Covered Metal Stent for Benign Biliary Stricture Caused by Chronic Pancreatitis - Full Text View

Purpose

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.

Condition	Intervention
Biliary Stricture Chronic Pancreatitis	Procedure: ERCP Device: covered self-expanding biliary metal stent, 12mm in diameter Device: covered self-expanding biliary metal stent, 10mm in diameter


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Covered Self-expandable Metal Stent, 6 Versus 12 Months, for Benign Biliary Stricture Caused by Chronic Pancreatitis: a Prospective Randomized Study

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary pancreatitis

MedlinePlus related topics: Pancreatitis

U.S. FDA Resources

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:

Stricture resolution of the common bile duct in the two study groups [ Time Frame: 2,5 years ] [ Designated as safety issue: No ]
Stricture resolution during stenting and follow-up period, defined by normal liver function tests and abdominal ultrasonography

Secondary Outcome Measures:

Stent removability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Ability to remove stents endoscopically after six months and one year without stent-removal related complications
Occurrence of complications related to stents and procedure [ Time Frame: 2,5 years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:

Biliary stricture Chronic pancreatitis [ Time Frame: 2,5 years ] [ Designated as safety issue: No ]


Estimated Enrollment:	30
Study Start Date:	August 2013
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Covered biliary metal stent, 12 mm ERCP and placement of a covered self-expanding biliary metal stent, 12mm in diameter	Procedure: ERCP endoscopic retrograde cholangiopancreatography Device: covered self-expanding biliary metal stent, 12mm in diameter
Active Comparator: covered Biliary metal stent, 10 mm ERCP and placement of a covered self-expanding biliary metal stent, 10 mm in diameter	Procedure: ERCP endoscopic retrograde cholangiopancreatography Device: covered self-expanding biliary metal stent, 10mm in diameter

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


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929538

Contacts


Contact: Leena Kylänpää, MD, PhD	+358-50-4272869	leena.kylanpaa@hus.fi

Locations


Finland
Helsinki University Central Hospital	Recruiting
Helsinki, Finland, 00029
Contact: Leena Kylänpää, MD, PhD +358-50-4272869 leena.kylanpaa@hus.fi
Sub-Investigator: Jorma Halttunen, MD, PhD
Sub-Investigator: Marianne Udd, MD, PhD
Sub-Investigator: Outi Lindström, MD, PhD

Sponsors and Collaborators

Helsinki University Central Hospital

Investigators


Principal Investigator:	Leena Kylänpää, MD, PhD	Helsinki University Central Hospital

More Information


Responsible Party:	Leena Kylanpaa, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:	NCT01929538 History of Changes
Other Study ID Numbers:	175/13/03/02/2013
Study First Received:	August 14, 2013
Last Updated:	February 18, 2016
Health Authority:	Finland: Ethics Committee

Keywords provided by Helsinki University Central Hospital:


Chronic pancreatitis Biliary stricture Endoscopic treatment cSEMS

Additional relevant MeSH terms:


Pancreatitis Constriction, Pathologic Pancreatitis, Chronic Cholestasis Pancreatic Diseases	Digestive System Diseases Pathological Conditions, Anatomical Bile Duct Diseases Biliary Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2016