Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer (NCT01774019) | Clinical Trial Compass
CompletedNot Applicable
Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
United States, Australia, Belgium284 participantsStarted 2013-02-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 …
What they're measuring
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