Refractory Pancreatic Duct StricturesNCT02135809
Pancreatic Metal Stents in Chronic Pancreatitis
A study testing WallFlex Pancreatic Stent in people with Refractory Pancreatic Duct Strictures and Painful Chronic Pancreatitis, run by Boston Scientific Corporation at 1 site in Belgium.
Trial summary
The purpose of this study is to document the performance of a new Fully Covered Self Expanding Metal Stents (FCSEMS) for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Pancreatic Duct Strictures, Painful Chronic Pancreatitis
- What is being tested?
- WallFlex Pancreatic Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2014to 30 Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study
- Chronic pancreatitis of Cremer Type IV (Segmental pancreatitis of the head of the pancreas). See Appendix for Cremer classifications.
- Improvement of pancreatic pain during previous placement of a single pancreatic plastic stent
- At least one of the following:
- Abdominal pain most probably related to chronic pancreatitis
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- Recurrent dominant main pancreatic duct stricture in the head of the pancreas after prior indwell of pancreatic plastic stent(s) if pain score was available prior to preceding stent therapy. Recurrent stricture to be visually assessed at endoscopy and confirmed by recurrent main pancreatic duct dilatation at MRCP.
- Relapsing pain due to pancreatic duct stent blockage (with only one stent in place)
- Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of SEMS placement with informed patient consent.
Who cannot join
- Strictures caused by malignancies
- Biliary strictures caused by chronic pancreatitis
- Perforated duct.
- Ansa pancreatica or H anatomy
- Pancreatic duct stenoses not located in the head of the pancreas
- Failed access during an attempted ERCP on a prior date
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- Prior pancreatic metal stent(s)
- Concurrent ESWL (Extracorporeal Shock Wave Lithotripsy) during the same treatment session
- Patients for whom endoscopic techniques are contraindicated.
- Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
- Inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational center that
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fully Covered Self Expanding Metal Stents (FCSEMS) for Refractory Pancreatic Duct Strictures in Patients With Chronic Pancreatitis
The purpose of this study is to document the performance of a new Fully Covered Self Expanding Metal Stents (FCSEMS) for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis.
Read the detailed description
This study is a prospective, single arm, pre-approval study. Treatment of 10 patients will take place at 1-3 clinical centers in two phases. Phase 1 will include treatment of five patients with a three month stent indwell period at one clinical center. Phase 2 will include treatment of five additional patients with a 3-6 month stent indwell period at 1-3 clinical centers. Expected duration of participation for each patient is approximately 27 months for Phase 1 and approximately 27-30 months for Phase 2. All patients, regardless of phase, will be followed for 24 months after stent removal. Post-removal follow-up visits will occur at 1, 3, 6, 12, 18 and 24 months.
- Being tested
- WallFlex Pancreatic Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WallFlex Pancreatic StentDevice
Temporary placement of the WallFlex Pancreatic Stent for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis. Stent will be removed after 3-6 months indwell.
| Study group | Role | What they receive |
|---|---|---|
| FCSEMS | Experimental | Patients will receive the WallFlex Pancreatic Stent. Receives: Device: WallFlex Pancreatic Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis
Clinical success defined as decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis 3 months after stent removal compared to baseline prior to stent indwell period.
Measured: 3 months after study stent removal
Secondary outcomes (13)
Occurrence and severity of serious adverse events related to the stenting procedure, to the indwelling stent and/or to stent removal
Measured: Duration of study participation, an average of 27-30 months
Stent placement success
Ability to deploy the stent in satisfactory position (Stent Placement Success). Satisfactory position is defined as the stent being across the stricture, without visible impaction at an angle and distal end visible into the duodenum.
Measured: Study Stent Placement Procedure
Type of additional intervention within pancreatic duct
Measured: Duration of study participation, an average of 27-30 months
Stent removal success
Successful stent removal (Stent Removal Success) defined as ability to remove stent endoscopically (grasper, snare, stent-in-stent) without serious stent removal-related adverse events
Measured: Study Stent Removal
Change of pain medication intake
Change of pain medication intake (type of medication) from baseline to each follow-up visit.
Measured: Duration of study participation, an average of 27-30 months
Number of device events
Device Events, including findings not associated with adverse events, such as but not limited to asymptomatic stent migration.
Measured: Duration of study participation, an average of 27-30 months
Stricture resolution of pancreatic duct after stent removal
Assessment of pancreatic duct after stent removal compared to baseline, including ERCP to document extent of stricture resolution, extent of resolution of ductal dilation above the treated dominant stricture, and presence or absence of secondary ductal strictures at the level of where the proximal edge of the stent was located
Measured: Study Stent Removal
For patients who proceed to surgery, impact of prior SEMS on surgical outcomes.
Measured: Up to surgery
Stent functionality
Stent functionality: Relief of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis at 3 days, 2 weeks, 1 month, 2 months, 4 months (Phase 2 patients as applicable) and just prior to stent removal compared to baseline prior to stent placement, using established pancreatic pain score
Measured: Up to time of study stent removal,average of 3-6 months on study
Stricture Resolution at stent removal
Stricture Resolution at stent removal, defined as pancreatographic confirmation of drainage of injected contrast medium after stent removal without visible persistent stricture
Measured: Study Stent Removal
Time to Recurrence of Stricture
Time to Recurrence of Stricture, established in patients who had stricture resolution at stent removal and defined as time elapsed from stent removal till recurrence of pain with associated documentation of narrowing of pancreatic duct. Recurrence of stricture will be documented at the time it is identified and absence of stricture recurrence will be ascertained at 1, 3, 6, 12, 18 and 24 months after stent removal. Pain will be documented using an established pancreatic pain score.
Measured: Duration of study participation, an average of 27-30 months
Reason for additional intervention within pancreatic duct
Measured: Duration of study participation, an average of 27-30 months
Timing of additional intervention within pancreatic duct
Measured: Duration of study participation, an average of 27-30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Pancreatic Duct StricturesStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacques Devière, MD, PhD, Principal investigator, ULB Erasme Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135809
- Sponsor's protocol ID
- E7093
- Status last verified
- Jul 2019
- First submitted
- 2 May 2014
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fully Covered Self Expanding Metal Stents (FCSEMS) for Refractory Pancreatic Duct Strictures in Patients With Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT02135809
- Acronym / sponsor ID
- E7093
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 12 May 2014 (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.
The purpose of this study is to document the performance of a new Fully Covered Self Expanding Metal Stents (FCSEMS) for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis.
Detailed description
This study is a prospective, single arm, pre-approval study. Treatment of 10 patients will take place at 1-3 clinical centers in two phases. Phase 1 will include treatment of five patients with a three month stent indwell period at one clinical center. Phase 2 will include treatment of five additional patients with a 3-6 month stent indwell period at 1-3 clinical centers. Expected duration of participation for each patient is approximately 27 months for Phase 1 and approximately 27-30 months for Phase 2. All patients, regardless of phase, will be followed for 24 months after stent removal. Post-removal follow-up visits will occur at 1, 3, 6, 12, 18 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FCSEMS | Experimental | Device: WallFlex Pancreatic StentPatients will receive the WallFlex Pancreatic Stent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 or older
- Willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study
- Chronic pancreatitis of Cremer Type IV (Segmental pancreatitis of the head of the pancreas). See Appendix for Cremer classifications.
- Improvement of pancreatic pain during previous placement of a single pancreatic plastic stent
- At least one of the following:
Key exclusion criteria (11 listed)
- Strictures caused by malignancies
- Biliary strictures caused by chronic pancreatitis
- Perforated duct.
- Ansa pancreatica or H anatomy
- Pancreatic duct stenoses not located in the head of the pancreas
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 |
|---|---|---|
| WallFlex Pancreatic StentTemporary placement of the WallFlex Pancreatic Stent for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis. Stent will be removed after 3-6 months indwell. | Device | FCSEMS |
Primary outcome
Decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis
Time frame: 3 months after study stent removal
Clinical success defined as decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis 3 months after stent removal compared to baseline prior to stent indwell period.
13 secondary outcomes
Occurrence and severity of serious adverse events related to the stenting procedure, to the indwelling stent and/or to stent removal
Time frame: Duration of study participation, an average of 27-30 months
Stent placement success
Time frame: Study Stent Placement Procedure
Type of additional intervention within pancreatic duct
Time frame: Duration of study participation, an average of 27-30 months
Stent removal success
Time frame: Study Stent Removal
Change of pain medication intake
Time frame: Duration of study participation, an average of 27-30 months
Number of device events
Time frame: Duration of study participation, an average of 27-30 months
Stricture resolution of pancreatic duct after stent removal
Time frame: Study Stent Removal
For patients who proceed to surgery, impact of prior SEMS on surgical outcomes.
Time frame: Up to surgery
Stent functionality
Time frame: Up to time of study stent removal,average of 3-6 months on study
Stricture Resolution at stent removal
Time frame: Study Stent Removal
Time to Recurrence of Stricture
Time frame: Duration of study participation, an average of 27-30 months
Reason for additional intervention within pancreatic duct
Time frame: Duration of study participation, an average of 27-30 months
Timing of additional intervention within pancreatic duct
Time frame: Duration of study participation, an average of 27-30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: No
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.
Jacques Devière, MD, PhD principal investigator
ULB Erasme 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 WallFlex Pancreatic Stent in people with Refractory Pancreatic Duct Strictures and Painful Chronic Pancreatitis, run by Boston Scientific Corporation at 1 site in Belgium.
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 9 inclusion and 11 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: finished, as of the sponsor's last update on 9 Jul 2019. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis (time frame: 3 months after study stent removal). 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 9 Jul 2019.