Trial Outcomes & Findings for WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures (NCT NCT02802020)

NCT ID: NCT02802020

Last Updated: 2022-11-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

67 participants

Primary outcome timeframe

Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration

Results posted on

2022-11-21

Participant Flow

Participants were considered "enrolled" after providing written informed consent. Participants who provided written informed consent but subsequently did not meet one or more of the selection criteria were considered screen failures and excluded from the study. Only participants who met all eligibility criteria were counted toward the enrollment ceiling and considered the primary analysis cohort.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	67
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The number of participants analyzed for time since CP diagnosis is lower than the number of baseline participants due to missing data or status unknown.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	WallFlex FCSEMS Recipients n=67 Participants 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.
Age, Continuous	52.7 years STANDARD_DEVIATION 12.5 • n=67 Participants
Sex: Female, Male Female	25 Participants n=67 Participants
Sex: Female, Male Male	42 Participants n=67 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=67 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	67 Participants n=67 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=67 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=67 Participants
Race (NIH/OMB) Asian	7 Participants n=67 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=67 Participants
Race (NIH/OMB) Black or African American	6 Participants n=67 Participants
Race (NIH/OMB) White	54 Participants n=67 Participants
Race (NIH/OMB) More than one race	0 Participants n=67 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=67 Participants
Region of Enrollment Belgium	9 Participants n=67 Participants
Region of Enrollment India	7 Participants n=67 Participants
Region of Enrollment Italy	7 Participants n=67 Participants
Region of Enrollment United States	44 Participants n=67 Participants
Time Since CP Diagnosed	6.4 years STANDARD_DEVIATION 6.4 • n=23 Participants • The number of participants analyzed for time since CP diagnosis is lower than the number of baseline participants due to missing data or status unknown.
Weight	71.5 kilograms STANDARD_DEVIATION 18.4 • n=67 Participants
CP Etiology Alcoholic	33 Participants n=67 Participants
CP Etiology Hereditary	3 Participants n=67 Participants
CP Etiology Gallstones	1 Participants n=67 Participants
CP Etiology Smoking	24 Participants n=67 Participants
CP Etiology Other	8 Participants n=67 Participants
CP Etiology Unknown	19 Participants n=67 Participants
Current Alcohol Consumption	8 Participants n=67 Participants
CP Calcific Yes	48 Participants n=67 Participants
CP Calcific No	18 Participants n=67 Participants
CP Calcific Unknown	1 Participants n=67 Participants
Type of Calcification Ductal	20 Participants n=48 Participants • Of the 67 baseline participants, 48 participants were reported to have calcific CP. As a result, only 48 participants were evaluated for type of calcification.
Type of Calcification Parenchymal	9 Participants n=48 Participants • Of the 67 baseline participants, 48 participants were reported to have calcific CP. As a result, only 48 participants were evaluated for type of calcification.
Type of Calcification Both	19 Participants n=48 Participants • Of the 67 baseline participants, 48 participants were reported to have calcific CP. As a result, only 48 participants were evaluated for type of calcification.
Surgical Candidate Yes	46 Participants n=67 Participants
Surgical Candidate No	12 Participants n=67 Participants
Surgical Candidate Unknown	9 Participants n=67 Participants
Smoking Status Current	36 Participants n=67 Participants
Smoking Status Previous	17 Participants n=67 Participants
Smoking Status Never	14 Participants n=67 Participants
Narcotic Dose	31.9 morphine milligram equivalents STANDARD_DEVIATION 52.3 • n=65 Participants • The number of participants analyzed for narcotic dose is lower than the number of baseline participants due to missing data or status unknown.
Time Since First Narcotic Medication	4.8 years STANDARD_DEVIATION 7.3 • n=28 Participants • The number of participants analyzed for time since first narcotic medication is lower than the number of baseline participants due to missing data or status unknown.
Steatorrhea	13 Participants n=67 Participants
Diabetes Status Insulin Dependent	20 Participants n=67 Participants
Diabetes Status Oral Medication	5 Participants n=67 Participants
Pancreas Divisum	18 Participants n=67 Participants
Prior Pancreatic Sphincterotomy Performed	47 Participants n=67 Participants
Prior Biliary or Pancreatic Sphincterotomy Performed	48 Participants n=67 Participants
History of Pancreatic Duct Stones Yes	37 Participants n=67 Participants
History of Pancreatic Duct Stones Unknown	4 Participants n=67 Participants
Stone Clearance Procedures Performed ESWL	16 Participants n=31 Participants • Of the 67 baseline participants, 31 participants were reported to have stone clearance procedures performed. As a result, only 31 participants were evaluated for type of stone clearance procedure(s) performed.
Stone Clearance Procedures Performed Balloon	20 Participants n=31 Participants • Of the 67 baseline participants, 31 participants were reported to have stone clearance procedures performed. As a result, only 31 participants were evaluated for type of stone clearance procedure(s) performed.
Stone Clearance Procedures Performed Basket	5 Participants n=31 Participants • Of the 67 baseline participants, 31 participants were reported to have stone clearance procedures performed. As a result, only 31 participants were evaluated for type of stone clearance procedure(s) performed.
Stone Clearance Procedures Performed Other	1 Participants n=31 Participants • Of the 67 baseline participants, 31 participants were reported to have stone clearance procedures performed. As a result, only 31 participants were evaluated for type of stone clearance procedure(s) performed.
Current Pancreatic Stones	42 Participants n=67 Participants
Largest Stone	6.2 millimeter STANDARD_DEVIATION 3.9 • n=40 Participants • Of the 67 baseline participants, 42 participants were reported to have current pancreatic stones. Only 40 participants were evaluated for largest stone size. The number of participants analyzed for largest stone size is lower than the number of participants with current pancreatic stones due to missing data or status unknown.

PRIMARY outcome

Timeframe: Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration

Population: 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.

Outcome measures

Outcome measures
Measure	WallFlex FCSEMS Recipients n=46 Participants 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.
Pain Reduction	12 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration

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: 1. Pain managed by medication, with the exception of injectable narcotic use for more than 24 hours. 2. Pain not causing pancreatic FCSEMS removal. 3. Pain resolved by 72 hours after pancreatic FCSEMS placement.

Outcome measures

Outcome measures
Measure	WallFlex FCSEMS Recipients n=67 Participants 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.
Rate of Related SAEs From WallFlex Pancreatic Stent Placement to End of Study	21 Participants

SECONDARY outcome

Timeframe: Assessed upon study stent placement. This endpoint is assessed at the Study Stent Placement visit (Day 0).

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.

Outcome measures

Outcome measures
Measure	WallFlex FCSEMS Recipients n=67 Participants 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.
Stent Placement Success	65 Participants

SECONDARY outcome

Timeframe: Assessed at study stent removal or observation of complete or partial stent migration. This is endpoint is assessed through the Month 6 Study Stent Removal visit.

Population: There were 67 participants who enrolled in the study and had attempted FCSEMS placement. Technical success (i.e., successful stent placement) was achieved in 65 of the 67 participants with attempted FCSEMS placement. As a result, 65 participants were evaluated for the endoscopic stent removal success endpoint.

Endoscopic stent removal success is defined as ability to remove stent endoscopically (forceps, snare) without serious stent removal-related adverse events.

Outcome measures

Outcome measures
Measure	WallFlex FCSEMS Recipients n=65 Participants 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.
Endoscopic Stent Removal Success	63 Participants

SECONDARY outcome

Timeframe: Study stent placement through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration

Stent migration is the change in location of a stent from its originally placed location. In this study, pancreatic stent migration was noted as partial or complete and either proximal (i.e., into the pancreas) or distal (i.e., out of the pancreas).

Outcome measures

Outcome measures
Measure	WallFlex FCSEMS Recipients n=65 Participants 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.
Stent Migration Rate	31 Participants

SECONDARY outcome

Timeframe: Study stent removal or observation of study stent migration through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration

Restenting is the placement of a non-study stent due to no improvement in clinical status and associated persistence of stricture following removal or complete distal migration of the study stent.

Outcome measures

Outcome measures
Measure	WallFlex FCSEMS Recipients n=65 Participants 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.
Restenting Rate	11 Participants

SECONDARY outcome

Timeframe: Study stent placement through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration

A secondary stricture is a ductal narrowing located at the intraductal edge of the study stent.

Outcome measures

Outcome measures
Measure	WallFlex FCSEMS Recipients n=65 Participants 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.
Secondary Stricture Rate	5 Participants

Adverse Events

WallFlex FCSEMS Recipients

Serious events: 21 serious events

Other events: 20 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	WallFlex FCSEMS Recipients n=67 participants at risk 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.
Gastrointestinal disorders Pain	14.9% 10/67 • Number of events 12 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Gastrointestinal disorders Post-ERCP pancreatitis	11.9% 8/67 • Number of events 8 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Gastrointestinal disorders Chronic pancreatitis exacerbation	4.5% 3/67 • Number of events 3 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Gastrointestinal disorders Duodenal ulceration	1.5% 1/67 • Number of events 1 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Investigations Elevated liver function tests	1.5% 1/67 • Number of events 1 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Hepatobiliary disorders Ampullary occlusion of the bile duct	1.5% 1/67 • Number of events 1 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Injury, poisoning and procedural complications Peripancreatic fluid collection	1.5% 1/67 • Number of events 1 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Vascular disorders Portal vein and SMV thrombosis	1.5% 1/67 • Number of events 1 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Infections and infestations Fatal multiorgan failure from sepsis	1.5% 1/67 • Number of events 1 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.

Other adverse events

Other adverse events
Measure	WallFlex FCSEMS Recipients n=67 participants at risk 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.
Gastrointestinal disorders Abdominal Pain	26.9% 18/67 • Number of events 21 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Gastrointestinal disorders Abdominal distension	3.0% 2/67 • Number of events 2 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Gastrointestinal disorders Cholangitis	1.5% 1/67 • Number of events 1 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Gastrointestinal disorders Gastritis	1.5% 1/67 • Number of events 1 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Investigations Liver function test increased	1.5% 1/67 • Number of events 1 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Gastrointestinal disorders Nausea	6.0% 4/67 • Number of events 4 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Gastrointestinal disorders Pancreatitis	3.0% 2/67 • Number of events 2 • Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.

Additional Information

Brian Vatcher

Boston Scientific Corporation

Phone: +1-508-683-5274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place