Management of malignant gastric outlet obstruction with a modified triple-layer covered metal stent.

BACKGROUND: A high incidence of migration with covered metal stents has been reported in malignant gastric outlet obstruction (GOO). A newly modified, partially covered, triple-layer nitinol stent was developed that has a longer uncovered portion (5-15 mm) to prevent stent migration. OBJECTIVE: To estimate the efficacy and safety of the modified covered, triple-layer metal stent. DESIGN: Multicenter, prospective cohort study. SETTING: Three tertiary referral centers. PATIENTS: Fifty consecutive patients (26 with pancreatic carcinoma, 14 with gastric carcinoma, 9 with cholangiocarcinoma, 1 with a metastatic node) who presented with symptomatic unresectable malignant GOO between April 2007 and March 2010. INTERVENTIONS: Endoscopic placement of the modified covered, triple-layer metal stent. MAIN OUTCOME MEASUREMENTS: The primary endpoint was to improve the GOO scoring system (GOOSS) score. Secondary endpoints were success rate, patency, and complications. RESULTS: The median GOOSS score improved significantly (P < .0001) after stenting (from 0 to 3). The technical and clinical success rates were 100% and 90%, respectively. Stent occlusion by tumor overgrowth or ingrowth at the uncovered portion developed in 5 patients (10%). Asymptomatic stent migration occurred in 3 patients (6%) receiving chemotherapy at 95, 230, and 553 days after stent placement, but these patients tolerated solid food 68, 260, and 142 days after stent migration, respectively. Other complications occurred in 1 patient with insufficient expansion, cholangitis, and pancreatitis. No procedure-related deaths occurred. LIMITATIONS: A single-arm study in tertiary-care centers. CONCLUSIONS: The modified covered, triple-layer metal stent was effective and safe for managing malignant GOO and can prevent tumor ingrowth and stent migration. ( CLINICAL TRIAL REGISTRATION NUMBER: UMIN000004566.).

Management of distal malignant biliary obstruction with the ComVi stent, a new covered metallic stent.

BACKGROUND: The covered metallic stent is effective for managing malignant distal biliary obstructions. The most popular covered metallic stent is the covered Wallstent (CWS). This study estimated the efficacy and safety of a new expanded polytetrafluoroethylene (e-PTFE)-covered nitinol metallic stent, the ComVi stent. This covered metallic stent consists of an e-PTFE membrane sandwiched between two uncovered metallic stents with weak axial (straightening) force. Wire is exposed on both the inner and outer surfaces. METHODS: Between May 2005 and April 2007, ComVi stents were placed consecutively in 47 patients with unresectable malignant distal biliary obstruction. The cases involved 35 pancreatic cancers, 8 metastatic nodes, 2 gallbladder cancers, and 2 bile duct cancers. The patients were compared with 47 patients who received CWS placement between August 2001 and May 2005 matched for age, sex, and causative disease from 133 cases. RESULTS: No significant differences in stent patency or patient survival were found. Stent occlusion was observed in 13 patients (27.7%) in the ComVi group and 10 patients (21.3%) in the CWS group. The cause of occlusion in both groups was tumor overgrowth (4.25% vs 4.2%), sludge (8.5% vs 6.3%), impaction of food scraps (14.9% vs 2.1%), and bile duct kinking (0% vs 8.4%). Other complications were migration (2.1% vs 17.0%; p = 0.0304) and cholecystitis (2.1% vs 6.3%), and there were significant differences in the incidence of complications except for occlusion (4.2% vs 24.6%; p = 0.0142). CONCLUSION: The ComVi stent has a patency similar to that of the CWS and a lower incidence of migration. However, early occlusion by food impaction was increased and should be resolved.

Intraarterial 5-fluorouracil and interferon therapy is safe and effective for nonresectable biliary tract adenocarcinoma.

PURPOSE: The prognosis in advanced biliary carcinoma has remained poor. The purpose of this study was to investigate the efficacy of intraarterial 5-fluorouracil and interferon therapy against unresectable biliary carcinoma. METHODS: Patients with unresectable biliary carcinoma with performance status 0 or 1 were enrolled between January 2002 and September 2012. They received pegylated interferon-α 2a and intraarterial 5-FU every 4 weeks. The therapy was either terminated at the end of the first cycle for the patients with progressive disease or continued for at least three cycles. Patients' characteristics (physical, laboratory and radiographic) at the time of starting intraarterial 5-FU therapy were investigated. The relationship between the patients' characteristics and outcome, i.e., survival time and radiographic therapeutic evaluation of patients, was statistically analyzed. RESULTS: Tumor sites were the intrahepatic bile ducts in 23 patients and gallbladder in 2 patients. Previous treatment had been administered in ten patients. The overall response rate was 24% (6 partial responses in 25 patients). Stable disease was observed in 13 patients. The median overall survival was 358 days. Among the six partial responses, three patients received surgery, and one patient received radiofrequency ablation because clinical downstaging was obtained. The treatment was well tolerated. The survival analyses revealed that two factors (serum albumin ≥ 3.5 and hypovascular tumor) were significantly associated with overall survival. CONCLUSIONS: Combination therapy with 5-FU and interferon-α was safe and may improve the prognosis of advanced biliary carcinomas.