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Are Fully Covered Metal Stents Superior to Plastic Stents for Preoperative Biliary Decompression in Malignant Distal Bile Duct Obstruction?

20 Years
Open (Enrolling)
Biliary Tract Cancer, Complications of Surgical Procedures or Medical Care, Disorder of Bile Duct Stent

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Trial Information

Are Fully Covered Metal Stents Superior to Plastic Stents for Preoperative Biliary Decompression in Malignant Distal Bile Duct Obstruction?

Pancreaticoduodenectomy (Whipple's procedure) is curative option in periampullary tumor.
Preoperative endoscopic retrograde cholangiopancreatog-raphy (ERCP) is usually undertaken in
patients with resectable disease to relieve biliary obstruction, which is thought to impair
immune response, clotting, and other functions that impact intraoperative and postoperative
outcomes. Despite conflicting data pertaining to preoperative biliary drainage, ERCP with
biliary stenting has become standard practice in patients with periampullary malignancies.
In a recent multicenter randomized trial, patients who underwent preoperative biliary
drainage had a 74% rate of complications compared with 39% for those who directly underwent
surgery without preoperative biliary drainage. In this trial, however, all patients
underwent placement of plastic stents. In ERCP, self-expandable metal stent are being
increasingly placed for palliation of malignant biliary obstruction. Compared with plastic
stents, self-expandable metal stents have large caliber and have demonstrated longer patency
duration. Even in patients with resectable malignant disease, self-expandable metal stents
which are placed below the level of transection may not impair technical outcomes at surgery
and can be safely removed along with the surgical specimen.

This prospective study is designed to compare the re-intervention rate, the incidence of
stent-related adverse events, the effectiveness of biliary drainage, surgical outcomes and
hospital stays in patients with periamupllary tumors who are undergone with self-expandable
metal stents or plastic stents placement for preoperative biliary drainage

Inclusion Criteria:

- Older than 20 years old of age

- Obstructive jaundice due to distal common bile duct cancer and pancreas head cancer

- No evidence of distant metastases or locally advanced tumor

Exclusion Criteria:

- Unresectable stage of cancer

- Preoperative gastric operation that preclude ERCP (total gastrectomy and subtotal
gastrectomy with B-II anastomosis)

- Severe gastric outlet obstruction or duodenal obstruction

- Severe comorbidity (Karnofsky<50%)

Type of Study:


Study Design:

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

Outcome Measure:

Re-intervention rate

Outcome Description:

Primary outcome parameter is re-intervention rate from stent insertion to surgery. Re-intervention is defined as endoscopic retrograde cholangiopancreatography or percutaneous transhepatic biliary drainage procedures which are required to achieve adequate preoperative biliary drainage after stent insertion.

Outcome Time Frame:

up to 4weeks

Safety Issue:


Principal Investigator

Tae Jun Song, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Internal Medicine, Inje University Ilsan Paik Hospital, Koyang, Korea


Korea: Institutional Review Board

Study ID:




Start Date:

May 2011

Completion Date:

May 2013

Related Keywords:

  • Biliary Tract Cancer
  • Complications of Surgical Procedures or Medical Care
  • Disorder of Bile Duct Stent
  • Bile Duct Diseases
  • Cholestasis
  • Biliary Tract Neoplasms