Track topics on Twitter Track topics that are important to you
Benign biliary strictures can be endoscopically treated with plastic or self-expandable metal stents (SEMS). The purpose of the prospective randomized study is to compare the safety and feasibility of covered SEMS with multiple plastic stents in the treatment of benign biliary stricture caused by chronic pancreatitis.
All consecutive patients admitted for ERCP and treated for benign biliary stricture caused by chronic pancreatitis are prospectively enrolled in the study.
At the initial ERCP, an endoscopic sphincterotomy will be performed and one 10 Fr plastic stent will be inserted for the initial treatment of cholestasis in all patients.Pancreatic stent will be inserted if indicated. One to three months after the initial ERCP the patients will be randomized into two groups: those who receive cSEMS and those who receive multiple plastic stents into the bile duct. For the randomization, sealed envelopes will be used. As for cSEMSs, removable cSEMSs with diameter of 10 mm will be placed. A dilation with a 8-10mm balloon will be performed before and after the stent placement to secure the stent expansion. As for plastic stents, minimum three simultaneous 10 Fr stents will be inserted after 8-10 mm balloon dilation.
After three months a further ERCP will be performed. The number of plastic stents will be increased maximally to six 10 Fr stents after dilation if possible. In the group with cSEMS, the position of the stent will be controlled.
Once the cSEMS or plastic stents have been in place for minimum six months, the stents will be removed at the last ERCP.
Clinical response (adequate biliary drainage) is the primary endpoint of the study. Therefore, blood liver function tests (bilirubin, alkaline phosphatase) as well as the minimum diameter of the common bile duct in the area of the stricture, the maximum diameter of the common bile duct above the stricture and the length of the stricture are measured at ERCPs at the time of the initial plastic stent insertion (i.e. the first ERCP) and at removal of cSEMS or multiple plastic stents (the last ERCP). In addition, blood liver function tests are measured and abdominal ultrasonography performed in the follow-up six months and two years after the stent removal.
Morbidity and mortality are additional endpoints of the study. Therefore, complications (deaths, stent occlusions, dislodgements or migrations, cholangitis, hemobilia, stone formation above the stent), management of complications, admission times, surgical interventions and any additional care needed are monitored and recorded during the follow-up time. Patients are asked to contact the physician at any time if symptoms such as fever, abdominal pain or jaundice occur.
Observational Model: Case Control, Time Perspective: Prospective
Helsinki University Central Hospital
Helsinki University Central Hospital
Published on BioPortfolio: 2014-07-24T14:06:54-0400
Biliary drainage is the mainstay of the palliative treatment in patients with inoperable malignant bile duct stricture. Endoscopic retrograde cholangiopancreatography (ERCP) is the corners...
Differentiation between malignant and benign biliary strictures can be challenging. Accurate differentiation of malignant biliary strictures from benign ones is crucial to guide management...
Evaluation of ERCP with placement of a winged plastic biliary stent without a lumen for management of benign biliary strictures.
Endoscopic insertion of plastic or metal stents in introhepatic bile duct under endoscopic retrograde cholangiopancreatography is a well established treatment of malignant or benign biliar...
The goal of this study is to evaluate the potential of comprehensive biliary Optical Frequency Domain Imaging (OFDI) for assessing common bile duct or common hepatic duct strictures, deter...
The rate of preoperative biliary drainage for pancreaticoduodenectomy has been increasing despite most recent evidence that favors avoiding it. Only a few studies have focused on late surgical complic...
Endoscopic ultrasound (EUS)-guided antegrade stenting combined with hepaticogastrostomy is useful in patients with malignant biliary stricture complicated by duodenal obstruction. Biliary radiofrequen...
Stricture formation at the biliary-enteric anastomosis can cause serious complications after pancreaticoduodenectomy while the anastomotic size is reported to significantly affect stricture formation....
Endoscopic biliary drainage is difficult in patients with biliary obstruction combined with gastric outlet stricture (GOS). Endoscopic ultrasound is useful for such patients, but needs advanced techni...
Biliary enteric anastomosis is a well-known biliary reconstruction method. Anastomosis stricture is one of the complications of this procedure that occurs in some patients over the long-term. We repor...
Non-invasive diagnostic technique for visualizing the PANCREATIC DUCTS and BILE DUCTS without the use of injected CONTRAST MEDIA or x-ray. MRI scans provide excellent sensitivity for duct dilatation, biliary stricture, and intraductal abnormalities.
Abnormal passage in any organ of the biliary tract or between biliary organs and other organs.
Chronic inflammatory disease of the BILIARY TRACT. It is characterized by fibrosis and hardening of the intrahepatic and extrahepatic biliary ductal systems leading to bile duct strictures, CHOLESTASIS, and eventual BILIARY CIRRHOSIS.
Infection of the biliary passages with CLONORCHIS SINENSIS, also called Opisthorchis sinensis. It may lead to inflammation of the biliary tract, proliferation of biliary epithelium, progressive portal fibrosis, and sometimes bile duct carcinoma. Extension to the liver may lead to fatty changes and cirrhosis. (From Dorland, 27th ed)
Tumors or cancer in the BILIARY TRACT including the BILE DUCTS and the GALLBLADDER.
Astroesophageal Reflux Disease (GERD) Barrett's Esophagus Celiac Disease Cholesterol Crohn's Disease Gastroenterology Hepatitis Hepatology Irritable Bowel Syndrome (IBS) Pancreatitis Peptic Ulcer Disease...
Pancreatitis Acute pancreatitis is inflammation of the pancreas caused by the release of activated pancreatic enzymes. Common triggers are biliary tract disease and chronic heavy alcohol intake. Diagnosis is based on clinical presentation...
A stent is a small mesh tube that's used to treat narrow or weak arteries. Arteries are blood vessels that carry blood away from your heart to other parts of your body. A stent is placed in an artery as part of a procedure called angioplasty. &...