| CTRI Number |
CTRI/2024/12/077630 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Determine Efficacy and Safety of Open vs Laparoscopic Radical Cholecystectomy (LRC) among patients with Early Gallbladder Cancer (GBC) |
|
Scientific Title of Study
|
To Determine Efficacy and Safety of Open vs Laparoscopic Radical Cholecystectomy (LRC) among patients with Early Gallbladder Cancer (GBC) - a 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 Shikha Tiwari |
| Designation |
Junior Resident |
| Affiliation |
GSVM Medical College, Kanpur |
| Address |
Department of General Surgery, GSVM Medical College, Kanpur, Uttar Pradesh, India.
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9721499555 |
| Fax |
|
| Email |
dktshikha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramendra Kumar Jauhari |
| Designation |
Professor |
| Affiliation |
GSVM Medical College, Kanpur |
| Address |
Department of General Surgery, GSVM Medical College, Kanpur, Uttar Pradesh, India.
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9453574632 |
| Fax |
|
| Email |
jauhariramendra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shikha Tiwari |
| Designation |
Junior Resident |
| Affiliation |
GSVM Medical College, Kanpur |
| Address |
Department of General Surgery, GSVM Medical College, Kanpur, Uttar Pradesh, India.
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9721499555 |
| Fax |
|
| Email |
dktshikha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, LLR and associated hospital, GSVM Medical College, Kanpur, Uttar Pradesh, India, 208002 |
|
|
Primary Sponsor
|
| Name |
Dr Shikha Tiwari |
| Address |
Department of General Surgery, LLR and associated hospitals, GSVM Medical College, Kanpur, Uttar Pradesh, India 208002 |
| Type of Sponsor |
Other [Self (Principal Investigator)] |
|
|
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 Shikha Tiwari |
GSVM Medical College, Kanpur |
Department of General Surgery, GSVM Medical College, Kanpur, Uttar Pradesh, India.
Kanpur Nagar
UTTAR PRADESH |
09721499555
dktshikha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee (For Biomedical Health and Research), GSVM Medical College, Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic Radical Cholecystectomy |
Position - Supine
Number of ports - 6
Steps- Laparoscopic lymphadenectomy followed by laparoscopic cholecystectomy with resection of adjoining liver bed (2cm margin) |
| Comparator Agent |
Open Radical Cholecystectomy |
Standard protocol for open radical cholecystectomy to be followed where the gallbladder is accessed through a right subcostal incision, under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients in age group 18 years or above with stage I and II (incidental early gallbladder cancer found on biopsy after simple cholecystectomy).
Patients with suspected gallbladder cancer without evidence of liver invasion or extrahepatic bile duct involvement at enhanced abdominal CT scan
|
|
| ExclusionCriteria |
| Details |
Involvement of aortocaval lymph nodes and lymph nodes along celiac trunk on preoperative Computed Tomography scan
Patients with distant metastasis
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Operative time and ease of performance
Incidence of early recurrence ( within 6 months)
|
at baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cost effectiveness
|
till the patient is discharged |
Average duration of hospital stay |
till the patient is discharged |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
This study is a randomized, open label, parallel group, active controlled trial determining the efficacy of and safety of open vs laparoscopic radical cholecystectomy (LRC) among patients with early gallbladder cancer. The study will be conducted in multiple health institutes in India. Primary outcome measure will be operative time and ease of performance and Incidence of early recurrence that is within 6 months, secondary outcomes will be duration of hospital stay in days, and cost effectiveness.
|