Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Turku
Oulu University Hospital
Information provided by (Responsible Party):
Halttunen Jorma, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01085747
First received: March 8, 2010
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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.


Condition
Biliary Stricture
Chronic Pancreatitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Covered Self-expandable Metal Stents Versus Multiple Plastic Stents for Benign Biliary Stricture Caused by Chronic Pancreatitis: a Prospective Randomized Study

Resource links provided by NLM:


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: Time from stent removal to 1 month post-stent removal ] [ Designated as safety issue: Yes ]
    Ability to remove stents endoscopically after six months without stent-removal related complications

  • Occurrence of complications related to stents and procedure [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
  • Length of endoscopic procedures in the two groups [ Time Frame: All endoscopic procedures ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2008
Estimated Study Completion Date: May 2015
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Plastic stent
Covered SEMS

Detailed Description:

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.

Follow-up

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All consecutive patients admitted for ERCP and treated for benign biliary stricture caused by chronic pancreatitis are prospectively enrolled in the study.

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085747

Locations
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00290
Sponsors and Collaborators
Helsinki University Central Hospital
University of Turku
Oulu University Hospital
Investigators
Principal Investigator: Jorma Halttunen, MD, PhD Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Halttunen Jorma, Jorma Halttunen, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01085747     History of Changes
Other Study ID Numbers: 98/13/03/03/08
Study First Received: March 8, 2010
Last Updated: August 14, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University Central Hospital:
Chronic pancreatitis
Biliary stricture
Endoscopic treatment
SEMS

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Cholestasis
Constriction, Pathologic
Pancreatic Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014