Clinical trial NCT02262845: Short Term Pancreatic Stenting Registry
Official title: A Prospective Multi-Center Registry Using Plastic Pancreatic Stents for Short Term Drainage of the Pancreatic Duct
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-ERCP Acute Pancreatitis
Pancreatic Duct Stricture
Pancreatic Duct Stones
Pancreatic Duct Leakage
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Success: Group A (PEP Risk)
timeFrame: Stent placement through 48 hours post stent placement
measure: Clinical Success: Group B (Impaired Pancreatic Duct Drainage)
timeFrame: Stent placement through stent removal
measure: Clinical Success: Group C (Pancreatic Duct Leak):
timeFrame: Stent Removal
measure: Clinical Success: Group D (Post Pancreatic Surgery)
timeFrame: Stent Removal
measure: Clinical Sucess: Group E (Other)
timeFrame: Stent Removal
Secondary outcomes:
measure: Serious Adverse Events and all occurrences of acute pancreatitis
timeFrame: Through end of study
measure: Technical Success
timeFrame: Stent Placement
measure: Ease of use
timeFrame: Stent Placement
measure: Removability
timeFrame: Stent Removal
measure: Stent Migration
timeFrame: Through end of study
measure: Reintervention
timeFrame: Through end of study
measure: Stent type preference
timeFrame: Stent Placement
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University School of Medicine
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Duesseldorf
country: Germany
facility: Evangelisches Krankenhaus Dusseldorf
city: Somajiguda
country: India
facility: Asian Institute of Gastroenterology
state: Hyderabad
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Paul Tarnasky, MD
role: PRINCIPAL_INVESTIGATOR
References: