Endoscopic Therapy of Malignant Bile Duct Strictures

NCT01543607 | Terminated Results DMC

• 1 other identifier: 11-405
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with malignant bile duct stenosis have poor prognosis and most of the patients are not good candidate for surgery at the time of diagnosis. Placement of the stent is the palliative care for these patients. However over 50% of the stents get blocked within 6-8 months. Use of the radiofrequency ablation before the stent placement may improve stent patency. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent. The investigators are looking to see how safe and feasible RFA (Radiofrequency ablation) catheter is in patient with malignant bile duct stenosis.

Conditions

Obstruction of Biliary Tree; Biliary Tract Cancer; Biliary Tract Neoplasms

Keywords

Bile duct; Cholangiocarcinoma; Bile duct stenosis; Malignant bile duct obstruction; Malignant bile duct stricture; Radiofrequency ablation; RFA; Endoscopic RFA catheter; EndoHPB

Outcome Measures

Primary Outcomes (1)

• Safety: Number of Bile Leak After RFA Procedure

  Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)

  2 years

Secondary Outcomes (2)

• Feasibility: Ease of the Radiofrequency Ablation Catheter Placement

  2 years

• Effectiveness: Change From Baseline in Bile Duct Diameter.

  2 years

Study Arms (1)

Treatment

EXPERIMENTAL

Radiofrequency ablation catheter

Device: Radiofrequency ablation catheter (Habib EndoHBP)

Interventions

Radiofrequency ablation catheter (Habib EndoHBP) DEVICE

Catheter placement into bile duct

Also known as: Habib EndoHBP

Treatment

Eligibility Criteria

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

You may qualify if:

• Documented malignant biliary obstruction requiring ERCP guided stenting

You may not qualify if:

• Coagulopathy (INR \> 2.0 or PTT \> 100 sec or platelet count \< 50,000)
• Evidence of high-grade symptomatic duodenal obstruction
• Poor performance status
• Active suppurative cholangitis
• Complex stenoses will not be eligible for the trial
• Patients without access to duodenum or ampulla are not candidates for ERCP and stenting
• Candidates for a Whipple resection
• Patients who do not speak English

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

Related Links

• Study information

MeSH Terms

Conditions

Biliary Tract Neoplasms; Cholangiocarcinoma

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: William R. Brugge
• Organization: Mass. General Hospital

wbrugge@partners.org

617-724-0578

Study Officials

• William R Brugge, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: March 5, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 24, 2017
• Results First Posted: April 24, 2017

Record last verified: 2017-03

Locations

US (1)