and tumor necrosis factor alpha by affected synovial cells.

We describe a case of left femoral neck fracture associated with multicentric reticulohistiocytosis (MR). Biopsy specimens from a skin nodule and from synovial tissue showed histiocytic multinucleated giant cells (MR cells) that are characteristic of MR. A surgical specimen from the resected femoral head revealed that multinucleated giant cells and mononuclear cells invaded the marginal subchondral bone, without evident pannus. These cells also infiltrated into the fracture site, with bone resorption by activated osteoclasts. Immunohistochemical studies of synovium from the left hip joint showed positive staining for interleukin-1beta (IL-1beta), IL-6, and tumor necrosis factor alpha, and abundant cytokine production by cultured synovial cells was demonstrated. These findings suggest that the subchondral invasion and intramedullary infiltration by MR cells caused articular destruction and/or fracture as a result of oversecretion of the cytokines.

Aged↗
PubMed1985

Pre- versus postoperative radiotherapy in rectal carcinoma: an interim report from a randomized multicentre trial.

Since October 1980 a randomized multicentre trial has been in progress among patients with rectal carcinoma, in whom high-dose fractionated pre-operative irradiation (total dose 25.5 Gy in 5-7 days) is being tested against postoperative irradiation to a high dose level using a conventional fractionation scheme (totally 60 Gy in 8 weeks) delivered only to a high-risk group of patients (Dukes' stages B and C). The primary aim of the trial is to investigate whether local recurrence rate differs between the two groups, and a secondary aim is to see whether 5-year survival will differ between the two groups of patients. Up to October 1984, 360 patients have been randomly allocated to these two groups. Locally curative surgery has been performed in 161 patients in the pre-operative irradiation group and in 152 patients in the postoperative irradiation group. Pre-operative irradiation was extremely well tolerated and there were no irradiation-related complications; 95 per cent of these patients received their treatment according to the intended schedule. However, 48 of the 161 patients had a tumour in Dukes' stage A. Pre-operative radiotherapy had no impact on postoperative mortality or the occurrence of anastomosis dehiscence, but significantly more patients with perineal wound sepsis after an abdominoperineal resection were found in the group of patients receiving pre-operative radiotherapy. This prolonged the stay in hospital after surgery. Postoperative radiotherapy was not so well tolerated as pre-operative treatment, and in a substantial number of patients the treatment could not be commenced until a relatively long time after surgery. To date, the local recurrence rate is acceptably low (approximately 10 per cent) in both treatment groups.

Clinical Trials as Topic↗
PubMed1986

Low molecular weight heparin once daily compared with conventional low-dose heparin twice daily. A prospective double-blind multicentre trial on prevention of postoperative thrombosis.

In a randomized, prospective, double-blind multicentre trial, the effect of conventional low-dose heparin 5000 units twice daily, was compared with that of a low molecular weight heparin fragment (4000-5000) 5000 anti-factor Xa units once daily. Four hundred and thirty-two patients fulfilled the inclusion criteria and were analysed for development of deep vein thrombosis (125I-labelled fibrinogen test) and haemorrhagic complications. Thrombosis occurred in a 4.3 per cent of patients in the low-dose heparin group and in 6.4 per cent of patients in the heparin fragment group, a difference which is not significant. There was a significant delay in the onset of thrombosis in the heparin fragment group. Mortality did not differ between the groups, nor did peroperative blood loss or transfusion requirements or infectious complications. Haemorrhagic complications occurred significantly more often in the fragment group (11.6 per cent) than in the conventional heparin group (4.6 per cent). Patients in the heparin fragment group experienced local pain following the subcutaneous injection significantly less often.

Adult↗
PubMed1986

Somatostatin in the treatment of severe upper gastrointestinal bleeding: a multicentre controlled trial.

To evaluate the effectiveness of somatostatin versus combined cimetidine and pirenzepine in the treatment of upper gastrointestinal (GI) bleeding of peptic origin, a multicentre controlled, prospective, randomized and double blind trial has been undertaken in 60 subjects. Strict selection criteria were followed. All subjects were diagnosed by endoscopy during the first 18 h after admission. Endoscopic stigmata of recent haemorrhage were also evaluated. Sixty-five per cent of the subjects presented with severe upper GI bleeding (blood pressure less than or equal to 100 mmHg, pulse rate greater than or equal to 110, haematocrit less than or equal to 30 per cent), and in 71.6 per cent stigmata were found. Thirty patients (Group 1) received a somatostatin infusion (250 micrograms/h continuously during 120 h) and 30 patients (Group 2) received cimetidine (200 mg IV every 4 h for 5 days) and pirenzepine (10 mg IV every 8 h for 5 days). Both groups were homogeneous for sex, age, backgrounds, bleeding source, grade of bleeding (moderate or severe) and presence or not of stigmata. Bleeding stopped in 27 subjects of Group 1 (90 per cent and in 20 subjects of Group 2 (66.67 per cent) (P less than 0.05, chi 2 test). The time until the bleeding stopped was significantly shorter in patients of group 1 (3.44 +/- 0.53 h) than in patients of group 2 (8.12 +/- 1.94 h) (P less than 0.05, Mann-Whitney U test). The number of blood units required for Group 1 (2.26 +/- 0.35) was significantly lower than the one required for Group 2 (3.90 +/- 0.51) (P less than 0.005, Wilcoxon test). Significant differences were not observed between the two groups regarding cross-over subjects, re-bleeding, surgery (P = 0.0635, Fisher's exact test) and hospital stay. The mortality of the trial was 5 per cent. There was no toxicity during somatostatin, cimetidine or pirenzepine infusion. In conclusion, somatostatin was more effective than cimetidine plus pirenzepine in the control of severe upper GI bleeding of peptic origin, with a lower interval time to stop bleeding and reduced transfusion requirements.

Cimetidine↗
PubMed1987

Splenic injury: a prospective multicentre study on non-operative and operative treatment. The Splenic Injury Study Group.

One hundred and forty-seven patients with splenic injury admitted to 18 different hospitals were included in a prospective multicentre study. The spleen was saved in 64 per cent. Out of the total series, 43 per cent of patients were not operated upon, 5 per cent had exploratory laparotomy only, and in 16 per cent splenic repair was performed. Treatment is discussed with reference to the nature of the splenic lesion, concomitant injuries, amount of blood transfusion given, and age of the patient. No deaths were definitely related to the splenic injury. The frequency of serious recurrent bleeding was not higher in the splenic salvage group when compared with the splenectomy group. Delayed bleeding was detected in 4 per cent of the patients. The mode of treatment varied considerably in different hospitals in that conservative treatment was performed in 14, splenic repair in 10 and splenectomy in 12 hospitals. Splenic salvage seems safe in most patients with a splenic injury. However, meticulous surveillance of the patient is mandatory.

Adolescent↗
PubMed1991

Prevention of perioperative deep vein thrombosis in general surgery: a multicentre double blind study comparing two doses of Logiparin and standard heparin. H.B.P.M. Research Group.

A total of 1290 patients were enrolled in a randomized multicentre double blind study in order to investigate the use of two doses of a new low molecular weight heparin, Logiparin, in the prevention of deep vein thrombosis (DVT) in general surgery. Patients who were included had no contraindication to heparin therapy and had at least one of the recognized risk factors for DVT. Patients were randomized to receive unfractionated heparin (UH) 5000 units b.d., Logiparin 2500 units daily or Logiparin 3500 units daily. Each treatment was given subcutaneously 2 h before surgery and continued for 7-10 days. Daily 125I-labelled fibrinogen uptake tests (FUTs) were performed from day 2 to day 7 to detect DVT, and phleboangiography was used to confirm the diagnosis. The wound was examined on a daily basis to check for haematoma formation, and all patients were followed up for 1 month after operation. All three treatment arms were well matched for age, sex, weight, diagnosis and type of operation performed. The three major inclusion criteria in the trial were malignancy, age over 60 years and a history of varicose veins. Positive FUTs (UH = 4.2 per cent, Logiparin 2500 units daily = 7.9 per cent, Logiparin 3500 units daily = 3.7 per cent) and positive angiograms (UH = 3.0 per cent, Logiparin 2500 units daily = 5.6 per cent, Logiparin 3500 units daily = 2.3 per cent) were significantly more common in the Logiparin 2500 units daily group than in the UH and Logiparin 3500 units daily groups. The rates of major complications (severe haemorrhage, death, pulmonary embolism, reintervention) were similar in the three groups.

Adult↗
PubMed1991

Clinical usefulness of polymorphonuclear elastase in predicting the severity of acute pancreatitis: results of a multicentre study.

The usefulness and clinical applicability of quantitative plasma polymorphonuclear elastase determinations in the diagnosis of the severity of acute pancreatitis was analysed in a multicentre study and was compared with the usual prognostic systems of Ranson and Osborne et al. The study comprised 182 patients, 154 with a mild episode of acute pancreatitis and 28 with a severe episode, defined by the development of major complications or a fatal outcome. In the severe cases neutrophilic elastase reached significantly higher values than in mild cases (P less than 0.001) by the time the patient was admitted (2-12 h after the onset of the disease), reflecting considerable leucocyte activation. The sensitivity and specificity of this test are therefore greater than 90 per cent, with a positive severity predictive value of almost 80 per cent at the time of admission and 97 per cent after 24 h, and a negative predictive value of approximately 98 per cent. In addition to requiring 48 h for evaluation, the usual prognostic systems show a sensitivity of 77-85 per cent, a specificity of 70-77 per cent, a positive predictive value of 40-48 per cent, and a negative predictive value of 92-95 per cent, clearly lower than those obtained with leucocyte elastase. Polymorphonuclear elastase is therefore a very early and reliable marker in the diagnosis of the severity of acute pancreatitis, in addition to being easily adaptable to the routine of any hospital laboratory.

Acute Disease↗
PubMed1991

Comparison of minimal and conventional surgery in patients with bleeding peptic ulcer: a multicentre trial.

A multicentre randomized prospective trial compared minimal surgery (under-running the vessel or ulcer excision and adjuvant ranitidine) with conventional ulcer surgery (vagotomy and pyloroplasty or partial gastrectomy) for the treatment of bleeding peptic ulcer. This report is based on 137 patients (eight withdrawn through misdiagnosis or lost data), of whom 62 received conservative surgery and 67 conventional operation. Twenty-nine patients died, 16 (26 per cent) after conservative surgery and 13 (19 per cent) after conventional operations. The only significant difference between the groups was the incidence of fatal rebleeding, which occurred in six patients after conservative surgery compared with none after conventional surgery (P less than 0.02, Fisher's exact test).

Adolescent↗
PubMed1993

Norwegian multicentre study of survival and prognostic factors in patients undergoing curative resection for gastric carcinoma. The Norwegian Stomach Cancer Trial.

The influence of clinical and tumour-related variables on long-term survival in patients with gastric carcinoma was studied in a national prospective multicentre study. A total of 532 patients underwent curative surgery with a 5-year survival rate of 40 per cent. In a Cox multivariate analysis, age, stage of disease and macroscopic appearance of tumour were the only factors that independently affected survival. The estimated probability of survival to 5 years for a 50-year-old patient with a flattened tumour type and stage I disease was 71 per cent, but 50 per cent for an 80-year-old with the same tumour type and stage. For stage II disease the rates were 56 and 32 per cent, for stage III 39 and 13 per cent and for stage IV 19 and 3 per cent, respectively. A 70-year-old patient with stage II linitis plastica tumour type had an estimated probability of 5-year survival of 20 per cent. Stage of disease was the single most important factor in determining survival. Laurén histopathological type and location of tumour, Karnofsky performance index, weight loss and type of resection had no significant effect on long-term survival.

Age Factors↗
PubMed1993

Multicentre study of a continent colostomy plug.

A multicentre clinical study was carried out to assess the performance of a new disposable device, the Conseal 1-Piece, for colostomy control and continence. Forty-three patients were studied; none had any complication at the stoma. The time elapsed since surgery and the condition of the stoma and surrounding skin were recorded. The new product was compared with the patients' usual colostomy bag, studying the following parameters: ease of application, reliability, leakage, confidence, ease of removal, adhesion and comfort. Thirty-seven patients completed the study. No complications arose, and complete faecal continence was obtained with 71.1 per cent of applications. The plug was kept in position for a mean of 11.5 h and a normal stoma bag was used for the remainder of the day. Of the 37 patients who completed the trial, 26 preferred the Conseal 1-Piece to a colostomy bag. In this preliminary study the device was easy to apply, involved no major complications and provided a high degree of continence. This product deserves further study because of its simplicity of use. However, research to improve the level of continence should continue.

Aged↗
PubMed1995

Early oesophageal cancer: results of a European multicentre survey. Group Européen pour l'Etude des Maladies de l'Oesophage.

Early oesophageal cancer has been extensively studied in Far-Eastern countries, where its prevalence is high. A multicentre survey was conducted within the Groupe Européen pour l'Etude des Maladies de l'Oesophage to analyse results of surgical treatment in patients with disease staged as pTis-T1 N0 M0 according to the tumour node metastasis classification. Of 9743 patients with squamous cell oesophageal carcinoma observed since 1980, 4663 underwent resection; 253 (5.4 per cent) of these fulfilled the criteria for inclusion in the study. The overall mortality rate was 9.1 per cent (23 patients), and was higher after transthoracic than transhiatal oesophagectomy (10.7 versus 6 per cent, P not significant). Pathological examination showed an intraepithelial tumour in 46 patients (18.2 per cent), intramucosal carcinoma in 64 (25.3 per cent) and a submucosal lesion in 143 (56.5 per cent). The overall 5-year survival rate for patients with intraepithelial, intramucosal and submucosal tumours was 92.8, 72.8 and 44.3 per cent respectively. The 5-year survival rate was higher after transthoracic than transhiatal oesophagectomy (66 versus 52 per cent). No survival advantage was observed after either operation in patients with mucosal tumours. Of 21 patients with recurrent disease, 20 had a submucosal lesion. The 5-year survival rate in patients with submucosal tumour was higher after transthoracic than transhiatal oesophagectomy (54.2 versus 25.5 per cent).

Adult↗
PubMed1995

Randomized controlled multicentre study of the prevention of complications by octreotide in patients undergoing surgery for chronic pancreatitis.

A randomized double-blind placebo-controlled multicentre trial was carried out in 247 patients undergoing major elective surgery for chronic pancreatitis to clarify whether the perioperative application of octreotide prevents postoperative complications. Eleven complications were defined, including death, anastomotic leakage, pancreatic fistula, abscess, fluid collection, shock, sepsis, bleeding, pulmonary insufficiency, renal insufficiency and postoperative pancreatitis. A total of 124 patients underwent pancreatic head resection, 55 left resection, 61 pancreaticojejunostomy and seven had other procedures. The overall mortality rate was 1.2 per cent (octreotide group 1.6 per cent, placebo group 0.8 per cent [corrected] (P not significant)). The postoperative complication rate in the octreotide group was 16.4 per cent (20 of 122 patients) and in the placebo group 29.6 per cent (37 of 125) (P < 0.007). The perioperative application of octreotide substantially reduces the risk of postoperative complications in patients undergoing major pancreatic surgery for chronic pancreatitis.

Adult↗
PubMed2005

French multicentre prospective observational study of laparoscopic versus open colectomy for sigmoid diverticular disease.

BACKGROUND: The aim of this study was to compare in-hospital morbidity and mortality rates after elective laparoscopic and open colorectal surgery for sigmoid diverticular disease (SDD). METHODS: This prospective national multicentre observational study included all consecutive patients undergoing open or laparoscopic elective colectomy for SDD in a 4-month period between June and September 2002. Postoperative in-hospital mortality and morbidity in the two groups were compared. RESULTS: Three hundred and thirty-two consecutive patients undergoing either laparoscopic (163 patients) or open (169 patients) colectomy for SDD were analysed. Overall postoperative mortality and morbidity rates were 0.3 and 23.8 per cent respectively. The morbidity rate was significantly higher in the open than in the laparoscopic group (P < 0.001), leading to a significantly longer hospital stay (P < 0.001). The morbidity rate remained significantly higher in the open group when the patients were matched for age (P = 0.015) or American Society of Anesthesiologists score (P = 0.028). An open procedure (relative risk (RR) 2.13 (95 per cent confidence interval (c.i.) 1.29 to 3.45)), age over 70 years (RR 1.62 (95 per cent c.i. 1.14 to 2.30)) and intraperitoneal contamination (RR 2.54 (95 per cent c.i. 1.18 to 5.50)) were identified as independent risk factors for morbidity. CONCLUSION: A laparoscopic approach to elective treatment of SDD may be associated with reduced postoperative morbidity and hospital stay. A randomized study is required to confirm these results.

Aged↗
PubMed2006

Evaluation of ZAP-70 expression by flow cytometry in chronic lymphocytic leukemia: A multicentric international harmonization process.

The clinical course of patients with chronic lymphocytic leukemia (CLL) is heterogeneous with some patients requiring early therapy whereas others will not be treated for years. The evaluation of an individual CLL patient's prognosis remains a problematic issue. The presence or absence of somatic mutations in the IgVH genes is currently the gold-standard prognostic factor, but this technique is labor intensive and costly. Genomic studies uncovered that 70 kDa zeta-associated protein (ZAP-70) expression was associated with unmutated IgVH genes and ZAP-70 protein expression was proposed as a surrogate for somatic mutational status. Among the available techniques for ZAP-70 detection, flow cytometry is most preferable as it allows the simultaneous quantification of ZAP-70 protein expression levels in CLL cells and residual normal lymphocyte subsets. However, several factors introduce variability in the results reported from different laboratories; these factors include the anti-ZAP-70 antibody clone and conjugate, the staining procedure, the gating strategy, and the method of reporting the results. The need for standardization of the approach led to the organization of an international working group focused on harmonizing all aspects of the technique. During this workshop, a technical consensus was reached on the methods for cell permeabilization and immunophenotyping procedures. An assay was then designed that allowed comparison of two clones of anti-ZAP-70 antibody and the identification of the expression of this molecule in B, T, and NK cells identified in a four multicolor analysis. This procedure was applied to three stabilized blood samples, provided by the UK NEQAS group to all participating members of this study, in order to minimize variability caused by sample storage and shipment. Analysis was performed in 20 laboratories providing interpretable data from 14 centers. Various gating strategies were used and the ZAP-70 levels were expressed as percentage positive (POS) relative to isotype control or normal B-cells or normal T-cells; in addition the levels were reported as a ratio of expression in CLL cells relative to T-cells. The reported level of ZAP-70 expression varied greatly depending on the antibody and the method used to express the results. The CLL/T-cell ZAP-70 expression ratio showed a much lower interlaboratory variation than other reporting strategies and is recommended for multicenter studies. Stabilization results in decreased expression of CD19 making gating more difficult and therefore stabilized samples are not optimal for multicentric analysis of ZAP-70 expression. We assessed the variation of ZAP-70 expression levels in fresh cells according to storage time, which demonstrated that ZAP-70 is labile but sufficiently stable to allow comparison using fresh samples distributed between labs in Europe. These studies have demonstrated progress toward a consensus reporting procedure, and further work is underway to harmonize the preparation and analysis procedures.

Antibodies, Monoclonal↗