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OBJECTIVE: To provide current information on the risks of endoscopic sphincterotomy for stone. SUMMARY BACKGROUND DATA: In recent years (since the popularity of laparoscopic cholecystectomy), endoscopic sphincterotomy has been used increasingly for the management of bile duct stones in relatively young and healthy patients. The validity of this trend has been questioned using data on short-term complications derived from earlier decades that involved more elderly and high-risk patients. METHODS: Seven academic centers collected data prospectively using a common database. Complications within 30 days of the procedures were documented by standard criteria. RESULTS: Of 1921 patients, 112 (5.8%) developed complications; two thirds of these events were graded as mild (

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. (Gastrointest Endosc 2003;57:830-6.)

Palliation of malignant esophageal obstruction is an important clinical problem. Expandable metal stents are a major advance in therapy, but many stents become obstructed because of tumor ingrowth. The aim of this study was to compare a new, membrane-covered expandable metal stent to conventional prostheses in a randomized controlled trial.Sixty-two patients with malignant inoperable esophageal obstruction at the gastroesophageal junction participated in the study. Patients were randomly assigned to covered or uncovered stents. The principal outcome measure was the need for reintervention because of recurrent dysphagia or migration. Secondary endpoints were relief of dysphagia measured by a dysphagia score (grade 0 = no dysphagia, grade 1 = able to eat solid food, grade 2 = semisolids only, grade 3 = liquids only, grade 4 = complete dysphagia) and the rate of complications and functional status. All patients were observed at monthly intervals until death or for 6 months.One week after stenting the dysphagia score improved significantly in both the uncovered (n = 32, 3 +/- 0.1 to 1 +/- 0.1 [means +/- SEMs], p0.001) and covered (n = 30, 3 +/- 0.1 to 1 +/- 0.2 [means +/- SEMs], p0.001) stents. Obstructing tumor ingrowth was significantly more likely in the uncovered stent group (9/30) than in the covered group (1/32) (p = 0.005). Significant stent migration occurred in 2/30 patients with uncovered stents, as compared with 4/32 patients in the covered group (p = 0.44). Reinterventions for tumor ingrowth were significantly greater in the uncovered stent group (27%), as compared with 0% in the covered group (p = 0.002). Life table analysis showed similar survival in both groups.Membrane-covered stents have significantly better palliation than conventional bare metal stents because of decreased rates of tumor ingrowth that necessitate endoscopic reintervention for dysphagia.

Two patients are reported who developed bile ascites as a result of cystic duct fistulas following laparoscopic cholecystectomy. Both patients were successfully treated with endoscopic retrograde cholangiopancreatography, utilizing sphincterotomy and nasobiliary tube placement. Characteristics of this syndrome and advantages of this form of therapy are emphasized.

Objective: To assess the efficacy and safety of the removal of pancreatic duct stones by a combined modality approach in patients with pancreatic ductal lithiasis and recurrent abdominal pain. Design: Retrospective review with a mean follow-up of 19 months (range, 1 to 56 months). Setting: A tertiary care, private community hospital with a university affiliation. Patients: The records of patients who presented to the hospital or who were referred with recurrent abdominal pain and who were demonstrated to have pancreatic ductal lithiasis between 1989 and 1994 were reviewed. ductients were assessed by their clinical response to pancreatic duct stone extraction by a variety of therapeutic interventions. Results: Fifteen patients were included in the study. One patient was excluded from analysis because of a concurrent choledochocele. Two patients required operative decompression and stone extraction for endoscopically inaccessible stones. Six patients were treated with endoscopic management alone, and six were treated with a combination of extracorporeal shock wave lithotripsy and endoscopic stone retrieval. Twelve patients had complete clearance of the pancreatic duct. One patient had a stone that was not removed, but adequate pancreatic ductal decompression was achieved. The remaining patient had incomplete clearance of pancreatic stone fragments following extracorporeal shock wave lithotripsy but had adequate ductal drainage. No patient has required further therapy or hospitalization for abdominal pain. No complications occurred as a result of any intervention in this study. Conclusions: A multidisciplinary combined modality approach is a safe and effective method for extracting pancreatic duct stones in symptomatic patients. Stone extraction and reestablishment of adequate ductal drainage appear to relieve symptoms in some patients. (Arch Surg. 1995;130:375-380)

(biliary stents) for improved drainage. Radiology 1983;148:8994. 14. Dooley JS, Dick R, George P, et al. Percutaneous transhepatic endoprosthesis for bile duct obstruction: complications and results. Gastroenterology 1984;86:905-9. 15. Mueller PR, Ferrucci JT, Teplick SK, et al. Biliary stent endoprosthesis: analysis of complications in 113 patients. Radiology 1985;156:637-9. 16. Lammer J, Neumayer K. Biliary drainage endoprostheses: experience with 201 placements. Radiology 1986;159:625-9. 17. Deviere J, Baize M, de Toeuf J, Cremer M. Long-term follow-up of patients with hilar malignant stricture treated by endoscopic internal drainage. Gastrointest Endosc 1988;34:95-6. 18. Motte S, Deviere J, Dumenceau JM, Serruys E, Thys JP, Cremer M. Risk factors for septicemia following endoscopic biliary stenting. Gastroenterology 1991;101:1374-81. 19. Coons HG. Self-expanding stainless steel biliary stents. Radiology 1989;170:979-83.

• During a 2-year interval, we identified 10 patients with symptoms of pancreaticobiliary disorders and small choledochoceles by endoscopic retrograde cholangiopancreatography. Patients ranged from 36 to 89 years of age. Eight were female. Seven presented with recurrent, acute pancreatitis, two presented with biliary colic, and one presented with cholangitis. Dilated common bile ducts were seen in four patients, and no other biliary lesions were demonstrated in any patients. Five patients were shown to have normal gallbladders by ultrasonographic or computed tomographic criteria. Choledochoceles were identified endoscopically as a bulge above or involving the ampulla. Diagnosis was confirmed by cholangiography. All patients underwent successful unroofing of the choledochocele and sphincterotomy of the common bile duct. One pancreatic sphincterotomy was performed for pancreatic ductal obstruction. We encountered no complications. Hospital stays ranged from 1 to 4 days. Follow-up intervals ranged from 2 to 20 months. At this time, no patients have had any recurrence of symptoms, and none has required rehospitalization or surgery. (Arch Surg. 1992;127:536-539)

Introduction: Evaluation of long-term patency for devices introduced for the treatment of extrahepatic malignant biliary obstruction require comparative trials in view of the high degree of variability among patients. Reported stent patencies of newly introduced products are frequently not confirmed in clinical practice (Gastrointest Endosc 1999:49:700(A)). New products, particularly those involving high risk interventions and high cost, should be studied carefully in multicenter trials to gain consensus as to their clinical utility.We propose to study the new spiral stent for malignant obstruction compared to the other metal stent (ZOOM). Study Goal: All our participating centers have obtained IRB approval to offer appropriate patients a randomized option of a standard uncoated Wallstent (Microvasive,Watertown, MA) or a new stainless steel uncoated Gianturco spiral Z-stent (Wilson-Cook, Winston-Salem, NC) for palliative treatment of malignant extrahepatic biliary obstruction. All strictures must be 2 cm or more below the bifurcation and patients must be in good physical condition as measured by a Karnofsky score of 60 or higher (Requires occasional care for most needs). Patients with prior temporary plastic stents can be accepted providing they do not show evidence of occlusion or cholangitis and have appropriate Karnofsky's scores. Patients will then have serum bilirubins measured at 1 month and clinical follow-up on a monthly basis. Every effort will be made to determine the cause of stent occlusion. A study of sufficient power to detect a 20% difference in results has been calculated to require 200 patients to be enrolled. Preliminary Results: 24 patients have been randomized after successful guidewire placement through their malignant obstructions. 12 patients have received Wallstents and 12 patients have received spiral Z-stents. There have been no initial failures of stent placement. All patients have achieved initial biliary drainage. More extensive data of initial stent placement and initial drainage will be forthcoming as patients are enrolled with long-term patency data anticipated in the next 1-2 years. Conclusion: A large randomized controlled study of the newly introduced uncoated Gianturco spiral Z-stent is underway to compare procedural success, initial drainage and, most importantly, long-term patency. Such trials are needed to permit the most appropriate employment of new devices.

Vitamin D-replete (+D) and vitamin D-deficient (−D) rats received large doses of calcium (2–18 mg) by intraperitoneal injection and their response to the calcium load was analysed in terms of the instantaneous and time-dependent responses of the plasma calcium concentration, [Cas]. Following an initial expansion, [Cas] returned to the preinjection value in a strictly exponential manner, with t1/2 = 22.5 ± 2.0 (SE) min in + D and 51 ± 5.2 min in −D animals. In both groups of animals, these rates were independent of the calcium load. Extraprolation of [Cas] to t = 0, i.e., the time just after administration of the calcium, revealed that the amount of calcium circulating at that moment was only about one-fifth of the amount that would have been found if all of the injected calcium had remained in the plasma. Calculations suggest that in all animals about four-fifths of the injected calcium load became distributed virtually instantaneously in the extracellular water. In both + D and − D groups the fraction of the injected load that left the plasma instantaneously was independent of the calcium load, of [Cas] at t = 0 or of the animals' plasma volume. The ability of rats to disperse some 80% of the load to outside the plasma would seem to constitute a major mechanism of acute plasma calcium regulation. Dilution was insufficient, however, totally to reduce [Cas] to the preinjection level. That occurred exponentially, with most of the calcium presumed to enter the skeleton. This exponential rate was markedly and significantly slower in the vitamin D-deficient animals than in their controls.