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

Periampullary Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789502
• Other study ID #: IB-1210-034
• Status: Completed
• Phase: N/A
• First received: February 5, 2013
• Last updated: August 2, 2015
• Start date: January 2012
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Fully covered metal stents
Fully covered metal stents were inserted by ERCP
• Plastic stents
Plastic stents were inserted by ERCP

Locations

Country	Name	City	State
Korea, Republic of	Daejun Eulji University Hospital	Daejun
Korea, Republic of	Inje University Ilsan Paik Hospital	Koyang	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	Hospital stay	Hospital stay is defined as the period between the date of stent insertion and that of discharge.	up to 1months	No
Secondary	Surgical outcomes	Surgical outcomes include the complete resection rate, complication rates related to surgery or the amount of transfusion during surgery.	up to 1months	Yes