Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography

NCT02985164 | Completed Phase 3 DMC

• 1 other identifier: 270/2558(EC2)
• Study Type: interventional
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief Summary

Radiation now becomes a dreadful effect as its outcomes are tremendous to be expected. As a result, anesthetists become an inevitable target to the radiation exposure since they have to monitor patients closely during the operation. Unfortunately, radiation may not have an immediate sequelae, but an accumulation of adverse effects. These sequelae happen by means of direct exposure and reflection. The reflected rays is inversely proportional to the distance between the origin and the target. Practically, the radiation source can be protected by individual cover and glass shield. Siriraj hospital is a tertiary, general university hospital with 2,200 beds. Annually, an Endoscopy centre has over 700 patients undergoing endoscopic retrograde cholangio pancreaticography (ERCP). Normally, fluoroscopy for pancreatic and biliary ducts visualisation is needed under anesthesia. Though the procedure is operated in a well-equipped, radiating-protection room; many medical personnel including 1-2 endoscopists, 2 scrub nurses, 1-2 anesthetists and 1 x-ray man, still have a chance of irradiation. During ERCP, all medical personnel particularly anesthetists are rinsed by radiation from here and there. Though they always wear lead aprons and collar shields to protect themselves from the rays, they are normally in the position - less than 1 meter - close to the fluoroscopy. Due to the advancement in technology, anesthetists can remotely monitor patients during the surgical procedure. This might cause a lesser effect of ray upon them. As a result, whether or not the positioning of anesthesia personnel relating to the distance of x-ray source would help to alleviate the effect of radiation exposure.

Conditions

Cholangiopancreatography, Endoscopic Retrograde; Occupational Exposure; Radiation Injuries

Keywords

Anesthesiology( H02.403.066 ); Radiation Protection( N06.850.810.425); Cholangiopancreatography, Endoscopic Retrograde(D002760 )

Outcome Measures

Primary Outcomes (1)

• Amount of radiative difference

  The amount of radiative difference on the outside of the shirt-covered box and the glass shield as compared to the inside.

  up to 1 year

Study Arms (2)

PDSa (Pocket radiation dosimeter a)

EXPERIMENTAL

A co-researcher reset and prepared 4 pocket dosimeters (PDS) and labelled as PDSa1, PDSa2, PDSb1 and PDSb2. The PDSa1 and PDSa2 were placed on the outside and inside of a lead shirt respectively. The shirt-covered box was close to an anesthetic machine. This box would represent anesthetic personnel on duty and marked as position A. Position A was 160 cm. above the floor

Radiation: PDSa

PDSb (Pocket radiation dosimeter b)

EXPERIMENTAL

The PDSb1 and PDSb2 were placed on the outside and inside of the glass shield of control room respectively. This glass shield would represent all personnel working in the operating theatre and marked as position B. Position B was 160 cm. above the floor.

Radiation: PDSb

Interventions

PDSa RADIATION

After an anesthesiologist administered a narcotic and an induction agent to a patient (total intravenous anesthesia, TIVA), an endoscopist commenced the procedure. A co-researcher turned on Pocket Radiation Dosimeter label as PDSa1 (outside lead apron),PDSa2 (inside lead apron).

PDSa (Pocket radiation dosimeter a)

PDSb RADIATION

After an anesthesiologist administered a narcotic and an induction agent to a patient (total intravenous anesthesia, TIVA), an endoscopist commenced the procedure. A co-researcher turned on Pocket Radiation Dosimeter label as PDSb1 (outside lead apron), PDSb2 (inside lead apron).

PDSb (Pocket radiation dosimeter b)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient who underwent ERCP

You may not qualify if:

• None

Sponsors & Collaborators

• Siriraj Hospital: lead

Related Publications (5)

• ASGE Technology Committee; Pedrosa MC, Farraye FA, Shergill AK, Banerjee S, Desilets D, Diehl DL, Kaul V, Kwon RS, Mamula P, Rodriguez SA, Varadarajulu S, Song LM, Tierney WM. Minimizing occupational hazards in endoscopy: personal protective equipment, radiation safety, and ergonomics. Gastrointest Endosc. 2010 Aug;72(2):227-35. doi: 10.1016/j.gie.2010.01.071. Epub 2010 May 26.

  PMID: 20537638 BACKGROUND

• Ismail S, Khan F, Sultan N, Naqvi M. Radiation exposure to anaesthetists during interventional radiology. Anaesthesia. 2010 Jan;65(1):54-60. doi: 10.1111/j.1365-2044.2009.06166.x. Epub 2009 Nov 17.

  PMID: 19922509 BACKGROUND

• Miller PS, Braiterman LT, Ts'o PO. Effects of a trinucleotide ethyl phosphotriester, Gmp(Et)Gmp(Et)U, on mammalian cells in culture. Biochemistry. 1977 May 3;16(9):1988-96. doi: 10.1021/bi00628a036.

  PMID: 557989 BACKGROUND

• Markou P. [Fetus radiation doses from nuclear medicine and radiology diagnostic procedures. Potential risks and radiation protection instructions]. Hell J Nucl Med. 2007 Jan-Apr;10(1):48-55. Greek, Modern.

  PMID: 17450255 BACKGROUND

• Daas AY, Agha A, Pinkas H, Mamel J, Brady PG. ERCP in pregnancy: is it safe? Gastroenterol Hepatol (N Y). 2009 Dec;5(12):851-5.

  PMID: 20567530 BACKGROUND

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Department of Anesthesiology Siriraj Hospital

  Department of Anesthesia, Faculty of Medicine Siriraj Hospital, Mahidol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Anesthetist

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: December 7, 2016
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share