Short Term Pancreatic Stenting Registry

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:

A Prospective Multi-Center Registry Using Plastic Pancreatic Stents for Short Term Drainage of the Pancreatic Duct

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262845
• Other study ID #: 90987979
• Status: Completed
• Phase: N/A
• First received: October 9, 2014
• Last updated: March 20, 2017
• Start date: February 2015
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Duct Leakage
• Pancreatic Duct Stones
• Pancreatic Duct Stricture
• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Device:
• The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers
Used to drain pancreatic ducts

Locations

Country	Name	City	State
Germany	Evangelisches Krankenhaus Dusseldorf	Duesseldorf
India	Asian Institute of Gastroenterology	Somajiguda	Hyderabad
Netherlands	Erasmus Medical Center	Rotterdam
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Methodist Dallas Medical Center	Dallas	Texas
United States	Temple University School of Medicine	Philadelphia	Pennsylvania
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Germany,  India,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success: Group A (PEP Risk)	Absence of acute pancreatitis from stent placement through 48 hours post stent placement	Stent placement through 48 hours post stent placement
Primary	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	Stent placement through stent removal
Primary	Clinical Success: Group C (Pancreatic Duct Leak):	Resolution of pancreatic duct leak at stent removal	Stent Removal
Primary	Clinical Success: Group D (Post Pancreatic Surgery)	Absence of pancreatic duct leak and stricture at stent removal	Stent Removal
Primary	Clinical Sucess: Group E (Other)	Resolution of the indication for stent placement at stent removal	Stent Removal
Secondary	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.	Through end of study
Secondary	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.	Stent Placement
Secondary	Ease of use	Evaluation of ease of use documenting overall ease of placement, pushability of stent and ability to visualize the stent fluoroscopically.	Stent Placement
Secondary	Removability	Evaluation of removability defined as ability to remove the Advanix stent endoscopically without serious stent removal related adverse events.	Stent Removal
Secondary	Stent Migration	Documentation of stent migration rates overall, by Group, and by stent type	Through end of study
Secondary	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.	Through end of study
Secondary	Stent type preference	Documenting stent type preference by subject presentation and pancreatic plastic stenting indication.	Stent Placement