Clinical trial NCT01789502: Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage
Official title: Are Fully Covered Metal Stents Superior to Plastic Stents for Preoperative Biliary Decompression in Malignant Distal Bile Duct Obstruction?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periampullary Cancer
Complications of Surgical Procedures or Medical Care
Disorder of Bile Duct Stent
Keywords: self-expandable metal stent; plastic stent
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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%)

Primary outcomes:
measure: Adverse events related to the stent insertion
timeFrame: up to 4weeks
Secondary outcomes:
measure: Re-intervention rate
timeFrame: up to 4weeks
measure: Hospital stay
timeFrame: up to 1months
measure: Surgical outcomes
timeFrame: up to 1months
Other outcomes:
Locations:
city: Koyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Daejun
country: Korea, Republic of
facility: Daejun Eulji University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Department of Internal Medicine, Inje University Ilsan Paik Hospital, Koyang, Korea
name: Tae Jun Song, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.