Biliary StrictureNCT01085747
Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis
An observational study of Biliary Stricture and Chronic Pancreatitis, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Stricture, Chronic Pancreatitis
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2008to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients admitted for ERCP and treated for benign biliary stricture caused by chronic pancreatitis are prospectively enrolled in the study.
Who may be able to join
- Benign biliary stricture caused by chronic pancreatitis
Who cannot join
- Malignancy, cirrhosis acute/chronic hepatitis or abnormal hepatic imaging. First attack of acute pancreatitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Covered Self-expandable Metal Stents Versus Multiple Plastic Stents for Benign Biliary Stricture Caused by Chronic Pancreatitis: a Prospective Randomized Study
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.
Read the 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.
- Conditions
- Biliary Stricture, Chronic Pancreatitis
- Keywords
- Chronic pancreatitis, Biliary stricture, Endoscopic treatment, SEMS
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Plastic stent | Not described | |
| Covered SEMS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stricture resolution of the common bile duct in the two study groups
Stricture resolution during stenting and follow-up period, defined by normal liver function tests and abdominal ultrasonography
Measured: 2.5 years
Secondary outcomes (3)
Stent removability
Ability to remove stents endoscopically after six months without stent-removal related complications
Measured: Time from stent removal to 1 month post-stent removal
Occurrence of complications related to stents and procedure
Measured: 2.5 years
Length of endoscopic procedures in the two groups
Measured: All endoscopic procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startMar 2008
- Primary completionMay 2013
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary StrictureStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku, Oulu University Hospital
- Responsible party
- Principal investigator, Halttunen Jorma, Helsinki University Central Hospital
- Investigators
- Jorma Halttunen, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085747
- Sponsor's protocol ID
- 98/13/03/03/08
- Status last verified
- Aug 2013
- First submitted
- 8 Mar 2010
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Haapamaki C, Kylanpaa L, Udd M, Lindstrom O, Gronroos J, Saarela A, Mustonen H, Halttunen J. Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis. Endoscopy. 2015 Jul;47(7):605-10. doi: 10.1055/s-0034-1391331. Epub 2015 Jan 15.
PubMed 25590182
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covered Self-expandable Metal Stents Versus Multiple Plastic Stents for Benign Biliary Stricture Caused by Chronic Pancreatitis: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01085747
- Acronym / sponsor ID
- 98/13/03/03/08
- Conditions
- Biliary Stricture, Chronic Pancreatitis
- Keywords
- Chronic pancreatitis, Biliary stricture, Endoscopic treatment, SEMS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Turku, Oulu University Hospital
- Study start
- Mar 2008
- Primary completion
- May 2013 (actual)
- Study completion
- May 2015 (estimated)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plastic stent | – | – |
| Covered SEMS | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients admitted for ERCP and treated for benign biliary stricture caused by chronic pancreatitis are prospectively enrolled in the study.
Key inclusion criteria (1 listed)
- Benign biliary stricture caused by chronic pancreatitis
Key exclusion criteria (1 listed)
- Malignancy, cirrhosis acute/chronic hepatitis or abnormal hepatic imaging. First attack of acute pancreatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Stent removability
Time frame: Time from stent removal to 1 month post-stent removal
Occurrence of complications related to stents and procedure
Time frame: 2.5 years
Length of endoscopic procedures in the two groups
Time frame: All endoscopic procedures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
- Derived from this study: PubMed 25590182Haapamaki C, Kylanpaa L, Udd M, Lindstrom O, Gronroos J, Saarela A, Mustonen H, Halttunen J. Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis. Endoscopy. 2015 Jul;47(7):605-10. doi: 10.1055/s-0034-1391331. Epub 2015 Jan 15.
Related trials for Biliary Stricture
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
Malignant Biliary Obstruction, Malignant Biliary Stricture
Not yet recruiting
The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.
Biliary Strictures Caused by Malignant Neoplasms
RecruitingPhase 2
Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
Primary Sclerosing Cholangitis, Liver Transplant, Complications
Recruiting
UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures
Biliary Obstruction, Bile Duct Stricture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorma Halttunen, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Stricture and Chronic Pancreatitis, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stricture resolution of the common bile duct in the two study groups (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01085747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2013.