Distal malignant biliary obstruction: a prospective randomised trial comparing plastic and uncovered self-expanding metal stents in the palliation of symptomatic jaundice

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Abstract

BACKGROUND: The aim of this study was to determine the safety and clinical effectiveness of 10Fr plastic biliary stents compared to uncovered self-expanding metal stents (SEMS) for palliative treatment of patients with inoperable extra-hepatic malignant biliary obstruction in a public hospital in South Africa METHODS: From January 2009 to December 2013, 40 patients who were admitted to a tertiary academic centre because of distal malignant biliary obstruction were enrolled in a prospective randomized study. Patients were randomly assigned to receive an uncovered SEMS or a plastic stent deployed through the biliary stricture during endoscopic retrograde cholangiopancreatography (ERCP RESULTS: Patient survival time in the two groups did not differ significantly (median: SEMS - 114 days; plastic - 107 days). Stent failure was more common in the plastic stent group (7/19 vs. 1/21). The results became significant after 6 months of follow-up. There was no significant difference between the two groups in the incidence of serious adverse events CONCLUSIONS: SEMS had a longer duration of patency than plastic stents, which recommends their use in the palliative treatment of patients with biliary obstruction due to distal malignant biliary obstruction

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Six hundred fifty consecutive pancreaticoduodenectomies in the 1990s: pathology, complications, and outcomes.

C J Yeo, J L Cameron, T Sohn … (1997)

The authors reviewed the pathology, complications, and outcomes in a consecutive group of 650 patients undergoing pancreaticoduodenectomy in the 1990s. Pancreaticoduodenectomy has been used increasingly in recent years to resect a variety of malignant and benign diseases of the pancreas and periampullary region. Between January 1990 and July 1996, inclusive, 650 patients underwent pancreaticoduodenal resection at The Johns Hopkins Hospital. Data were recorded prospectively on all patients. All pathology specimens were reviewed and categorized. Statistical analyses were performed using both univariate and multivariate models. The patients had a mean age of 63 +/- 12.8 years, with 54% male and 91% white. The number of resections per year rose from 60 in 1990 to 161 in 1995. Pathologic examination results showed pancreatic cancer (n = 282; 43%), ampullary cancer (n = 70; 11%), distal common bile duct cancer (n = 65; 10%), duodenal cancer (n = 26; 4%), chronic pancreatitis (n = 71; 11%), neuroendocrine tumor (n = 31; 5%), periampullary adenoma (n = 21; 3%), cystadenocarcinoma (n = 14; 2%), cystadenoma (n = 25; 4%), and other (n = 45; 7%). The surgical procedure involved pylorus preservation in 82%, partial pancreatectomy in 95%, and portal or superior mesenteric venous resection in 4%. Pancreatic-enteric reconstruction, when appropriate, was via pancreaticojejunostomy in 71% and pancreaticogastrostomy in 29%. The median intraoperative blood loss was 625 mL, median units of red cells transfused was zero, and the median operative time was 7 hours. During this period, 190 consecutive pancreaticoduodenectomies were performed without a mortality. Nine deaths occurred in-hospital or within 30 days of operation (1.4% operative mortality). The postoperative complication rate was 41%, with the most common complications being early delayed gastric emptying (19%), pancreatic fistula (14%), and wound infection (10%). Twenty-three patients required reoperation in the immediate postoperative period (3.5%), most commonly for bleeding, abscess, or dehiscence. The median postoperative length of stay was 13 days. A multivariate analysis of the 443 patients with periampullary adenocarcinoma indicated that the most powerful independent predictors favoring long-term survival included a pathologic diagnosis of duodenal adenocarcinoma, tumor diameter <3 cm, negative resection margins, absence of lymph node metastases, well-differentiated histology, and no reoperation. This single institution, high-volume experience indicates that pancreaticoduodenectomy can be performed safely for a variety of malignant and benign disorders of the pancreas and periampullary region. Overall survival is determined largely by the pathology within the resection specimen.

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Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study.

Jacques Fritsch, M Kaassis, Jean-Philippe Rey … (2003)

The systematic use of metal stents to treat biliary obstruction is restricted by high cost compared with plastic stents. The aims of this study were to compare cost and efficacy of plastic stents and metal stents in the treatment of patients with malignant common bile duct strictures and to define factors that predict survival of these patients. One hundred eighteen patients (mean age 75 years) with malignant strictures of the common bile duct were randomized to placement of a plastic stent or metal stent. Comparisons were made with the Mann-Whitney or chi-square test as indicated; survival rates were compared with a Cox proportional hazards model. There was no significant difference in survival between the two groups. Time to first obstruction was longer for patients in the metal stent group (metal stent, median not reached vs. plastic stent, 5 months; p = 0.007). The number of additional days of hospitalization, days of antibiotic therapy, and the numbers of ERCPs and transabdominal US procedures was significantly higher in the plastic stent group. After multivariate analysis, only the presence of liver metastases was independently related to survival (p < 0.0005; OR = 2.25). This variable defined a group with a shorter survival. Median survival of patients with hepatic metastasis at diagnosis was 2.7 months compared with 5.3 months for patients without liver metastasis; in the latter group, the overall cost associated with metal stents was lower than for plastic stents. Metal stent placement is the most effective treatment of inoperable malignant common bile duct stricture. Placement of a metal stent is cost effective in patients without hepatic metastases, whereas a plastic stent should be placed in patients with spread of the tumor to the liver.

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

Jacob Freedman, C Rudberg, Martin Ljungman … (2010)

Covered biliary metal stents have been developed to prevent tumor ingrowth. Previous comparative studies are limited and often include few patients. To compare differences in stent patency, patient survival, and complication rates between covered and uncovered nitinol stents in patients with malignant biliary obstruction. Randomized, multicenter trial conducted between January 2006 and October 2008. Ten sites serving a total catchment area of approximately 2.8 million inhabitants. A total of 400 patients with unresectable distal malignant biliary obstruction. ERCP with insertion of covered or uncovered metal stent. Follow-up conducted monthly for symptoms indicating stent obstruction. Time to stent failure, survival time, and complication rate. 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). Randomization was not blinded. 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. Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

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Author and article information

Contributors

MM Bernon: Role: ND

J Shaw: Role: ND

S Burmeister: Role: ND

G Chinnery: Role: ND

S Hofmeyr: Role: ND

JC Kloppers: Role: ND

E Jonas: Role: ND

JEJ Krige: Role: ND

Journal

Journal ID (publisher-id): sajsurg

Title: South African Journal of Surgery

Abbreviated Title: S. Afr. j. surg.

Publisher: Association of Surgeons of South Africa (Cape Town, Western Cape Province, South Africa )

ISSN (Print): 0038-2361

ISSN (Electronic): 2078-5151

Publication date (Print and electronic): March 2018

Volume: 56

Issue: 1

Pages: 30-34

Affiliations

[04] Saskatchewan orgnameRoyal University Hospital Canada

[03] orgnameUniversity of Saskatchewan orgdiv1Division of General Surgery orgdiv2Hepatobiliary Surgery Unit

[06] Cape Town orgnameTygerberg Hospital orgdiv1Health Sciences Faculty South Africa

[02] Cape Town orgnameGroote Schuur Hospital orgdiv1Health Sciences Faculty South Africa

[05] orgnameUniversity of Stellenbosch orgdiv1Department of Surgery

[01] orgnameUniversity of Cape Town orgdiv1Department of Surgery orgdiv2Surgical Gastroenterology and HPB Surgical Unit

Article

Publisher ID: S0038-23612018000100006

DOI: 10.17159/2078-5151/2018/v56n1a2208

SO-VID: 9733ed03-5fcf-4b9b-8c7f-cf52ba7cd4c0

License:

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

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Figures: 0, Tables: 0, Equations: 0, References: 19, Pages: 5

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SciELO South Africa

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