Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

AdventHealth

Status: Completed

Conditions: Pancreatic Cancer; Obstructive Jaundice

Treatments: Procedure: Stent Dysfunction; Procedure: Complications

Study type: Interventional

Funder types: Other

Identifiers

NCT01675908

356090

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Metal stent

Active Comparator group

Description:

Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated.

Treatment:

Procedure: Stent Dysfunction

Procedure: Complications

Plastic Stent

Active Comparator group

Description:

At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.

Treatment:

Procedure: Stent Dysfunction

Procedure: Complications