In this clinical trial study, population of patients with obstructive jaundice after Pancreases tumor or periampulary will be selected of Ahvaz Golestan hospital and Alzahra Isfahan hospital during the years 2013-2016. Patients with obstructive jaundice after surgical pancreatic tumor will be included. Patients with underlying severe lack of surgical facilities curative; therapy for this malignancy and metastatic liver need to neoadjuvant will be excluded. Drainage will be done with two method, for external percutaneous trans-hepatic bile duct by inserting a catheter or endoscopic retrograde cannulation of the bile duct, for internal put a Endoprosthesis. Both methods used today, but the benefits of biliary drainage before cancer surgery do not agreed. Patients after six months will be tested for bilirubin, liver function enzymes, albumin, amylase, lipase, blood tests of kidney function after surgery, the incidence of long-term outcomes and mortality will be studied
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050327725N1
Registration date:2016-06-20, 1395/03/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-20, 1395/03/31
Registrant information
Name
Amin Bahreini
Name of organization / entity
Ahvaz Joundishapour University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 913 435 2718
Email address
bahreini-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Ahvaz jundishapour University of Medical Sceiences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of preoperative billiary drainage in periampulary cancer
Public title
Evaluation of the effect of preoperative billiary drainage in periampulary cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients with obstructive jaundice after surgical pancratic tumor.
Exclusion criteria: patients with underlying severe lack of surgical facilities curative; therapy for this malignancy and metastatic liver need to Neoadjvnt .
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics committee of Ahvaz Jundishapour University of Medical Sceiences
Street address
Golestan ave, Ahvaz Jundishapour University of Medical Sceiences, Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2015-05-19, 1394/02/29
Ethics committee reference number
IR.AJUMS.REC.1394.229
Health conditions studied
1
Description of health condition studied
Periampulary cancer
ICD-10 code
c22
ICD-10 code description
Malignant neoplasm of liver and intrahepatic bile ducts
Primary outcomes
1
Description
Length of stay
Timepoint
After Surgery
Method of measurement
Length of stay After Surgery
Secondary outcomes
1
Description
Mortality
Timepoint
After surgery
Method of measurement
Check the number of deceased
Intervention groups
1
Description
Biliary drainage Surgery in Ahvaz Golestan Hospital patients
Category
Treatment - Surgery
2
Description
Biliary drainage Surgery inIsfahan Alzahra Hospital patients
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Dr Amin Bahreini
Street address
Golestan Hospital, Ahvaz, Iran
City
Ahvaz
2
Recruitment center
Name of recruitment center
Azahra Isfahan Hospital
Full name of responsible person
Dr Esmaeil Naderi
Street address
Azahra hospital, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Ahvaz Jundishapour University of Medical Sceincese
Full name of responsible person
Dr Nader Saki
Street address
Ahvaz Jundishapour University of Medical Sceincese, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Ahvaz Jundishapour University of Medical Sceincese
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Amin Bahreini
Position
surgery specialist
Other areas of specialty/work
Street address
Golestan hospital, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 913 435 2718
Fax
Email
bahrieni-a@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Joundishapour University of Medical Sceinces
Full name of responsible person
Dr Esmail Naderi
Position
Surgery specialist
Other areas of specialty/work
Street address
Azahra hospital, Isfahan, Iran
City
Isfehan
Postal code
Phone
+98 916 622 8363
Fax
Email
ab55di@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur of Medical Sciences
Full name of responsible person
Dr Amin Bahreini
Position
Surgry Specialist
Other areas of specialty/work
Street address
Golestan hospital, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)