Randomized control trial to compare cautery (heated loop) versus non heated (cold cup) method for restaging of bladder cancer

Phase 3

Not yet recruiting

• Conditions: Bladder disorders in diseases classified elsewhere, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2021/05/033608
• Lead Sponsor: AIIMS New Delhi

Brief Summary

Carcinoma bladder is among the topten most common cancer types in the world,with approximately 550,000 new casesannually.1 In about 75%, the disease isconfined to the mucosa andlamina propria and denoted as non-muscle invasive bladder cancer (NMIBC). Managementof bladder cancer is dependent on exact staging using and involvesdifferentiation of Ta,T1 and T2 disease.

Restage TURBT isan important aspect and standard of care in selected patients for any high grade Carcinoma Urinary Bladder and both the EuropeanAssociation of Urology (EAU) and American Urological Association guidelinesrecommend restage TURBT in all T1 as well as all high-grade tumors.2,9

Standard method ofrestaging is by TURBT using cautery loop. There are a number of disadvantagesthat it has to be done under Spinal/General Anaesthesia and additionally cauteryartifacts may interfere with the accurate diagnosis of stage of disease..

In Indian setup, theproblem of restage TURBT are logistics, cost of repeat surgery,long waitinglist and the complications associated with TURBT, such as bladder perforationand stricture4. Moreover, restage may not be performed in thestipulated time because of lack of Operataing Theatre slot availability inpublic hospitals or poor compliance of patients.

So an alternate techniqueof taking biopsy is available in form of Cold Cup biopsy which could beperformed as Office biopsy but adequacy of biopsy using Cold Cup has not yetbeen established.In our study,we would perform Cold cup biopsy under General/Spinal anaesthesiaand if results are similar then it could be performed as anoffice procedure under local anaesthesia.

In this study our aim isto perform a non inferiority trial of obtaining the bladder biopsy by cold cup andcomparing it with the standard method of cautery loop biopsy during a restageTURBT.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-25
• Last Update Posted: 2021-12-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

All patients who need restage TURBT as per standard treatment guidelines (Ta high grade,T1).

Exclusion Criteria

• 1.Not giving consent to participate in study.
• 2.Residual tumor after TURBT.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To compare adequacy of biopsy obtained by cold cup versus cautery loop.	4 weeks
2. To compare the histomorphological features in the biopsy samples obtained by these two methods.	4 weeks

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

AIIMS New Delhi; 🇮🇳 South, DELHI, India

AIIMS New Delhi

🇮🇳South, DELHI, India

Dr Ankit Sachan

Principal investigator

8318240146

ankicool007@gmail.com