To compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture resolution rates, complication rates and number of ERCP…
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
- Endocrine neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint: Stricture resolution at 24 months.
Stricture resolution at 24 months is defined by the following two criteria
being met:
• Absence of re-stenting after the per-protocol stenting period through the 24
month visit
• Absence of cholestasis at the 24 month visit, defined as alkaline phosphatase
level not exceeding 2 times the level at completion of the per-protocol
stenting period
Secondary outcome
1. Occurrence of adverse events related to the stent and/or the stent placement
or removal procedures
2. Number of ERCP procedures through 24 months after initial stent placement
3. Ability to deploy the stent(s) in satisfactory position
4. Stent removal:
- Ability to remove the stent(s) without serious stent removal related adverse
events at each procedure involving removal of stent(s) (technical success at
removal)
- Complete distal migration without serious stent removal related adverse events
5. Liver Function Tests (LFT*s):
- Baseline LFTs compared to LFTs taken at the time of original plastic stent
placement for any subject with a prior plastic stent.
- LFT improvement at month 1 compared to baseline LFTs (and/or compared to LFTs
taken at the time of original plastic stent placement for any subject with a
prior plastic stent)
- LFTs at month 24 compared to LFTs at removal of last stent (applicable for
subjects who had not been re-stented at time of month 24 visit)
6. Health Economic Endpoints:
o Number of outpatient procedures
o Number of hospitalizations
o Duration of hospitalizations
o Length of procedures
o Number of devices
Background summary
Benign strictures of the common bile duct may occur in approximately 3%-45% of
subject with chronic pancreatitis. Previously, surgery was typically performed
for subjects with chronic pancreatitis, but is associated with high morbidity
and mortality. Chronic pancreatitis subjects are also typically poor surgical
candidates due to concomitant malnutrition, cirrhosis or portal hypertension.
Non-surgical candidates will usually undergo endoscopic treatment with one or
more multiple plastic stents placed, resulting in adequate short-term
resolution of pancreatitis but can be associated with high occlusion and
migration rates and poor long-term results.
Plastic stents, which are intended for temporary placement and are removable,
have become standard of care for endoscopic treatment of benign strictures due
to chronic pancreatitis. More recently, physicians are using self-expandable
metal stents (SEMS) for treatment of and removal from such strictures due to
the long-term patency, lower occlusion and obstruction rates, of metal stents
compared to single or multiple plastic stents.
This study is intended to help determine which currently available treatment
methodology, multiple plastic stents or a single metal stent, is a better
option in terms of safety and efficacy for patients diagnosed with benign
biliary stricture secondary to chronic pancreatitis.
Study objective
To compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for
the treatment of benign biliary strictures secondary to chronic pancreatitis as
it pertains to stricture resolution rates, complication rates and number of
ERCP procedures during 24 months.
Study design
This study is designed as a multi-center, prospective, randomized study. Ten to
15 sites will participate, and enrollment of 164 patients is planned. The
proposed duration of the study is approximately 4 years (2 months for
enrollment, plus 2 years to complete follow-up).
Intervention
Patients who are consented and meet inclusion/exclusion criteria will undergo
stenting procedure(s) with either the WallFlex Biliary Fully Covered Stent
System or standard of care plastic stents (1:1 randomization). Per-protocol,
patients randomized to metal stents will have a metal stent in place for 12
months at which point it will be removed via ERCP. Patients randomized to
plastic stents will have their stents exchanged/bile ducts calibrated at 4 and
8 months and stents removed at 12 months via ERCP.
Study burden and risks
Potential Complications associated with Metal Stent Placement and Removal:
As per the commercial DFU included with the study devices, the potential
complications associated with metal stent placement include, but are not
limited to:
• Pain
• Bleeding
• Fever
• Nausea
• Vomiting
• Infection
• Inflammation
• Stent occlusion
• Tumor overgrowth around ends of stent
• Tumor ingrowth through the stent
• Mucosal hyperplasia
• Cholangitis
• Cholecystitis*
• Pancreatitis
• Ulceration of duodenum or bile duct
• Perforation of duodenum or bile duct
• Stent migration
• Death (other than that due to normal disease progression)
• Stent misplacement
• Perforation of the gallbladder due to the stent covering the cystic duct*
• Stent Fracture
• Hepatic abscess
*Note: In a small clinical trial of this device, two out of four (50%) subjects
who had a stent placed across the cystic duct developed cholecystitis. One of
these subjects suffered a perforated gallbladder due to the stent covering the
cystic duct, requiring a drain to be placed.
As per the commercial DFU included with the study devices, potential
complications associated with stent removal include, but are not limited to:
• Pain
• Bleeding
• Fever
• Nausea
• Vomiting
• Infection
• Inflammation
• Recurrent obstructive jaundice
• Mucosal hyperplasia
• Cholangitis
• Cholecystitis
• Pancreatitis
• Ulceration of duodenum or bile duct
• Perforation of duodenum or bile duct
• Death (other than that due to normal disease progression)
• Impaction to the common bile duct wall
Boston Scientific Way M-60 100
Marlborough MA 01752
US
Boston Scientific Way M-60 100
Marlborough MA 01752
US
Listed location countries
Age
Inclusion criteria
• Age 18 or older
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study
• Chronic pancreatitis
• Symptomatic bile duct stricture (defined by cholangitis or persistent jaundice for at least one month or cholestasis associated with at least 3 times normal alkaline phosphatase levels) documented at time of enrollment for naive stricture or at the time of prior plastic stent placement - in strictures that had one prior plastic stent inserted.
• Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts
Exclusion criteria
• Biliary stricture of benign etiology other than chronic pancreatitis
• Prior biliary metal stent or any plastic stenting other than one plastic stent of 10Fr or less for 6 months or fewer.
• Developing obstructive biliary symptoms associated with an attack of acute pancreatitis
• Biliary stricture of malignant etiology
• Stricture within 2 cm of common bile duct bifurcation
• Known bile duct fistula or leak
• Subjects for whom endoscopic techniques are contraindicated
• Known sensitivity to any components of the stent or delivery system
• Symptomatic duodenal stenosis (with gastric stasis)
• Participation in another investigational study within 90 days prior to consent
• Investigator Discretion
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 |
|---|---|
| CCMO | NL39896.078.12 |