Clinical trial NCT01774019: Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
Official title: Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Carcinoma
Keywords: Pancreatic
Periampullary Cancer
Preoperative Biliary Drainage
Resectable
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-01-23
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 120 to 150 days
Secondary outcomes:
measure: Stent Placement Success
timeFrame: Procedure
measure: Number of Patients With Biliary Re-interventions
timeFrame: 120 to 150 days
measure: Success Rate of Curative Intent Surgery
timeFrame: 4 weeks
measure: All-cause Mortality
timeFrame: 150 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Standford University Medical Center
state: California
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brussels
country: Belgium
facility: ULB Erasme Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases Fourth Military Medical University
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital, the Chinese University of Hong Kong
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Tokyo
country: Japan
facility: Tokyo Medical University
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli
name: Guido Costamagna, MD
role: PRINCIPAL_INVESTIGATOR
References: