Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry

NCT ID: NCT01439698

Last Updated: 2017-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2018-12-30

Brief Summary

The objective of this protocol is to establish a multicenter registry to evaluate the impact of radiofrequency ablation in the management of patients with pancreatico-biliary disorders including malignancies.

Detailed Description

Bile duct cancer and pancreatic cancer are cancers that cannot be surgically removed. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gall bladder and pancreas to the small intestine. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed during which a tube with a tiny camera attached is inserted through the subject's mouth and advanced to a place in the small intestine where the bile duct empties. Through this scope the doctor enlarges the ducts with tiny balloons and places plastic or metal stents (straws) that help keep the bile ducts open so they can drain properly. However, due to the cancer, the stents are blocked eventually.

The purpose of this registry is to record information and evaluate the impact of radiofrequency ablation (RFA) of endoscopic radiofrequency ablation (RFA) probes in improving the management of bile duct cancer or pancreatic cancer by ablating the tissue in the bile duct(s) before the stent(s) are implanted. By using radiofrequency (RF) energy to heat the tissue in the duct(s) prior to stent(s) insertion, the surrounding tissue becomes coagulated and this may delay tumor growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent implantation(s). The registry will evaluate the efficacy and safety of RFA procedures conducted for pancreatico-biliary disorders.

The safety and efficacy of various radio frequency ablation probes have been assessed in a series of studies. This multi-center registry has been initiated:

1. To document the immediate and post procedure clinical performance of radio frequency ablation in a 'real world' patient population requiring stent implantation for pancreaticobiliary disorders.

2. To assess the immediate and 6 months post procedure adverse event rate in patients.

3. To assess the impact of RFA on the life expectancy of patients suffering from pancreaticobiliary malignancies.

Conditions

Cholangiocarcinoma; Pancreatic Cancer; Bile Duct Cancer; Biliary Stricture; Bile Duct Obstruction

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

RFA for Pancreatico-biliary disorders

Subjects who will receive radiofrequency ablation for pancreatico-biliary disorders, including malignancies.

Radio Frequency ablation Probe

Intervention Type: DEVICE

Any probe that can conduct radiofrequency ablation within biliary ducts.

Interventions

Radio Frequency ablation Probe

Any probe that can conduct radiofrequency ablation within biliary ducts.

Intervention Type: DEVICE

Other Intervention Names

ENDOHPB

Eligibility Criteria

Inclusion Criteria

• Patients who have undergone RFA for pancreaticobiliary disorders
• Above 18 years of age

Exclusion Criteria

• Patients who have not undergone RFA
• Below 18 years of age

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Michel Kahaleh

Chief, Advanced Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel Kahaleh, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Weill Cornell Medical College

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michel Kahaleh, MD

Role: CONTACT

mik9071@med.cornell.edu

646-962-4000

Monica R Gaidhane, MD, MPH

Role: CONTACT

mog2012@med.cornell.edu

646-962-4796

Facility Contacts

William R Brugge, MD

Role: primary

WBRUGGE@PARTNERS.ORG

617-724-0578

Michel Kahaleh, MD

Role: primary

mik9071@med.cornell.edu

646-962-4000

Monica R Gaidhane, MD, MPH

Role: backup

mog2012@med.cornell.edu

646 962 4797

References

Sharaiha RZ, Natov N, Glockenberg KS, Widmer J, Gaidhane M, Kahaleh M. Comparison of metal stenting with radiofrequency ablation versus stenting alone for treating malignant biliary strictures: is there an added benefit? Dig Dis Sci. 2014 Dec;59(12):3099-102. doi: 10.1007/s10620-014-3264-6. Epub 2014 Jul 18.

Reference Type: RESULT

PMID: 25033929 (View on PubMed)

Other Identifiers

1108011875

Identifier Type: -

Identifier Source: org_study_id