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Completed

NCT Number: NCT02238847

Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CUB Hopital Erasme, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

Device

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

Primary outcomes

  1. Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms

    Time frame: 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)

    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.

Secondary outcomes

  1. Procedure-related or Stent-related Serious Adverse Events

    Time frame: From stent placement procedure up to one year after stent placement procedure

    Serious adverse events related to the stent placement procedure or to the stent

  2. Technical Success

    Time frame: During the Stent Placement Procedure

    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.

  3. Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention

    Time frame: 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

    The ability to complete neoadjuvant therapy as intended without stent-related interruptions of neoadjuvant therapy and without biliary reintervention

  4. Number of Participants With Stent Migration

    Time frame: At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS

    The number of participants with stent migration

  5. Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure

    Time frame: At the time of curative intent surgery (CIS) (median 110 days to CIS)

    The subjective impression of the surgeon that the presence of a self-expanding metal stent (SEMS) may have impacted the surgical procedure.

  6. For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement

    Time frame: From stent placement to one year after stent placement for participants not undergoing curative intent surgery

    For participants not undergoing curative intent surgery, sustained biliary drainage from stent placement to one year after stent placement.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2014
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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