WallFlex Pancreatic Metal Stent for Pancreatic Duct Stric... | NCT02802020

NCT02802020

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
WallFlex FCSEMS Recipients	Experimental	The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent. Patients 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. A patient is considered "enrolled" after signing the study-specific Informed Consent Form (ICF). Patients who sign the ICF but subsequently do not meet one or more of the selection criteria will be considered screen failures and excluded from the study.	Device: Pancreatic fully-covered self-expanding metal stent (FCSEMS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pancreatic fully-covered self-expanding metal stent (FCSEMS)	Device	The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain Reduction	The self-reported pain score (0-100) was the mean of the Visual Analogue Scale (VAS) and Izbicki Frequency of Pain subscore (sum treated as a continuous variable).The primary efficacy endpoint was the proportion of patients who had complete (pain score ≤ 10) or partial (pain score ˃ 10 but reduced at least 50% compared to pain as baseline) pain relief by 6 months after FCSEMS removal or observation of CDM or partial stent migration. Primary efficacy endpoint failure included any of the following: 1) no pain relief, 2) complete or partial pain relief in the setting of a 50% higher average daily narcotic dose compared to the patient's daily average narcotic dose in the month prior to baseline and at 6 months post-stent removal/observation of CDM, 3) stent migration in setting of recurring pain (VAS Pain Score of ≥ 20), 4) restenting in the setting of recurring pain.	Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration
Rate of Related SAEs From WallFlex Pancreatic Stent Placement to End of Study	The primary safety endpoint was the rate of serious adverse events (SAEs) related to the FCSEMS or study procedures from FCSEMS placement to end of study follow-up. Pain thought to be caused by FCSEMS pancreatic stent expansion was reported but did not count towards the endpoint if all three of the following conditions applied: Pain managed by medication, with the exception of injectable narcotic use for more than 24 hours. Pain not causing pancreatic FCSEMS removal. Pain resolved by 72 hours after pancreatic FCSEMS placement.	Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration

Secondary Outcomes

Measure	Description	Time Frame
Stent Placement Success	Satisfactory position is defined as the stent being across the stricture, without visible occluding impaction at the genu of the pancreatic duct and with distal end of the stent visible in the duodenum.	Assessed upon study stent placement. This endpoint is assessed at the Study Stent Placement visit (Day 0).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or older
Willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study
Chronic pancreatitis induced stricture of Cremer Type IV, namely distal dominant stricture with upstream ductal dilation.
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.
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.
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.
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.
Minimum 5 mm diameter of dilated duct immediately upstream of pancreatic duct stricture
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.
Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of SEMS placement as applicable.

Exclusion Criteria:

Pancreatic or peri-ampullary cancer with or without pancreatic duct strictures caused by malignancy
Biliary strictures caused by chronic pancreatitis that are symptomatic and/or in need of therapeutic intervention
Perforated duct
Ansa pancreatica
Presence of pancreatic cysts suspected to be cystic tumor or requiring transmural drainage
Duodenal/groove pancreatitis
Autoimmune pancreatitis
Pancreatic duct stenoses not located in the head of the pancreas
Failed access during an attempted ERCP on a prior date at the investigational center
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
History of prior single pancreatic plastic stent(s) followed by a stent-free period shorter than 1 year before enrollment into the study
History of prior side-by-side multiple pancreatic plastic stents up to one year prior to enrollment
History of prior pancreatic metal stent(s)
Reported recent history of acute relapsing pancreatitis in the absence of chronic pancreatitis
Patients for whom endoscopic techniques are contraindicated
Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
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

Name	Affiliation	Role
Jacques Deviere, MD, PhD	ULB Erasme Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado School of Medicine		Aurora	Colorado	80045	United States
Indiana University Health Medical Center

PubMed Identifier	Type	Citation	Retractions
36208796	Derived	Sherman S, Kozarek RA, Costamagna G, Reddy DN, Tarnasky P, Shah RJ, Slivka A, Fogel E, Watkins J, Delhaye M, Irani SS, Tringali A, Lakhtakia S, Kedia P, Edmundowicz S, Peetermans JA, Rousseau MJ, Deviere J; Pancreatic SEMS in Chronic Pancreatitis Study Group. Soft self-expandable metal stent to treat painful pancreatic duct strictures secondary to chronic pancreatitis: a prospective multicenter trial. Gastrointest Endosc. 2023 Mar;97(3):472-481.e3. doi: 10.1016/j.gie.2022.09.021. Epub 2022 Oct 5.

ID	Title	Description
FG000	WallFlex FCSEMS Recipients	The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent. Patients 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. A patient is considered "enrolled" after signing the study-specific Informed Consent Form (ICF). Patients who sign the ICF but subsequently do not meet one or more of the selection criteria will be considered screen failures and excluded from the study. Pancreatic fully-covered self-expanding metal stent (FCSEMS): The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	WallFlex FCSEMS Recipients	The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent. Patients 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. A patient is considered "enrolled" after signing the study-specific Informed Consent Form (ICF). Patients who sign the ICF but subsequently do not meet one or more of the selection criteria will be considered screen failures and excluded from the study. Pancreatic fully-covered self-expanding metal stent (FCSEMS): The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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	Pain Reduction	The self-reported pain score (0-100) was the mean of the Visual Analogue Scale (VAS) and Izbicki Frequency of Pain subscore (sum treated as a continuous variable).The primary efficacy endpoint was the proportion of patients who had complete (pain score ≤ 10) or partial (pain score ˃ 10 but reduced at least 50% compared to pain as baseline) pain relief by 6 months after FCSEMS removal or observation of CDM or partial stent migration. Primary efficacy endpoint failure included any of the following: 1) no pain relief, 2) complete or partial pain relief in the setting of a 50% higher average daily narcotic dose compared to the patient's daily average narcotic dose in the month prior to baseline and at 6 months post-stent removal/observation of CDM, 3) stent migration in setting of recurring pain (VAS Pain Score of ≥ 20), 4) restenting in the setting of recurring pain.	There were 67 participants who enrolled in the study and had attempted FCSEMS placement. Of the 67 participants with attempted FCSEMS placement, 21 were excluded because they were not eligible for the primary efficacy endpoint analysis (i.e., 16 had insufficient pain, 2 died, and 3 were lost to follow-up). As a result, 46 participants were eligible for the primary efficacy endpoint analysis.	Posted		Count of Participants		Participants		Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration

Adverse Events Module

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	WallFlex FCSEMS Recipients	The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent. Patients 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. A patient is considered "enrolled" after signing the study-specific Informed Consent Form (ICF). Patients who sign the ICF but subsequently do not meet one or more of the selection criteria will be considered screen failures and excluded from the study. Pancreatic fully-covered self-expanding metal stent (FCSEMS): The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent.

ID	Term
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease