Nitinol versus steel partially covered self-expandable metal stent for malignant distal biliary obstruction: a randomized trial.

BACKGROUND AND STUDY AIMS: Covered nitinol alloy self-expandable metal stents (SEMSs) have been developed to overcome the shortcomings of steel SEMS in patients with malignant biliary obstruction. In a randomized, multicenter trial, we compared stent patency, patient survival, and adverse events in patients with partly covered stents made from steel or nitinol. PATIENTS AND METHODS: A total of 400 patients with unresectable distal malignant biliary obstruction were randomized at endoscopic retrograde cholangiopancreatography (ERCP) to insertion of a steel or nitinol partially covered SEMS, with 200 patients in each group. The primary outcome was confirmed stent failure during 300 days of follow-up.  RESULTS: At 300 days, the proportion of patients with patent stents was 77 % in the steel group, compared with 89 % in the nitinol group (P = 0.01). Confirmed stent failure occurred more often in the steel SEMS group compared with the nitinol SEMS group, in 30 versus 14 patients (P = 0.02). Stent migration occurred in 13 patients in the steel group and in 3 patients in the nitinol group (P = 0.01). Median patient survival (secondary outcome) was 137 days and 120 days in the steel SEMS and nitinol SEMS groups, respectively (P = 0.59). CONCLUSIONS: The nitinol SEMS showed longer patency time, and the nitinol group had fewer patients with stent failure, compared with the steel SEMS group. We could not detect any differences between the two groups regarding survival time, and regarding adverse event rate.Clinical trial registration : NCT 00980889.

Use of non-steroidal anti-inflammatory drugs and proton pump inhibitors in correlation with incidence, recurrence and death of peptic ulcer bleeding: an ecological study.

BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs) and proton pump inhibitors (PPIs) are regarded as two types of drugs that respectively increase and decrease the risk of peptic ulcer bleeding. However, their relation to occurrence, recurrence and death of bleeding in the population level is not clear. STUDY OBJECTIVE: To clarify recent calendar-time correlations between sales of NSAIDs and PPIs and the occurrence of peptic ulcer bleeding, re-bleeding and death. DESIGN: Ecological study. RESULTS: The time trend of peptic ulcer bleeding did not correlate with PPI sales but did correlate with NSAIDs in mem (R(male)=0.6571, P(male)=0.05). Sales of PPIs (inverse) and NSAIDs correlated with re-bleeding in women (R(male)=-0.8754, P(male)=0.002 and R(female)=0.7161, P(female)=0.03, respectively), but not in men. An inverse correlation between PPI sales and 30-day death after bleeding was found (R(male)=-0.9392, P(male)=0.0002 and R(female)=-0.8561, P(female)=0.003), and NSAID sales were found to correlate with increased death after bleeding ((R(male)=0.7278, P(male)=0.03, R(female)=0.7858, P(female)=0.01). CONCLUSIONS: The sales of NSAIDs and PPIs correlate with recurrence of peptic ulcer bleeding in women and death after peptic ulcer bleeding in both genders in the population level.

Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study.

BACKGROUND: Covered biliary metal stents have been developed to prevent tumor ingrowth. Previous comparative studies are limited and often include few patients. OBJECTIVE: To compare differences in stent patency, patient survival, and complication rates between covered and uncovered nitinol stents in patients with malignant biliary obstruction. DESIGN: Randomized, multicenter trial conducted between January 2006 and October 2008. SETTING: Ten sites serving a total catchment area of approximately 2.8 million inhabitants. PATIENTS: A total of 400 patients with unresectable distal malignant biliary obstruction. INTERVENTIONS: ERCP with insertion of covered or uncovered metal stent. Follow-up conducted monthly for symptoms indicating stent obstruction. MAIN OUTCOME MEASUREMENTS: Time to stent failure, survival time, and complication rate. RESULTS: The patient survival times were 116 days (interquartile range 242 days) and 174 days (interquartile range 284 days) in the covered and uncovered stent groups, respectively (P = .320). The first quartile stent patency time was 154 days in the covered stent group and 199 days in the uncovered stent group (P = .326). There was no difference in the incidence of pancreatitis or cholecystitis between the 2 groups. Stent migration occurred in 6 patients (3%) in the covered group and in no patients in the uncovered group (P = .030). LIMITATIONS: Randomization was not blinded. CONCLUSIONS: There were no significant differences in stent patency time, patient survival time, or complication rates between covered and uncovered nitinol metal stents in the palliative treatment of malignant distal biliary obstruction. However, covered stents migrated significantly more often compared with uncovered stents, and tumor ingrowth was more frequent in uncovered stents.

Factors influencing the use of precut technique at endoscopic sphincterotomy.

BACKGROUND/AIMS: Endoscopic sphincterotomy (EST) is a prerequisite for invasive procedures in the biliary tract or the pancreas. Access to the desired duct system may be facilitated by a precut in the papilla but this has also been described as a risk factor of the procedure. The present study is focused on the clinical situation and anatomical conditions which may increase the need for a precut procedure. METHODOLOGY: During a 2-year period, (2001-2002), 562 patients underwent EST. The precut was performed with a papillotome knife when cannulation failed using standard techniques. RESULTS: EST was successful in 545 (97.0%) of the patients, and in 522 (92.8%) in the first session. 173 patients (30.8%) were subjected to precutting. Precutting was used less frequently in patients with biliary stone disease, in 39 of 183, than in those without (P < 0.01). In the presence of a tumor, precut technique was warranted more often, in 62 of 143, as compared to benign disease, 111 of 419 (P < 0.01). Changed anatomical conditions at the papilla increased precut use, in 79 of 143 (P < 0.001), as well as duodenal stenosis, 15 of 22 (P < 0.001). The complication rates were equal, 13.3% using precut and 12.4% in standard EST. The 30-day mortality was higher in the precut group: 8 (4.6%) as compared to 5 (1.3%) using standard EST (P < 0.05) but it was mainly caused by advanced malignancies or severe underlying acute pancreatitis. CONCLUSIONS: The need for precut technique seems to be related to the diagnosis and was decreased in the presence of bile duct stones, while it was increased in malignancies. The precut procedure was used more frequently when the anatomical conditions at the papilla were abnormal and in duodenal stenosis.

Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial.

BACKGROUND: Most patients with malignant common bile duct strictures are suited only for palliation of jaundice by placement of a polyethylene (PE) stent using an endoscopic retrograde cholangiographic technique. Occlusion of these stents occurs after 3 to 4 months, whereas uncovered self-expanding metal stents (SEMS) remain open twice as long. The initial higher cost of the latter might be balanced by a decreased need for repeat intervention. OBJECTIVE: To compare the patency of 10F PE stents and covered 30F steel SEMS (Wallstent; Boston Scientific Nordic AB, Helsingborg, Sweden). DESIGN: Single-center, prospective, randomized, controlled trial. SETTING: General hospital in Stockholm, Sweden, which has a catchment area of 0.6 million people. PATIENTS: Non-referred, unresectable malignant common bile duct strictures. INTERVENTIONS: Endoscopic retrograde cholangiography with plastic stents or covered SEMS. MAIN OUTCOME MEASUREMENTS: Time to stent failure, requiring a new stent. LIMITATIONS: Similar setting and patients, and costs in Scandinavia. RESULTS: Fifty-one and 49 patients were allocated to the PE stent and SEMS groups, respectively. Fifty-six patients died without stent failure within 10 months (median, 2.6 months). Twenty-two PE stent and 9 SEMS patients (P = .009) developed failure after a median of 1.1 and 3.5 months, respectively (P = .007). Median patency times were 1.8 and 3.6 months in the PE and SEMS groups, respectively (P = .002). Median survival was 4.5 months; in 35 patients with distant metastases, the median survival was 2.5 months (P = .002)(PE group, 1.9 months). CONCLUSIONS: The more-effective SEMS are recommended in unresectable patients with malignant common bile duct strictures, who survive a median of 4.5 months. Less costly plastic stents are preferable in the one third of patients who have distant metastases. In our study, the cost was equal.

Bile duct injuries at laparoscopic cholecystectomy: a single-institution prospective study. Acute cholecystitis indicates an increased risk.

During the last decade laparoscopic cholecystectomy (LC) has become established as the gold standard. The drawbacks in the form of bile duct (BD) injuries have also come into focus. We present the results of a prospective, consecutive series of 1568 patients with reference to BD injuries regarding risks, management, and preventive measures. The significant complications of all patients operated upon with LC between October 1999 and December 2003 were recorded prospectively. BD injuries were classified according to Strasberg into types A-E. Transected major BDs, injuries of type E, were regarded as "major" injuries and types A, B, C, and D were "minor" injuries. Major BDs were transected in five patients (0.3%), three of whom had acute cholecystitis. In the two patients operated on electively, the BD injuries were detected postoperatively, while they were detected intraoperatively when the operation was performed of necessity. The BDs were all reconstructed with a Roux-en-Y hepaticojejunostomy. Two patients had anastomotic strictures. Minor BD injuries were encountered in 19 patients (1.2%). The 13 patients with leakage from the cystic duct or gallbladder bed, injury type A, were treated by endoscopic (ERC) stenting without sequelae. Five patients sustained a lateral BD injury, type D; they were treated with a simple suture over a T-tube (at LC) or endoscopically (ERC) without further problems. A transected aberrant right hepatic BD, type C injury, was due to its small-caliber sutured. Minor BD injuries could be managed at the primary hospital if the endoscopic expertise were at hand. Acute cholecystitis seems to be a risk factor for BD injuries.