Randomized clinical trial of sacral nerve stimulation for refractory constipation.

BACKGROUND: Open studies have reported favourable results for sacral nerve stimulation in the treatment of refractory constipation. Here, its efficacy was assessed in a double-blind crossover RCT. METHODS: Patients with at least two of the following criteria were included: fewer than three bowel movements per week; straining to evacuate on more than 25 per cent of attempts; or sensation of incomplete evacuation on more than 25 per cent of occasions. Response to therapy was defined as at least three bowel movements per week and/or more than 50 per cent improvement in symptoms. Responders to an initial 3-week peripheral nerve evaluation were offered permanent implantation of a pulse generator and were assigned randomly in a crossover design to two 8-week intervals of active or sham stimulation. At the end of the two trial periods, the patients received active stimulation until the final evaluation at 1 year. RESULTS: Thirty-six patients (34 women; mean(s.d.) age 45(14) years) underwent peripheral nerve evaluation. Twenty responded and received a permanent stimulator. A positive response was observed in 12 of 20 and 11 of 20 patients after active and sham stimulation periods respectively (P = 0·746). Pain related to the device occurred in five patients and wound infection or haematoma in three, leading to definitive removal of the pulse generator in two patients. At 1 year, 11 of the 20 patients with an implanted device continued to respond. Stimulation had no significant effect on colonic transit time. CONCLUSION: These results do not support the recommendation of permanent implantation of a pulse generator in patients with refractory constipation who initially responded to temporary nerve stimulation. Registration number: NCT01629303 (http://www.clinicaltrials.gov).

Antireflux versus conventional self-expanding metallic Stents (SEMS) for distal esophageal cancer: results of a multicenter randomized trial.

INTRODUCTION: Self-expanding metal stents (SEMS) are commonly used in the palliation of dysphagia in patients with inoperable esophageal carcinoma. However, they predispose to gastroesophageal reflux when deployed across the gastroesophageal junction. The aims of this study were to: 1) assess the influence of the antireflux valve on trans-prosthetic reflux (primary outcome); and 2) compare the results of SEMS with and without antireflux valve in terms of reflux symptoms, quality of life (QOL), improvement of dysphagia and adverse events (secondary outcomes). PATIENTS AND METHODS: Thirty-eight patients were enrolled in nine centers. Carcinomas were locally advanced (47 %) or metastatic. After randomization, patients received either a covered SEMS with antireflux valve (n = 20) or a similar type of SEMS with no antireflux device but assigned to standard proton pump inhibitor therapy and postural advice (n = 18). Trans-prosthetic reflux was assessed at day 2 using a radiological score based on barium esophagography performed after Trendelenburg maneuver and graded from 0 (no reflux) to 12 (maximum). Monthly telephone interviews were conducted for Organisation Mondiale de la Santé (OMS) scoring from 0 (excellent) to 5 (poor), QOL assessment (based on the Reflux-Qual Simplifié scoring system) from 0 (poor) to 100 (excellent), dysphagia scoring from 0 (no dysphagia) to 5 (complete dysphagia) and regurgitation scoring from 0 (no regurgitation) to 16 (maximum). RESULTS: No difference was noted in terms of age, sex, size of lesion, prosthesis length or need for dilation prior to SEMS placement. No difficulty in placing SEMS nor complications were noted. Radiological scores of reflux were found to be significantly lower in patients with an antireflux stent compared to the conventional stent and associated measures. The regurgitation scores were significantly decreased in patients with antireflux stents during the first 2 months after stent placement and thereafter, they were similar in the two groups. QOL and dysphagia were improved in both groups. Survival rates were comparable in the two groups. CONCLUSIONS: No difference was observed between the two types of SEMS regarding the palliation of dysphagia and improvement of QOL. However, SEMS with an antireflux valve were more effective in preventing trans-prosthetic gastroesophageal reflux but at the cost of an increased likehood of minor adverse events (migrations and/or obstruction of the SEMS).

Accuracy of computed tomographic colonography in a nationwide multicentre trial, and its relation to radiologist expertise.

OBJECTIVE: Reports on the accuracy of computed tomographic colonography (CTC) mainly involve series from expert institutions. The aims of this study were to assess CTC accuracy in a nationwide population and to relate it to radiologist performance in their initial training. DESIGN: Nationwide multicentre trial. SETTING: Twenty-eight radiologists, working in 26 mostly academic clinical units, were involved in the study after having attended a formal specialised 2-day training session on CTC. They worked through a training set of 52 cases with automatic feedback after an attempt at each case. PATIENTS: The study enrolled 845 patients with average and high risk of colorectal cancer, 737 of whom had both complete CTC and videocolonoscopy data, which constituted the dataset. INTERVENTIONS: Patients underwent same-day CTC followed by videocolonoscopy with segmental unblinding of CTC results. MAIN OUTCOME MEASURES: Sensitivity, specificity and positive and negative predictive values for detection of polyps ≥ 6 mm in per-patient and per-lesion analyses of CTC without computer-aided detection. RESULTS: Sensitivity, specificity and positive and negative predictive values for patients with polyps ≥ 6 mm were 69% (95% CI 61% to 77%), 91% (95% CI 89% to 94%), 67% (95% CI 59% to 74%) and 92% (95% CI 90% to 94%), respectively. Univariate analysis showed that the detection rate for polyps ≥ 6 mm was linked to neither radiologist case volume nor number of polyps, but was related to sensitivity achieved in the training set. Pooled sensitivity was 72% (95% CI 63% to 80%) versus 51% (95% CI 40% to 60%) for radiologists achieving above and below median sensitivity in the training set (61%), respectively. Multivariate analysis showed that sensitivity for polyps ≥ 6 mm in the training set was the only remaining significant predictive factor for subsequent performance. CONCLUSIONS: Radiologist sensitivity CTC for detection of polyps ≥ 6 mm in training was the sole independent predictor for subsequent sensitivity in detection of such polyps.

Similar performance but higher cholecystitis rate with covered biliary stents: results from a prospective multicenter evaluation.

BACKGROUND AND STUDY AIMS: Endoscopic biliary stenting is now a well-established treatment method in patients with unresectable malignant biliary obstruction. Despite advances with metal stents, the problem of stent occlusion has not yet been resolved. Covered metal stents could reduce the occlusion rate by preventing tumor ingrowth, but have not been well evaluated. A prospective multicenter study was therefore conducted to evaluate the efficacy and disadvantages of covered Wallstents. PATIENTS AND METHODS: Covered Wallstents were implanted endoscopically in 62 patients with inoperable distal malignant biliary obstruction. Complications, stent patency, and patient survival were analyzed. RESULTS: Stent insertion was achieved in 61 of the 62 patients (98.4 %). Procedure-related complications were observed in four patients, consisting of minor pancreatitis (n = 2) and abdominal pain due to stent expansion (n = 2). There was no procedure-related mortality. Seven patients died too early for proper assessment, so that a total of 54 patients were ultimately evaluated. Stent dysfunction occurred in 17 of the 54 patients (31.5 %). The reasons for dysfunction were proximal tumor overgrowth (n = 5), migration (n = 3), lithiasis or food impaction (n = 3), cholangitis without the need for a repeat biliary intervention (n = 5), and unknown (n = 1). The median period of stent patency was 142 days. No tumor ingrowth was observed. Acute cholecystitis was diagnosed in five patients (10 %) and was responsible for one death. Three stents were successfully removed. CONCLUSIONS: Covered biliary metal stents are effective for the drainage of distal malignant biliary obstruction, with a dysfunction rate apparently similar to that of uncovered stents. However, the risk of acute cholecystitis appears to be a major concern with this type of stent in patients with gallbladder in situ. Further comparative studies are needed.

Value of magnetic resonance cholangiography in the preoperative diagnosis of common bile duct stones.

OBJECTIVE: The aim of this study was to assess the performance of magnetic resonance cholangiography (MRC) in the preoperative diagnosis of choledocholithiasis. METHODS: A total of 147 consecutive patients underwent MRC for clinical and biological signs of common bile duct stones. ERCP was then carried out in 101 patients in whom there was a past history of cholecystectomy. The remaining 46 patients without a past history of biliary surgery underwent cholecystectomy and intraoperative cholangiography (IOC). The diagnosis obtained by MRC was compared with the final diagnosis established after endoscopic or surgical removal of calculi. RESULTS: A total of 113 patients had choledocholithiasis (single or multiple, including 15 cases of microlithiasis). There were no false-positive results with MRC. The false-negative results were caused mainly by small stones <3 mm in diameter, and to a lesser extent, cholangitis. Overall, the sensitivity was 93% and the specificity 100% for MRC in detecting common bile duct stones. The sensitivity and specificity of ERCP were respectively 94% and 100%, versus 93.5% and 93.3% for IOC. There was no statistically significant difference, however, between MRC and the other techniques. CONCLUSION: MRC is a key technique in the preoperative diagnosis of choledocholithiasis. Its diagnostic value is comparable to ERCP, but it appears to be more specific than IOC. Nevertheless, its diagnostic capability remains limited in cases of microlithiasis and cholangitis.

Prevention of biliary stent occlusion by ursodeoxycholic acid plus norfloxacin: a multicenter randomized trial.

We report a prospective randomized multicenter trial that tested the efficacy of combining ursodeoxycholic acid and norfloxacin in the prevention of polyethylene stent clogging in patients with obstructive jaundice due to an unresectable malignancy at the level of the common bile duct. After insertion of a 10-Fr straight polyethylene stent, patients were allocated to receive oral treatment with ursodeoxycholic acid and norfloxacin, or conservative treatment. The primary outcome measure was stent blockage within six months. Thirty-three patients (group I) received ursodeoxycholic acid and norfloxacin, and 29 received conservative treatment (group II). At six months, cumulative stent patency rate did not differ significantly between group I (47+/-11%, mean +/- SE, median 149 days) and group II patients (24+/-10%, mean +/- SE, median 100 days, P = 0.23, log-rank test). Four stents were clogged by ursodeoxycholic acid. Survival did not differ between the two groups. Combined therapy with ursodeoxycholic acid and norfloxacin failed to improve stent patency. Moreover, ursodeoxycholic acid can cause stent obstruction.

Value of MR cholangiography in the diagnosis of obstructive diseases of the biliary tree: a study of 58 cases.

OBJECTIVE: The aim of this study was to evaluate magnetic resonance cholangiography (MRC) in the diagnosis of biliary tree obstruction. METHODS: Fifty-eight consecutive patients underwent MRC (GYROSCAN ACS II 1.5 Tesla, TSE T2 axial/coronal-MIP sequences) for clinical and biochemical signs of main bile duct obstruction. MRC images were interpreted by two radiologists and consensus was established according to presence or absence of main bile duct dilation, choledocholithiasis, and malignant or benign stricture. MRC was compared to a final diagnosis established by ultrasound and CT in 19 cases, endoscopic retrograde cholangiopancreatography (ERCP) in 25, intraoperative cholangiography and exploration in 14, and clinical, biochemical, and histological presentation when relevant. Included were single or multiple choledocholithiasis (28, including 11 < or = 3 mm), malignant (10) and benign (12) strictures, and intrahepatic cholestasis (9). RESULTS: Overall, MRC was sensitive (94%) and specific (92%) in detecting main bile duct dilation and choledocholithiasis (86 % and 97 %), but was less sensitive (64%) for small stones < or = 3 mm. Sensitivity for stones > 3 mm was 100%. For benign and malignant strictures, MRC was less sensitive (67% and 80%) but remained specific (98% and 96%). In the detection of normal main bile duct, MRC was highly sensitive (100%) and specific (94%). Diagnostic accuracy ranged from 91% to 98%. CONCLUSION: MRC appears to be specific for choledocholithiasis and sensitive except for small stones. Results for biliary stricture are less satisfactory, but remain specific. Our data confirm that MRC can be useful in the diagnostic workup of main bile duct obstruction.

Dual-energy CT in the diagnosis and quantification of fatty liver: limited clinical value in comparison to ultrasound scan and single-energy CT, with special reference to iron overload.

BACKGROUND/AIMS: It has been suggested that dual-energy CT could differentiate irregular fatty liver from other hypodense lesions. We compared dual-energy CT to ultrasound scan and single-energy CT in the diagnosis and quantification of fatty liver, with special reference to iron overload. METHODS: Twenty-seven patients were included according to ultrasound: fatty liver (n=16) and normal liver (n=11). Single and dual-energy CT were performed. Attenuation measurements of hepatic lobes and control tissues were taken at 140 kV and 80 kV CT-guided liver biopsy was done in fatty liver patients, the degree of infiltration was estimated, and the histologic iron overload determined (iron overload, n=11; iron-free, n=5). RESULTS: The mean changes in attenuation for the right hepatic lobe were: normal liver: -0.8 (ns); iron overloaded fatty liver: 1.5 (ns); and iron-free fatty liver: 7.7 (p<0.0053). A spleen-liver attenuation differential threshold of 12H (140 kV, single-energy CT) and a right hepatic lobe 140 kV to 80 kV attenuation differential threshold of 9 H (dual-energy CT) were specific for fatty liver. Histology confirmed all cases of fatty liver diagnosed by ultrasound, independently of iron overload. Ultrasound did not differentiate cases of irregular from diffuse fatty liver detected on CT. Iron overload produced a masking effect in CT, decreasing its sensitivity: fatty liver was diagnosed in 67% of cases by single-energy CT and in 20% by dual-energy CT. Degree of fatty infiltration correlated with single-energy CT. CONCLUSIONS: Ultrasound diagnosed fatty liver best. Single-energy CT quantifies fatty infiltration, and best differentiates the irregular from the diffuse forms. Dual-energy CT is limited by poor sensitivity, especially in iron overload.

[Ultrasonographic aspect of the rectal wall in liver cirrhosis]. / Aspect échographique de la paroi rectale au cours de la cirrhose.

The aim of this study was to assess the ultrasonographic abnormalities of the rectal wall and surrounding structures in patients with cirrhosis and to correlate these findings with endoscopy. From November 1992 to May 1993, 53 cirrhotic patients and 30 control subjects were examined by transrectal ultrasonography and rectoscopy. In addition to rectoscopy and transrectal ultrasonography, patients with cirrhosis underwent an upper gastrointestinal endoscopy. Ultrasonography abnormalities of the rectum were detected in 32 cases of cirrhosis (60.5%): a) in 21 cases the rectal wall thickness was greater than 5 mm and the sub-mucosa was thickened ( > or = 2 mm) and dissected by thin echo-free elements; b) the remaining 11 patients presented, in addition to the previously described abnormalities, rounded elongated echo-free structures surrounding the rectum which were not found in the control group. All these 11 patients had rectal varices at rectoscopy. In the group of cirrhotic patients, rectoscopy showed abnormal dilated veins in 23 cases (43.5%) and rectal varices in 11 cases. Ultrasonographic and endoscopic abnormalities of the rectum were more often visualized in the group of cirrhotic patients than in the control group (P < 0.001). In patients with cirrhosis, the demonstration of rectal varices was associated with transrectal ultrasound abnormalities (P < 0.01), and in particular peri-rectal vascular formations. In cases of cirrhosis the rectal wall abnormalities were not associated with gastric varices at endoscopic inspection but were linked with large esophageal varices or gastric mucosal abnormalities demonstrated on endoscopy (P < 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

[Diaphragm of inferior vena cava associated with Budd-Chiari syndrome. Contribution of ultrasonography and color Doppler echocardiography]. / Diaphragme de la veine cave inférieure associé à un syndrome de Budd-Chiari. Apport de l'échographie et du Doppler couleur.

We report the case of a young man presenting clinical features of portal hypertension of unknown origin. The ultrasonographic examination showed suprahepatic blockage signs leading to the diagnosis of Budd-Chiari syndrome caused by incomplete diaphragm of the inferior vena cava. The color Doppler examination suggested caval obstruction, showing an abrupt shift from a laminar to a bosterous flux. Secondly cavograms and surgery later confirmed the diagnosis.

[Recto-colonic and hepatic involvement in graft-vs-host disease after bone marrow transplantation]. / Atteinte recto-colique et hépatique lors de la réaction de greffon contre l'hôte aprés une greffe de moelle osseuse.

We report the case of a child suffering from a graft versus host disease after an allogenic bone marrow transplantation. He developed intestinal, hepatic and cutaneous symptoms. The outcome after treatment was favorable with a total normalization.

[Hepatic adenoma and degeneration in the human. Apropos of a case]. / Adénome hépatique et dégénérescence chez l'homme. A propos d'un cas.

The authors report about one case of degenerated adenoma of the liver without any inducing hormonal therapy in a male patient. This case seems to be the first known to date. The authors discuss its aspects according to the data given by the literature.