Clinical trial NCT02238847: Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreatic
Pancreatic Cancer
Preoperative Biliary Drainage
Neoadjuvant Therapy
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms
timeFrame: 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 outcomes:
measure: Procedure-related or Stent-related Serious Adverse Events
timeFrame: From stent placement procedure up to one year after stent placement procedure
measure: Technical Success
timeFrame: During the Stent Placement Procedure
measure: Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention
timeFrame: 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
measure: Number of Participants With Stent Migration
timeFrame: At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS
measure: Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure
timeFrame: At the time of curative intent surgery (CIS) (median 110 days to CIS)
measure: For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement
timeFrame: From stent placement to one year after stent placement for participants not undergoing curative intent surgery
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
city: Brussels
country: Belgium
facility: CUB Hopital Erasme
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
state: Quebec
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Tokyo
country: Japan
facility: Tokyo University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Tokyo University
name: Yousuke Nakai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Dong-Wan Seo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seo DW, Sherman S, Dua KS, Slivka A, Roy A, Costamagna G, Deviere J, Peetermans J, Rousseau M, Nakai Y, Isayama H, Kozarek R; Biliary SEMS During Neoadjuvant Therapy Study Group. Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: a randomized trial. Gastrointest Endosc. 2019 Oct;90(4):602-612.e4. doi: 10.1016/j.gie.2019.06.032. Epub 2019 Jul 2.