FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/11/047155 [Registered on: 09/11/2022] Trial Registered Prospectively
Last Modified On: 10/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Symptoms of gall bladder cancer and treatment advised for management 
Scientific Title of Study   Clinical presentation and management of gall bladder cancer : An Observational Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sujoy Mukherjee 
Designation  Professor 
Affiliation  Rohilkhand medical college and hospital  
Address  Room no. 1063, Rohilkhand medical college and hospital near pillibhit bypass road, oppo. Suresh Sharma nagar, Bareilly, 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  9927991062  
Fax    
Email  dr_joy22001@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Sujoy Mukherjee 
Designation  Professor 
Affiliation  Rohilkhand medical college and hospital  
Address  Room no. 1063, Rohilkhand medical college and hospital near Suresh Sharma nagar, Bareilly, 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  9927991062  
Fax    
Email  dr_joy22001@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Yusuf bhalamwala 
Designation  Junior resident 
Affiliation  Rohilkhand medical college and hospital  
Address  Room no. 1063, Rohilkhand medical college and hospital near Suresh Sharma nagar, Bareilly, 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  9766567352  
Fax    
Email  ybhalam3@gmail.com  
 
Source of Monetary or Material Support  
Room no. 1063, Rohilkhand medical college and hospital near pillibhit bypass road, oppo. Suresh Sharma nagar, Bareilly, 243006 
 
Primary Sponsor  
Name  Rohilkhand medical college and hospital, Bareilly opposite Suresh Sharma nagar 
Address  Rohilkhand medical college and hospital, Bareilly opposite Suresh Sharma nagar Room no.50 
Type of Sponsor  Private medical college 
 
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 
Sujoy Mukherjee  Rohilkhand medical college and hospital  Room no. 1063, Rohilkhand medical college and hospital near pillibhit bypass road, oppo. Suresh Sharma nagar, Bareilly, 243006
Bareilly
UTTAR PRADESH 
9927991062

dr_joy22001@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RMCH, U.P.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patient presenting with clinical features of carcinoma gall bladder and have investigations indicating gall bladder cancer 
 
ExclusionCriteria 
Details  All the patients with suspected carcinoma gall bladder, which were later found out to be benign intraepithelial neoplasia/ cholecystitis after radical cholecystectomy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine clinical presentation of gall bladder cancer, management advised to patient  6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Treatment planned and quality of life  4 weeks 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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)   19/11/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  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 (Others) -  Nil

  6. For how long will this data be available start date provided 12-10-2023 and end date provided 12-10-2026?
    Response (Others) -  Nil

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

Gall bladder cancer (GBC) is a common malignancies of the gastrointestinal tract and is the most common malignancy of  biliary tract cancer in India. having an age standardized incidence rate of 1.8 per 100,000 population.

The patients can be incidental diagnosis after simple cholecystectomy (SC) or can present with a  gall bladder mass. Incidental diagnosis of  GBC can be determined during or after Simple cholecystectomy for benign disease. Incidental diagnosis of GBC is reported in 0.2–2.9% of patients who are undergoing Simple cholecystectomy.

 

Maxmillan de Stol in 1777,first described gall bladder carcinoma,Studies have revealed a trend of GBC illness late diagnosis and inadequate therapy. 

Gall bladder cancer often features vascular invasion, distant metastases, and substantial regional lymph node metastasis.

 

5- year survival rate of 17.6% was observed in (2007 to 2013).

Incidence varies widely within the country of GBC but Majority of cases are reported widely from the northern belt (The Ganges belt) and mainly from the country’s centre regions, although from the sought is hardly ever reported. 

 

Dianosis when made , patients with GBC are typically asymptomatic or report symptoms including stomach discomfort, nausea or vomiting, indigestion, weakness, anorexia, loss of appetite, weight loss, and sometimes jaundice, which might be misdiagnosed as cholecystitis due to its ambiguous description. As the disease’s stage progresses Cancerous biliary obstruction causes jaundice, cola-colored urine, clay-coloured faeces, and itchy skin  has a bad prognosis since it is unresectable when it is presented.

Overall Resection is the most effective modality to treat gall bladder cancer. Early-detected GBC with early stage of disease are curable and with a better median survival.

 

Since treatment for gallstones is much less expensive, less complex, and risky than treatment for GBC, it is clinically important to confirm causality for the association of gallstones with GBC. This could guide intervention strategies in nations with high risk of GBC.

Patients typically present late, by the time GBC is either metastatic or incurable with a terrible prognosis. More effective treatment options include open surgical resection, adjuvant chemotherapy, and targeted molecular  therapy for patients with advanced GBC who come with a suspect clinical presentation.

 

This study will examine the various clinical manifestations of gallbladder cancer and determine the treatment advised to them.

 
Close