Biliary StrictureNCT01929538
Covered Metal Stent for Benign Biliary Stricture Caused by Chronic Pancreatitis
A study testing ERCP, covered self-expanding biliary metal stent, 12mm in diameter and covered self-expanding biliary metal stent, 10mm in diameter in people with Biliary Stricture and Chronic Pancreatitis, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biliary Stricture, Chronic Pancreatitis
- What is being tested?
- ERCP, covered self-expanding biliary metal stent, 12mm in diameter and covered self-expanding biliary metal stent, 10mm in diameter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2013to Dec 2023
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 Stent, 6 Versus 12 Months, for Benign Biliary Stricture Caused by Chronic Pancreatitis: a Prospective Randomized Study
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.
Read the 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.
- Conditions
- Biliary Stricture, Chronic Pancreatitis
- Being tested
- ERCP, covered self-expanding biliary metal stent, 12mm in diameter, covered self-expanding biliary metal stent, 10mm in diameter
- Keywords
- Chronic pancreatitis, Biliary stricture, Endoscopic treatment, cSEMS
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
endoscopic retrograde cholangiopancreatography
covered self-expanding biliary metal stent, 12mm in diameterDevice
covered self-expanding biliary metal stent, 10mm in diameterDevice
| Study group | Role | What they receive |
|---|---|---|
| Covered biliary metal stent, 12 mm | Active comparator | ERCP and placement of a covered self-expanding biliary metal stent, 12mm in diameter Receives: Procedure: ERCP; Device: covered self-expanding biliary metal stent, 12mm in diameter |
| covered Biliary metal stent, 10 mm | Active comparator | ERCP and placement of a covered self-expanding biliary metal stent, 10 mm in diameter Receives: Procedure: ERCP; Device: covered self-expanding biliary metal stent, 10mm in diameter |
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 (2)
Stent removability
Ability to remove stents endoscopically after six months and one year without stent-removal related complications
Measured: 1 year
Occurrence of complications related to stents and procedure
Measured: 2,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leena Kylanpaa, Helsinki University Central Hospital
- Investigators
- Leena Kylänpää, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929538
- Sponsor's protocol ID
- 175/13/03/02/2013
- Status last verified
- Aug 2022
- First submitted
- 14 Aug 2013
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covered Self-expandable Metal Stent, 6 Versus 12 Months, for Benign Biliary Stricture Caused by Chronic Pancreatitis: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01929538
- Acronym / sponsor ID
- 175/13/03/02/2013
- Conditions
- Biliary Stricture, Chronic Pancreatitis
- Keywords
- Chronic pancreatitis, Biliary stricture, Endoscopic treatment, cSEMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Aug 2013 (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 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covered biliary metal stent, 12 mm | Active comparator | Procedure: ERCP, Device: covered self-expanding biliary metal stent, 12mm in diameterERCP and placement of a covered self-expanding biliary metal stent, 12mm in diameter |
| covered Biliary metal stent, 10 mm | Active comparator | Procedure: ERCP, Device: covered self-expanding biliary metal stent, 10mm in diameterERCP and placement of a covered self-expanding biliary metal stent, 10 mm in diameter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCPendoscopic retrograde cholangiopancreatography | Procedure or surgery | Covered biliary metal stent, 12 mm, covered Biliary metal stent, 10 mm |
| covered self-expanding biliary metal stent, 12mm in diameter | Device | Covered biliary metal stent, 12 mm |
| covered self-expanding biliary metal stent, 10mm in diameter | Device | covered Biliary metal stent, 10 mm |
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
2 secondary outcomes
Stent removability
Time frame: 1 year
Occurrence of complications related to stents and procedure
Time frame: 2,5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
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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.
Leena Kylänpää, 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?
A study testing ERCP, covered self-expanding biliary metal stent, 12mm in diameter and covered self-expanding biliary metal stent, 10mm in diameter in people with 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 17 Aug 2022. 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?
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 17 Aug 2022.