| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, |
|
|
Intervention / Comparator Agent
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Nil
- For how long will this data be available start date provided 12-10-2023 and end date provided 12-10-2026?
Response (Others) - Nil
- 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. |