Comparative study of the results of Simple and Modified PAIR methods in the treatment of liver hydatid cyst
Design
This is a non-blinded randomized clinical trial with a parallel design. This randomized study will be conducted on 24 patients with hepatic hydatid cysts. A simple randomization method will be used for randomization, and participants will be assigned to two intervention groups.
Settings and conduct
This study, which will be conducted at Imam Reza Hospital in Kermanshah, is not blinded. Before the intervention begins, the size and volume of the cyst, as well as the presence of a fluid component in the cavity, irregularity, and thickening of the cyst wall, will be carefully examined and recorded in a checklist for each patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Individuals diagnosed with hepatic hydatid cysts. Exclusion criteria: Patients concurrently infected with pulmonary hydatid cysts;
Intervention groups
In the Simple PAIR method, an 18-gauge Shiba needle is inserted into the cyst under ultrasound guidance, and a portion of the cyst contents is evacuated with volume control and then aspirated. The entire cyst contents are aspirated and the cyst is filled with a mixture of nonionic contrast medium and saline solution (½ contrast medium + ½ saline solution 0.09% [NaCl]) equal to the aspirated amount. The contents of the cyst cavity are aspirated again after the cystogram, and then absolute alcohol (97% ethyl alcohol from Merck) is injected in a volume equivalent to 30% of the aspirate. In the Modified PAIR method, the cyst is punctured with an 18-gauge Shiba needle and a hydrophilic wire is inserted into it. Then, the dissecting route is inserted and fixed inside the cyst with a thin 6f dilator and the thinnest available 8f catheter using the Seldinger method.
Main outcome variables
Hydatid cyst volume; Hydatid cyst size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N267
Registration date:2025-09-30, 1404/07/08
Registration timing:prospective
Last update:2025-09-30, 1404/07/08
Update count:0
Registration date
2025-09-30, 1404/07/08
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-10-12, 1404/07/20
Expected recruitment end date
2026-11-11, 1405/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the results of Simple and Modified PAIR methods in the treatment of liver hydatid cyst
Public title
Comparative study of two treatment of liver hydatid cyst
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
People diagnosed with hepatic hydatid cysts
Exclusion criteria:
Patients who are simultaneously infected with pulmonary hydatid cysts
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method. 24 cards are selected and numbers from 1-24 are inserted on the cards. The cards are placed in an envelope. Two of the design partners take one card out of the envelope each time and announce the card number. Paired numbers are assigned to the intervention group and odd numbers to the control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences, Ethics Committee of the Faculty of Medicine
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2025-04-27, 1404/02/07
Ethics committee reference number
IR.KUMS.MED.REC.1404.043
Health conditions studied
1
Description of health condition studied
Liver Hydatid Cysts
ICD-10 code
B67.0
ICD-10 code description
Echinococcus granulosus infection of liver
Primary outcomes
1
Description
Hydatid cyst size
Timepoint
First month, third and sixth months, and first year
Method of measurement
Using ultrasound
2
Description
Hydatid cyst volume
Timepoint
First month, third and sixth months, and first year
Method of measurement
Using ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group (Simple PAIR method), an 18-gauge Shiba needle is inserted into the cyst under ultrasound guidance, and a portion of the cyst contents is evacuated with volume control and then aspirated. The entire cyst contents are aspirated and the cyst is filled with a mixture of nonionic contrast agent and saline solution (½ contrast agent + ½ saline solution 0.09% [NaCl]) equal to the aspirated volume. The cyst cavity contents are aspirated again after the cystogram, and then absolute alcohol (97% ethyl alcohol Merck) is injected in a volume equal to 30% of the aspirated volume.
Category
Treatment - Other
2
Description
In the second intervention group (Modified PAIR method), the cyst is punctured with an 18-gauge Shiba needle and a hydrophilic wire is inserted into it. Then, the dissected route is inserted and fixed inside the cyst using a thin 6f dilator and the thinnest available 8f catheter using the Seldinger method.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Mohammad Gharib Salehi
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Kumssalehi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Zohreh Rahimi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
Zrahimi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Leila Arghand
Position
Radiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Leiliarghand71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Gharib Salehi
Position
University faculty member
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Keranshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Fax
Email
Kumssalehi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Mohammad Gharib Salehi
Position
University faculty member
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Kumssalehi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD