A prospective randomised study comparing double-balloon colonoscopy and conventional colonoscopy in pre-defined technically difficult cases

Backgrounds and aimTechnically ‘difficult’ (TD) colonoscopy is associated with incomplete colonoscopy, discomfort and longer procedures. Double-balloon colonoscopy (DBC) may facilitate TD colonoscopy. The primary outcome was to compare the time taken to achieve caecal intubation during conventional colonoscopy (CC) and DBC in patient with a TD colon.MethodsWe performed a prospective, randomised study comparing DBC and CC for TD colonoscopy. Patients were screened for parameters predictive of TD colonoscopy using an original scoring system and randomised to DBC or CC. Pain, sedation dose, colonoscopy completeness, time taken for cecal intubation, procedure completion, recovery time and patient satisfaction were recorded.ResultsForty-four patients were recruited (DBC = 22; CC = 22). DBC facilitated total colonoscopy in 22 cases whereas 9 CC procedures were incomplete (P = 0.019). Median pre-procedure difficulty scores were equal for both groups (4.0 vs. 4.0). Mean patient discomfort, pain scores and recovery time were significantly lower for the DBC group (2.3 vs. 5.5, P = 0.001; 2.0 vs. 5.9, P = 0.005; 5 vs. 20 min, P = 0.014 respectively). Mean time taken for cecal intubation was similar (17.5 vs. 14 min, P = 0.18);ConclusionDBC facilitates colonoscopy completion and may be a more comfortable alternative to CC for TD cases although the time taken to achieve caecal intubation was similar.     

Comparison of magnetic wire navigation with the conventional wire technique for percutaneous coronary intervention of chronic total occlusions: a randomised,controlled study

Wire crossing of a chronic total coronary occlusion (CTO) is time consuming and limited by the amount of contrast agent and time of radiation exposure. Magnetic wire navigation (MWN) might accelerate wire crossing by maintaining a coaxial vessel orientation. This study compares MWN with the conventional approach for recanalization of CTOs. Forty symptomatic patients with CTO were randomised to MWN (n = 20) or conventional approach (n = 20) for antegrade crossing of the occlusion. In the intention-to-treat analysis, MWN showed a shorter crossing time (412 versus 1131 s; p = 0.001), and, consequently, lower usage of contrast agent (primary endpoint 42 versus 116 ml; p = 0.01), and lower radiation exposure (dose-area product: 29 versus 80 Gy*cm²; p = 0.002) during wire crossing compared to the conventional approach. Accordingly, in the per-protocol analysis, the wire-crossing rate was, in trend, higher using the conventional approach (17 of 31) compared to MWN (9 of 28; p = 0.08). The use of MWN for revascularisation of CTOs is feasible and reduces crossing time, use of contrast agent, and radiation exposure. However, due to a broader selection of wires, the conventional approach enables wire crossing in cases failed by MWN and seems to be the more successful choice.     

The use of the Tracker catheter as a guidewire support device in angioplasty of angulated and tortuous circumflex coronary arteries

Marked angulation and tortuosity of the coronary arteries, particularly the circumflex, can limit coronary angioplasty. Despite the use of adequate guide catheter support and high performance guidewires, it is often difficult or even impossible to reach the distal segment of the target vessel with the guidewire. We describe three cases of successful complex circumflex coronary artery angioplasty where guidewire advancement through proximal angulated and tortuous anatomy was facilitated by the Tracker-18 Hi-Flow catheter after failure of conventional angioplasty hardware.     

The use of multiple coronary guidewires to occupy secondary branch vessels and facilitate PCI of a complex aneurysmal stenosis.

Percutaneous revascularization of complex coronary stenosis is dependent on establishing suitable guidewire position in the vascular bed distal to the lesion. We report the use of multiple 0.0014' coronary guidewires to occupy unintended branch vessels and to facilitate PCI of a high-grade left circumflex obtuse marginal branch lesion with post-stenotic aneurysmal dilation of the vessel and multiple branch vessels. This technique enabled successful placement of a nitinol hydrophilic-coated wire into the distal vascular bed beyond the region of obstruction followed by placement of a drug-eluting stent with restoration of luminal dimensions and TIMI-3 angiographic flow.     

A multireader reliability study comparing conventional high-field magnetic resonance imaging with extremity low-field MRI in rheumatoid arthritis

The use of extremity low-field magnetic resonance imaging (E-MRI) is increasing, but relatively few data exist on its reproducibility and accuracy in comparison with high-field MRI, especially for multiple readers. The aim of this multireader exercise of rheumatoid arthritis wrist and metacarpophalangeal joints was to assess the intermachine (high vs low-field) agreement and to assess the interreader agreement on high and low-field images. Study findings suggested that E-MRI performs similarly to conventional high-field MRI regarding assessment of bone erosions. However, for synovitis and bone edema, considerable intermachine and interreader variability was found. Further studies are needed before recommendations on multireader E-MRI assessment of these pathologies can be given.     

Allopurinol improves endothelial function in sleep apnoea: a randomised controlled study.

Increased oxidative stress in obstructive sleep apnoea is thought to contribute to endothelial dysfunction. The objective of this study was to test the hypothesis that inhibition of xanthine oxidase by allopurinol can improve endothelial function in patients with obstructive sleep apnoea. A randomised double-blind placebo-controlled crossover study was performed on 12 patients with moderate-to-severe obstructive sleep apnoea, comparing 300 mg allopurinol daily for 2 weeks with placebo. Endothelial function was assessed using hyperaemia-induced flow-mediated vasodilation (FMD) at baseline and following treatment. Plasma malondialdehyde levels were compared in order to assess significant changes in oxidative stress. Baseline FMD correlated significantly with the severity of sleep apnoea and the time spent with an arterial oxygen saturation of <90%. Allopurinol caused a significant increase in FMD compared to placebo (10.4+/-3.2 versus 7.4+/-2.8%, respectively). Plasma malondialdehyde levels were significantly reduced with allopurinol treatment (1.5+/-0.3 versus 1.2+/-0.3 micromol.L(-1)), consistent with reduced oxidative stress. Allopurinol improves endothelial dysfunction in patients with moderate-to-severe obstructive sleep apnoea. These observations suggest that xanthine oxidase contributes significantly to vasodilatory impairment.     

Late results of a prospective randomised study comparing forceful dilatation and oesophagomyotomy in patients with achalasia.

Late results in 81 patients with achalasia treated in a prospective randomised study comparing forceful pneumatic dilatation with the Mosher bag and surgical anterior oesophagomyotomy by abdominal route, are reported. There were no deaths from either of the treatments. Two patients (5.6%) had a perforation of the abdominal oesophagus after pneumatic dilatation and were excluded from late follow up. In patients having surgery at radiological evaluation there was gullet diameter significantly increased at the oesophagogastric junction and decreased at the middle third of the oesophagus. One patient was lost from follow up and one died of an oesophageal carcinoma, leaving 95% of excellent results at the late follow up (median 62 months). Resting gastro-oesophageal sphincter pressure decreased significantly to approximately 10 mmHg; this was maintained five years after surgery. By contrast, in patients having pneumatic dilatation, there were good results in only 65% (follow up median 58 months), with 30% failures. One patient was lost from follow up and one developed oesophageal carcinoma. Measurement of resting gastro-oesophageal sphincter pressure after dilatation was highly predictive of the outcome. The study shows that surgical treatment offers a better final clinical result than pneumatic dilatation with the Mosher bag.     

Efficacy and safety of a fixed low-dose perindopril/indapamide combination in essential hypertension. A randomised controlled study

This multicenter, double-blind, parallel-group study was designed to assess the efficacy and the safety of fixed low dose combination perindopril 2 mg/indapamide 0.625 mg (Per/Ind) versus atenolol 50 mg (Ate). After a 4-week placebo run-in, 446 hypertensive patients (mean age : 55.8 +/- 11.0 years) were randomised to receive Per/Ind or Ate for 12 weeks. The primary outcome measures were the changes in trough supine systolic and diastolic blood pressure (sSBP, sDBP) between baseline and the last observation. Equivalence was assessed in an intention-to-treat analysis using a two one-sided tests procedure. Per/Ind and Ate decreased sSBP by -20.5 mmHg and -20.1 mmHg, respectively; the 90% confidence interval [-2.3; 1.5] of the intertreatment difference (-0.4 mmHg) fell within the predefined equivalence interval [-8; +8 mmHg]. Similarly, the sDBP decreased by -15.1 mmHg (Per/Ind) and -16.2 mmHg (Ate) with an intertreatment difference of 1.1 mmHg whose 90% confidence interval [-0.1; 2.2 mmHg] fell within the predefined equivalence interval [-4; +4 mmHg]; thus antihypertensive efficacy of Per/Ind and Ate were equivalent (P <0.001). In patients older than 65, Per/Ind induces a statistically greater decrease in sSBP than Ate (P <0.05). Per/Ind was well tolerated. Further controlled studies are needed to confirm these results on a long-term period.     

A prospective randomised controlled trial comparing the efficacy of somatostatin with injection sclerotherapy in the control of bleeding oesophageal varices.

Since previous reports have suggested that somatostatin may be of value in the control of acute variceal haemorrhage, we compared its efficacy with that of injection sclerotherapy in a randomised controlled clinical trial. Eighty consecutive patients with endoscopically-proven severe variceal bleeding were randomised to injection sclerotherapy (n = 41) or somatostatin (n = 39) given as a continuous infusion of 250 micrograms/h for 5 days plus daily bolus administration of 250 micrograms. The efficacy of injection sclerotherapy and somatostatin infusion in controlling haemorrhage and preventing rebleeding (censored at 5 days), mortality (censored at 28 days) and complications was compared. The aetiology of the portal hypertension and transfusion requirements was similar between the two groups, but there were more patients with severe liver disease (Child's C) in the somatostatin group. There was no significant difference between the two treatments in the initial (p = 1.0) or overall control of bleeding (p = 0.58). Furthermore, somatostatin was as effective as injection sclerotherapy in controlling bleeding in patients with severe liver disease or in those actively bleeding at the time of their endoscopy. The relative risk of rebleeding whilst receiving somatostatin compared to injection sclerotherapy was 1.39 [95% Confidence Interval (CI) 3.73; 0.52], but this was reduced to 0.98 (95% CI 0.37; 2.67) when readjusted for Child's grading, the only prognostic factor shown to be of significance. Mortality was not significantly different between the two groups of patients (p = 0.31). The relative risk of dying whilst receiving somatostatin compared to injection sclerotherapy was 1.6 (95% CI 3.93; 0.66) but was reduced to 1.03 (95% CI 0.47; 2.47) when adjusted for Child's grading, the only significant prognostic factor. Complications in the somatostatin group were minor and less frequent than after injection sclerotherapy. The results of this study indicate that somatostatin is a safe treatment, which is as effective an endoscopic injection sclerotherapy for acute variceal bleeding.     

Minimal residual coronary obstructions in patients who suffered a first myocardial infarction. A prospective study comparing coronary angiography and exercise thallium scintigraphy

The purpose of the present study was to correlate the presence of minimal coronary obstruction (≤ 50%) assessed by coronary angiography with the presence of myocardial scar and ischemia detected by thallium-201 myocardial perfusion imaging. The study included 83 consecutive patients (74 men and 9 women) with a mean age 55.4±8.5 years who suffered a first myocardial infarction and did not undergo thrombolytic therapy. In all patients, coronary angiography, left ventriculography, and exercise thallium-201 tomographic scintigraphy were performed within 3 to 5 months of the myocardial infarction. Coronary arteriograms showed minimal residual obstructions in 37 (45%) patients. Of a total of 54 patients with ≤ 50% obstruction, 18 showed persistent defects and 22 reversible defects on thallium scintigrams. The present study showing estimated angiographic stenosis of ≤ 50% as being responsible either for myocardial scar or myocardial ischemia on postexercise thallium scintigrams leads us to conclude that percent value of stenosis does not accurately predict the pathophysiologic significance of coronary atherosclerotic lesions in patients who suffer a myocardial infarction. After a first myocardial infarction, coronary angiographies and thallium-201 scintigrams are complementary for an optimal treatment strategy for selected subsets of patients.     

Efficacy of the heater probe in peptic ulcer with a non-bleeding visible vessel. A controlled, randomised study.

A controlled, randomised study was performed to evaluate the efficacy of treatment with heater probe in the prevention of rebleeding from peptic ulcer with a non-bleeding visible vessel. One hundred and one patients were randomised into two groups: patients to be treated by heater probe (n = 51) and controls without active treatment (n = 50). In the heater probe group rebleeding occurred in five patients (10%) v 13 (26%) in the control group (p = 0.03), with a comparative risk of 0.38 in favour of the heater probe group. The difference in proportions of successful treatment for each group was 16.2% in favour of the heater probe (95% CI = 2 to 31%). Haemorrhage directly related to heater probe treatment occurred in four patients. In three of them bleeding was easily controlled by further heater probe pulses. There were no other complications and no death in the heater probe group. One patient in the control group died of pulmonary embolism. No significant differences in the length of stay in hospital, blood transfusions, surgical rates, or death were found; the design of the study, however, precluded an adequate assessment of these variables, because the heater probe was an optional rescue treatment when high surgical risk patients rebled. These results suggest that the heater probe is an effective and safe procedure in the prevention of recurrent haemorrhage in peptic ulcer with a non-bleeding visible vessel.     

Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a meta-analysis.

AIMS: To evaluate the effect of drug-eluting vs. bare metal stents for the treatment of coronary artery disease on overall, cardiac, and non-cardiac mortalities. METHODS AND RESULTS: We conducted a systematic literature search to identify all randomized controlled trials comparing sirolimus or paclitaxel-eluting stents with bare metal stents and reporting mortality data after at least 1 year of follow-up. Trial data were reviewed and extracted independently by two investigators in an unblinded standardized manner. Seventeen trials including a total of 8221 patients were analysed. Peto's odds ratios (ORs) for total mortality after 1 (n=8221), 2 (n=4631), 3 (n=4105), and 4 (n=1293) years of follow-up were 0.94 [95% confidence interval (CI) 0.66-1.34], 1.11 (95% CI 0.76-1.61), 1.25 (95% CI 0.91-1.73), and 1.46 (95% CI 0.92-2.31), respectively. Corresponding ORs for non-cardiac mortality were 1.07 (95% CI 0.64-1.80), 1.72 (95% CI 1.01-2.94), 1.45 (95% CI 0.93-2.25), and 1.65 (95% CI 0.89-3.10). There was no difference in OR for cardiac mortality among all trials. In sensitivity analyses, sirolimus- but not paclitaxel-eluting stents were associated with an increase in non-cardiac mortality at 2 and 3 years of follow-up. CONCLUSION: Drug-eluting stents for the treatment of coronary artery disease do not reduce total mortality when compared with bare metal stents. Preliminary evidence suggests that sirolimus- but not paclitaxel-eluting stents may lead to increased non-cardiac mortality. Long-term follow-up and assessment of cause-specific deaths in patients receiving drug-eluting stents is mandatory to determine the long-term safety of these devices.     

Chemotherapy in advanced gastric cancer: a controlled, prospective, randomised multi-centre study.

Seventy-six patients with advanced gastric adenocarcinoma were studied in a prospecitive, randmoised, controlled trial using vincristine, methotrexate, cyclophosphamide, and 5-fluorouracil in an initiation course and mitomycin-C with 5-fluorouracil as maintenance therapy. Thirty-seven patients were inoperable and 39 had the primary tumour resected with histological evidence of residual disease. Survival in the inoperable group was short and showed no significant difference between treated and control patients. The median survival times for treated and control groups were 9.5 and 9.0 weeks respectively. In the resected patients there was no difference in ultimate overall survival between the groups but up to 20 weeks there was a suggestion that the probability of survival in treated patients was higher (P = 0.06). The patients were well-matched and it is concluded that chemotherapy has had an early effect but that a further trial with more detailed stratification, particularly of staging and histological grade, is needed. No patient received treatment for longer than two years and unacceptable toxicity occurred in only two patients. Nausea occurred more frequently in the treated group but was short-lived and clinically manageable.     

A prospective controlled study comparing brush and bile exfoliative cytology for diagnosing bile duct strictures.

Imaging of biliary strictures may suggest malignancy but cytology can provide a tissue diagnosis. The aim of this study is to compare the diagnostic value of brush cytology and bile cytology. Thirty two patients (20 males, 12 females, median age 66 years, range 31-84) with biliary strictures at endoscopic retrograde cholangio pancreatography (24) or percutaneous transhepatic cholangiography (8) had bile cytology and brush cytology. Brushings were taken using a modified Geenan cytology brush (6 Fr gauge, Wilson Cook) passed alongside a guide wire placed through the stricture. Bile was aspirated after insertion of an internal/external catheter or an endoprosthesis. Bile and brushings were examined by one experienced cytologist (AD) and was reported as positive or negative for malignant cells. Twenty nine patients had malignant strictures. Sixteen were confirmed by histology and 13 had malignancy suggested by clinical follow up. Three patients had resection of histologically benign strictures. The overall sensitivity of brush cytology (17 of 29 positive, 59%) was significantly greater than bile cytology (seven of 29 positive, 24%) (p < 0.01) as was the diagnostic accuracy (63 v 31%, p < 0.01). None of the patients had positive bile cytology with negative brush cytology. There were no procedure related complications and the average sampling time once the guide wire had been inserted was less than five minutes. It is concluded that brush cytology is more sensitive than bile cytology and with the technique described is safe and rapid.     

A controlled study comparing the conventional treatment of idiopathic anorectal abscess with that of incision,curettage and primary suture under systemic antibiotic cover

Summary The treatment of anorectal abscess by deroofing and packing on an initial inpatient basis has been compared in a controlled trial with that of incision curettage and primary suture under systemic antibiotic cover in the Accident and Emergency Department. Over a three-year period 219 patients with anorectal abscess were randomly allocated to one or other treatment and subsequently followed up in a rectal clinic. In terms of the time taken for complete healing and the periods lost from work postoperatively, the method of incision, curettage and primary suture under systemic antibiotic cover was found to be significantly superior, without any increased risk of recurrence of the abscess or of subsequent fistula formation.