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CTRI Number  CTRI/2025/01/079699 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 28/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   In toto Removal of Bladder Tumor with Laser versus Piecemeal removal to see efficacy and safety of laser removal in patients with bladder tumor 
Scientific Title of Study   Holmium LASER enbloc Transurethral Resection of Bladder Tumor (HoL-ERBT) Vs Conventional Transurethral Resection of Bladder Tumor (cTURBT) for primary bladder tumors: Randomized controlled 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  Dr Aquib Javed Mubarak Ali Patel 
Designation  Senior Resident 
Affiliation  AIIMS JODHPUR 
Address  OPD Room 550,5th floor, C Block, Department of Urology, Basni (Phase II), Industrial Area, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8905477606  
Fax    
Email  patelaquib2012@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gautam Ram Choudhary 
Designation  Additional Professor, Department of Urology 
Affiliation  AIIMS Jodhpur 
Address  OPD Room 550,5th floor, C Block, Department of Urology, Basni (Phase II), Industrial Area, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9414294982  
Fax    
Email  gautamoshu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gautam Ram Choudhary 
Designation  Additional Professor, Department of Urology 
Affiliation  AIIMS Jodhpur 
Address  OPD Room 550,5th floor, C Block, Department of Urology, Basni (Phase II), Industrial Area, Jodhpur


RAJASTHAN
342005
India 
Phone  9414294982  
Fax    
Email  gautamoshu@gmail.com  
 
Source of Monetary or Material Support  
Department of Urology, All India Institue of Medical Sciences, Basni (Phase II), Industrial Area, Jodhpur, Rajasthan, India - 342005 
 
Primary Sponsor  
Name  Dr Aquib Javed Mubarak Ali Patel 
Address  OPD Room 550,5th floor, C Block, Department of Urology, Basni (Phase II), Industrial Area, Jodhpur 
Type of Sponsor  Other [Self] 
 
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 Aquib Javed Mubarak Ali Patel  All India Institute of Medical Sciences, Jodhpur  OPD Room 550,5th floor, C Block, Department of Urology, Basni (Phase II), Industrial Area, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN 		 8905477606

patelaquib2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Clinical Trial), All India Institute of Medical Sciences (AIIMS)- Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Transurethral Resection of Bladder Tumor   Resection of Bladder tumor in Standard way Device 2: Conventional cTURBT Conventional cTURBT using OLYMPUS and WOLF cystoscope size 4 mm 30 degree and 19.5Fr sheath for cystoscopy and 26 Fr for TUR. Energy used Monopolar 120 J for cutting, 80 J for coagulation Duration of intervention: usually takes 60-90 minutes 
Intervention  Holmium LASER enbloc Transurethral Resection of Bladder Tumor   Device 1: HoLERBT En Bloc resection will be performed at our center using Holmium Quanta System Fiber size 272 micron Energy Used: 1 J and 10 Hz for cutting 0.8 J and 8 Hz for coagulation Duration of intervention depends on size of tumor, usually takes 60-90 minutes  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. All patients diagnosed with Bladder Mass
2. Size of tumour up to 4 cm
3. No invasion of adjacent organs
4. Up to 4 tumours in number.
 
 
ExclusionCriteria 
Details  1. Not Fit for Surgery.
2. Patient refused to participate.
3. Tumor larger than 4 cm in size.
4. Tumors more than 4 in number.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of histopathological parameters (Deep Muscle Presence, Cautery Artefact) in HoL-ERBT and cTURBT  14 days, 6 weeks, 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess efficiency of HoL-ERBT vs cTURBT in terms of complete resection of tumor.
2. Compare peri-operative complications.
3. To compare oncological outcomes between two modalities.
 		 6 weeks, 6 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   14/02/2025 
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)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [patelaquib2012@gmail.com].

  6. For how long will this data be available start date provided 01-03-2027 and end date provided 01-03-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

With the ubiquitous availability of Holmium LASER major centers started using holmium LASER as energy source for resection in ERBT (HoL-ERBT). The current available literature says that HoL-ERBT represents an improvement in the surgical management of bladder tumor. The resection is more precise and complete compared to cTURBT. However, the limitations were large tumors, difficult locations and methods of retrieval.  Moreover, the quality of an en-bloc specimen, including the tumor with its adjacent bladder wall layers, allows an accurate pathological review which leads to correct risk allocation and therapy. In comparison to cTURBT, HoL-ERBT has advantages in reducing irrigation time and avoiding bladder perforation, although it may require a longer operating time; no benefit in terms of recurrence rates has been demonstrated. However limited RCTs are available and inclusion criteria are narrow on this topic.

 

Our randomized controlled trial (RCT) aims to evaluate the feasibility, histopathological benefits, and clinical outcomes of HoL-ERBT compared to cTURBT. This study seeks to address existing gaps in research and provide valuable insights into the optimal surgical management of bladder tumors.

 
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