Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy

Randomized Trial Comparing Next Generation Fluoroscopy System With Conventional Fluoroscopy System in Fluoroscopy-guided Endoscopic Procedures

Fluoroscopy is an integral part of both basic and advanced gastrointestinal endoscopy procedures. Given the risks of radiation exposure and inherent limitations of preventive measures, there is a need for additional effective protective methods.

In this randomized trial, we will be comparing radiation exposure between a next generation fluoroscopy system and conventional fluoroscopy system during fluoroscopy-guided endoscopic procedures.

Fluoroscopy is an integral part of both basic and advanced gastrointestinal endoscopy procedures such as stricture dilation, enteral feeding tube placement, double balloon enteroscopy, endoscopic retrograde cholangiopancreatography (ERCP) and interventional endoscopic ultrasound (EUS). Use of fluoroscopy exposes patients, gastroenterologists and endoscopy support personnel to ionizing radiation. While exposure to high-dose-rate ionizing radiation has been shown to be associated with genomic instability, data indicate that exposure to even low-dose radiation, typically utilized for diagnostic imaging, may be associated with an increase in cancer mortality. The lifetime cancer risk is based on the effective dose (ED) of radiation received, which is measured in sieverts (Sv).

In a recent study conducted at a high-volume endoscopy center, the estimated dose equivalent at eye level was estimated to be 126 mSv for an endoscopist performing 500 therapeutic ERCPs per year. Consequently, exposure to ionizing radiation is considered a health hazard to patients as well as gastroenterologists and endoscopy support personnel. As such, appropriate measures to keep radiation exposure as low as reasonably achievable (ALARA) should be implemented. Professional societies such as the American Society for Gastrointestinal Endoscopy (ASGE) and the European Society of Gastrointestinal Endoscopy (ESGE) have published guidelines on radiation safety.

The two main sources of radiation during fluoroscopic procedures are the incident beam, which is the main source of radiation to the patient, and scatter radiation that emanates from the patient's body, which is the main source of radiation to individuals around the patient. Larger the radiation dose to the patient, the greater the scatter. Attempts to minimize radiation exposure include decreasing fluoroscopy time, using pulsed fluoroscopy, increasing the distance from radiation source, shielding, limiting magnification, using collimation, altering x-ray beam angulation, use of artificial intelligence fluoroscopy system, and avoiding use of C-arm units or over-couch x-ray systems. Use of personal protective equipment also reduces occupational exposure; however, many gastroenterologists performing ERCP do not routinely wear optimal protective clothing.

Given the risks of radiation exposure and inherent limitations of the preventive measures outlined, there is a need for additional effective protective methods that are easy to implement. The Soteria E-View system is an FDA-approved, next generation fluoroscopy system that is new to Orlando Health, for use in fluoroscopy-guided endoscopic procedures per standard of care (Omega Medical Imaging, Orlando Florida, USA). The system has been designed to minimize radiation exposure to patients and medical personnel by integrating second-generation artificial intelligence framework (for improved system performance and responsiveness), upgraded C-arm and tables (with enhanced lead flaps along the edges of the table), fluoroless positioning (to reduce reliance on fluoroscopy for positioning steps), reducing frame rate, and robotic system design (to enable automated positioning and movement).

The objective of the study is to compare the radiation exposure and scatter effect between the next generatoin fluoroscopy system and conventional fluoroscopy system during fluoroscopy-guided endoscopic procedures.

Inclusion Criteria:

• Age ≥ 18 years
• Patients undergoing fluoroscopy-guided endoscopic procedure
• Physicians and anesthesia staff participating in endoscopic procedures

Exclusion Criteria:

• Age < 18 years
• Pregnancy