Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

Not Applicable

Completed

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

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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System	WallFlex™ Biliary RX Fully Covered/Uncovered Stent System	Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent)

Primary Outcome Measures

Name	Time	Method
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	120 to 150 days	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Biliary Re-interventions	120 to 150 days	Count of patients with biliary interventions after baseline
Stent Placement Success	Procedure	Stent placement success: ability to deploy the stent in satisfactory position across the stricture (For patients who are randomized to biliary drainage with a metal stent)
All-cause Mortality	150 days	Mortality which occurs within 150 days of baseline
Success Rate of Curative Intent Surgery	4 weeks	This is the number of patients that had successful resection

Locations (11): Asian Institute of Gastroenterology
🇮🇳
Hyderabad, India
Queen Elizabeth Hospital
🇭🇰
Kowloon, Hong Kong
Standford University Medical Center
🇺🇸
Stanford, California, United States
ULB Erasme Hospital
🇧🇪
Brussels, Belgium
Beijing Friendship Hospital
🇨🇳
Beijing, China
Hopital Edouard Herriot
🇫🇷
Lyon, France
Xijing Hospital of Digestive Diseases Fourth Military Medical University
🇨🇳
Xi'an, China
Prince of Wales Hospital, the Chinese University of Hong Kong
🇭🇰
Sha Tin, Hong Kong
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹
Rome, Italy
Tokyo Medical University
🇯🇵
Tokyo, Japan
Westmead Hospital
🇦🇺
Westmead, New South Wales, Australia