| CTRI Number |
CTRI/2025/07/090625 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
an observational study to find out the usefulness of staging laparoscopy- a small operation where a thin tube with a tiny camera is inserted through a small cut- in the detection extent or spread of gallbladder cancer inside abdominal cavity. |
|
Scientific Title of Study
|
Defining the role of Staging Laparoscopy in the diagnostic algorithm of gallbladder cancers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project No 4835_version 1.0_9MAY2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh Goel |
| Designation |
Professor and Cheif Hepato-Billiary Surgeon |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
OPD No 314, 3rd Floor, Homi Bhabha Building, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820504492 |
| Fax |
|
| Email |
drmaheshgoel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Goel |
| Designation |
Professor and Cheif Hepato-Billiary Surgeon |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
OPD No 314, 3rd Floor, Homi Bhabha Building, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820504492 |
| Fax |
|
| Email |
drmaheshgoel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Goel |
| Designation |
Professor and Cheif Hepato-Billiary Surgeon |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
OPD No 314, 3rd Floor, Homi Bhabha Building, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820504492 |
| Fax |
|
| Email |
drmaheshgoel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Parel Mumbai, Maharashtra, India-400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Road,Parel, Mumbai, Maharashtra, India 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Mahesh Goel |
Tata Memorial Hospital |
OPD No 324, 3rd Floor, Gastro-Intestianal Disease management Group, Homi Bhabha Building, Tata Memorial Hospital,Dr E Borges Road, Parel
Mumbai
MAHARASHTRA |
9820504492
drmaheshgoel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee-II |
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
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients where Staging Laproscopy was used in the diagnostic or treatment pathway for GBC
2.Patients with both, per primum GBC (pGBC) and incidental GBC (iGBC) will be included
|
|
| ExclusionCriteria |
| Details |
1. Patients with incomplete EMR records |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| role of staging laparoscopy in the diagnostic algorithm of gallbladder cancers |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| percentage of missed metastases on SL and to identify clinical predictors for metastatic disease detected during SL |
6 months |
|
|
Target Sample Size
|
Total Sample Size="338"
Sample Size from India="338"
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)
|
28/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients
with gallbladder cancer (GBC) diagnosed at an advanced stage have poor outcomes
(5-year survival rates ranging from 4 to 12%) than those diagnosed with early-stage
disease (5-year survival rates of around 60-70%). Hence, a thorough
preoperative evaluation is paramount for accurate staging of the disease and
prognostication. This will help in reducing non-therapeutic laparotomies and
surgical morbidity while also initiating systemic therapy at the earliest.
Despite
the advances in imaging, the sensitivity of contrast enhanced computed
tomography (CECT) for detecting metastases in GBC patients remains low,
reportedly between 70 and 80%. The use of 18 Fluorodeoxyglucose
positron emission tomography CT (18FDG PET CT) as an adjunct,
has been shown to identify occult metastasis in almost 46% of patients with
locally advanced disease. However, the accuracy of 18FDG
PET CT in the detection of small nodal, liver,
and peritoneal metastases smaller than 7 mm is limited by its resolution and
partial volume effect.
Staging Laparoscopy
(SL) has been often employed in practice to enhance the rate of detection of
radiologically occult metastases, especially in patients with “high-risk” GBC.
The use of SL in the diagnostic algorithm is an extrapolation from the experience
of treating other gastro-intestinal malignancies. The current study explores the possible
avenues for utility of SL in the diagnostic algorithm of GBC. By developing an accurate
staging tool, this research is expected to guide better clinical decision-making
for patients undergoing treatment of GBCs |