Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP

NCT02611453 | Unknown

• 1 other identifier: 18285
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Carbon dioxide (CO2) gas is widely used for luminal insufflation during endoscopic retrograde cholangiopancreatography (ERCP) of the biliary tract. While frequently observed during routine ERCP, there are few data on the topic of "air" or "CO2" cholangiography. Our primary aim is to compare radiographic cholangiograms in patients with biliary tract disease (from stones or strictures) during ERCP obtained by using carbon dioxide as the contrast medium vs. conventional iodinated contrast.

Conditions

Choledocholithiasis; Bile Duct Diseases; Bile Duct Carcinoma

Keywords

choledocholithiasis; ERCP; cholangiography; biliary stricture; bile ducts; carbon dioxide

Outcome Measures

Primary Outcomes (1)

• Technical success of CO2 cholangiography vs. iodinated contrast

  For choledocholithiasis: correct identification of the number and location of stones. For biliary strictures: correct identification of number and location of strictures.

  Intraprocedural/immediate (during ERCP)

Secondary Outcomes (2)

• Technical success of digital subtraction fluoroscopy vs. traditional fluoroscopy (while using CO2 as the contrast medium)

  Intraprocedural/immediate (during ERCP)

• Radiation usage/exposure of CO2 cholangiography using conventional fluoroscopy or digital subtraction fluoroscopy vs. iodinated contrast

  Intraprocedural/immediate (during ERCP)

Study Arms (1)

Single arm

EXPERIMENTAL

All patients will undergo endoscopic retrograde cholangiopancreatography (ERCP) that is indicated for suspected or confirmed choledocholithiasis or biliary strictures. "Air" contrast cholangiography using carbon dioxide gas will be performed with standard fluoroscopy and digital subtraction fluoroscopic image capture followed by routine cholangiography using iodinated contrast and standard fluoroscopy. Carbon dioxide (CO2) is routinely used in ERCP procedures and would flow into the biliary tree of patients at the time of ERCP, irrespective of this study's interventions. Digital subtraction image capture is a commercially available setting on certain fluoroscopy units that optimizes resolution with air or CO2 used as a contrast medium.

Other: "Air" contrast cholangiography using carbon dioxide gas

Interventions

"Air" contrast cholangiography using carbon dioxide gas OTHER

Carbon dioxide (CO2) will be injected into the biliary tree (which is already exposed to CO2 during routine ERCP) and images will be obtained by using fluoroscopy and digital subtraction imaging (a specific setting on certain fluoroscopy tables).

Single arm

Eligibility Criteria

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

You may qualify if:

• Patients 18 years of age or older
• Patients with choledocholithiasis, benign biliary strictures, malignant biliary strictures
• Biliary pathology suggested or confirmed by imaging with abdominal ultrasonography, CT scan, MRI/MRCP scan, or endoscopic ultrasonography (EUS)

You may not qualify if:

• Pregnancy (self reported)
• Presence of cholangitis before ERCP
• Prior history of surgery on the stomach or duodenum that precludes conventional ERCP or prior biliary tree surgery (not including cholecystectomy)
• Failure to selectively cannulate the bile duct
• Life expectancy less than 30 days
• Prisoners
• Patients unable to give consent

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (2)

• Zhang R, Zhao L, Liu Z, Wang B, Hui N, Wang X, Huang R, Luo H, Fan D, Pan Y, Guo X. Effect of CO2 cholangiography on post-ERCP cholangitis in patients with unresectable malignant hilar obstruction - a prospective, randomized controlled study. Scand J Gastroenterol. 2013 Jun;48(6):758-63. doi: 10.3109/00365521.2013.779745. Epub 2013 Apr 29.

  PMID: 23621432 BACKGROUND

• Pisello F, Geraci G, Modica G, Sciume C. Cholangitis prevention in endoscopic Klatskin tumor palliation: air cholangiography technique. Langenbecks Arch Surg. 2009 Nov;394(6):1109-14. doi: 10.1007/s00423-009-0548-y. Epub 2009 Aug 26.

  PMID: 19707784 BACKGROUND

MeSH Terms

Conditions

Choledocholithiasis; Bile Duct Diseases; Bile Duct Neoplasms

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Andrew Y. Wang, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: February 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)