Fully Covered Self Expanding Metal Stent in Painful Chronic Pancreatitis
- Conditions
- Health Condition 1: null- Chronic pancreatitisHealth Condition 2: K861- Other chronic pancreatitis
- Registration Number
- CTRI/2018/02/012063
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
1. Age 18 or older
2. Willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study
3. Chronic pancreatitis induced stricture of Cremer Type IV, namely distal dominant stricture with upstream ductal dilation.
4. For patients with a prior plastic pancreatic stent: VAS Pain Score and Frequency of Pain sectors of the Izbicki pain scale at the time of placement of the plastic stent.
5. Availability of narcotic dosage for at least one month prior to baseline visit for patients who do not have a prior plastic pancreatic stent or availability for one month prior to placement of prior plastic pancreatic stent, where applicable.
6. VAS Pain Score of = 20 before study stent placement for patients without a prior plastic pancreatic stent. VAS Pain Score of = 20 before initial plastic pancreatic stent placement for patients with a prior plastic pancreatic stent indwelling for 90 days or less before study stent placement. VAS Pain Score is captured via Izbicki pain scale.
7. Pain occurring weekly or more frequently (assessed by Frequency of Pain sector of the Izbicki pain scale) as reported before study stent placement for patients without a prior plastic pancreatic stent, or before placement of initial plastic pancreatic stent for patients with a prior plastic pancreatic stent indwelling for 90 days or less before study stent placement.
8. Minimum 5 mm diameter of dilated duct immediately upstream of pancreatic duct stricture
9. Prior clearance of pancreatic stones where needed
• If pancreatic duct stone clearance prior to placement of the study stent includes ESWL, then a plastic pancreatic stent may be placed immediately after the ESWL procedure at the discretion of the Investigator, for example, if there is concern about stone fragments of stone sludge in side branches of the pancreatic duct, and may be left indwelling for 30-90 days.
• If new pancreatic duct stones requiring ESWL have formed by the time of intended study stent placement, then the patient will not receive the study stent and be excluded from the study. Further treatment of the patient will be provided per standard of practice outside of the study. In case the study stent is not placed during the same session in which the plastic stent is removed, the pain score needs to be collected again prior to study stent placement.
10. Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of SEMS placement as applicable.
1. Pancreatic or peri-ampullary cancer with or without pancreatic duct strictures caused by malignancy
2. Biliary strictures caused by chronic pancreatitis that are symptomatic and/or in need of therapeutic intervention
3. Perforated duct
4. Ansa pancreatica
5. Presence of pancreatic cysts suspected to be cystic tumor or requiring transmural drainage
6. Duodenal/groove pancreatitis
7. Autoimmune pancreatitis
8. Pancreatic duct stenoses not located in the head of the pancreas
9. Failed access during an attempted ERCP on a prior date at the investigational center
10. Duration of indwell of one single plastic pancreatic stent or cumulative duration of consecutive single plastic pancreatic stents immediately prior to study stent placement exceeding 90 days
11. History of prior single pancreatic plastic stent(s) followed by a stent-free period shorter than 1 year before enrollment into the study
12. History of prior side-by-side multiple pancreatic plastic stents up to one year prior to enrollment
13. History of prior pancreatic metal stent(s)
14. Reported recent history of acute relapsing pancreatitis in the absence of chronic pancreatitis
15. Patients for whom endoscopic techniques are contraindicated.
16. Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
17. Inability or refusal to comply with the follow-up schedule including patients living at such a distance from the investigational center that attending follow-up visits would be unusually difficult or burdensome
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain reduction is the primary effectiveness endpoint and will be assessed at 6 months post-stent removal or 6 months post-observation of complete or partial stent migration compared to pain collected at baseline. <br/ ><br>Pain will be scored between 0 and 100 as the mean of the VAS Pain Score and Frequency of Pain sectors of the Izbicki pain scale. <br/ ><br> <br/ ><br>The primary safety endpoint is the rate of related SAEs from study stent placement to end of study.Timepoint: Pain reduction is the primary effectiveness endpoint and will be assessed at 6 months post-stent removal or 6 months post-observation of complete or partial stent migration compared to pain collected at baseline. <br/ ><br>Pain will be scored between 0 and 100 as the mean of the VAS Pain Score and Frequency of Pain sectors of the Izbicki pain scale. <br/ ><br> <br/ ><br>The primary safety endpoint is the rate of related SAEs from study stent placement to 6 months post-study stent removal.
- Secondary Outcome Measures
Name Time Method