Covered Metal Stent for Benign Biliary Stricture Caused by Chronic Pancreatitis

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
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	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	August 2013
Estimated Primary Completion Date :	December 2017
Estimated Study Completion Date :	December 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Stricture resolution of the common bile duct in the two study groups [ Time Frame: 2,5 years ]
   Stricture resolution during stenting and follow-up period, defined by normal liver function tests and abdominal ultrasonography

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Biliary stricture Chronic pancreatitis [ Time Frame: 2,5 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	August 28, 2013
Last Update Posted:	January 16, 2017
Last Verified:	January 2017

Keywords provided by Leena Kylanpaa, 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