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
Verified date | March 2017 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
United States, Germany, India, Netherlands,
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 |
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