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

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

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.

Study Overview

• Status: Completed
• Conditions: Periampullary Cancer; Disorder of Bile Duct Stent; Complications of Surgical Procedures or Medical Care
• Intervention / Treatment: Device: Plastic stents; Device: Fully covered metal stents

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejun, Korea, Republic of, 302-799
    • Daejun Eulji University Hospital
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Gyeonggi-do
    • Koyang, Gyeonggi-do, Korea, Republic of, 411-706
      • Inje University Ilsan Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Plastic stents; Plastic stents are inserted by ERCP	Device: Plastic stents; Plastic stents were inserted by ERCP; Other Names: Biliary stents, Cook Endoscopy, Winston-Salem, NC
Experimental: Fully covered metal stents; Fully covered metal stents are inserted by ERCP	Device: Fully covered metal stents; Fully covered metal stents were inserted by ERCP; Other Names: BONASTENT, Standard Sci Tech, Seoul, Korea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events related to the stent insertion	Primary outcome parameter is adverse events related to the stent insertion includes post-ERCP pancreatitis, cholecystitis, cholangitis, bowel perforation or hemorrhage.	up to 4weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-intervention rate	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.	up to 4weeks
Hospital stay	Hospital stay is defined as the period between the date of stent insertion and that of discharge.	up to 1months
Surgical outcomes	Surgical outcomes include the complete resection rate, complication rates related to surgery or the amount of transfusion during surgery.	up to 1months

Collaborators and Investigators

• Sponsor: Inje University
• Investigators: Principal Investigator: Tae Jun Song, MD, PhD, Department of Internal Medicine, Inje University Ilsan Paik Hospital, Koyang, Korea

Publications and helpful links

General Publications

• Song TJ, Lee JH, Lee SS, Jang JW, Kim JW, Ok TJ, Oh DW, Park DH, Seo DW, Lee SK, Kim MH, Kim SC, Kim CN, Yun SC. Metal versus plastic stents for drainage of malignant biliary obstruction before primary surgical resection. Gastrointest Endosc. 2016 Nov;84(5):814-821. doi: 10.1016/j.gie.2016.04.018. Epub 2016 Apr 22.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: February 5, 2013
• First Submitted That Met QC Criteria: February 8, 2013
• First Posted (Estimate): February 12, 2013

Study Record Updates

• Last Update Posted (Estimate): August 4, 2015
• Last Update Submitted That Met QC Criteria: August 2, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: self-expandable metal stent; plastic stent
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases
• Other Study ID Numbers: IB-1210-034