Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage

Inje University

Status

Completed

Conditions

Complications of Surgical Procedures or Medical Care

Periampullary Cancer

Disorder of Bile Duct Stent

Treatments

Device: Plastic stents

Device: Fully covered metal stents

Study type

Interventional

Funder types

Other

Identifiers

NCT01789502

IB-1210-034

Details and patient eligibility

About

This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays.

Full description

Pancreaticoduodenectomy 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 incidence of stent-related adverse events, the re-intervention rate, 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

Enrollment

86 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Older than 20 years old of age
Obstructive jaundice due to common bile duct cancer and pancreas head cancer, or ampullary 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%)