| CTRI Number |
CTRI/2021/05/033608 [Registered on: 13/05/2021] Trial Registered Prospectively |
| Last Modified On: |
12/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Randomized control trial to compare cautery (heated loop) versus non heated (cold cup) method for restaging of bladder cancer |
|
Scientific Title of Study
|
Randomized Control Trial on TUR Loop versus Cold cup biopsy for Restage in Carcinoma Urinary Bladder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankit Sachan |
| Designation |
Senior Resident (Acad) Urology |
| Affiliation |
AIIMS New Delhi |
| Address |
C4 Ward
Room No 4
Department of Urology
AIIMS New Delhi
South DELHI 110023 India |
| Phone |
8318240146 |
| Fax |
|
| Email |
ankicool007@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Amlesh Seth |
| Designation |
Professor and Head AIIMS Urology |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No 6
CMET
Department of Urology
AIIMS New Delhi
near AIIMS Library
South DELHI 110023 India |
| Phone |
9868397433 |
| Fax |
|
| Email |
amlesh.seth@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Amlesh Seth |
| Designation |
Professor and Head AIIMS Urology |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No 6
CMET
Department of Urology
AIIMS New Delhi
near AIIMS Library
South DELHI 110023 India |
| Phone |
9868397433 |
| Fax |
|
| Email |
amlesh.seth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Urology,AIIMS New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Urology |
| 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 Ankit Sachan |
AIIMS New Delhi |
Department of Urology
Aiims New Delhi South DELHI |
8318240146
ankicool007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE AIIMS NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N33||Bladder disorders in diseases classified elsewhere, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold cup Biopy |
Biopsy using cold cup biopsy forceps for restage biopsy in Carcinoma Urinary Bladder patients under Anaethesia |
| Comparator Agent |
TUR Loop Biopsy |
Transurethral biopsy using bipolar loop cautery for restage biopsy in Carcinoma Urinary Bladder under Anaethesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients who need restage TURBT as per standard treatment guidelines (Ta high grade,T1) |
|
| ExclusionCriteria |
| Details |
1. Not giving consent to participate in study.
2. Residual tumor after TURBT
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare adequacy of biopsy obtained by cold cup versus cautery loop.
2. To compare the histomorphological features in the biopsy samples obtained by these two methods.
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare cancer pick up rate on restage TURBT for those who undergo TURBT at our institute versus those done elsewhere
2. To compare the number of obturator jerks and bladder perforations, duration of catheterization and hospital stay between the two techniques.
|
1. 1 month
2. 1 week |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/05/2021 |
| 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="2" Months="1" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Carcinoma bladder is among the top
ten most common cancer types in the world,with approximately 550,000 new cases
annually.1 In about 75%, the disease isconfined to the mucosa and
lamina propria and denoted as non-muscle invasive bladder cancer (NMIBC). Management
of bladder cancer is dependent on exact staging using and involves
differentiation of Ta,T1 and T2 disease.
Restage TURBT is
an important aspect and standard of care in selected patients for any high grade Carcinoma Urinary Bladder and both the European
Association of Urology (EAU) and American Urological Association guidelines
recommend restage TURBT in all T1 as well as all high-grade tumors.2,9
Standard method of
restaging is by TURBT using cautery loop. There are a number of disadvantages
that it has to be done under Spinal/General Anaesthesia and additionally cautery
artifacts may interfere with the accurate diagnosis of stage of disease..
In Indian setup, the
problem of restage TURBT are logistics, cost of repeat surgery,long waiting
list and the complications associated with TURBT, such as bladder perforation
and stricture4. Moreover, restage may not be performed in the
stipulated time because of lack of Operataing Theatre slot availability in
public hospitals or poor compliance of patients.
So an alternate technique
of taking biopsy is available in form of Cold Cup biopsy which could be
performed as Office biopsy but adequacy of biopsy using Cold Cup has not yet
been established.In our study,we would perform Cold cup biopsy under General
/Spinal anaesthesiaand if results are similar then it could be performed as an
office procedure under local anaesthesia.
In this study our aim is
to perform a non inferiority trial of obtaining the bladder biopsy by cold cup and
comparing it with the standard method of cautery loop biopsy during a restage
TURBT. |