Evaluation of the outcomes and complications of use of extended carotid artery with Y-graft technique versus conventional Y-graft technique in pancreatic transplant surgery in the treatment of type 1 diabetic patients; A prospective randomized controlled trial
To study a specific arterial reconstruction policy for pancreatic transplants and its outcome
Design
A therapeutic clinical trial with the control group, not blinded, randomized, on 60 patients. Samples are randomly allocated into two groups using random allocation software 2.0.
Settings and conduct
In this therapeutic RCT, samples are selected by available sampling method from patients with type 1 diabetes who require SPK transplantation. Samples will be divided into intervention (n=30) and control (n=30) groups by simple randomization.Two different techniques for SPK transplantation in these patients at Abu Ali Sina Transplant Hospital in Shiraz are studied and compared in terms of results and complications.
Participants/Inclusion and exclusion criteria
-Inclusion criteria:
Patient's consent
Pancreas transplant form
Having a simultaneous pancreas-kidney (SPK) transplant
Patients with diabetic nephropathy who undergo portal venous drainage
Exclusion criteria:
Unwillingness to participate in study
Patients who undergo systemic venous drainage
Patients who undergo pancreas transplant alone (PTA)
Intervention groups
Both intervention and control groups include patients who are candidates SPK transplant in patients with type 1 diabetes.
In intervention group, the extension of the right iliac artery is passed through the mesentery and placed next to the SMV for anastomosis. The Y graft is completely shortened and the carotid artery is removed from the donor for extension.
In control group, a long Y graft is placed directly in the right iliac artery, while trying to reach the maximum length to maintain the anastomosis without stretching.
Main outcome variables
1. Operation time 2. Incidence of arterial complications 3. Incidence of postoperative pancreatitis 4. The cold ischemic phase 5. The warm ischemic time 6. Transplant rejection 7. Mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210625051701N2
Registration date:2022-05-12, 1401/02/22
Registration timing:prospective
Last update:2022-05-12, 1401/02/22
Update count:0
Registration date
2022-05-12, 1401/02/22
Registrant information
Name
Mohamad mahdi Mahmoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2246 5035
Email address
mm.mahmoudi70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-01, 1401/03/11
Expected recruitment end date
2023-06-01, 1402/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the outcomes and complications of use of extended carotid artery with Y-graft technique versus conventional Y-graft technique in pancreatic transplant surgery in the treatment of type 1 diabetic patients; A prospective randomized controlled trial
Public title
Evaluation of the results of two different pancreatic transplant surgery techniques in the treatment of type 1 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's consent
Pancreas transplant form (living donor or deceased donor)
Having a simultaneous pancreas-kidney (SPK) transplant
Patients with diabetic nephropathy who undergo portal venous drainage
Exclusion criteria:
Unwillingness to participate in study
Patients who undergo systemic venous drainage
Patients who undergo pancreas transplant alone (PTA)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by simple randomization method with individual units with the help of the help of Excel program randomization capability. In this method, for each of the numbers 1 to 60, one of letters of A (for the intervention group) and B (for the control group) are assigned equally. To execute a random sequence, the method of hiding numbered envelopes is used. In this method, the envelopes are numbered based on a random sequence, and inside the envelopes, the desired intervention, on which random allocation is written based on letter A or B, is provided to the executor with the condition that the envelopes are completely sealed, and the researcher, based on the order of patients' entry. Allocates them in the intervention group and the control group. The envelopes will be the same shape and will be prepared by an independent researcher. Patients are assigned to one of the two groups in order of enrollment by number.
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 Shiraz University of Medical Sciences
Street address
Fars Province, Shiraz, Zand,
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۱۴۳۳۶
Approval date
2022-04-18, 1401/01/29
Ethics committee reference number
IR.SUMS.MED.REC.1401.045
Health conditions studied
1
Description of health condition studied
دیابت نوع 1
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
2
Description of health condition studied
Pancreas transplant
ICD-10 code
Z94.83
ICD-10 code description
Pancreas transplant status
Primary outcomes
1
Description
Transplant rejection
Timepoint
Up to 28 days after surgery
Method of measurement
Clinical features and diagnostic tests
2
Description
Incidence of arterial complications
Timepoint
Up to 28 days after surgery
Method of measurement
Sonography
3
Description
Mortality
Timepoint
Up to 28 days after surgery
Method of measurement
Absence of pulse rate and flat ECG
Secondary outcomes
1
Description
Operation time
Timepoint
During operation
Method of measurement
Using the timer
2
Description
Incidence of postoperative pancreatitis
Timepoint
Up to 28 days after surgery
Method of measurement
Lab data and Sonography
3
Description
The cold ischemic phase
Timepoint
From 24 hours before surgery
Method of measurement
Using the timer
4
Description
The warm ischemic time
Timepoint
From the time the donor organ is removed from the storage ice to the start of re-perfusion after transplantation
Method of measurement
Using the timer
Intervention groups
1
Description
Intervention group: Laparotomy will be performed first and then portal vein drainage will be done. In case of difficulty in exploration and exposing SMV, anastomosis to IVC will be performed.The right iliac artery is selected as the inflow and the anastomosis with the ileum will be done for GI drainage. Therefore, after exploring and finding the SMV,In the first group, an extension of the right iliac artery will be placed first. It will passed through the mesentery and be placed next to the SMV for anastomosis. The Y-graft is completely shortened and the carotid artery will be harvested from the donor for extension.
Category
Treatment - Surgery
2
Description
Control group: Operation will be same as first group but In the second group, a long Y-graft will be inserted directly into the right iliac artery, while also trying to maintain the maximum length to reach the anastomosis without tension.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu Ali Sina Hospital
Full name of responsible person
Hamed Nikoupour Deilami
Street address
Fars Province, Sadra, Sadra Highway
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3344 0000
Email
nikoupour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamed Nikoupour Deilami
Street address
Shiraz, Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 917 112 3500
Email
nikoupour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohamad mahdi Mahmoudi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Mahalati Ave.
City
Tehran
Province
Tehran
Postal code
7134814336
Phone
+98 21 2246 5035
Fax
Email
Mm.mahmoudi70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamed Nikoupour Deilami
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shiraz, Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 917 112 3500
Email
nikoupour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohamad mahdi Mahmoudi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Mahalati Ave.
City
Tehran
Province
Tehran
Postal code
7134814336
Phone
+98 21 2246 5035
Fax
Email
Mm.mahmoudi70@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available