The objective of this study is to prospectively document the performance of a fully covered self expanding metal stents (FCSEMS) for treatment of pancreatic duct strictures in patients with painful chronic pancreatitis.
ID
Source
Brief title
Condition
- Other condition
- Exocrine pancreas conditions
- Gastrointestinal therapeutic procedures
Synonym
Health condition
Chronic pancreatitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary effectiveness endpoint is pain reduction at 6 months after removal
of the WallFlex stent or 6 months after observation of migration of the stent.
The primary safety endpoint is the rate of related serious adverse events from
the placement of the WallFlex stent to the end of the study.
Secondary outcome
The secondary endpoints include stricture resolution, clinical status
improvement, recurrence of stricture, stent functionality, Izbicki pain score,
average daily narcotic use, ability to deploy the stent in a satisfactory
position, successful stent removal, and device event rate.
Background summary
Chronic pancreatitis (CP) is commonly defined as a chronic inflammatory process
of the pancreas, characterized by irreversible morphologic changes. CP is a
relatively rare disorder occurring in about 20 cases per 100,000 per year. The
disease is progressive with persistent inflammation leading to damage and/or
destruction of the pancreas. This chronic inflammation can lead to chronic
abdominal pain and/or impairment of endocrine and exocrine function of the
pancreas. Inflammatory changes of the pancreas associated with CP may involve
some or all of the following: fibrosis, calcification, pancreatic ductal
inflammation, and pancreatic stone formation. Chronic pancreatitis is also
associated with obstruction of the pancreatic duct secondary to strictures
related to pancreatic inflammation, or benign or malignant tumors.
While pancreatic duct stones are sequelae of chronic pancreatitis, they also
may be responsible for recurrent acute pancreatitis or exacerbations of chronic
pain related to ductal obstruction and increased ductal pressure. Stones
usually form proximal to ductal strictures and usually require a pancreatic
duct sphincterotomy and stricture dilation to enable their extraction. In
addition to various endoscopic techniques, extracorporeal shockwave lithotripsy
(ESWL) often is necessary to break up impacted or large stones into smaller
pieces suitable for removal.
In the treatment of benign pancreatic duct strictures caused by CP, the
ultimate clinical objective is durable pain control without major
complications. The gold standard of treatment for benign pancreatic strictures
remains surgery; however, the morbidity associated with these major surgical
procedures has made less-invasive endoscopic alternatives a first line approach
for treatment of simple benign main pancreatic duct strictures associated with
CP.
Endoscopic placement of a single or multiple plastic stents is widely used for
patients with painful CP and associated dominant pancreatic duct strictures.
Approximately half of patients with severe CP who undergo endoscopic treatment
require pancreatic stent placement in order to relieve obstruction of the main
pancreatic duct caused by a dominant stricture, usually located in the
pancreatic head. Transpapillary pancreatic duct stent placement in symptomatic
CP associated with pancreatic duct stricture has been shown, in multiple
studies, to be effective, with long-term pain relief achieved in approximately
two thirds of patients.
Placement of SEMSs in the pancreatic duct may offer advantages over multiple
plastic stents. Although literature regarding pancreatic SEMS is scarce, some
preliminary conclusions based on biliary SEMS used for the treatment of
malignant biliary obstruction may also be theoretically applicable to
pancreatic SEMS. By analogy with the biliary tract, the larger diameter of
SEMSs may offer longer-lasting drainage of the main pancreatic duct.
Conventional plastic pancreatic stents typically remain patent for less than 2
months, likely because the lumen is small (5 F - 7 F); whereas, the larger
lumens of SEMSs may potentially remain patent for extended periods.
Uncovered SEMSs have been successfully placed in the pancreatic duct for
malignant conditions; however, placement of uncovered SEMSs for treatment of
benign pancreatic diseases has been unsatisfactory because of tissue ingrowth
through the wire mesh and migration. Moreover, difficult removability of a
malfunctioning uncovered metal stent is problematic. In contrast, covered
metal stents have the advantage of prevention of tissue hyperplasia and easy
removability compared with uncovered stents.
SEMSs were first reported as an alternative to plastic stenting of benign
pancreatic duct strictures in the 1990s. A study by Eisendrath and Deviere,
published in1999, reported on 38 patients with CP associated with dominant
stricture of the main pancreatic duct; 20 treated using an uncovered SEMSs and
18 using a partially- or fully-covered SEMSs. The authors concluded that while
uncovered and partially-covered SEMSs should be avoided due to excessive tissue
ingrowth, fully-covered SEMSs (FCSEMSs) showed promising long-term patency
results for treatment of CP-associated pancreatic strictures compared to
outcomes using plastic stents. The authors concluded that the use of FCSEMSs
may reduce the number of interventions compared to plastic stenting.
Study objective
The objective of this study is to prospectively document the performance of a
fully covered self expanding metal stents (FCSEMS) for treatment of pancreatic
duct strictures in patients with painful chronic pancreatitis.
Study design
This study is a prospective, single arm, pre-approval study. Treatment of up to
92 patients will take place at up to 10 clinical centers. Patient who meet all
eligibility criteria will receive the WallFlex Pancreatic stent for up to 6
months stent indwell and 6 months follow-up after stent removal.
Intervention
Patients will receive the WallFlex Pancreatic Stent, which will be placed in
the pancreatic duct during endoscopic retrograde cholangiopancreatography and
remain indwelling for up to 6 months.
Study burden and risks
The following anticipated adverse events (AE) have been identified for this
study associated with the placement and removal of the study device.
* Pain
* Cholestasis
* Cholangitis
* Pancreatitis
* Secondary stricture formation
* Obstructive Jaundice
* Vomiting
* Bleeding
* Infection
* Sepsis
* Abscess Formation
* Hyperplastic Tissue Reaction
* Tissue trauma (including events such as duct injury, rupture, edema,
inflammation, impaction, laceration and necrosis)
* Pancreatic Duct Rupture
* Allergic Reaction
* Pseudocyst development
* Fever
* Death (excluding disease progression)
* Impaction to pancreatic duct wall
* Perforation with or without pneumoperitoneum
* Pseudoaneurysm
Participation in the trial may be demanding and time consuming. Additional
risks may exist. Risks can be minimized through compliance with this protocol,
performing procedures in the appropriate hospital environment, adherence to
patient selection criteria, close monitoring of the patient*s physiologic
status during research procedures and/or follow-ups and by promptly supplying
the Sponsor with all pertinent information required by this protocol.
Patients may not receive any benefit from participating in this study. However,
medical science and future patients may benefit from this study. Based on
collected reports in literature to-date, the risk-to-benefit ratio is within
reason for foreseeable risks. However, literature reports do not always capture
all side effects. Observation and follow-up of patients is required as outlined
in the protocol.
100 Boston Scientific Way N/A
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100 Boston Scientific Way N/A
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NL
Listed location countries
Age
Inclusion criteria
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 one 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 stent or availability for one month prior to placement of prior plastic stent, where applicable.
6. VAS Pain Score of 20 at the time of study stent placement for patients with no history of pancreatic stenting. VAS Pain Score of 20 at time of initial plastic pancreatic stent for patients with history of one prior plastic pancreatic stent indwelling for 3 months or less. VAS Pain Score is captured via Izbicki pain scale.
7. Pain occuring weekly or more frequently (assessed by Frequency of Pain sector of the Izbicki pain scale).
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 stent should be placed immediately after the ESWL procedure instead and left indwelling 1-3 months.
* 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
Exclusion criteria
1. Pancreatic or peri-ampullary cancer with or without pancreatic duct strictures caused by malignancy
2. Biliary strictures caused by chronic pancreatitis
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. Pancreatic duct stenoses not located in the head of the pancreas
8. Failed access during an attempted ERCP on a prior date at the investigational center
9. History of prior side-by-side multiple pancreatic plastic and/or history of prior pancreatic metal stent(s)
10. Reported recent history of acute relapsing pancreatitis
11. Patients for whom endoscopic techniques are contraindicated.
12. Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
13. 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02802020 |
| CCMO | NL57735.078.16 |