Short Term Pancreatic Stenting Registry

Boston Scientific

Status: Completed

Conditions: Pancreatic Duct Stones; Post-ERCP Acute Pancreatitis; Pancreatic Duct Leakage; Pancreatic Duct Stricture

Treatments: Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers

Study type: Observational

Funder types: Industry

Identifiers

NCT02262845

90987979

Details and patient eligibility

About

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.

Full 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

Enrollment: 246 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

   1. high risk of acute pancreatitis post ERCP
   2. 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
   3. need to maintain proper pancreatic duct drainage in the presence of a pancreatic duct leak
   4. 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.

Trial design

246 participants in 5 patient groups

Group A: PEP Risk

Description:

In subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP)

Treatment:

Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers

Group B: Impaired Pancreatic Duct Drainage

Description:

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

Treatment:

Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers

Group C: Pancreatic Duct Leak

Description:

In subjects with a pancreatic duct leak

Treatment:

Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers

Group D: Post Pancreatic Surgery

Description:

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

Treatment:

Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers

Group E: Other

Description:

In subjects with other indications

Treatment:

Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers