Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

NCT01774019 | Completed Results

• 2 other identifiers: 90914721E7059
• Study Type: interventional
• Target: 284
• Locations: 9 countries
• Sites: 11

Brief Summary

The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.

Conditions

Pancreatic Carcinoma

Keywords

Pancreatic; Periampullary Cancer; Preoperative Biliary Drainage; Resectable

Outcome Measures

Primary Outcomes (1)

• Number of Serious Pre-operative, Operative and Post-operative Adverse Events to 120 Days Post Randomization or to 30 Days Post Surgery, Whichever Comes Last

  The primary end point was all serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.

  120 to 150 days

Secondary Outcomes (4)

• Stent Placement Success

  Procedure

• Number of Patients With Biliary Re-interventions

  120 to 150 days

• Success Rate of Curative Intent Surgery

  4 weeks

• All-cause Mortality

  150 days

Study Arms (2)

WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

ACTIVE COMPARATOR

Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent)

Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

None (No Pre-Operative Biliary Drainage)

NO INTERVENTION

Patients in this group will not receive pre-operative biliary drainage with a study SEMS

Interventions

WallFlex™ Biliary RX Fully Covered/Uncovered Stent System DEVICE

WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study
• Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required)
• Biliary obstructive symptoms or signs
• Bilirubin level at/above 100 umol per liter (5.8 mg/dL)
• Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy
• Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum
• Patients deemed as resectable by pancreatic protocol CT or MRI
• Surgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion
• Surgery intent within 4 weeks
• Endoscopic and surgical treatment to be provided by same team

You may not qualify if:

• Biliary strictures caused by confirmed benign tumors
• Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers
• Surgically altered biliary tract anatomy, not including prior cholecystectomy
• Neoadjuvant chemotherapy for current malignancy
• Palliative indication due to reasons other than surgical candidate status
• Previous biliary drainage by ERCP/PTC
• Patients for whom endoscopic techniques are contraindicated
• Participation in another investigational trial within 90 days
• Pregnancy

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (11)

Standford University Medical Center

Stanford, California, 94305, United States

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

ULB Erasme Hospital

Brussels, 1070, Belgium

Location

Beijing Friendship Hospital

Beijing, China

Location

Xijing Hospital of Digestive Diseases Fourth Military Medical University

Xi'an, China

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Queen Elizabeth Hospital

Kowloon, Hong Kong

Location

Prince of Wales Hospital, the Chinese University of Hong Kong

Shatin, Hong Kong

Location

Asian Institute of Gastroenterology

Hyderabad, 500 082, India

Location

Fondazione Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Location

Tokyo Medical University

Tokyo, 160-0023, Japan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Andrea Burbage
• Organization: Boston Scientific

Andrea.Burbage@bsci.com

15086834387

Study Officials

• Guido Costamagna, MD

  Fondazione Policlinico Universitario Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: January 23, 2013
• Study Start: February 20, 2013
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: April 10, 2023
• Results First Posted: April 10, 2023

Record last verified: 2023-04

Locations

CN (2); HK (2); IN (1); FR (1); JP (1); BE (1); AU (1); US (1); IT (1)