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Examination and treatment of bile duct strictures following biliary anastomosis in patients referred to Ghaem (Aj) and Imam Reza (A) hospitals.

Protocol summary

Study aim
Eliminating the symptoms of fever, chills and jaundice in patients with a history of hepatojejunostomy surgery
Design
All patients who underwent biliary anastomosis surgery in the form of hepatojejunostomy were included in the study. At this stage, informed consent was again obtained from patients who had strictures due to malignancy, or had a history of taking immunosuppressive drugs, or had complete obstruction of the bile ducts. were excluded from the study Patients who had symptoms of icterus, fever, chills and symptoms of cholangitis and suspected anastomotic stenosis and were confirmed by ultrasound and MRCP were included in the study, they were subjected to endoscopic surgery and enterotomy was performed, and then with a urological nephroscope, which has a working port, we enter the lumen of the intestine and determine the location of the anastomosis, and then widen the anastomotic stricture with a dilator. and if there is a stone before the anastomosis, we remove the stone by washing and using a special tool.
Settings and conduct
In two educational, research and medical centers of Qaem Hospital (Aj) and Imam Reza Hospital, which have a general surgery department and laparoscopy facilities.
Participants/Inclusion and exclusion criteria
Patients with symptoms of biliary strictures who have already undergone surgery
Intervention groups
Patients with symptoms of biliary strictures who have undergone endoscopic surgery
Main outcome variables
Patients who underwent biliary anastomosis surgery as hepatojejunostomy were included in the study. At this stage, informed consent was again obtained from the patients. The patients who had symptoms of jaundice, fever, chills, and symptoms of cholangitis, and suspected anastomotic stenosis and were confirmed by ultrasound and mrcp, were excluded from the study.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090826002373N2
Registration date: 2022-07-10, 1401/04/19
Registration timing: prospective

Last update: 2022-07-10, 1401/04/19
Update count: 0
Registration date
2022-07-10, 1401/04/19
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
8012806-8012841
Email address
tavassolia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-01, 1401/05/10
Expected recruitment end date
2022-11-01, 1401/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examination and treatment of bile duct strictures following biliary anastomosis in patients referred to Ghaem (Aj) and Imam Reza (A) hospitals.
Public title
Discussion and Treatment Icter
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of surgery
Exclusion criteria:
Jaundice due to complete obstruction of the bile ducts
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 7
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Park squere,Mashhad University of Medical Sciences
City
mashhad
Province
Razavi Khorasan
Postal code
3316-913791
Approval date
2022-06-13, 1401/03/23
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.171

Health conditions studied

1

Description of health condition studied
Icter
ICD-10 code
K83.1
ICD-10 code description
Obstruction of bile duct

Primary outcomes

1

Description
Eliminate the symptoms of fever, chills and jaundice
Timepoint
Liver function test (LFT) with 30 day
Method of measurement
Liver function test (LFT)

Secondary outcomes

empty

Intervention groups

1

Description
Patients with symptoms of biliary strictures who underwent endoscopic surgery. 7 patients underwent minimally invasive surgery.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Qhaem hospital
Full name of responsible person
Dr Tavakkoli
Street address
Ahmad abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
3316-913791
Phone
+98 915 310 1013
Email
tavakkoliri971@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Iman Tavakkoli
Street address
Ahmadabad Ave ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
3316-913791
Phone
+98 915 310 1013
Email
tavakkoliri971@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad university
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
Mashhad University of Medical Sciences
Full name of responsible person
Iman Tavakkoli
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Ahmad abad Ave,ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
3316-913791
Phone
+98 915 310 1013
Email
tavakkoliri971@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Tavassoli
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Ahmadabad Ave,ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
3316-913791
Phone
+98 915 115 3658
Email
tavassolia@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Tavassoli
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Ahmadabad Ave, ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
3316-913791
Phone
+98 915 115 3658
Email
tavassolia@mums.ac.ir

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
No information about that
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared after de-identification.
When the data will become available and for how long
Access starts 6 months after the study
To whom data/document is available
The data is accessible to all.
Under which criteria data/document could be used
Those who work in the same field.
From where data/document is obtainable
Dr Tavakkoli
What processes are involved for a request to access data/document
tavakkoliri971@mums.ac.ir
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