A newly designed uncovered biliary stent for palliation of malignant obstruction: results of a prospective study.

BACKGROUND: Biliary decompression can reduce symptoms and improve quality of life in patients with malignant biliary obstruction. Endoscopically placed stents have become the standard of care for biliary drainage with the aim of improving hepatic function, relieving jaundice, and reducing adverse effects of obstruction. The purpose of this study was to evaluate the performance characteristics of a newly-designed, uncovered metal biliary stent for the palliation of malignant biliary obstruction. METHODS: This post-market, prospective study included patients with biliary obstruction due to a malignant neoplasm treated with a single-type, commercially available uncovered self-expanding metal stent (SEMS). Stents were placed as clinically indicated for palliation of jaundice and to potentially facilitate neo-adjuvant chemotherapy. The main outcome measure was freedom from recurrent biliary obstruction (within the stent) requiring re-intervention within 1, 3, and 6 months of stent insertion. Secondary outcome measures included device-related adverse events and technical success of stent deployment. RESULTS: SEMS were placed in 113 patients (73 men; mean age, 69); a single stent was inserted in 106 patients, and 2 stents were placed in 7 patients. Forty-eight patients survived and/or completed the 6 month study protocol. Freedom from symptomatic recurrent biliary obstruction requiring re-intervention was achieved in 108 of 113 patients (95.6, 95%CI = 90.0-98.6%) at study exit for each patient. Per interval analysis yielded the absence of recurrent biliary obstruction in 99.0% of patients at 1 month (n = 99; 95%CI = 97.0-100%), 96.6% of patients at 3 months (n = 77; 95%CI = 92.7-100%), and 93.3% of patients at 6 months (n = 48; 95%CI = 86.8-99.9%). In total, only 5 patients (4.4%) were considered failures of the primary endpoint. Most of these failures (4/5) were due to stent occlusion from tumor ingrowth or overgrowth. Overall technical success rate of stent deployment was 99.2%. There were 2 cases of stent-related adverse events (1.8%). There were no cases of post-procedure stent migration, stent-related perforation, or stent-related deaths. CONCLUSIONS: This newly designed and marketed biliary SEMS system appears to be effective at relieving biliary obstruction and preventing re-intervention within 6 months of insertion in the overwhelming majority of patients. The device has an excellent safety profile, and associated high technical success rate during deployment. TRIAL REGISTRATION: The study was registered on clinicaltrials.gov on 14 October 2013 and the study registration number is NCT01962168. University of Massachusetts Medical School did not participate in the study.

Improved oral intake after palliative duodenal stenting for malignant obstruction: a prospective multicenter clinical trial.

OBJECTIVES: We sought to test the hypothesis that placement of a new nitinol duodenal self-expandable metallic stent (SEMS) for palliation of malignant gastroduodenal obstruction is effective and safe in allowing patients to tolerate an oral diet. METHODS: In a prospective multicenter study, SEMSs (Duodenal WallFlex, Boston Scientific) were placed to alleviate gastroduodenal obstruction in inoperable patients without the ability to tolerate solid food. The primary study end point was improvement in oral intake monitored according to the 4-point Gastric Outlet Obstruction Scoring System (GOOSS) up to 24 weeks after stent placement. RESULTS: Forty-three patients received SEMSs, which were successfully deployed on the first attempt in 41 cases (95%) and the second attempt in two (5%). Within 1 day and 7 days after SEMS placement, 52% and 75% of patients, respectively, benefited from a GOOSS increase > or =1. Resumption of solid food intake (GOOSS 2-3) was attained by 56% of patients within 7 days and 80% by 28 days. Of the patients attaining GOOSS 2-3, 48% remained on solid food until death or last follow-up. Device-related adverse events included stent occlusion/malfunction in 9% of patients and perforation in 5% of patients. CONCLUSIONS: Duodenal WallFlex stent placement promptly improves oral intake in a majority of inoperable patients with malignant gastroduodenal obstruction. In approximately half the patients achieving GOOSS 2-3, the capacity for solid food intake endures until death or last follow-up.

Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial.

BACKGROUND: The Wallstent has remained the industry standard for biliary self-expanding metal stents (SEMSs). Recently, stents of differing designs, compositions, and diameters have been developed. OBJECTIVE: To compare the new nitinol 6-mm and 10-mm Zilver stents with the 10-mm stainless steel Wallstent and determine the mechanism of obstruction. DESIGN: Randomized, prospective, controlled study. SETTING: Nine centers experienced in SEMS placement during ERCP. PATIENTS: A total of 241 patients presenting between September 2003 and December 2005 with unresectable malignant biliary strictures at least 2 cm distal to the bifurcation. MAIN OUTCOME MEASUREMENT: Stent occlusions requiring reintervention and death. RESULTS: At interim analysis, a significant increase in occlusions was noted in the 6-mm Zilver group at the P = .04 level, resulting in arm closure but continued follow-up. Final study arms were 64, 88, and 89 patients receiving a 6-mm Zilver, 10-mm Zilver, and 10-mm Wallstent, respectively. Stent occlusions occurred in 25 (39.1%) of the patients in the 6-mm Zilver arm, 21 (23.9%) of the patients in the 10-mm Zilver arm, and 19 (21.4%) of the patients in the 10-mm Wallstent arm (P = .02). The mean number of days of stent patency were 142.9, 185.8, and 186.7, respectively (P = .057). No differences were noted in secondary endpoints, and the study was ended at the 95% censored study endpoints. Biopsy specimens of ingrowth occlusive tissue revealed that 56% were caused by benign epithelial hyperplasia. CONCLUSIONS: SEMS occlusions were much more frequent with a 6-mm diameter SEMS and equivalent in the two 10-mm arms despite major differences in stent design, material, and expansion, suggesting that diameter is the critical feature. Malignant tumor ingrowth produced only a minority of the documented occlusions.

Incidence of benign inflammatory disease in patients undergoing Whipple procedure for clinically suspected carcinoma: a single-institution experience.

BACKGROUND: We evaluated the incidence of chronic pancreatitis and chronic bile duct inflammation in patients undergoing pancreaticoduodenectomy (PD) for suspected periampullary cancer. METHODS: Differences between clinical presentation, surgical management, and outcomes were compared between patients with malignancy and benign inflammatory disease. RESULTS: The incidence of chronic inflammatory disease was 12.9% (21/162). Patients with chronic inflammatory disease were associated with a higher incidence of smoking (75.0% versus 64.7%) and chronic alcohol use (66.7% versus 46.2%). Jaundice was significantly more frequent in patients with malignant disease (83.6% versus 42.9%, P < .05). Surgery for chronic inflammatory disease was associated with significantly more intraoperative bleeding (P < .05). CONCLUSIONS: The finding of chronic inflammatory disease after PD for suspected carcinoma is justifiable because (1) none of the available diagnostic modalities are infallible, (2) early treatment of pancreatic cancer is crucial for achieving cure, and (3) PD may relieve clinical symptoms in patients with chronic pancreatitis or pancreatic cancer.

Palliation of patients with malignant gastric outlet obstruction with the enteral Wallstent: outcomes from a multicenter study.

BACKGROUND: Endoscopic placement of self-expandable metallic stents for palliation of patients with malignant gastric outlet obstruction is safe and feasible. METHODS: Patients with malignant gastric outlet obstruction undergoing enteral stent insertion were identified from endoscopy databases. Duration of oral intake after stent insertion was calculated by using the log-rank test. Factors associated with duration of oral intake were assessed by using Cox multivariable regression analysis. RESULTS: A total of 176 patients (mean age 65 [14] years) treated at 4 centers from 1996 to 2003 were identified. Obstruction was caused by cancer of the pancreas in 84, the stomach in 20, the bile duct in 15, the major duodenal papilla in 8, another primary site in 16, and metastases in 33. The site of obstruction was the duodenum in 125, the distal stomach in 17, the stomach and the duodenum in 18, and surgical anastomosis in 16 patients. Stent deployment was technically successful in 173. Complications occurred in 14 patients. Seventeen patients were lost to follow-up. Of the remaining 159 patients, 133 resumed oral intake for a median time of 146 days: 95% CI [65, 202]. On regression analysis, chemotherapy after stent placement was associated with prolonged duration of oral intake (hazard ratio 0.41: 95% CI [0.23, 0.72]). CONCLUSIONS: After enteral stent insertion for malignant gastric outlet obstruction, 84% of patients resumed oral intake for a median time of 146 days. Chemotherapy after enteral stent insertion was independently associated with prolongation of oral intake.

Multicenter randomized trial of the spiral Z-stent compared with the Wallstent for malignant biliary obstruction.

BACKGROUND: The industry standard since 1990 for self-expanding biliary metallic stents has been the Wallstent. In 1998 the Spiral Z-stent was released. This randomized trial compared the Z-stent with the Wallstent in the treatment of malignant biliary obstruction. METHODS: Patients with unresectable malignant biliary obstruction distal to the bile duct bifurcation were randomized to receive a 10-mm diameter Wallstent or a 10-mm diameter Z-stent. RESULTS: A total of 145 patients were randomized; 13 were excluded. Sixty-four patients who received a Z-stent and 68 who had a Wallstent are included in the analysis. Tumors responsible for bile duct obstruction were pancreatic cancer (108), cholangiocarcinoma (15), metastatic cancer (6), and papillary cancer (3). Metallic stents were successfully placed in all patients. Seven technical problems were encountered during placement of the Z-stent and 5 with the Wallstent. There were 21 occlusions requiring reintervention (8 Z-stent, 13 Wallstent; p = 0.30). Median time to reintervention was the following: Z-stent, 162 days; Wallstent, 150 days (p = 0.22). A total of 104 patients died of progressive disease or other cause; 7 patients remain alive with patent stents. The overall calculated median patency rates were: Z-stent, 152 days; Wallstent, 154 days (p = 0.90). CONCLUSIONS: The Spiral Z-stent is comparable with the Wallstent in terms of placement, occlusion rates, and overall patency. Occasional early occlusion of both stents suggests tumor characteristics instead of the size of the mesh openings in the stents as important factors.

Percutaneous hepatolithotomy: the Northwestern University experience.

Obstruction of intrahepatic ducts by calculi can lead to abdominal pain, cholestasis, abscesses, and cholangitis. Patients with stones recalcitrant to extraction using endoscopic retrograde cholangiopancreatography (ERCP) have traditionally been referred to a general surgeon for open stone extraction or hepatic lobectomy despite its great potential morbidity. Borrowing techniques, instrumentation, and experience in performing percutaneous nephrolithotomy, we describe our experience with percutaneous hepatolithotomy (PHL), a minimally invasive, safe, and effective alternative to open surgery for recalcitrant biliary stones.

Extracorporeal shock wave lithotripsy of pancreatic duct stones using the Healthtronics LithoTron lithotriptor and the Dornier HM3 lithotripsy machine.

PURPOSE: Pancreatic duct stones, which are most often a result of alcohol induced chronic pancreatitis, can lead to chronic abdominal pain, pseudocysts, and exocrine and endocrine failure of the pancreas. Others have reported success using extracorporeal shock wave lithotripsy (ESWL) (Dornier Medical Systems, Inc., Marietta, Georgia) for pancreatic stones. We report our experience with pancreatic ESWL using the LithoTron (Healthtronics, Marietta, Georgia) and HM3 (Dornier) lithotripsy machines. MATERIALS AND METHODS: We performed pancreatic ESWL in 23 patients in 4 years, including in 12 with the LithoTron and in 11 with the HM3. After ESWL endoscopic retrograde cholangio-pancreatography (ERCP) was performed in all cases. Stone-free status was defined as no stone fragments visualized or the elimination of all post-ESWL stones by ERCP. RESULTS: Stone-free status was documented in 83% and 82% of patients treated with the LithoTron and HM3, respectively, and 2 per group later required open surgical intervention. There were no changes in pancreatic enzymes and no cases of sepsis or fever after ERCP. CONCLUSIONS: In association with post-procedure ERCP pancreatic ESWL is an effective and safe procedure that enables patients with obstructing pancreatic duct stones recalcitrant to primary endoscopic extraction to avoid a potentially morbid open procedure. The HM3 and LithoTron have comparable efficacy and safety. This modality is particularly effective for a stone aggregate of less than 20 mm., while a larger stone burden of greater than 20 mm. in aggregate and multiple stones are clear risk factors for treatment failure.