Pancreatic Metal Stents in Chronic Pancreatitis
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|ClinicalTrials.gov Identifier: NCT02135809|
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : July 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Refractory Pancreatic Duct Strictures Painful Chronic Pancreatitis||Device: WallFlex Pancreatic Stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fully Covered Self Expanding Metal Stents (FCSEMS) for Refractory Pancreatic Duct Strictures in Patients With Chronic Pancreatitis|
|Actual Study Start Date :||June 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||March 30, 2017|
Patients will receive the WallFlex Pancreatic Stent.
Device: WallFlex Pancreatic Stent
Temporary placement of the WallFlex Pancreatic Stent for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis. Stent will be removed after 3-6 months indwell.
- Decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis [ Time Frame: 3 months after study stent removal ]Clinical success defined as decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis 3 months after stent removal compared to baseline prior to stent indwell period.
- Occurrence and severity of serious adverse events related to the stenting procedure, to the indwelling stent and/or to stent removal [ Time Frame: Duration of study participation, an average of 27-30 months ]
- Stent placement success [ Time Frame: Study Stent Placement Procedure ]Ability to deploy the stent in satisfactory position (Stent Placement Success). Satisfactory position is defined as the stent being across the stricture, without visible impaction at an angle and distal end visible into the duodenum.
- Type of additional intervention within pancreatic duct [ Time Frame: Duration of study participation, an average of 27-30 months ]
- Stent removal success [ Time Frame: Study Stent Removal ]Successful stent removal (Stent Removal Success) defined as ability to remove stent endoscopically (grasper, snare, stent-in-stent) without serious stent removal-related adverse events
- Change of pain medication intake [ Time Frame: Duration of study participation, an average of 27-30 months ]Change of pain medication intake (type of medication) from baseline to each follow-up visit.
- Number of device events [ Time Frame: Duration of study participation, an average of 27-30 months ]Device Events, including findings not associated with adverse events, such as but not limited to asymptomatic stent migration.
- Stricture resolution of pancreatic duct after stent removal [ Time Frame: Study Stent Removal ]Assessment of pancreatic duct after stent removal compared to baseline, including ERCP to document extent of stricture resolution, extent of resolution of ductal dilation above the treated dominant stricture, and presence or absence of secondary ductal strictures at the level of where the proximal edge of the stent was located
- For patients who proceed to surgery, impact of prior SEMS on surgical outcomes. [ Time Frame: Up to surgery ]
- Stent functionality [ Time Frame: Up to time of study stent removal,average of 3-6 months on study ]Stent functionality: Relief of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis at 3 days, 2 weeks, 1 month, 2 months, 4 months (Phase 2 patients as applicable) and just prior to stent removal compared to baseline prior to stent placement, using established pancreatic pain score
- Stricture Resolution at stent removal [ Time Frame: Study Stent Removal ]Stricture Resolution at stent removal, defined as pancreatographic confirmation of drainage of injected contrast medium after stent removal without visible persistent stricture
- Time to Recurrence of Stricture [ Time Frame: Duration of study participation, an average of 27-30 months ]Time to Recurrence of Stricture, established in patients who had stricture resolution at stent removal and defined as time elapsed from stent removal till recurrence of pain with associated documentation of narrowing of pancreatic duct. Recurrence of stricture will be documented at the time it is identified and absence of stricture recurrence will be ascertained at 1, 3, 6, 12, 18 and 24 months after stent removal. Pain will be documented using an established pancreatic pain score.
- Reason for additional intervention within pancreatic duct [ Time Frame: Duration of study participation, an average of 27-30 months ]
- Timing of additional intervention within pancreatic duct [ Time Frame: Duration of study participation, an average of 27-30 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135809
|ULB Erasme Hospital|
|Brussels, Belgium, B-1070|
|Principal Investigator:||Jacques Devière, MD, PhD||ULB Erasme Hospital|