Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

Pancreatic Carcinoma Clinical Trial

Official title:

Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774019
• Other study ID #: 90914721
• Secondary ID: E7059
• Status: Completed
• Phase: N/A
• Start date: February 20, 2013
• Est. completion date: December 13, 2021

Study information

• Verified date: April 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Pancreatic Carcinoma
• Pancreatic Neoplasms

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  China,  France,  Hong Kong,  India,  Italy,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stent Placement Success	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)	Procedure
Secondary	Number of Patients With Biliary Re-interventions	Count of patients with biliary interventions after baseline	120 to 150 days
Secondary	Success Rate of Curative Intent Surgery	This is the number of patients that had successful resection	4 weeks
Secondary	All-cause Mortality	Mortality which occurs within 150 days of baseline	150 days