Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction

NCT01038713 | Completed Results DMC

• 1 other identifier: 2009-01
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, randomized, unblinded study to compare the rate of occlusion of plastic, uncovered metal, or fully covered metal biliary stents in patient's with surgically resectable disease or those undergoing neoadjuvant chemoradiotherapy. We will also compare occlusion rates between uncovered metal and fully covered metal biliary stents in those patients determined to have surgically unresectable disease.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction.

  Number of participants who developed stent occlusion, attempted surgical resection or death following stent placement

  Time of stent occlusion, attempted surgical resection or patient death to 300 days

Secondary Outcomes (4)

• Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement.

  Costs measured up to 500 days

• Determine the Days of Hospitalization Following Stent Placement

  From stent placement up to 500 days post stent

• Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents

  Time from stent placement to 500 days

• Assess Rate of Acute Cholecystitis Associated With Each Type of Stent

  time from stent placement to 500 days

Study Arms (5)

Resectable; plastic stent

EXPERIMENTAL

Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.

Device: Biliary stent placement

Resectable; uncovered metal stent

EXPERIMENTAL

Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.

Device: Biliary stent placement

Resectable; fully covered metal stent

EXPERIMENTAL

Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.

Device: Biliary stent placement

Unresectable; uncovered metal stent

EXPERIMENTAL

Patients determined to have surgically non-resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.

Device: Biliary stent placement

Unresectable; fully covered metal stent

EXPERIMENTAL

Patients determined to have surgically non-resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.

Device: Biliary stent placement

Interventions

Biliary stent placement DEVICE

Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.

Resectable; fully covered metal stent; Resectable; plastic stent; Resectable; uncovered metal stent; Unresectable; fully covered metal stent; Unresectable; uncovered metal stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female older than 18
• Capable of providing written informed consent
• Presenting with malignant biliary obstruction requiring biliary drainage either from proximal pancreatic malignancy, metastatic disease, or intrinsic biliary malignancy. The patient must have an established diagnosis of underlying malignancy, and surgical resectability status established, prior to enrollment in this study.

You may not qualify if:

• Inability to undergo conscious sedation or monitored anesthesia
• Prior pancreatico-biliary surgery
• Evidence of acute cholecystitis at time of endoscopic procedure
• Intraluminal filling defect requiring endoscopic removal prior to stent placement
• Inability to provide written informed consent
• Malignancy not verified prior to stent placement

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• Gardner TB, Spangler CC, Byanova KL, Ripple GH, Rockacy MJ, Levenick JM, Smith KD, Colacchio TA, Barth RJ, Zaki BI, Tsapakos MJ, Gordon SR. Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial. Gastrointest Endosc. 2016 Sep;84(3):460-6. doi: 10.1016/j.gie.2016.02.047. Epub 2016 Mar 10.

  PMID: 26972022 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Timothy Gardner
• Organization: Dartmouth-Hitchcock Medical Center

timothy.b.gardner@hitchcock.org

603-650-6472

Study Officials

• Timothy Gardner, M.D.

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 24, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 23, 2016
• Results First Posted: June 22, 2016

Record last verified: 2016-06

Locations

US (1)