Primary objective: 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 objective: To…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
acute pancreatitis, pancreatic duct strictures, pancreatic duct stones, pancreatic duct sludge or debris, pancreatic duct leak
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical success defined as follows:
* Group A (PEP Risk): Absence of acute pancreatitis from stent placement
through 48 hours post stent placement
* 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
* Group C (Pancreatic Duct Leak): Resolution of pancreatic duct leak at stent
removal
* Group D (Post Pancreatic Surgery): Absence of pancreatic duct leak and
stricture at stent removal
* Group E (Other): Resolution of the indication for stent placement at stent
removal
Secondary outcome
1. 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.
2. 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.
3. Evaluation of ease of use documenting overall ease of placement, pushability
of stent and ability to visualize the stent fluoroscopically.
4. Evaluation of removability defined as ability to remove the Advanix stent
endoscopically without serious stent removal related adverse events.
5. Documentation of stent migration rates overall, by Group, and by stent type
6. 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.
7. Documenting stent type preference by subject presentation and pancreatic
plastic stenting indication.
8. For subjects in Group B with a documented dominant pancreatic duct stricture
at stent placement: Evaluation of stricture resolution at time of stent removal
based on pancreatogram
Background summary
Pancreatico-biliary endoscopy (ERCPs) represent approximately 1/3 of the global
Endoscopy business, historically mostly focused on biliary procedures. With the
recent addition of devices used in endoscopic ultrasound (EUS) procedures and
with ERCP and combined EUS/ERCP procedures becoming increasingly therapeutic in
nature, expansion of the Endoscopy product portfolio to include device for use
in the pancreas are a significant focus. Pancreatic guide wires and pancreatic
stents, plastic and metal, are being developed.
The Endoscopy clinical strategy accordingly includes several new trials
studying indications for use of Endoscopy devices in pancreatic diseases and
pancreatic endotherapy.
Four principle clinical presentations lend themselves to placement of
pancreatic stents to provide pancreatic duct drainage:
-Painful chronic pancreatitis in setting of pancreatic duct strictures
-Painful chronic pancreatitis prior to a scheduled pain-relieving procedure
(surgery, or extracorporeal shock wave lithotripsy (ESWL), or intra-ductal
laser or electro hydraulic lithotripsy)
-Deemed need to maintain pancreatic duct drainage to minimize risk of acute
pancreatitis
-Deemed need to maintain pancreatic duct integrity and drainage during healing
The first scenario requires long term stenting and is not the subject of study
in this registry. The second, third, and fourth scenarios may be managed with
short term stenting.
Demonstrated by numerous publications, plastic pancreatic stents are being used
to facilitate drainage of the pancreas in a variety of clinical settings. The
purpose of this registry 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.
Study objective
Primary objective: 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 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
The study is designed as an all-comer, prospective, multi-center, consecutive
cohort series, open-label study. A maximum of 250 subjects will be treated at
up to 10 centers globally.
Subjects will be assigned to the following groups according to local standard
of practice:
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 visits for subjects being treated for short-term drainage will include
the following:
*Baseline
*Stent Placement Procedure
*48 Hour Post Stent Placement (phone call)
*1-6 Weeks Post Stent Placement (phone call)
*Unless there was desired spontaneous full distal migration, Stent Removal at 1
Week to 4 Months Post Stent Placement (depending on clinical presentation)
*End of Study: Documented full distal migration without need of re-stenting, or
stent removal, or 4 months, whichever comes first.
Study burden and risks
As per the commercial DFU included with the study devices, the potential
complications associated with metal stent placement include, but are not
limited to:
* Acute pancreatitis
* Relapse of pain in chronic pancreatitis
* Abdominal pain
* Cholangitis
* Hemorrhage
* Stent migration
* Stent occlusion
* Nausea and vomiting
* Perforation
* Erosion
* Allergic reaction to contrast medium
* Pancreatic duct occlusion or obstruction
* Pancreatic necrosis
* Organ failure
Endoscopy Clinical Operations 100 Boston Scientific Way
Marlborough, MA 01752
US
Endoscopy Clinical Operations 100 Boston Scientific Way
Marlborough, MA 01752
US
Listed location countries
Age
Inclusion criteria
1. Subjects age 18 or older.
2. Subjects who require pancreatic drainage and are amenable to endoscopic techniques.
3. 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.
4. Subjects satisfying at least one of the following clinical presentations:
a. high risk of acute pancreatitis post ERCP
b. 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
c. need to maintain proper pancreatic duct drainage in the presence of a pancreatic duct leak
d. 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
Exclusion criteria
1. Subjects for whom endoscopic techniques are contraindicated.
2. Subjects with known sensitivity to any components of the stents or delivery systems.
3. Subjects with coagulopathy outside of what is deemed acceptable for ERCPs per standard of practice
4. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
5. 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02262845 |
| CCMO | NL51244.078.14 |