Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

Completed · Not applicable

Conditions studied: Pancreatic Carcinoma

In brief

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.

Key facts

Study ID

NCT01774019

Run by

Boston Scientific Corporation

People needed

284

Starts

2013-02-20

Expected to finish

2021-12-13

Last updated by the study team

2023-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Standford University Medical Center — Stanford, California, United States
• Westmead Hospital — Westmead, New South Wales, Australia
• ULB Erasme Hospital — Brussels, Belgium
• Beijing Friendship Hospital — Beijing, China
• Xijing Hospital of Digestive Diseases Fourth Military Medical University — Xi'an, China
• Hopital Edouard Herriot — Lyon, France
• Queen Elizabeth Hospital — Kowloon, Hong Kong
• Prince of Wales Hospital, the Chinese University of Hong Kong — Shatin, Hong Kong
• Asian Institute of Gastroenterology — Hyderabad, India
• Fondazione Policlinico Universitario Agostino Gemelli — Rome, Italy
• Tokyo Medical University — Tokyo, Japan

Full record on ClinicalTrials.gov

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