Clinical Trial: Echo Detection of Endoscopic Retrograde Cholangiopancreatography (ERCP) Air Embolus

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Echocardiographic Surveillance of Patients Undergoing Scheduled Endoscopic Retrograde Cholangiopancreatography for the Presence of Intracardiac Air Embolus

Brief Summary: Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopy technique to visualize and evaluate the pancreatic and biliary systems. It has been reported that rare instances of air embolus have been found associated with the performance of an ERCP and many of these events are fatal. It is our proposal to use transthoracic echocardiography to continuously evaluate for the presence of intra-cardiac air secondary to ERCP venous air embolism and attempt to quantify the incidence of this complication and any potential patient factors that might increase the risk of this complication.

Detailed Summary:

Endoscopic Retrograde Cholangiopancreatography (ERCP) is commonly used in the diagnosis and treatment of biliary and pancreatic disease. There are case reports presented in the literature demonstrating adverse and often fatal events following air embolization associated with the performance of ERCP. The frequency of air embolus is extremely rare with the exact incidence unknown. In recent years the utilization of echocardiography to evaluate individuals with hemodynamic instability has led to the discovery of intracardiac air embolus seen in those individuals that demonstrated changes in either hemodynamic parameters or capnography values. There exists proposed mechanisms for the translocation of air from the foregut to the systemic venous circulation but not one of these mechanisms has yet been validated. Some proposed mechanisms include either through intrahepatic mechanisms where air crosses from the biliary tract to hepatic venules or potentially from the foregut into the portal vein and through shunt vessels into systemic venous circulation.

The exact frequency of air embolus is likely higher than the incidence of fatal or near-fatal complications reported in the literature. Individuals that had the best outcomes were usually intubated and had capnography to demonstrate a change suggestive of air embolus prior to significant hemodynamic changes.1 As this phenomenon has not previously been well described, it is possible that other patients suffer significant air embolus with myocardial or cerebral ischemic sequelae that were not recognized because echocardiography was not used as an early tool for evaluation of hemodynamically unstable patients. It is also possible that there are a number of patients that may suffer a venous air embolus from ERCP that is sub-clinical and therefore not causing enough change in cardiac function to alter either hemodynamic parameters or
Sponsor: University of Nebraska

Current Primary Outcome: Incidence of ERCP associated air embolism [ Time Frame: Participation will be for one day, during the time of the ERCP ]

Patients who are scheduled for ERCP as part of their routine care will be assessed for the presence of air embolus, both clinically relevant (in the form of hemodynamic changes) and those situations where air is identified and does not appear to have a clinical effect. This is scheduled to occur over one day's time and only during the procedure are we planning on performing the echo for surveillance of air emboli.


Original Primary Outcome: Same as current

Current Secondary Outcome: Risk Factors associated with ERCP air embolus [ Time Frame: Participation will be for one day, during the time of the ERCP ]

If it is found that there is a significant number of individuals that are found to have ERCP associated air embolus it would be a secondary goal to attempt to identify patient factors that might confer additional risk of air embolus to the patient.


Original Secondary Outcome: Same as current

Information By: University of Nebraska

Dates:
Date Received: August 8, 2011
Date Started: March 2012
Date Completion:
Last Updated: November 30, 2015
Last Verified: November 2015