Post-ERCP Acute PancreatitisNCT02262845
Short Term Pancreatic Stenting Registry
An observational study of Post-ERCP Acute Pancreatitis and Pancreatic Duct Stricture, run by Boston Scientific Corporation at 7 sites in 4 countries.
Trial summary
The purpose of this study is to document clinical utility and distribution of indications for short term pancreatic stenting, and stent type preference by indication at tertiary referral centers with expertise in pancreatic endotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ERCP Acute Pancreatitis, Pancreatic Duct Stricture, Pancreatic Duct Stones
- What is being tested?
- The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers
- Type of treatment
- Medical device
- How many people
- 246 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Feb 2015to Sep 2016
- How long will I take part?
- 6 Weeks
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will examine how well the Advanix Pancreatic stent helps drainage of the pancreas when used per standard-of-practice in many different situations.
Who may be able to join
- Subjects age 18 or older.
- Subjects who require pancreatic drainage and are amenable to endoscopic techniques.
- Subjects willing and able to comply with the study procedures and follow up schedule and willing to provide written informed consent to participate in the study.
- Subjects satisfying at least one of the following clinical presentations:
- high risk of acute pancreatitis post ERCP
- impaired pancreatic duct drainage and pain associated with a pancreatic duct dominant stricture and/or stones and/or sludge/debris, possibly before ESWL or before pancreatic surgery
- need to maintain proper pancreatic duct drainage in the presence of a pancreatic duct leak
- need to maintain proper pancreatic duct drainage after surgical resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy
Who cannot join
- Subjects for whom endoscopic techniques are contraindicated.
- Subjects with known sensitivity to any components of the stents or delivery systems.
- Subjects with coagulopathy outside of what is deemed acceptable for ERCPs per standard of practice
- Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
- Subjects unable or refusing to comply with the follow-up schedule including subject living at such a distance from the investigational center that attending follow-up visits would be unusually difficult or burdensome.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States4 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Methodist Dallas Medical Center
Dallas, Texas, 75208
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: A Prospective Multi-Center Registry Using Plastic Pancreatic Stents for Short Term Drainage of the Pancreatic Duct
The purpose of this study is to document clinical utility and distribution of indications for short term pancreatic stenting, and stent type preference by indication at tertiary referral centers with expertise in pancreatic endotherapy.
Read the detailed description
The study is designed as an all-comer, prospective, multi-center, consecutive cohort series, open-label study.
Detailed objective: To confirm the clinical utility of Advanix™ Pancreatic Stents when used per standard of practice to facilitate pancreatic duct drainage in the following clinical presentations:
- Group A: PEP Risk - In subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP)
- Group B: Impaired Pancreatic Duct Drainage - In subjects with a pancreatic duct stricture and/or pancreatic duct stones and/or pancreatic duct sludge or debris, possibly, but not exclusively before or after ESWL or before pancreatic surgery
- Group C: Pancreatic Duct Leak - In subjects with a pancreatic duct leak
- Group D: Post Pancreatic Surgery - In subjects at risk of pancreatic duct leak or strictures after resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy
- Group E: Other - In subjects with other indications
- Conditions
- Post-ERCP Acute Pancreatitis, Pancreatic Duct Stricture, Pancreatic Duct Stones, Pancreatic Duct Leakage
- Being tested
- The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and PushersDevice
Used to drain pancreatic ducts
| Study group | Role | What they receive |
|---|---|---|
| Group A: PEP Risk | In subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP) Receives: Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers | |
| Group B: Impaired Pancreatic Duct Drainage | In subjects with a pancreatic duct stricture and/or pancreatic duct stones and/or pancreatic duct sludge or debris, possibly, but not exclusively before or after ESWL or before pancreatic surgery Receives: Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers | |
| Group C: Pancreatic Duct Leak | In subjects with a pancreatic duct leak Receives: Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers | |
| Group D: Post Pancreatic Surgery | In subjects at risk of pancreatic duct leak or strictures after resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy Receives: Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers | |
| Group E: Other | In subjects with other indications Receives: Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success: Group A (PEP Risk)
Absence of acute pancreatitis from stent placement through 48 hours post stent placement
Measured: Stent placement through 48 hours post stent placement
Clinical Success: Group B (Impaired Pancreatic Duct Drainage)
Absence of acute pancreatitis from stent placement through stent removal and, where applicable, improvement of pain at stent removal compared to baseline
Measured: Stent placement through stent removal
Clinical Success: Group C (Pancreatic Duct Leak):
Resolution of pancreatic duct leak at stent removal
Measured: Stent Removal
Clinical Success: Group D (Post Pancreatic Surgery)
Absence of pancreatic duct leak and stricture at stent removal
Measured: Stent Removal
Clinical Sucess: Group E (Other)
Resolution of the indication for stent placement at stent removal
Measured: Stent Removal
Secondary outcomes (7)
Serious Adverse Events and all occurrences of acute pancreatitis
Occurrence and severity of serious adverse events related to the stent and/or the stent placement and/or stent removal procedures as applicable and all occurrences of acute pancreatitis.
Measured: Through end of study
Technical Success
Evaluation of technical success defined as the ability to place the stent in a satisfactory position in the main pancreatic duct as determined by fluoroscopy.
Measured: Stent Placement
Ease of use
Evaluation of ease of use documenting overall ease of placement, pushability of stent and ability to visualize the stent fluoroscopically.
Measured: Stent Placement
Removability
Evaluation of removability defined as ability to remove the Advanix stent endoscopically without serious stent removal related adverse events.
Measured: Stent Removal
Stent Migration
Documentation of stent migration rates overall, by Group, and by stent type
Measured: Through end of study
Reintervention
Evaluation of the occurrence of reintervention defined as any type of endoscopic, percutaneous, or surgical procedure to aid drainage of the pancreas after initial stent placement through end of follow-up.
Measured: Through end of study
Stent type preference
Documenting stent type preference by subject presentation and pancreatic plastic stenting indication.
Measured: Stent Placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ERCP Acute PancreatitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Tarnasky, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262845
- Sponsor's protocol ID
- 90987979
- Status last verified
- Mar 2017
- First submitted
- 9 Oct 2014
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Center Registry Using Plastic Pancreatic Stents for Short Term Drainage of the Pancreatic Duct
- ClinicalTrials.gov ID
- NCT02262845
- Acronym / sponsor ID
- 90987979
- Conditions
- Post-ERCP Acute Pancreatitis, Pancreatic Duct Stricture, Pancreatic Duct Stones, Pancreatic Duct Leakage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 Oct 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 clinical utility and distribution of indications for short term pancreatic stenting, and stent type preference by indication at tertiary referral centers with expertise in pancreatic endotherapy.
Detailed description
The study is designed as an all-comer, prospective, multi-center, consecutive cohort series, open-label study.
Detailed objective: To confirm the clinical utility of Advanix™ Pancreatic Stents when used per standard of practice to facilitate pancreatic duct drainage in the following clinical presentations:
- Group A: PEP Risk - In subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP)
- Group B: Impaired Pancreatic Duct Drainage - In subjects with a pancreatic duct stricture and/or pancreatic duct stones and/or pancreatic duct sludge or debris, possibly, but not exclusively before or after ESWL or before pancreatic surgery
- Group C: Pancreatic Duct Leak - In subjects with a pancreatic duct leak
- Group D: Post Pancreatic Surgery - In subjects at risk of pancreatic duct leak or strictures after resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy
- Group E: Other - In subjects with other indications
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A: PEP Risk | – | Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and PushersIn subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP) |
| Group B: Impaired Pancreatic Duct Drainage | – | Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and PushersIn subjects with a pancreatic duct stricture and/or pancreatic duct stones and/or pancreatic duct sludge or debris, possibly, but not exclusively before or after ESWL or before pancreatic surgery |
| Group C: Pancreatic Duct Leak | – | Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and PushersIn subjects with a pancreatic duct leak |
| Group D: Post Pancreatic Surgery | – | Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and PushersIn subjects at risk of pancreatic duct leak or strictures after resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy |
| Group E: Other | – | Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and PushersIn subjects with other indications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will examine how well the Advanix Pancreatic stent helps drainage of the pancreas when used per standard-of-practice in many different situations.
Key inclusion criteria (8 listed)
- Subjects age 18 or older.
- Subjects who require pancreatic drainage and are amenable to endoscopic techniques.
- Subjects willing and able to comply with the study procedures and follow up schedule and willing to provide written informed consent to participate in the study.
- Subjects satisfying at least one of the following clinical presentations:
Key exclusion criteria (5 listed)
- Subjects for whom endoscopic techniques are contraindicated.
- Subjects with known sensitivity to any components of the stents or delivery systems.
- Subjects with coagulopathy outside of what is deemed acceptable for ERCPs per standard of practice
- Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
- Subjects unable or refusing to comply with the follow-up schedule including subject living at such a distance from the investigational center that attending follow-up visits would be unusually difficult or burdensome.
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 |
|---|---|---|
| The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and PushersUsed to drain pancreatic ducts | Device | Group A: PEP Risk, Group B: Impaired Pancreatic Duct Drainage, Group C: Pancreatic Duct Leak, Group D: Post Pancreatic Surgery, Group E: Other |
Primary outcome
Clinical Success: Group A (PEP Risk)
Time frame: Stent placement through 48 hours post stent placement
Absence of acute pancreatitis from stent placement through 48 hours post stent placement
Clinical Success: Group B (Impaired Pancreatic Duct Drainage)
Time frame: Stent placement through stent removal
Absence of acute pancreatitis from stent placement through stent removal and, where applicable, improvement of pain at stent removal compared to baseline
Clinical Success: Group C (Pancreatic Duct Leak):
Time frame: Stent Removal
Resolution of pancreatic duct leak at stent removal
Clinical Success: Group D (Post Pancreatic Surgery)
Time frame: Stent Removal
Absence of pancreatic duct leak and stricture at stent removal
Clinical Sucess: Group E (Other)
Time frame: Stent Removal
Resolution of the indication for stent placement at stent removal
7 secondary outcomes
Serious Adverse Events and all occurrences of acute pancreatitis
Time frame: Through end of study
Technical Success
Time frame: Stent Placement
Ease of use
Time frame: Stent Placement
Removability
Time frame: Stent Removal
Stent Migration
Time frame: Through end of study
Reintervention
Time frame: Through end of study
Stent type preference
Time frame: Stent Placement
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 21 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Paul Tarnasky, MD principal investigator
The Methodist Hospital Research Institute
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-ERCP Acute Pancreatitis and Pancreatic Duct Stricture, run by Boston Scientific Corporation at 7 sites in 4 countries.
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 8 inclusion and 5 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Germany, India, Netherlands. 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?
Clinical Success: Group A (PEP Risk) (time frame: Stent placement through 48 hours post stent placement). The study lists 5 primary outcomes in all. 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 21 Mar 2017.