| CTRI Number |
CTRI/2025/10/096575 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to understand the pattern of spread of Esophageal Cancer to regional lymph nodes |
|
Scientific Title of Study
|
Distribution of lymph node metastasis in Carcinoma Esophagus |
| 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 Neethu Tomy |
| Designation |
SR, Department of Surgical Oncology, KMC Manipal |
| Affiliation |
KMC Manipal |
| Address |
Shirdi Sai Baba Cancer Hospital and Research center, Department of Surgical Oncology, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9400142795 |
| Fax |
|
| Email |
neethukozhamthadathil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveena AN |
| Designation |
Head of The Department, Department of Surgical Oncology |
| Affiliation |
KMC Manipal |
| Address |
Shirdi Sai Baba Cancer Hospital and Research center, Department of Surgical Oncology, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9969523579 |
| Fax |
|
| Email |
naveenkumar.an@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananth S Mathad |
| Designation |
Assistant Professor, Department of Surgical Oncology |
| Affiliation |
KMC Manipal |
| Address |
Shirdi Sai Baba Cancer Hospital and Research center, Department of Surgical Oncology, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9900730715 |
| Fax |
|
| Email |
ananth.mathad@manipal.edu |
|
|
Source of Monetary or Material Support
|
| KMC, Manipal,Tiger circle road, Madhav Nagar Karnataka, INDIA
PIN- 576104 |
|
|
Primary Sponsor
|
| Name |
DR. Anil K Bhatt |
| Address |
KMC Manipal,Tiger Circle Road, Madhav Nagar, Manipal, Karnataka |
| 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 |
| Dr Neethu Tomy |
Kasturba Medical College |
Room no. 2, Department of Surgical Oncology,Shirdi Sai Baba Cancer Hospital, Manipal Karnataka, India- 576104
Udupi
KARNATAKA |
9400142795
neethu.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Katurba Medical College and Kasturba Hospital Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C158||Malignant neoplasm of overlappingsites of esophagus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Primary scc of thoracic esophagus - mid and lower
2.Surgically resectable tumor ( cT1-4a, N0-3, M0 ) |
|
| ExclusionCriteria |
| Details |
Previous esophageal surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical distribution of lymph node metastasis in thoracic esophageal SCC.
|
At the time of presentation to OPD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lymph node yield and lymph node metastasis as per lymph node station in patients who are treated with or without NACT, post surgery |
At the time of definitive surgery |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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)
|
10/11/2025 |
| 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
|
The survival rate following esophageal resection is a median of 25 - 74 months, and an important parameter for survival is lymph node status. The distribution of lymph node metastasis depends on tumor characterestics such as location, histology, T stage, and neoadjuvant treatment. If a distribution pattern of lymph node metastasis of esophageal carcinoma can be identified, optimal neoadjuvant and surgical treatment can be determined. |