Trial Outcomes & Findings for Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions. (NCT NCT02791659)

NCT ID: NCT02791659

Last Updated: 2017-05-30

Results Overview

The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 55 participants
• Primary outcome timeframe: Immediate after procedure
• Results posted on: 2017-05-30

Participant Flow

Participant milestones

Measure	Left Lateral Decubitus In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality. Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.	Prone In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality. Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.
Overall Study STARTED	27	28
Overall Study COMPLETED	27	27
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Left Lateral Decubitus In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality. Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.	Prone In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality. Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.
Overall Study Protocol Violation	0	1

Baseline Characteristics

Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions.

Baseline characteristics by cohort

Measure	Left Lateral Decubitus n=27 Participants In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality. Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.	Prone n=27 Participants In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality. Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.	Total n=54 Participants Total of all reporting groups
Age, Continuous	67 years n=5 Participants	67 years n=7 Participants	67 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
BMI	22.9 kg/m2 STANDARD_DEVIATION 3.45 • n=5 Participants	22.2 kg/m2 STANDARD_DEVIATION 4.07 • n=7 Participants	22.5 kg/m2 STANDARD_DEVIATION 3.77 • n=5 Participants
Indication for ERCP Choledocholithiasis	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Indication for ERCP Malignant biliary obstruction	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Indication for ERCP Benign biliary obstruction	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Vertical thickness	27.2 cm STANDARD_DEVIATION 3.71 • n=5 Participants	20.2 cm STANDARD_DEVIATION 4.18 • n=7 Participants	23.7 cm STANDARD_DEVIATION 5.31 • n=5 Participants
Fluoroscopy time	4.06 min n=5 Participants	4.14 min n=7 Participants	4.11 min n=5 Participants
Dose area product	22.3 Gy-cm2 n=5 Participants	23.2 Gy-cm2 n=7 Participants	22.65 Gy-cm2 n=5 Participants
Patient entrance skin dose	5.7 mGy/min n=5 Participants	5.5 mGy/min n=7 Participants	5.6 mGy/min n=5 Participants

PRIMARY outcome

Timeframe: Immediate after procedure

The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups.

Outcome measures

Measure	Left Lateral Decubitus n=27 Participants In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality. Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.	Prone n=27 Participants In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality. Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.
Effective Radiation Dose	0.0307 mSv Interval 0.0192 to 0.0437	0.0192 mSv Interval 0.0115 to 0.0322

Adverse Events

Left Lateral Decubitus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Prone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Phonthep Angsuwatcharakon, MD

Gastroenterology endoscopy center

Phone: 6622564265

Email: borndeb@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place