Covered Metal Stent for Benign Biliary Stricture Caused by Chronic Pancreatitis
Information source: Helsinki University Central Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Biliary Stricture; Chronic Pancreatitis
Intervention: ERCP (Procedure); covered self-expanding biliary metal stent, 12mm in diameter (Device); covered self-expanding biliary metal stent, 10mm in diameter (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Helsinki University Central Hospital Official(s) and/or principal investigator(s): Leena Kylänpää, MD, PhD, Principal Investigator, Affiliation: Helsinki University Central Hospital
Overall contact: Leena Kylänpää, MD, PhD, Phone: +358-50-4272869, Email: leena.kylanpaa@hus.fi
Summary
Benign biliary strictures caused by chronic pancreatitis can be endoscopically treated with
covered self-expandable metal stents (cSEMS).The purpose of the prospective randomized study
is to define the optimal duration of stenting and the diameter of the cSEMS.
Clinical Details
Official title: Covered Self-expandable Metal Stent, 6 Versus 12 Months, for Benign Biliary Stricture Caused by Chronic Pancreatitis: a Prospective Randomized Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Stricture resolution of the common bile duct in the two study groups
Secondary outcome: Stent removabilityOccurrence of complications related to stents and procedure
Detailed description:
All consecutive patients admitted for ERCP and treated for benign biliary stricture caused
by chronic pancreatitis with or without acute pancreatitis are prospectively enrolled in the
study. The age and gender of the patients and the aetiology of the pancreatitis will be
recorded.
At initial presentation, clinical and laboratory findings recorded include liver function
tests, abdominal pain, jaundice and cholangitis. Pancreatic calcifications are documented
in abdominal computed tomography. Patients with malignancies, cirrhosis, acute/chronic
hepatitis or abnormal hepatic imaging studies are excluded. Patients with first attack of
acute pancreatitis will be excluded.
The approval of the ethics committee of the hospital has been obtained. An informed consent
will be obtained from all patients.
All patients are prepared and sedated for ERCP as per standard medical practice of the
hospital. At the initial ERCP, an endoscopic sphincterotomy will be performed and the
presence/absence of bile duct stones above the stricture and the treatment of stones are
recorded. A pancreatic stent will be inserted if indicated. For the initial ERCP the
patients will be randomized into two groups: those who receive 10 mm diameter cSEMS and
those who receive 12 mm diameter cSEMS into the bile duct. For the randomization, sealed
envelopes will be used. The length of the cSEMS is recorded.
Further ERCP for stent removal will be performed after six months for the patients with 12
mm diameter cSEMS and after twelve months for the patients with 10 mm diameter cSEMS. In
case of stent migration during the follow-up, the stent will be replaced by a similar new
cSEMS. If a pancreatic stent will be placed, the removal or replacement will be handled
according to the hospital practice.
After each ERCP procedure, all patients will stay in hospital for monitoring the occurrence
of primary complications such as acute pancreatitis and cholangitis, bile leak, bleeding or
perforation. Plasma amylase activity is measured same day > 4h after ERCP. Post-ERCP
pancreatitis is defined as the presence of abdominal pain attributable to acute pancreatitis
and plasma amylase level at least three times above the upper limit of the reference
interval. The treatment of primary complications is recorded.
Follow-up
Clinical response (adequate biliary drainage) and recurrent stricture formation are the
primary endpoints 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 ERCP and at removal of
cSEMS. Blood liver function tests are measured in the morning before ERCPs; the exact widths
and lengths in mm: s are obtained by comparison the widths and lengths with the diameter of
the scope. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Benign biliary stricture caused by chronic pancreatitis
Exclusion Criteria:
- Malignancy, cirrhosis, acute/chronic hepatitis or abnormal hepatic imaging. First
attack of acute pancreatitis
Locations and Contacts
Leena Kylänpää, MD, PhD, Phone: +358-50-4272869, Email: leena.kylanpaa@hus.fi
Helsinki University Central Hospital, Helsinki 00029, Finland; Recruiting Leena Kylänpää, MD, PhD, Phone: +358-50-4272869, Email: leena.kylanpaa@hus.fi Jorma Halttunen, MD, PhD, Sub-Investigator Marianne Udd, MD, PhD, Sub-Investigator Outi Lindström, MD, PhD, Sub-Investigator
Additional Information
Starting date: August 2013
Last updated: August 20, 2015
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