Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

AdventHealth46 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Jaundice Pancreatic Cancer

Interventions

Stent DysfunctionPROCEDURE

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

ComplicationsPROCEDURE

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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).

Locations (1)

Florida Hospital

Orlando, Florida, United States

Outcomes

Primary Outcomes

Complications related to stent dysfunction

Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.

Time frame: 30 days

Secondary Outcomes

Procedural complications

This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage.

Time frame: 30 days

Data from ClinicalTrials.gov

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