| CTRI Number |
CTRI/2024/12/078306 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of performing and omitting a restage transurethral resection of bladder tumour in patients with non-muscle invasive bladder tumours. |
|
Scientific Title of Study
|
The impact of avoiding a restage TURBT(Transurethral resection of bladder tumours) in non muscle invasive bladder tumours: A randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOUNIKA BALABOLU |
| Designation |
Senior Resident ( McH Urology) |
| Affiliation |
All India Institute of Medical Sciences , New Delhi |
| Address |
Department of Urology, AIIMS, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8056697019 |
| Fax |
|
| Email |
mounikabalabolu9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. BRUSABHANU NAYAK |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences , New Delhi |
| Address |
Department of Urology, AIIMS, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9868449607 |
| Fax |
|
| Email |
brusabhanu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MOUNIKA BALABOLU |
| Designation |
Senior Resident ( McH Urology) |
| Affiliation |
All India Institute of Medical Sciences , New Delhi |
| Address |
Department of Urology, AIIMS, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8056697019 |
| Fax |
|
| Email |
mounikabalabolu9@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, NEW DELHI |
| Address |
Department of Urology, AIIMS,Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mounika Balabolu |
All India Institute of Medical Sciences |
Department of Urology,C4 ward, All India Institute of Medical Sciences, New Delhi 110029
South
DELHI |
8056697019
mounikabalabolu9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate Research, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C67||Malignant neoplasm of bladder, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Omission of restage TURBT |
The process of randomization will begin once histopathology report of the primary TUR is obtained. No re-TUR arm:
1. Patients with TaHG/T1LG histopathologies will receive intravesical Mitomycin C induction weekly for 6 weeks followed by monthly for 1 year.
2. Patients with T1HG histopathology will receive intravesical BCG induction weekly for 6 weeks followed by monthly for 1 year .
They will be on regular follow-up check CPE every three months and urine cytology. All the check CPE findings will be recorded. The first check CPE will be done under general anaesthesia so that any residual tumours can be resected.In case of a recurrence, patients will undergo a re-TUR and the HPE will be recorded followed by standard management as per risk stratification.
|
| Comparator Agent |
Performing Restage TURBT |
The process of randomization will begin once histopathology report of the primary TUR is obtained. ReTUR arm: Patients will undergo a reTUR within 2 to 6 weeks from the initial TURBT. The cystoscopy findings will be recorded during the reTUR. All reTURs will be performed with a 26 French resectoscope with bipolar loop. In patients with no obvious tumors, resection of the tumor bed will be performed and sent for HPE. The HPE reports of all patients will be recorded.
After re-TUR, the patients will receive the same intravesical therapy and follow up as in the “no re-TUR arm†unless there is an upstaging which will be managed according to the AUA guidelines. QOL will be recorded at 6 monthly intervals with the QOL-15 questionnaire
Study follow-up: One year
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Primary presentation bladder cancer without any prior resection or intravesical treatment
Patients with HPE report of LG, T1 or HG, Ta with presence of detrusor muscle in the specimen
Tumour size less than 3cm
Tumours less than 3 in number
Patients with HPE report of HG T1 with a single tumour less than 3cm in size operated by faculty with presence of detrusor muscle in the specimen
Aged more than 18 years
Written informed consent |
|
| ExclusionCriteria |
| Details |
Patients who have undergone TURBT for bladder cancer with a postop HPE report of HG T2
Patients with history of previous TURBT
CIS
Tumour size more than 3cm
Multiple tumours more than 3 in number
Patients with a postop HPE report of HGT1 with tumour size more than 3cm or more than 1 tumour
Absence of detrusor muscle in the specimen
Incomplete resection of tumour
Variant histology
Patients who do not give informed consent.
Perforation during initial TURBT
American Society of Anesthesiologists Score more than 3 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of recurrence in patients who undergo reTUR vs those who do not undergo reTUR
Incidence of progression in patients who undergo reTUR vs those who do not undergo reTUR
Tumor upstaging in patients who undergo a reTUR.
|
Followup at 3 months, 6 months, 9 months and 1 year after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to recurrence & progression between the two groups
Time to delay in definitive treatment in patients who undergo a reTUR
|
Followup of 3 months, 6 months, 9 months & 1 year after surgery |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients providing informed consent with bladder tumors fulfilling the inclusion criteria and undergoing
an initial TURBT with complete resection with deep muscle included in the specimen
will be recruited for participation in this prospective RCT. Completion of TURBT was
defined as complete resection of visible tumor.
Data Collection: Utilizing a data collection sheet , a systematic
collection of data will be done. This will encompass clinical evaluation, including
demographic information, relevant medical history, and pathological parameters such
as stage, grade, presence of concomitant carcinoma in situ (CIS), number of tumors,
and presence of detrusor muscle in the specimen.
Basic Investigations: After obtaining written informed consent, participants will
undergo a series of basic investigations in accordance with institutional guidelines
which are part of routine clinical practice. These include a comprehensive hemogram,
renal function test, liver function tests, chest X-ray, and urine culture.
Group stratification and randomization: The process of randomization will begin
once histopathology report of the primary TUR is obtained. Randomization will be
done using a computer-generated randomization schedule using block randomization
technique. Sequentially numbered, opaque, sealed envelopes (SNOSE) will be used for
22
allocation concealment. Both the treating surgeon and the patients will be aware of the
management proposed.
No reTUR arm: Patients with TaHG/T1LG histopathologies will receive intravesical
Mitomycin C induction weekly for 6 weeks followed by monthly for 1 year based on
AUA guidelines (8). Patients with T1HG histopathology will receive intravesical
BCG induction weekly for 6 weeks followed by monthly for 1 year based on AUA
guidelines (8). They will be on regular follow-up check cystopanendoscopy (CPE)
every three months and urine cytology. The first check CPE will be done under general anaesthesia, so that any residual tumours would be resected in the same sitting. All the check CPE findings will be recorded.
In case of a recurrence, patients will undergo a reTUR and the HPE will be recorded
followed by standard management as per risk stratification. QOL will be recorded at 6
monthly intervals with the QOL-15 questionnaire.
ReTUR arm: Patients will undergo a reTUR within 2 to 6 weeks from the initial
TURBT. The cystoscopy findings will be recorded during the reTUR. All reTURs
will be performed with a 26French resectoscope with bipolar loop. In patients with no
obvious tumors, resection of the tumor bed will be performed and sent for HPE. The
HPE reports of all patients will be recorded. After reTUR, the patients will receive the
same intravesical therapy and follow up as in the “no reTUR arm†unless there is an
upstaging which will be managed according to the AUA guidelines . Study follow-up: One year
5)
Ethical Considerations: The study will be conducted in compliance with ethical
principles, ensuring patient confidentiality, privacy, and adherence to all relevant
ethical guidelines and regulatory requirements. |