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

NCT04937322 | Completed

• 1 other identifier: 003.GID.2016.D
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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 gallbladder 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 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

Conditions

Bile Duct Cancer; Pancreas Cancer

Keywords

ERCP, endoscopic retrograde cholangiopancreatography; radiofrequency ablation; pancreatico-biliary disorders

Outcome Measures

Primary Outcomes (2)

• Measurement of Bile Duct Stricture Diameter

  Change from Baseline in Bile Duct Stricture Diameter

  June 2011 through June 2021

• Adverse Events

  Number of Participants with Adverse Events, Type of adverse events, frequency and intensity

  June 2011 through June 2021

Secondary Outcomes (2)

• survival duration

  June 2011 through June 2023

• stent occlusion-free duration

  June 2011 through June 2023

Study Arms (1)

Interventional Endoscopy procedures

All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations for pancreatico-biliary disorders since June 2011 and extending forward through June 2023.

Procedure: Interventional Endoscopy procedures

Interventions

Interventional Endoscopy procedures PROCEDURE

• All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders.

Interventional Endoscopy procedures

Eligibility Criteria

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

Study Population

All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders.

You may qualify if:

• All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders.
• Above 18 years of age.

You may not qualify if:

• Any patient who has not undergone interventional endoscopy with RFA and stent insertion(s).
• Below 18 years of age

Sponsors & Collaborators

• Methodist Health System: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Bile Duct Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Prashant Kedia, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: June 24, 2021
• Study Start: January 25, 2016
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: June 2011 through June 2023

Locations

US (1)