Endoscopic Therapy of Malignant Bile Duct Strictures

Biliary Tract Cancer Clinical Trial

Official title:

Endoscopic Therapy of Malignant Bile Duct Strictures: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01543607
• Other study ID #: 11-405
• Status: Terminated
• Phase: N/A
• First received: February 15, 2012
• Last updated: February 14, 2014
• Start date: February 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 catheter is in patient with malignant bile duct stenosis.

Description:

As part of medical care subjects will be undergoing an endoscopic procedure (ERCP) in order to evaluate and stent a bile duct blockage. During the ECRP and just prior to the stent placement subjects will undergo the placement of a radiofrequency ablation catheter into the bile duct blockage. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent; after the radiofrequency ablation, stent will be placed. Three days after the procedure subjects will receive a phone call from the research coordinator to check any adverse or unwanted effects of the treatment. The study procedure (radiofrequency ablation) takes place over 10 minutes during ERCP. The subjects will undergo routine follow up for their medical problems. No follow up visits are required as part of the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented malignant biliary obstruction requiring ERCP guided stenting

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Obstruction of Biliary Tree

Intervention

Device:
• Radiofrequency ablation catheter (Habib EndoHBP)
Catheter placement into bile duct

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Feasibility: Ease of the radiofrequency Ablation Catheter Placement	Determine the feasibility of radiofrequency ablation catheter placement across malignant strictures with using a subjective scale, 0 is being impossible to place the catheter and 10 is being very easy to place the catheter.	2 years	No
Secondary	Effectiveness: Change from Baseline in bile duct diameter.	Effectiveness will be determined by change in stricture diameter (increase or decrease) after RFA procedure.	2 years	No

External Links

•   Study information