WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis... | NCT01543256

NCT01543256

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metal stents	Active Comparator	The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.	Device: WallFlex™ Biliary RX Fully Covered Stent System RMV
Plastic Stents	Active Comparator	Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.	Device: Commercially available Plastic Stent Per Investigator preference

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WallFlex™ Biliary RX Fully Covered Stent System RMV	Device	Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell. ("RMV" in intervention name indicates "removable")

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Stricture Resolution	Stricture resolution defined as absence of re-stenting after the 12-month stenting period, and 24 months serum alkaline phosphatase level not exceeding twice the level at the end of stenting period.	After 12-month stenting period through 24 month follow-up (approximately 12 months)

Secondary Outcomes

Measure	Description	Time Frame
Serious Adverse Events Related to the Device or Procedure	Device or procedure related serious adverse events from the initial stent placement procedure to the 24 month follow-up.	Initial stent placement procedure to 24 month follow-up
Number of ERCP Procedures Through 24 Months After Initial Stent Placement.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
D.Nageshwar Reddy, MD	Asian Institute of Gastroenterology	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Royal Prince Alfred Medical Center		Newtown	New South Wales	2042	Australia
Westmead Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33741314	Derived	Ramchandani M, Lakhtakia S, Costamagna G, Tringali A, Puspoek A, Tribl B, Dolak W, Deviere J, Arvanitakis M, van der Merwe S, Laleman W, Ponchon T, Lepilliez V, Gabbrielli A, Bernardoni L, Bruno MJ, Poley JW, Arnelo U, Lau J, Roy A, Bourke M, Kaffes A, Neuhaus H, Peetermans J, Rousseau M, Reddy DN. Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial. Gastroenterology. 2021 Jul;161(1):185-195. doi: 10.1053/j.gastro.2021.03.015. Epub 2021 Mar 17.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Metal Stents	The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 15, 2013	Oct 5, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Metal Stents	The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
BG001	Plastic Stents	Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00080 BG00184 BG002164

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

- ParticipantsBG00080
- ParticipantsBG00184
- ParticipantsBG002164

Title	Measurements

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00080 ParticipantsBG00184 ParticipantsBG002

Race and Ethnicity Not Collected

Race and Ethnicity were not collected from any participant.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Region of Enrollment

Number

participants

Title	Denominators	Categories
Canada	ParticipantsBG00080 ParticipantsBG00184 ParticipantsBG002

Time since chronic pancreatitis (CP) diagnosed

Median

Full Range

years

Title	Denominators	Categories
	ParticipantsBG00080 ParticipantsBG00184 ParticipantsBG002

Gallbladder in situ

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00080 ParticipantsBG00184 ParticipantsBG002

CP etiology alcoholic

The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00071 ParticipantsBG00178 ParticipantsBG002

Calcifying CP

The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00074 ParticipantsBG00180 ParticipantsBG002

Candidate for surgery

The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00072 ParticipantsBG00177 ParticipantsBG002

Prior plastic stent

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00080 ParticipantsBG00184 ParticipantsBG002

Prior Biliary Sphincterotomy

The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00079 ParticipantsBG00182 ParticipantsBG002

Prior pancreatic sphincterotomy

The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00079 ParticipantsBG00182 ParticipantsBG002

Baseline Bilirubin

Median

Full Range

mg/dL

Title	Denominators	Categories
	ParticipantsBG00080 ParticipantsBG00184 ParticipantsBG002

Baseline Alkaline Phosphatase

Median

Full Range

IU/L

Title	Denominators	Categories
	ParticipantsBG00080 ParticipantsBG00184 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Stricture Resolution

Stricture resolution defined as absence of re-stenting after the 12-month stenting period, and 24 months serum alkaline phosphatase level not exceeding twice the level at the end of stenting period.

Of 80 participants in metal stent arm, only 62 were eligible for primary endpoint evaluation. Of 84 participants in plastic stent arm, only 70 were eligible for primary endpoint evaluation.

Posted

Count of Participants

Participants

After 12-month stenting period through 24 month follow-up (approximately 12 months)

ID	Title	Description
OG000	Metal Stents	The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
OG001	Plastic Stents	Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.

Units	Counts
Participants	OG00062 OG00170

Title

Denominators

Categories

Title	Measurements
	OG00047 OG00154

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Exact non-inferiority		.008														Non-Inferiority	Non-Inferiority margin was 20%

Secondary

Serious Adverse Events Related to the Device or Procedure

Device or procedure related serious adverse events from the initial stent placement procedure to the 24 month follow-up.

Posted

Count of Participants

Participants

Initial stent placement procedure to 24 month follow-up

ID	Title	Description
OG000	Metal Stents	The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
OG001	Plastic Stents	Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.

Units	Counts
Participants

Secondary

Number of ERCP Procedures Through 24 Months After Initial Stent Placement.

The number of endoscopic retrograde cholangiopancreatography (ERCP) procedures through 24 months, after initial stent placement.

Of 80 participants in metal stent arm, 1 participant failed technical success at baseline and did have a completed ERCP procedure. Of 84 participants in plastic stent arm, 2 participants failed technical success at baseline and did have a completed ERCP procedure.

Posted

Mean

Standard Deviation

procedures

Initial stent placement procedure to 24 month follow-up

ID	Title	Description
OG000	Metal Stents	The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
OG001	Plastic Stents	Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.

Secondary

Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)

Technical success defined as the ability to deploy the stent(s) in satisfactory position during initial stent placement procedure.

Posted

Count of Participants

Participants

Initial stent placement procedure

ID	Title	Description
OG000	Metal Stents	The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
OG001	Plastic Stents	Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.

Units	Counts
Participants

Secondary

Length of Stent Placement and Removal Procedures

Length of stent placement procedures and stent removal procedures.

Posted

Median

Full Range

minutes

Initial stent placement procedure to 24 month follow-up

Procedures

ID	Title	Description
OG000	Metal Stents	The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
OG001	Plastic Stents	Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.

Units	Counts
Participants

Secondary

Number of Stents Placed

Number of stents placed throughout study to 24 month follow-up

Of 80 participants in metal stent arm, 1 participant never had a stent placed. Of 84 participants in plastic stent arm, 2 participants never had a stent placed, 1 participant withdrew from the study.

Posted

Mean

Standard Deviation

number of stents

Initial stent placement procedure to 24 month follow-up

ID	Title	Description
OG000	Metal Stents	The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
OG001	Plastic Stents	Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Metal Stents	The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.	5	80	19	80	3	80
EG001	Plastic Stents	Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.	3	84	16	84	8	84

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Abdominal pain	Gastrointestinal disorders	Systematic Assessment		EG0005 affected80 at risk EG0015 affected84 at risk
Cholangitis/fever/jaundice	Gastrointestinal disorders	Systematic Assessment		EG0007 affected80 at risk EG0019 affected84 at risk
Cholecystitis	Gastrointestinal disorders	Systematic Assessment	among patients with a gallbladder	EG0003 affected69 at risk EG0011 affected72 at risk
Post-ERCP pancreatitis	Gastrointestinal disorders	Systematic Assessment		EG0002 affected80 at risk EG0010 affected84 at risk
Acute-on-chronic pancreatitis	Gastrointestinal disorders	Systematic Assessment		EG0002 affected80 at risk EG0010 affected84 at risk
Perforation of duodenum	Gastrointestinal disorders	Systematic Assessment		EG0000 affected80 at risk EG0011 affected84 at risk
Post-sphincterotomy bleed	Gastrointestinal disorders	Systematic Assessment	among patients who had a sphincterotomy	EG0001 affected77 at risk EG0010 affected76 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0003 affected80 at risk EG0014 affected84 at risk
Duodenal Ulcer	Gastrointestinal disorders	Systematic Assessment	EG0000 affected80 at risk EG0011 affected84 at risk
Gastrointestinal Oedema	Gastrointestinal disorders	Systematic Assessment	EG0000 affected80 at risk EG0011 affected84 at risk
Acute Pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected80 at risk EG0011 affected84 at risk
Upper Respiratory Tract Infection	Gastrointestinal disorders	Systematic Assessment	EG0000 affected80 at risk EG0011 affected84 at risk
Chronic Obstruction Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected80 at risk EG0010 affected84 at risk
Neuropathy Peripheral	Nervous system disorders	Systematic Assessment	EG0001 affected80 at risk EG0010 affected84 at risk