NCT01599351

Brief Summary

The objective of this study is to evaluate the radiation dose to patient at two positions (prone and left lateral) and to medical staff during Endoscopic retrograde cholangiopancreatography (ERCP) procedure using dose area product (DAP) meter and thermoluminescent dosimeter (TLD). Data were recorded on 20 patients at prone position and 20 patients at left lateral position.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

6 months

First QC Date

May 14, 2012

Last Update Submit

May 15, 2012

Conditions

Exposure to Ionizing Radiation

Keywords

Radiation exposureERCP

Outcome Measures

Primary Outcomes (1)

  • Patients' entrance surface dose

    Transparent ionization chamber was placed at the light beam diaphragm of the x-ray tube to measure the dose in the air and the verification film was placed on the couch at fluoroscopic area to determine exposed area. Patient's dose-area product will express in cGy.cm2.

    within 12 hours after procedure

Secondary Outcomes (1)

  • Endoscopists' radiation dose

    Within 12 hours after procedure

Study Arms (2)

Prone

ACTIVE COMPARATOR

Patients were in prone position along the ERCP procedure.

Radiation: The radiographic-fluoroscopic system

Left lateral decubitus

ACTIVE COMPARATOR

Patients were in left lateral decubitus along the ERCP procedure.

Radiation: The radiographic-fluoroscopic system

Interventions

The radiographic-fluoroscopic systemRADIATION

Fluoroscopy was used during ERCP procedure. With automatic brightness adjustment, patients with thicker body will get greater radiation dose.

Also known as: Siemens Model Polystar
Left lateral decubitusProne

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with common bile duct (CBD) stone and underwent ERCP
  • age over 18 years
  • ASA class I-II

You may not qualify if:

  • Pregnant
  • Abnormal coagulation
  • ASA class III-IV
  • Emergency/urgency conditions
  • Unstable vital signs
  • Denied to participate the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, 10330, Thailand

Location

Study Officials

  • Phonthep Angsuwatcharakon, MD, MSc

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 16, 2012

Study Start

July 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

TH(1)