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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Periampullary Cancer Complications of Surgical Procedures or Medical Care Disorder of Bile Duct Stent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plastic stents

Plastic stents are inserted by ERCP

Group Type ACTIVE_COMPARATOR

Plastic stents

Intervention Type DEVICE

Plastic stents were inserted by ERCP

Fully covered metal stents

Fully covered metal stents are inserted by ERCP

Group Type EXPERIMENTAL

Fully covered metal stents

Intervention Type DEVICE

Fully covered metal stents were inserted by ERCP

Interventions

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Fully covered metal stents

Fully covered metal stents were inserted by ERCP

Intervention Type DEVICE

Plastic stents

Plastic stents were inserted by ERCP

Intervention Type DEVICE

Other Intervention Names

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BONASTENT, Standard Sci Tech, Seoul, Korea Biliary stents, Cook Endoscopy, Winston-Salem, NC

Eligibility Criteria

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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%)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No