Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography Between Prone and Left Lateral Decubitus

NCT ID: NCT01599351

Last Updated: 2012-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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The radiographic-fluoroscopic system manufactured by Siemens Model POLYSTAR was used for ERCP procedure at King Chulalongkorn Memorial Hospital. Dose Area Product (DAP) manufactured by PTW Model DIAMENTOR E, a transmission ionization chamber was attached to X-ray collimator to record the dose-area (cGy.cm2) in order to determine the entrance surface air kerma (ESAK, mGy) of the patients at two positions (prone and left lateral) while the Kodak Portal Pack for localization imaging was placed on the patient's couch to determine the exposed area (cm2) on the surface of the patient. TLD was attached at five positions, left eye, thyroid, left forearm, lower abdomen and left leg of the medical staff during ERCP procedure.

Conditions

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Exposure to Ionizing Radiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Prone

Patients were in prone position along the ERCP procedure.

Group Type ACTIVE_COMPARATOR

The radiographic-fluoroscopic system

Intervention Type RADIATION

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

Left lateral decubitus

Patients were in left lateral decubitus along the ERCP procedure.

Group Type ACTIVE_COMPARATOR

The radiographic-fluoroscopic system

Intervention Type RADIATION

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

Interventions

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The radiographic-fluoroscopic system

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

Intervention Type RADIATION

Other Intervention Names

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Siemens Model Polystar

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Phonthep Angsuwatcharakon, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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PA-E-RAD001

Identifier Type: -

Identifier Source: org_study_id

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