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Completed

NCT Number: NCT01789502

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

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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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daejun Eulji University Hospital, Daejun, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Fully covered metal stents

Device

Fully covered metal stents were inserted by ERCP

Other names: BONASTENT, Standard Sci Tech, Seoul, Korea

Plastic stents

Device

Plastic stents were inserted by ERCP

Other names: Biliary stents, Cook Endoscopy, Winston-Salem, NC

Primary outcomes

  1. Adverse events related to the stent insertion

    Time frame: up to 4weeks

    Primary outcome parameter is adverse events related to the stent insertion includes post-ERCP pancreatitis, cholecystitis, cholangitis, bowel perforation or hemorrhage.

Secondary outcomes

  1. Re-intervention rate

    Time frame: up to 4weeks

    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.

  2. Hospital stay

    Time frame: up to 1months

    Hospital stay is defined as the period between the date of stent insertion and that of discharge.

  3. Surgical outcomes

    Time frame: up to 1months

    Surgical outcomes include the complete resection rate, complication rates related to surgery or the amount of transfusion during surgery.

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Feb 12, 2013
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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