Palliative management of malignant rectosigmoidal obstruction. Colostomy vs. endoscopic stenting. A randomized prospective trial. A prospective randomised study of "covered" versus "uncovered" diamond stents for the management of distal malignant biliary obstruction. A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct. A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct. Tannenbaum and metal stents in the palliative treatment of malignant distal bile duct obstruction: a comparative study of patency and cost effectiveness. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Randomised trial of endoscopic endoprosthesis versus operative bypass in malignant obstructive jaundice. Randomised trial of endoscopic stenting versus surgical bypass in malignant low bileduct obstruction. Endolaparoscopic approach vs conventional open surgery in the treatment of obstructing left-sided colon cancer: a randomized controlled trial.
Colostomy was the palliative treatment of choice in patients with malignant unresectable rectosigmoid obstruction. Palliative endoscopic treatment of malignant rectosigmoid obstruction by endoluminal self-expanding metallic stents is nowadays a well-established procedure.
                Twenty-two patients, referred for treatment with diagnosis of malignant obstruction of the rectosigmoid region presenting an advanced unresectable stage, were enrolled. Patients were randomly assigned into two treatment groups (endoscopic stenting vs colostomy) according to random-number tables. The length of procedure, morbidity and mortality rate, canalization of the gastrointestinal tract, restoration of oral intake and hospital stay were assessed.
                Endoscopic group: The median length of procedure was 36 minutes. No death was observed. None of the patients reported complications. All patients resumed bowel function within 24 hours. The restoration of oral intake was achieved one day after stent placement. The median hospital stay was 2.6 days. Colostomy group: The median length of the operation was 75.4 minutes. No mortality was reported. In 1 patient (9.1%) stoma prolapse was observed 3 days after the operation. Canalization of the gastrointestinal tract was restored when colostomy was opened (on postoperative day 3). All patients were able to resume oral feedings on postoperative day 3. The median hospital stay was 8.1 days.
                There were no statistically significant differences between the 2 groups concerning morbidity and mortality. Endoscopic stenting was significantly more effective concerning operative time, restoration of bowel function and oral intake and median hospitalization. Our results would suggest that endoscopically placed metal stents offer an effective alternative to surgical palliation in patients suffering from unresectable malignant rectosigmoid obstruction. Covered self-expandable metal stents (EMS) were recently developed to overcome tumour ingrowth in conventional EMS. However, supporting evidence for the efficacy of covered EMS is lacking.
                We enrolled 112 patients with unresectable distal biliary malignancies. They were randomly assigned to polyurethane covered (n = 57) or original diamond stent (n = 55).
                Stent occlusion occurred in eight patients (14%) after a mean of 304 days in the covered group, and in 21 patients (38%) after a mean of 166 days in the uncovered group. The incidence of covered EMS occlusion was significantly lower than that of uncovered EMS (p = 0.0032). The cumulative stent patency of covered stents was significantly higher than that of uncovered stents (p = 0.0066). No tumour ingrowth occurred in the covered group while it was observed in 15 patients in the uncovered group. In subgroup analysis, the cumulative patency of the covered EMS was significantly higher in pancreatic cancer (p = 0.0363) and metastatic lymph nodes (p = 0.0354). There was no significant difference in survival between the two groups. Acute cholecystitis was observed in two of the covered group and in none of the uncovered group. Mild pancreatitis occurred in five of the covered group and in one of the uncovered group.
                Covered diamond stents successfully prevented tumour ingrowth and were significantly superior to uncovered stents for the treatment of patients with distal malignant biliary obstruction. However, careful attention must be paid to complications specific to covered self-expandable metal stents, such as acute cholecystitis and pancreatitis. Although metallic stents remain patent longer than plastic stents, the optimal palliation of inoperable malignant biliary strictures remains controversial because of the high cost of metallic stents and short patient survival.
                A total of 101 patients (mean age 72.5+/-12.9 years) with malignant strictures of the common bile duct were included in this study, after three exclusions for technical failure (n = 3) and one for noncompliance with study design. The etiology of the strictures included pancreatic cancer (65), cholangiocarcinoma (21), ampullary tumor (3), and metastatic lymph nodes (12). Patients were randomized to receive either an 11.5F polyethylene stent to be exchanged in case of dysfunction (group 1, n = 33), an 11.5F stent to be exchanged every 3 months (group 2, n = 34), or a self-expanding metallic Wallstent (group 3, n = 34).
                Endoscopic procedures were successful (including complete relief of jaundice) in 97.1 % of cases. Procedure-related morbidity was 11.9%, and mortality was 2.9%. Bilirubinemia after 48 hours (37.2%+/-21.7% decrease from the preoperative level) did not differ between groups. Patients were followed for a mean of 166 days (median 143, range 0 to 596 days). Overall survivals were not different between groups, but complication-free survival for groups 2 and 3 was longer than that of group 1 (p < 0.05). Cumulated hospital days were 7.4+/-1.5, 10.6+/-1.7, and 5.5+/-1.4 (groups 1, 2, and 3, respectively) (p < 0.05; analysis of variance). Cost analysis showed that metallic stents were advantageous in patients surviving more than 6 months, whereas a plastic stent was advantageous in patients surviving 6 months or less.
                Metallic stents and plastic stents exchanged every 3 months are valuable alternatives for increasing complication-free survival in patients with malignant strictures of the common bile duct. Metal stents are advantageous in patients with the longest life expectancy. Endoscopic insertion of biliary stents is the preferred method of palliation for inoperable malignant biliary obstruction; however, migration and clogging are frequent problems with conventional endoprostheses. We sought to determine if expandable metal stents offer improved palliation compared to conventional stents. Sixty-two patients with common bile duct lesions were randomized to receive polyethylene or metal stents. Stents were placed endoscopically or by the combined percutaneous-endoscopic route. Early results (< 1 month) were similar in both groups. Long-term follow-up (n = 28 polyethylene, median: 5 months; n = 27 metal, median: 5 months) showed a higher stent failure rate in the polyethylene (n = 12; 43%) compared to the metal group (n = 6; 22%). The incidence of cholangitis was significantly higher (p < 0.05) in the polyethylene (n = 10; 36%) compared to the metal group (n = 4; 15%). Life-table analysis showed a significantly reduced incidence of stent failure (p = 0.0035) in the metal stent compared to the polyethylene group. The total duration of hospital stay for treatment of stent related problems was significantly higher in the polyethylene (11.8 +/- 3 days) compared to the metal group (4 +/- 1.9 days; p = 0.02). The costs for retreatment because of stent failure were significantly higher in the plastic (DM 5900 +/- 1516) compared to the metal group (DM 2070 +/- 977). As a result, the overall costs (treatment of stent related complications & stents) were higher in the polyethylene group (DM 6000 +/- 1500).(ABSTRACT TRUNCATED AT 250 WORDS) Stent clogging is the major limitation of palliative treatment for malignant biliary obstruction. Metal stents have much better patency than plastic stents, but are more expensive. Preliminary data suggest that the recently designed plastic (Tannenbaum) stent has better duration of patency than the polyethylene stent. This study aimed to compare the efficacy and cost effectiveness between the Tannenbaum stent without side holes and the uncovered metal stent for patients with malignant distal common bile duct obstruction.
                In this study, 47 patients (median age, 73 years, range, 56-86 years) with inoperable malignant distal common bile duct strictures were prospectively randomized to receive either a Tannenbaum stent (n = 24) or an uncovered self-expandable metal stent (n = 23). The patients were clinically evaluated, and biochemical tests were analyzed if necessary until their death or surgery for gastric outlet obstruction. Cumulative first stent patency and patient survival were compared between the two groups. Cost-effectiveness analysis also was performed for the two study groups.
                The two groups were comparable in terms of age, gender, and diagnosis. The median first stent patency was longer in the metal group than in the Tannenbaum stent group (255 vs 123.5 days; p = 0.002). There was no significant difference in survival between the two groups. The total cost associated with the Tannenbaum stents was lower than for the metal stents (17,700 vs 30,100 euros; p = 0.001), especially for patients with liver metastases (3,000 vs 6,900 euros; p < 0.001).
                Metal stent placement is an effective treatment for inoperable malignant distal common bile duct obstruction, but Tannenbaum stent placement is a cost-saving strategy, as compared with metal stent placement, especially for patients with liver metastases and expected short survival time. Self-expanding metal stents are claimed to prolong biliary-stent patency, although no formal comparative trial between plastic and expandable stents has been done. In a prospective randomised trial, we assigned 105 patients with irresectable distal bile-duct malignancy to receive either a metal stent (49) or a straight polyethylene stent (56). Median patency of the first stent was significantly prolonged in patients with a metal stent compared with those with a polyethylene stent (273 vs 126 days; p = 0.006). The major cause of stent dysfunction was tumour ingrowth in the metal-stent group and sludge deposition in the polyethylene-stent group. Treatment after any occlusion included placement of a polyethylene stent. In the metal-stent group none of 14 second stents occluded, whereas 11 of 23 (48%) second stents clogged in the polyethylene-stent group (p = 0.002). Overall median survival was 149 days and did not differ significantly between treatment groups. Incremental cost-effectiveness analysis showed that initial placement of a metal stent results in a 28% decrease of endoscopic procedures. Self-expanding metal stents have a longer patency than polyethylene stents and offer adequate palliation in patients with irresectable malignant distal bile-duct obstruction. In patients with obstructive jaundice caused by malignant stricture of the extrahepatic bile duct we compared survival time, complication rates, hospitalisation requirements, and quality of life after palliation by endoscopic endoprosthesis or bypass surgery. During diagnostic endoscopic cholangiography 50 patients were randomised to the two treatment alternatives. All 25 patients randomised to endoprosthesis were treated by this procedure, whereas only 19 of 25 patients randomised to bypass surgery underwent operative biliary-digestive anastomosis. Life table analysis revealed no difference in survival between treatment groups or randomisation groups. No differences were found when other variables were compared. We conclude, that palliation of obstructive jaundice in malignant bile duct obstruction with endoscopically introduced endoprosthesis is as effective as operative bypass. The development of non-surgical techniques for the relief of malignant low bileduct obstruction has cast doubt on the best way of relieving jaundice, particularly in patients fit for surgery whose life expectancy is more than a few weeks. We did a randomised prospective controlled trial comparing endoscopic stent insertion and surgical biliary bypass in patients with malignant low bileduct obstruction. 204 patients were randomised (surgery 103, stent 101); 3 subsequently proved to have benign disease and were excluded, leaving 101 surgical and 100 stented patients for assessment. Technical success was achieved in 94 surgical and 95 stented patients, with functional biliary decompression obtained in 92 patients in both groups. In stented patients, there was a lower procedure-related mortality (3% vs 14%, p = 0.01), major complication rate (11% vs 29%, p = 0.02), and median total hospital stay (20 vs 26 days, p = 0.001). Recurrent jaundice occurred in 36 stented patients and 2 surgical patients. Late gastric outlet obstruction occurred in 17% of stented patients and 7% of the surgical group. Despite the early benefits of stenting there was no significant difference in overall survival between the two groups (median survival: surgical 26 weeks; stented 21 weeks; p = 0.065). Endoscopic stenting and surgery are effective palliative treatments with the former having fewer early treatment-related complications and the latter fewer late complications. To compare self-expanding metal stents with emergency open surgery in the treatment of obstructing left-sided colon cancer.
                A randomized controlled trial.
                An acute care hospital.
                Adult patients with an obstructing tumor between the splenic flexure and rectosigmoid junction.
                Successful 1-stage operation, cumulative operative time, blood loss, hospital stay, pain score, and postoperative complications.
                Forty-eight patients were analyzed. Twenty-four underwent endoluminal stenting followed by laparoscopic resection and 24 underwent emergency open surgery. The 2 groups were matched for age, sex, body mass index, and disease staging. Patients in the endolaparoscopic group had significantly less cumulative blood loss and lower pain, incidence of anastomotic leak, and wound infection. Significantly more patients in the endolaparoscopic group had a successful 1-stage operation performed (16 vs 9, P = .04). None of the patients in the endolaparoscopic group had a permanent stoma compared with 6 patients in the emergency open surgery group (P = .03).
                Self-expanding metal stents serve as a safe and effective bridge to subsequent laparoscopic surgery in patients with obstructing left-sided colon cancer. This endolaparoscopic approach makes a 1-stage operation more feasible, is associated with reduced incidence of stoma creation, and allows patients with malignant large-bowel obstruction to enjoy the full benefit of minimally invasive surgery. Trial Registration clinicaltrials.gov Identifier: NCT00654212.
Endoscopic metal stents are the intervention of choice at present in patients with malignant distal obstructive jaundice due to pancreatic carcinoma. In patients with short predicted survival, their patency benefits over plastic stents may not be realised. Further RCTs are needed to determine the optimal stent type for these patients.