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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome Time Frame:

120 days

Safety Issue:

Yes

Principal Investigator

Guido Costamagna, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universita Cattolica del Sacro Cuore

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CDM00047339

NCT ID:

NCT01774019

Start Date:

February 2013

Completion Date:

May 2015

Related Keywords:

  • Pancreatic Carcinoma
  • Pancreatic
  • Periampullary Cancer
  • Preoperative Biliary Drainage
  • Resectable
  • Carcinoma
  • Pancreatic Neoplasms

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