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Endoscopic Therapy of Malignant Bile Duct Strictures: A Pilot Study

18 Years
Open (Enrolling)
Obstruction of Biliary Tree, Biliary Tract Cancer, Biliary Tract Neoplasms

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Trial Information

Endoscopic Therapy of Malignant Bile Duct Strictures: A Pilot Study

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.

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

- Candidates for a Whipple resection

- Patients who do not speak English

Type of Study:


Study Design:

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

Outcome Measure:

Safety: Number of bile leak after RFA procedure

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

William R Brugge, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

February 2012

Completion Date:

June 2014

Related Keywords:

  • Obstruction of Biliary Tree
  • Biliary Tract Cancer
  • Biliary Tract Neoplasms
  • Bile duct
  • Cholangiocarcinoma
  • Bile duct stenosis
  • Malignant bile duct obstruction
  • Malignant bile duct stricture
  • Radiofrequency ablation
  • RFA
  • Endoscopic RFA catheter
  • EndoHPB
  • Biliary Tract Neoplasms
  • Neoplasms
  • Cholestasis
  • Constriction, Pathologic



Massachusetts General Hospital Boston, Massachusetts  02114-2617