Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01675908

Enrollment

Registered

2012-08-30

Start date

2012-08-22

Completion date

2019-08-21

Last updated

2022-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Jaundice, Pancreatic Cancer

Brief summary

Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression

Detailed description

Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.

Interventions

PROCEDUREStent Dysfunction

Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.

PROCEDUREComplications

Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with pancreatic cancer and mass in the head of pancreas causing jaundice. 2. Patients 19 yrs of age and older 3. Serum bilirubin \> 2mg/dl 4. CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin).

Exclusion criteria

1. Karnofsky score \< 60 2. Prior (ERCP or PTC) attempts at biliary decompression for the same indication 3. Tumor-related gastric outlet obstruction (vomiting and oral intake of \< 1L/day) 4. Ongoing or planned neoadjuvant therapy 5. Cholangitis at presentation or coagulopathy needing reversal medication 6. Post-surgical anatomy 7. Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum 8. Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).

Design outcomes

Primary

Measure	Time frame	Description
Complications related to stent dysfunction	30 days	Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.

Secondary

Measure	Time frame	Description
Procedural complications	30 days	This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026