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Benign biliary strictures: utility of novel biodegradable biliary stents in surgically altered anatomy
... A multicenter study of 159 patients with benign post-surgical biliary strictures showed a 100% technical success with 26.6% recurrent biliary obstruction rate (5). More recently publications inlcude short endoscopic case series on surgically altered anatomy (6,7) or hybrid techniques (8). The recent pilot study from Anderloni et al (9) including 38 patients suggested that the biodegradation of the new biliary and pancreatic stents is reliable and in line with expected times. ...
Introduction:
biodegradable stents of various designs are reportedly used in pancreato-biliary conditions with promising results. Their major advantage is the avoidance of repeat endoscopic procedure for stent removal, thereby reducing overall costs and endoscopic retrograde cholangiopancreatography (ERCP) associated adverse events. The aim of the study was to evaluate the feasibility and safety of a new biodegradable stent in patients with pancreato-biliary diseases.
Methods:
a prospective multicenter pilot study was performed. All consecutive patients ≥ 18 years old who underwent biliary or pancreatic stenting using the new biodegradable Archimedes stent were included in the study. There were three biodegradation profiles. Technical and clinical success and feasibility and safety were assessed during a pre-established follow-up schedule.
Results:
fifty-three patients (mean age: 48.54 ± 19.29, 66 % male) with biliary (n = 29, 54.7 %) or pancreatic (n = 24, 45.3 %) indications were included. The distribution of stents used according to degradation properties were as follows: fast (n = 11, 20.8 %), medium (n = 16, 30.2 %) and slow (n = 26, 49.1 %). The technical and clinical success were 100 % and 77.8 %, respectively. Thirty-five patients were followed for a median of 26 weeks (range: 4-56, 66 %). There were nine procedure-related adverse events (17 %), all mild, including one uneventful stent-related event (external migration).
Conclusion:
the biodegradable Archimedes stent placement is feasible and safe in pancreato-biliary diseases.
This article is part of a combined publication that expresses the current view of the European Society of Gastrointestinal Endoscopy about endoscopic biliary stenting. The present Clinical Guideline describes short-term and long-term results of biliary stenting depending on indications and stent models; it makes recommendations on when, how, and with which stent to perform biliary drainage in most common clinical settings, including in patients with a potentially resectable malignant biliary obstruction and in those who require palliative drainage of common bile duct or hilar strictures. Treatment of benign conditions (strictures related to chronic pancreatitis, liver transplantation, or cholecystectomy, and leaks and failed biliary stone extraction) and management of complications (including stent revision) are also discussed. A two-page executive summary of evidence statements and recommendations is provided. A separate Technology Review describes the models of biliary stents available and the stenting techniques, including advanced techniques such as insertion of multiple plastic stents, drainage of hilar strictures, retrieval of migrated stents and combined stenting in malignant biliary and duodenal obstructions.The target readership for the Clinical Guideline mostly includes digestive endoscopists, gastroenterologists, oncologists, radiologists, internists, and surgeons while the Technology Review should be most useful to endoscopists who perform biliary drainage.
To assess the outcome of self-expandable, biodegradable stent insertion for anastomotic strictures following treatment for rectosigmoid carcinoma.
Three male patients (median age 66) developed benign strictures after radiotherapy and resection of a recto-sigmoid carcinoma. These were resistant to balloon dilatation and prevented stoma reversal. Biodegradable stent insertion was performed as an experimental treatment on a named-patient basis with approval of the institutional review board. Patients had monthly follow-up with endoscopy and contrast medium enemas to monitor performance and degradation of the stents.
All stents were placed successfully without complications after pre-dilatation to 20 mm under fluoroscopic guidance. Stent degradation occurred in all patients 4-5 months following implantation, and long-term anastomotic patency was demonstrated in all. This allowed reversal of the colostomy and physiological defecation in two patients. Reversal was not undertaken in one due to subsequent development of liver metastases. No stent migration or occlusion occurred.
Biodegradable stents can maintain an adequate lumen across anastomotic strictures resistant to balloon dilatation. They seem to allow stricture re-modelling resulting in maintained dilatation after degradation. This potentially allows reversal of a colostomy, which might otherwise be prevented by stricture recurrence.
Biodegradable (BD) oesophageal stents have been available commercially only since 2008 and previous published research is limited. Our aim was to review the use of BD stents to treat dysphagia in benign or malignant oesophageal strictures.
Patients were identified from a prospective interventional radiological database. BD stents were inserted radiologically under fluoroscopic control.
Between July 2008 and February 2011, 25 attempts at placing SX-ELLA biodegradable oesophageal stents were made in 17 males and five females, with a median age of 69 (range = 54-80) years. Two patients required more than one BD stent. Indications were benign strictures (n = 7) and oesophageal cancer (n = 17). One attempt was unsuccessful for a technical success rate of 96% with no immediate complications. Clinical success rate was 76%. Median dysphagia score before stent insertion was 3 (range = 2-4) compared to 2 (range = 0-3) after stent insertion (p = 0.0001).
BD stents provide good dysphagia relief for the life time of the stent. They may help avoid the use of feeding tubes in patients having radical chemoradiotherapy or awaiting oesophagectomy. They do not require removal or interfere with radiotherapy planning via imaging. However, the reintervention rate is high after the stent dissolves.
The long-term efficacy of sequential insertion of multiple plastic stents for benign biliary strictures is poorly defined. The aims of this study were to evaluate the long-term outcome (bile duct patency, complications) of this therapy and to identify predictors of a good outcome.
Retrospective review of 29 cases of benign biliary strictures treated with sequential plastic stent insertion in progressively increasing numbers and/or of increasing diameter.
Stricture etiology was as follows: postoperative 19 (66%), chronic pancreatitis 9 (31%), and idiopathic 1 (3%). Therapy succeeded in 18 patients (62%) (mean follow-up 48.0 [11.56] months after stent removal). Therapy failed in 11 patients (38%) (mean interval to failure 11.59 [9.79] months after stent removal). The 2 groups of patients in which therapy failed had either a hilar stricture (n = 4, 25% success) or distal common bile duct stricture caused by chronic pancreatitis (n = 9, 44% success). In the remaining cases, therapy succeeded in 13 of 16 (81% success). The observed differences in success rate among subgroups were not statistically significant. There were no ERCP-related deaths. One episode of mild pancreatitis and 2 episodes of cholangitis developed during 126 ERCPs over a period of stent insertion of 36 patient years.
In selected patients with benign biliary strictures, sequential endoscopic insertion of multiple biliary stents may lead to long-term success that could be equal to or superior to surgery with minimal morbidity. Hilar strictures and those caused by chronic pancreatitis appear to respond poorly to this therapy.
Biliary stenting: indications, choice of stents and results
- J-M Dumonceau
- A Tringali
- D Blero