Comparing the intravesical effect of gemcitabine with distilled water after trans urethral resection of tumor on prevention of recurrence in non-muscle-invasive bladder cancer
Comparing the intravesical effect of gemcitabine with distilled water after transurethral resection of tumor on prevention of recurrence in non-muscle-invasive bladder cancer
Design
A double-blind, randomized-controlled clinical trial study with parallel groups and phases 3 on134 patients. Patients will be divided into distilled water and gemcitabine groups using simple randomization.
Settings and conduct
In this study, 134 patients of non-muscle-invasive bladder cancer undergoing transurethral resection of tumor (TURT) in Urmia Imam Khomeini hospital will be included. The study will be conducted as a double-blind clinical trial. The patients and the researcher who will be evaluating the outcomes will be blind about the allocation of patients into distilled water or gemcitabine groups. Group names will be encoded with the letters A and B.
Participants/Inclusion and exclusion criteria
In this study, 134 patients of non-muscle-invasive bladder cancer undergoing transurethral resection of tumor (TURT) will be included. Inclusion criteria will be new cases of tumors with tumor size less than or equal to 3 cm and low-grade tumors on cystoscopy. patients with frequent recurrence will be excluded.
Intervention groups
In the intervention group, at the end of the surgery, 2000 mg of gemcitabine will be dissolved in 100 ccs of normal saline and injected into the duct through a catheter and the catheter will be closed for 3 hours. In the control group, at the end of the surgery, a three-way catheter will be inserted and the bladder will be washed continuously with sterile distilled water for three hours.
Main outcome variables
Tumor size and Tumor recurrence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220207053961N1
Registration date:2022-04-03, 1401/01/14
Registration timing:prospective
Last update:2022-04-03, 1401/01/14
Update count:0
Registration date
2022-04-03, 1401/01/14
Registrant information
Name
Mohammad Sadri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3345 7286
Email address
sadri.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-20, 1401/02/30
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the intravesical effect of gemcitabine with distilled water after trans urethral resection of tumor on prevention of recurrence in non-muscle-invasive bladder cancer
Public title
The effect of intravesical gemcitabine on prevention of recurrence in non-muscle-invasive bladder cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non-muscle-invasive bladder cancer
Patients candidate of trans urethral resection of tumor (TURT)
Tumor size less than or equal to 3 cm
Low grade tumor on cystoscopy
Diagnosed tumors in first time
Exclusion criteria:
Frequent recurrence
Tumor size above 3 cm
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into distilled water and gemcitabine groups using simple randomization. So that, based on determining sample in each group, the letters A (distilled water) and B (gemcitabine) will be written on the cards and all the cards will be placed in an envelope. then patients will be assigned to A or B groups by picking up cards.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted as a double-blind clinical trial. The patient and the researcher who will be evaluating the outcomes will be blind about the allocation of patients into distilled water or gemcitabine groups. Group names will be encoded with the A and B letters.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2021-11-10, 1400/08/19
Ethics committee reference number
IR.UMSU.REC.1400.341
Health conditions studied
1
Description of health condition studied
Bladder tumor
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder
Primary outcomes
1
Description
Tumor size
Timepoint
Three and six months after surgery
Method of measurement
In millimeters on sonography
2
Description
Tumor recurrence
Timepoint
Three and six months after surgery
Method of measurement
Having a recurrence based on sonography
Secondary outcomes
1
Description
Tumor site
Timepoint
Three and six months after surgery
Method of measurement
Sonography
Intervention groups
1
Description
Intervention group: At the end of the surgery, 2000 mg of gemcitabine will be dissolved in 100 ccs of normal saline and injected into the duct through a catheter and the catheter will be closed for 3 hours.
Category
Treatment - Other
2
Description
Control group: At the end of the surgery, a three-way catheter will be inserted and the bladder will be washed continuously with sterile distilled water for three hours.