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CTRI Number  CTRI/2019/10/021526 [Registered on: 03/10/2019] Trial Registered Prospectively
Last Modified On: 19/05/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   observational study with data collection only 
Study Design  Other 
Public Title of Study   Observation study on the distribution of esophageal cancers in lymph node  
Scientific Title of Study   Distribution of lymph node metastases in esophageal carcinoma [TIGER]  
Trial Acronym  TIGER study 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT03222895  ClinicalTrials.gov 
Version 006 Dated 04-06-2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr C S Pramesh 
Designation  Director Tata Memorial Hospital Professor Thoracic Surgical Oncology 
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177070  
Fax    
Email  prameshcs@tmc.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Dr C S Pramesh 
Designation  Director Tata Memorial Hospital Professor Thoracic Surgical Oncology 
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177070  
Fax    
Email  prameshcs@tmc.gov.in  
 
Details of Contact Person
Public Query  
Name  Dr C S Pramesh 
Designation  Director Tata Memorial Hospital Professor Thoracic Surgical Oncology 
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177070  
Fax    
Email  prameshcs@tmc.gov.in  
 
Source of Monetary or Material Support  
Tata Memorial Hospital Dr Ernest Borges Rd Parel Mumbai Maharashtra 400012 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Belgium
Brazil
Canada
Finland
France
Germany
Hong Kong
India
Ireland
Italy
Japan
Netherlands
Spain
Sweden
Switzerland
United Kingdom
United States of America  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr C S Pramesh  Tata Memorial Hospital  3rd floor, Room number: 301, Surgical Oncology, Thoracic DMG, Homi Bhabha Block Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai 400012 India
Mumbai
MAHARASHTRA 		 02224177070

prameshcs@tmc.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee II of Tata Memorial Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K22||Other diseases of esophagus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Primary squamous cell or adenocarcinoma of the esophagus or esophagogastric junction
2. Surgically resectable (cT1-4a, N0-3, M0)
3. Adequate physical condition to undergo transthoracic surgery (ASA 1-3)
4. Transthoracic esophagectomy
5. 18 Years and above
 
 
ExclusionCriteria 
Details  1. A potential subject who meets any of the following criteria will be excluded from participation in this study:
2. Previous thoracic or abdominal (upper GI) surgery disturbing lymph drainage of the esophagus and stomach
3. Patients with in situ carcinoma or high-grade dysplasia.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The distribution of lymph node metastases in esophageal and esophago-gastric junction carcinoma specimens following transthoracic esophagectomy with at least 2-field lymphadenectomy in relation to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node metastases, pre-operative diagnostics, neo-adjuvant therapy and (disease free) survival.   Demographic
Pre Operative
Per Operative
Post Operative  
 
Secondary Outcome  
Outcome  TimePoints 
Accuracy of preoperative diagnostics (especially EUS and PET-CT) and added value of EBUS to existing staging with EUS/PET-CT
Analysis of the phenomenon skip nodal metastases
Ratio of nodal metastases inside and outside the radiation field
Number of harvested lymph nodes in patients who are treated with and without neo-adjuvant chemoradiotherapy
In-field- or out-field nodal recurrence in case of neo-adjuvant chemoradiation
 		 3- and 5-year overall and disease free survival  
 
Target Sample Size   Total Sample Size="5000"
Sample Size from India="300" 
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)   21/10/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/03/2019 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="7"
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 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Lymph node status is an important prognostic parameter in esophageal carcinoma and an independent predictor of survival. Distribution of metastatic lymph nodes may vary with tumor location, tumor histology, tumor invasion depth, and neo-adjuvant therapy. The surgical strategy depends on the distribution pattern of nodal metastases but consensus on the extent of lymphadenectomy differs worldwide. Especially for adenocarcinoma, the distribution of lymph node metastases has not yet been described in large series.

Aim of the present study is to evaluate the distribution of lymph node metastases in esophageal carcinoma specimens following transthoracic esophagectomy with at least a 2-field lymphadenectomy.

This multicenter prospective observational study will help to determine the distribution of lymph node metastases in all patients with resectable esophageal or gastro-esophageal junction carcinoma in whom a transthoracic esophagectomy with a 2- or 3-field lymphadenectomy is performed in order to develop a uniform worldwide staging system and to establish the optimal surgical strategy for esophageal cancer patients. This will also support optimal treatment of Indian patients with esophageal cancer.

 
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