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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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