| CTRI Number |
CTRI/2020/04/024635 [Registered on: 15/04/2020] Trial Registered Prospectively |
| Last Modified On: |
15/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Variations in structure and branching pattern of bile ducts and blood vessels in upper abdomen |
|
Scientific Title of Study
|
A study of variations in the biliovascular anatomy pertaining to gastro-hepato-pancreato-biliary malignancy surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lt Col Ramanathan Saranga Bharathi |
| Designation |
CLASSIFIED SPECIALIST (SURGERY) & GI SURGEON |
| Affiliation |
Armed Forces Medical Services |
| Address |
Department of Gastrointestinal Surgery
Command Hospital Central Command
Lucknow Cantonment
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
8554061554 |
| Fax |
|
| Email |
sarangabharathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raj Shukla |
| Designation |
Post Graduate Resident |
| Affiliation |
Command Hospital Central Command |
| Address |
Department of Gastrointestinal Surgery
Command Hospital Central Command
Lucknow Cantonment
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9212027549 |
| Fax |
|
| Email |
rajnitinshukla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Col SS Kumar |
| Designation |
Senior Advisor and Head |
| Affiliation |
Command Hospital Central Command |
| Address |
Department of Gastrointestinal Surgery
Command Hospital Central Command
Lucknow Cantonment
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9596774003 |
| Fax |
|
| Email |
sskumar9169@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical Services |
| Address |
Command Hospital Central Command
Lucknow Cantonment |
| 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 |
| Lt Col Ramanathan Saranga Bharathi |
Command Hospital Central Command |
Department of Gastrointestinal Surgery,
Surgical Division
Lucknow
UTTAR PRADESH |
8554061554
sarangabharathi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Command Hospital Central Command |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C258||Malignant neoplasm of overlappingsites of pancreas, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing investigation and or surgery for gastric hepatic biliary and pancreatic malignancies |
|
| ExclusionCriteria |
| Details |
Patients who are obviously metastatic at presentation who do not warrant further investigations and or surgery
Patients with poor performance status |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge about the anatomical variations in the set of population undergoing surgery for heoatobiliopancreatic malignancies |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in inadvertent trauma and vascular injuries related complications due to better understanding of regional anatomical variations |
At 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/05/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Knowledge of regional anatomy, especially of the biliovascular structures, is pivotal for safe oncological dissection in hepatobiliopanceatic malignancies. Studies documenting the variations in anatomy of these structures from dissections are sparse from India, especially Uttar Pradesh. This study aims to document these variations from the dissections that are carried out for curative resections of tumours originating from gastric and hepatobiliopancreatic tract at a tertiary care centre in Uttar Pradesh. |