Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

Pancreatic Cancer Clinical Trial

Official title:

Randomized Controlled Trial Comparing Covered and Uncovered Biliary Self Expanding Metal Stents (SEMS) for Pre-operative Drainage During Neoadjuvant Therapy in Patients With Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238847
• Other study ID #: 90905950
• Secondary ID: E7034
• Status: Completed
• Phase: N/A
• Start date: March 24, 2015
• Est. completion date: April 10, 2018

Study information

• Verified date: February 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: April 10, 2018
• Est. primary completion date: February 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Patient indicated for biliary metal stent placement for the treatment of jaundice and/or cholestasis

• Willing and able to comply with the study procedures and provide written informed consent to participate in the study

• Suspicion of pancreatic adenocarcinoma

• Likely indicated for neoadjuvant treatment

• Distal biliary obstruction consistent with pancreatic cancer

• Location of distal biliary obstruction such that it would allow the proximal end of a stent to be positioned at least 2 cm from the hilum

• Endoscopic and surgical treatment to be provided at the same institution

Exclusion Criteria:

• Benign biliary strictures

• Malignancy secondary to Intraductal Papillary Mucinous Neoplasm

• Surgically altered anatomy where ERCP is not possible

• Previous biliary drainage using a SEMS or multiple plastic stents

• Contraindications for endoscopic techniques

• Patients who are currently enrolled in another investigational trial that would directly interfere with the current study

• Pregnancy

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System

Locations

Country	Name	City	State
Belgium	CUB Hopital Erasme	Brussels
Canada	Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital	Montreal	Quebec
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Rome
Japan	Tokyo University Hospital	Tokyo
Korea, Republic of	Asan Medical Center	Seoul
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	The Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Italy,  Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms	Sustained biliary drainage, defined as absence of reinterventions for the management of biliary obstructive symptoms, assessed from self-expanding metal stent (SEMS) placement until curative intent surgery (CIS) when applicable, or to one year after SEMS placement otherwise.	From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)
Secondary	Procedure-related or Stent-related Serious Adverse Events	Serious adverse events related to the stent placement procedure or to the stent	From stent placement procedure up to one year after stent placement procedure
Secondary	Technical Success	Technical success defined as the ability to deploy the stent in a satisfactory position across the stricture; proximal end of the stent is no more than 1-2cm beyond the proximal end of the stricture.	During the Stent Placement Procedure
Secondary	Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention	The ability to complete neoadjuvant therapy as intended without stent-related interruptions of neoadjuvant therapy and without biliary reintervention	From initial stent placement procedure to curative intent surgery (CIS) (median 110 days to CIS), or from initial stent placement procedure to one year after initial stent placement for participants not undergoing CIS
Secondary	Number of Participants With Stent Migration	The number of participants with stent migration	At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS
Secondary	Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure	The subjective impression of the surgeon that the presence of a self-expanding metal stent (SEMS) may have impacted the surgical procedure.	At the time of curative intent surgery (CIS) (median 110 days to CIS)
Secondary	For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement	For participants not undergoing curative intent surgery, sustained biliary drainage from stent placement to one year after stent placement.	From stent placement to one year after stent placement for participants not undergoing curative intent surgery